<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03040414</url>
  </required_header>
  <id_info>
    <org_study_id>UC4DK108611</org_study_id>
    <secondary_id>UC4DK108611</secondary_id>
    <nct_id>NCT03040414</nct_id>
  </id_info>
  <brief_title>Fuzzy Logic Automated Insulin Regulation</brief_title>
  <acronym>FLAIR</acronym>
  <official_title>Home Use of MD-Logic Automated Insulin Delivery System: Safety and Efficacy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>HealthPartners Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medtronic</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jaeb Center for Health Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Schneider Children's Medical Center, Israel</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Ljubljana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Joslin Diabetes Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>International Diabetes Center at Park Nicollet</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Kinderkrankenhaus auf der Bult</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>HealthPartners Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adolescents and young adults with type 1 diabetes often have a difficult time achieving good&#xD;
      glucose control, which is so important in reducing the risk for diabetes complications.&#xD;
      Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is&#xD;
      still a need for many individuals to further improve glucose levels without causing low blood&#xD;
      glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an&#xD;
      insulin pump can receive glucose readings from a continuous glucose monitor and adjust the&#xD;
      insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems&#xD;
      are called hybrid closed loop (HCL). This means that much of the insulin delivery is&#xD;
      automated, yet the patient still interacts regularly with the system, particularly to help&#xD;
      determine the insulin dose to deliver to cover a meal. Results of early studies using HCL&#xD;
      systems in adolescents and adults with type 1 diabetes are encouraging.&#xD;
&#xD;
      The objective of this study is to compare the efficacy and safety of the automated insulin&#xD;
      delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0&#xD;
      HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced&#xD;
      Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can&#xD;
      reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without&#xD;
      increasing hypoglycemia.&#xD;
&#xD;
      Up to 124 adolescents and young adults (ages 14-&lt;30) will be recruited to test each system&#xD;
      for three months in a randomized crossover trial. Investigators will compare how effective&#xD;
      each hybrid closed loop system is at preventing high blood glucose readings during the day.&#xD;
      The investigators will also evaluate the safety of each system and how participants adjust to&#xD;
      the daily use of the technology.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose of the study: A randomized crossover trial involving up to four clinical sites in the&#xD;
      United States and three sites outside the US (Germany, Israel and Slovenia) will compare the&#xD;
      efficacy and safety of an AID system with a PID algorithm versus an AID system with a PID&#xD;
      algorithm enhanced with a fuzzy logic algorithm.&#xD;
&#xD;
      Study Objectives:&#xD;
&#xD;
        1. EFFICACY: The co-primary outcomes are difference in continuous glucose monitoring&#xD;
           (CGM)-measured metrics between periods:&#xD;
&#xD;
             -  Superiority for percent of time &gt;180 mg/dL (10.0 mmol/L) from 6 AM to 11:59 PM; and&#xD;
&#xD;
             -  Non-inferiority of percent of time &lt;54 mg/dL (3.0 mmol/L) during the entire 24-hour&#xD;
                period.&#xD;
&#xD;
        2. KEY SAFETY OUTCOMES:&#xD;
&#xD;
             -  Percentage of sensor glucose readings &lt;54 mg/dL (overall is a co-primary outcomes)&#xD;
                and &lt;70 mg/dL (3.0 and 3.9 mmol/L, respectively)&#xD;
&#xD;
             -  Diabetic Ketoacidosis (DKA) events&#xD;
&#xD;
             -  Severe hypoglycemia events&#xD;
&#xD;
           Study design: Randomized crossover trial with two 12-week crossover periods in automode,&#xD;
           preceded by a run-in phase.&#xD;
&#xD;
           Population: A maximum of 124 individuals may be enrolled and start the run-in phase.&#xD;
           Approximately 112 are expected to enter the crossover trial, with a goal of at least 100&#xD;
           people completing the trial.&#xD;
&#xD;
           Maximum duration of a study for a subject: Approximately 28-36 weeks.&#xD;
&#xD;
           Recruitment: Subjects will be recruited through the clinical sites.&#xD;
&#xD;
           Consent: Written consent/assent will be obtained for all subjects and/or guardians, in&#xD;
           accordance with human subjects and regulatory requirements.&#xD;
&#xD;
           Screening Assessments:&#xD;
&#xD;
             -  Informed consent will be signed and eligibility will be assessed&#xD;
&#xD;
             -  Medical history and physical examination&#xD;
&#xD;
             -  HbA1c measurement&#xD;
&#xD;
             -  Urine pregnancy test (if applicable)&#xD;
&#xD;
             -  Surveys investigating participants' quality of life, psychosocial and cognitive&#xD;
                functioning, and response to their current treatment will be distributed.&#xD;
&#xD;
           Study Training:&#xD;
&#xD;
           Run-In Period: (2-8 weeks)&#xD;
&#xD;
           * Eligible participants will use the study 670G 3.0 HCL pump during the run-in.&#xD;
           Participants who were pump users at screening may skip the Pump Run-In period (but must&#xD;
           participate in the Pump+CGM Run-In period) per investigator discretion. 670G auto mode&#xD;
           users may use the 670G pump in auto mode.&#xD;
&#xD;
           Screening and start of run-in training visits may occur on the same day or separate&#xD;
           days, but no more than 14 days apart.&#xD;
&#xD;
           Standardized pump training will be provided to study participants and their diabetes&#xD;
           care partners (for participants &lt;18 years old). The study team will assist the&#xD;
           participant in study pump infusion site initiation and will start the participant on the&#xD;
           study pump. For current pump users, the study pump will be programmed with the&#xD;
           participants usual basal rates and pump parameters. The participants personal pump will&#xD;
           be removed. Participants may continue to use their personal CGM if applicable.&#xD;
&#xD;
           The pump will be used for at least two weeks during the Pump Run-In, with the option of&#xD;
           repeating Pump Run-In for an additional two weeks per investigator discretion. Contact&#xD;
           will be made each week with additional contacts as needed. Prior to each contact,&#xD;
           participants will be asked to upload device data for study staff to review.&#xD;
&#xD;
           After completion of Pump Run-In, participants will proceed to use the study CGM along&#xD;
           with the study 670G HCL pump during the Pump+CGM Run-In period.&#xD;
&#xD;
           * Pump+CGM Run-In (670G 3.0 HCL + Guardian Sensor (3)) All participants must complete a&#xD;
           two-week run-in period with the use of the study pump and CGM before being randomized&#xD;
           into the crossover trial. During Pump+CGM Run-In, the predictive low glucose suspend&#xD;
           feature will be turned on and auto mode will be off (i.e. manual mode). Participants who&#xD;
           were 670G auto mode users at screening may use the pump in auto mode.&#xD;
&#xD;
           Standardized device training will be provided to study participants and their diabetes&#xD;
           care partners (for participants &lt;18 years old). Personal pumps and CGMs will be removed&#xD;
           during the Pump+CGM Run-In period as applicable.&#xD;
&#xD;
           Contact will be made each week with additional contacts as needed. Prior to each&#xD;
           contact, participants will be asked to upload device data for study staff to review.&#xD;
&#xD;
           Run-In Assessment Successful completion of Pump Run-In is per investigator discretion.&#xD;
           Pump Run-In may be repeated once.&#xD;
&#xD;
           Successful completion of the Pump+CGM Run-In requires CGM data to be collected on at&#xD;
           least 80% of the possible time in the prior 14 days of use. An average of at least three&#xD;
           blood glucose meter (BGM) tests per day also will be required. If these are not&#xD;
           achieved, the Pump+CGM Run-In period may be repeated once.&#xD;
&#xD;
           Randomization into the Crossover Trial&#xD;
&#xD;
           Eligible participants who successfully complete the Pump+CGM Run-In will be randomly&#xD;
           assigned to begin with one Automated Insulin Delivery (AID) system during Period 1 and&#xD;
           then crossover to the other AID system during Period 2. The two study AID systems&#xD;
           (treatments) are:&#xD;
&#xD;
             -  670G 3.0 Hybrid Closed-Loop (HCL) (PID) insulin pump + Guardian Sensor (3) CGM&#xD;
&#xD;
             -  670G 4.0 Advanced Hybrid Closed-Loop (AHCL) (PID + Fuzzy Logic) insulin pump +&#xD;
                Guardian Sensor (3) CGM&#xD;
&#xD;
           Home Use of AID System during the Crossover Trial Period 1 (~13 weeks) Participants and&#xD;
           their diabetes care partners (for participants &lt;18 years old) will be trained by&#xD;
           qualified personnel on the use of the assigned pump and on auto mode feature use&#xD;
           including meal announcement, meal bolusing, and exercise.&#xD;
&#xD;
           Training will also be provided in performing specific tasks including the following:&#xD;
&#xD;
             -  Confirming pump parameters&#xD;
&#xD;
             -  When not to use or rely on auto mode particularly during significant illness or&#xD;
                acetaminophen use&#xD;
&#xD;
             -  CGM calibration instructions&#xD;
&#xD;
             -  Meal bolus procedures&#xD;
&#xD;
             -  What to do when exercising while using the system&#xD;
&#xD;
             -  How to react to safety/alert notifications&#xD;
&#xD;
             -  How to perform fingerstick blood glucose measurements in accordance with the&#xD;
                labeling of the study CGM device&#xD;
&#xD;
             -  When and how to contact study staff to ask questions during the study&#xD;
&#xD;
           Study staff will discuss the visit and contact schedule with the participant and will&#xD;
           make arrangements for follow-up appointments. Participants will be asked to upload data&#xD;
           before each contact and at least every two weeks.&#xD;
&#xD;
           After auto mode training has been completed, participants will proceed with home use of&#xD;
           the AID system (meaning free-living use at work, home, etc.) during Period 1 with either&#xD;
           the 670G 3.0 HCL or 670G 4.0 AHCL pump. The predictive low glucose suspend feature will&#xD;
           be on.&#xD;
&#xD;
           The system will initially be used with auto mode deactivated (except for 670G auto mode&#xD;
           users at screening who may activate auto mode if using the 670G 3.0 HCL pump) until&#xD;
           participants are contacted 6-10 days into Period 1 with instructions to activate auto&#xD;
           mode. Participants will be instructed to obtain an overnight fingerstick blood glucose&#xD;
           measurement (between 2-3AM) for 2-3 nights following auto mode initiation and if&#xD;
           fingerstick blood glucose is &lt;70 mg/dL to treat with carbohydrate. Participants will&#xD;
           then continue using the AID system for 12 weeks after auto mode is initialized.&#xD;
&#xD;
           Participants will be expected to use auto mode at all times at home with some exceptions&#xD;
           (e.g. times of illness, acetaminophen use).&#xD;
&#xD;
           Participants on the 670G 4.0 AHCL will begin with an auto mode target glucose set point&#xD;
           of 120 mg/dL (6.7 mmol/L) that may be lowered to 100 mg/dL (5.6 mmol/L) if participant&#xD;
           meets the safety criteria per protocol and investigator discretion.&#xD;
&#xD;
           HbA1c, C-peptide, and glucose levels will be collected for central lab analysis at the&#xD;
           beginning of Study Period 1. Human Factors and Diabetes Technology Attitude Surveys will&#xD;
           be administered at the end of Study Period 1.&#xD;
&#xD;
           Period 2 (~13 weeks) At the beginning of Period 2, a urine pregnancy test will be&#xD;
           completed as applicable. Eligible participants will then use the other AID system during&#xD;
           Period 2. The procedures in Period 1 will be repeated in Period 2.&#xD;
&#xD;
           At the end of the 12-weeks of AID use in auto mode at home, the participant will&#xD;
           complete a final study visit. That visit may be completed in-person in clinic or in an&#xD;
           alternate location such as the participant's home. The study visit may occur remotely&#xD;
           via phone or videoconferencing. Certain procedures, such as the measurement of height,&#xD;
           weight, vitals, and collection of the central HbA1c sample, may be missed if the visit&#xD;
           is not completed in-person. Participants requiring a remote final visit will be&#xD;
           transitioned off of the study device during the remote contact and an arrangement will&#xD;
           be made between site staff and the participant to return all required study devices&#xD;
           either in-person or via mail.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 3, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Randomized crossover trial with two 12-week crossover periods in auto mode preceded by a run-in phase.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Time Glucose Levels Were &gt; 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Glucose levels based on sensor glucose data</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Non-inferiority for Percent of Time &lt;54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period.</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Glucose levels based on sensor glucose data</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy: CGM Derived Indices: Mean Glucose Only</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Continuous Glucose Monitoring derived indices over the first 84 days of each treatment period for 24 hours (excluding time before auto mode is turned on). Glucose levels based on sensor glucose data for Mean glucose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: CGM Derived Indices</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>CGM derived indices over the first 84 days of each treatment period for 24 hours. Glucose levels based on sensor glucose data for coefficient of variation; percentage of sensor glucose readings in the range of 70 to 180 mg/dL (3.9-10.0 mmol/L) and 70 to 140 mg/dL (3.9 to 7.8 mmol/L); percentage of sensor glucose readings &gt;180 mg/dL (daytime is a co-primary outcome) and &gt;250 mg/dL (10.0 and 13.9 mmol/L, respectively)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Amount of total, basal, and bolus daily insulin over the first 84 days of each treatment period (excluding time before auto mode is turned on) for 24 hours. Glucose levels based on sensor glucose data. Sum of daytime and nighttime values may not equal total daily values due to rounding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: HbA1c</measure>
    <time_frame>Time Frame: End of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
    <description>Glycated hemoglobin (HbA1c) was measured at a central laboratory (Advanced Research and Diagnostic Laboratory University of Minnesota, MN, USA) at randomization and at the end of each period by use of an International Federation of Clinical Chemistry and Laboratory Medicine aligned method (Tosoh HPLC Glycohemoglobin Analyzer, Tosoh Medics, San Francisco, CA, USA; coefficient of variation range 1.4 1.9%).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: BMI for Participants Age ≥18 Years</measure>
    <time_frame>Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
    <description>Height and weight. Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Efficacy: BMI Percentile for Participants Age &lt;18 Years</measure>
    <time_frame>Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
    <description>Height and weight based on CDC standards of measurement. Age and gender adjusted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were &lt;54 mg/dL and &lt;70 mg/dL (3.0 and 3.9 mmol/L, Respectively</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Glucose levels based on sensor glucose data</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Safety Outcome 2) Number of DKA Events</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>DKA as defined by the Diabetes Control and Complications Trial (DCCT) and described below:&#xD;
Symptoms such as polyuria, polydipsia, nausea, or vomiting;&#xD;
Serum ketones &gt;1.5 mmol/L or large/moderate urine ketones;&#xD;
Either arterial blood pH &lt;7.30 or venous pH &lt;7.24 or serum bicarbonate &lt;15; and&#xD;
Treatment provided in a health care facility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Key Safety Outcome 3) Number of Severe Hypoglycemia Events</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Severe hypoglycemia event as defined by the Diabetes Control and Complications Trial (DCCT) and described below:&#xD;
The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or loss of consciousness.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Amount of Total Insulin at Daytime, Nighttime and Post-meal</measure>
    <time_frame>12 weeks for each arm of the crossover</time_frame>
    <description>Based on sensor glucose data</description>
  </other_outcome>
  <other_outcome>
    <measure>Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires</measure>
    <time_frame>Time Frame: Screening visit, at initiation (Day 0); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
    <description>Surveys completed by participants. The Glucose Monitoring Satisfaction Survey is 15 items on a 1-5 scale; Total score calculated as mean of all item scores; higher scores indicate greater satisfaction. The Diabetes Distress Scale is 17 items on a 1-6 scale; Total score calculated as mean of all item scores; higher score denotes more distress. The Hypoglycemia Confidence Survey is 8 items on a 1-4 scale; Total score calculated as mean of all item scores; higher score denotes more confidence. The Diabetes Technology Attitudes Survey is 5 items on a 0-4 scale; Total score calculated as sum of all item scores; higher score denotes more satisfaction with diabetes technology. The Adult INSPIRE Survey is 22 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID. The Adolescent INSPIRE Survey is 17 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>PID Algorithm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PID + Fuzzy Logic Algorithm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MedtronicMinimed 670G 3.0 hybrid closed loop system</intervention_name>
    <description>The components of the intervention are the insulin pump with insulin delivery algorithm (PID).</description>
    <arm_group_label>PID Algorithm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.</intervention_name>
    <description>The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
    <arm_group_label>PID + Fuzzy Logic Algorithm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Type 1 diabetes mellitus (as diagnosed clinically) for at least one year&#xD;
&#xD;
          2. Age 14-&lt;30 years at enrollment&#xD;
&#xD;
          3. For females, not currently known to be pregnant, be breast-feeding or planning to&#xD;
             become pregnant within the study duration.&#xD;
&#xD;
          4. Using an insulin pump or multiple daily injections of insulin&#xD;
&#xD;
               1. Participant must be able to obtain U-100 rapid acting insulin analogues, Aspart&#xD;
                  or Lispro, for use during the study (since these are the only insulins approved&#xD;
                  for the study pump and the study is not supplying insulin)&#xD;
&#xD;
               2. MDI users must be on a basal/bolus regimen&#xD;
&#xD;
               3. Participants must have a minimum total daily dose (TDD) of at least eight units&#xD;
&#xD;
          5. HbA1c from an approved HbA1c point of care analyzer with a value 7.0%-11.0%&#xD;
&#xD;
          6. Willingness or ability to do carbohydrate counting&#xD;
&#xD;
          7. In the investigator's judgment, able to understand and likely to be adherent to the&#xD;
             protocol&#xD;
&#xD;
          8. For subjects &lt;18 years old, living with one or more diabetes care partners (eg.g.&#xD;
             parent/legal guardian), of whom at least one is committed to participating in study&#xD;
             training for emergency procedures for severe hypoglycemia and able to contact the&#xD;
             participant in case of an emergency.&#xD;
&#xD;
          9. Have adequate internet access and a computer system that meets requirements for&#xD;
             uploading data.&#xD;
&#xD;
         10. For participants currently using CGM or insulin pump, willingness to discontinue&#xD;
             personal CGM and pump when using the study CGM and pumps (note: including implantable&#xD;
             CGMs).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Individuals meeting any of the following exclusion criteria at screening will be excluded&#xD;
        from study participation:&#xD;
&#xD;
          1. Concomitant disease that influences metabolic control or HbA1c interpretation (e.g.&#xD;
             anemia, significantly impaired hepatic function, confirmed gastroparesis, renal&#xD;
             failure, history of adrenal insufficiency, sickle cell disease, haemoglobinopathy, or&#xD;
             has received red blood cell transfusion or erythropoietin within three months prior to&#xD;
             time of screening) or other medical condition which, in the Investigator's opinion,&#xD;
             may compromise patient safety, affect outcome assessments, or affect the participant's&#xD;
             ability to follow the protocol&#xD;
&#xD;
          2. Oral or parenteral glucocorticoids taken within 1 month prior to enrollment, or plans&#xD;
             to take oral or parenteral glucocorticoids within the planned study duration.&#xD;
             Exceptions: Short term oral or parenteral glucocorticoids up to seven days&#xD;
&#xD;
          3. Use of antidiabetic agents other than insulin&#xD;
&#xD;
          4. Use of other medications, which in the judgment of the investigator would be a&#xD;
             contraindication to participation in the study&#xD;
&#xD;
          5. One or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by&#xD;
             another person) within the previous six months&#xD;
&#xD;
          6. Known allergy to medical grade adhesives&#xD;
&#xD;
          7. Participation in another study of a medical device or drug that could affect glucose&#xD;
             measurements or glucose management or receipt of any investigational medical product&#xD;
             within 1 month prior to enrollment&#xD;
&#xD;
          8. Current eating disorder such as anorexia or bulimia&#xD;
&#xD;
          9. Currently abusing illicit drugs, marijuana, prescription drugs, or alcohol&#xD;
&#xD;
         10. Visual impairment or hearing loss, which may compromise the participant's ability to&#xD;
             perform all study procedures safely, as determined by the investigator&#xD;
&#xD;
         11. One or more episodes of diabetic ketoacidosis (DKA) requiring hospitalization within&#xD;
             six months prior to screening&#xD;
&#xD;
         12. Working night shifts&#xD;
&#xD;
         13. Untreated celiac disease, hyperthyroidism, or hypothyroidism&#xD;
&#xD;
         14. Clinically significant nephropathy (eGFR &lt;45 mL/min) or on dialysis. Creatinine to&#xD;
             determine eGFR must have been obtained as part of usual care within 12 months prior to&#xD;
             enrollment (if not available, at time of enrollment, screening can proceed but it must&#xD;
             be available prior to randomization)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard Bergenstal, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>International Diabetes Center, HealthPartners Institute</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Moshe Phillip, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Schneider Children's Medical Center, Israel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Joslin Diabetes Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>International Diabetes Center</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kinderkrankenhaus Auf Der Bult</name>
      <address>
        <city>Hannover</city>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center of Israel</name>
      <address>
        <city>Petah Tikva</city>
        <zip>4920235</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ljubljana</name>
      <address>
        <city>Ljubljana</city>
        <country>Slovenia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Israel</country>
    <country>Slovenia</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20. doi: 10.1056/NEJMoa1002853. Epub 2010 Jun 29. Erratum In: N Engl J Med. 2010 Sep 9;363(11):1092.</citation>
    <PMID>20587585</PMID>
  </reference>
  <reference>
    <citation>Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.</citation>
    <PMID>23445093</PMID>
  </reference>
  <reference>
    <citation>Bergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann AJ, Welsh JB, Lee SW, Kaufman FR; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369(3):224-32. doi: 10.1056/NEJMoa1303576. Epub 2013 Jun 22.</citation>
    <PMID>23789889</PMID>
  </reference>
  <reference>
    <citation>Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.</citation>
    <PMID>25078901</PMID>
  </reference>
  <reference>
    <citation>Nimri R, Phillip M. Artificial pancreas: fuzzy logic and control of glycemia. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):251-6. doi: 10.1097/MED.0000000000000073.</citation>
    <PMID>24937038</PMID>
  </reference>
  <reference>
    <citation>Nimri R, Muller I, Atlas E, Miller S, Kordonouri O, Bratina N, Tsioli C, Stefanija MA, Danne T, Battelino T, Phillip M. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. 2014 Mar;15(2):91-9. doi: 10.1111/pedi.12071. Epub 2013 Aug 15.</citation>
    <PMID>23944875</PMID>
  </reference>
  <reference>
    <citation>Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.</citation>
    <PMID>27629148</PMID>
  </reference>
  <reference>
    <citation>Nimri R, Bratina N, Kordonouri O, Avbelj Stefanija M, Fath M, Biester T, Muller I, Atlas E, Miller S, Fogel A, Phillip M, Danne T, Battelino T. MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial. Diabetes Obes Metab. 2017 Apr;19(4):553-561. doi: 10.1111/dom.12852. Epub 2017 Jan 19.</citation>
    <PMID>27981804</PMID>
  </reference>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 31, 2017</study_first_submitted>
  <study_first_submitted_qc>February 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <results_first_submitted>January 4, 2021</results_first_submitted>
  <results_first_submitted_qc>April 19, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 20, 2021</results_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hybrid closed loop</keyword>
  <keyword>Closed loop</keyword>
  <keyword>Artificial pancreas</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03040414/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03040414/SAP_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 17, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/14/NCT03040414/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>13 participants were not randomized from the 126 enrolled due to ineligibility or lost to follow up.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PID Algorithm First, Then PID + Fuzzy Logic Algorithm</title>
          <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
        </group>
        <group group_id="P2">
          <title>PID + Fuzzy Logic Algorithm First, Then PID Algorithm</title>
          <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="57"/>
                <participants group_id="P2" count="56"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Period 1</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Started Period 2</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="56"/>
                <participants group_id="P2" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PID Algorithm First, Then PID + Fuzzy Logic Algorithm</title>
          <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
        </group>
        <group group_id="B2">
          <title>PID + Fuzzy Logic Algorithm First, Then PID Algorithm</title>
          <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="57"/>
            <count group_id="B2" value="56"/>
            <count group_id="B3" value="113"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20" spread="4"/>
                    <measurement group_id="B2" value="19" spread="4"/>
                    <measurement group_id="B3" value="19" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="104"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black/ African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>More than One Race</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Time Glucose Levels Were &gt; 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM</title>
        <description>Glucose levels based on sensor glucose data</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Time Glucose Levels Were &gt; 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM</title>
          <description>Glucose levels based on sensor glucose data</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37" spread="9"/>
                    <measurement group_id="O2" value="34" spread="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Non-inferiority for Percent of Time &lt;54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period.</title>
        <description>Glucose levels based on sensor glucose data</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Non-inferiority for Percent of Time &lt;54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period.</title>
          <description>Glucose levels based on sensor glucose data</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".50" spread=".35"/>
                    <measurement group_id="O2" value=".46" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: CGM Derived Indices: Mean Glucose Only</title>
        <description>Continuous Glucose Monitoring derived indices over the first 84 days of each treatment period for 24 hours (excluding time before auto mode is turned on). Glucose levels based on sensor glucose data for Mean glucose.</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: CGM Derived Indices: Mean Glucose Only</title>
          <description>Continuous Glucose Monitoring derived indices over the first 84 days of each treatment period for 24 hours (excluding time before auto mode is turned on). Glucose levels based on sensor glucose data for Mean glucose.</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>mg/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="166" spread="13"/>
                    <measurement group_id="O2" value="159" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: CGM Derived Indices</title>
        <description>CGM derived indices over the first 84 days of each treatment period for 24 hours. Glucose levels based on sensor glucose data for coefficient of variation; percentage of sensor glucose readings in the range of 70 to 180 mg/dL (3.9-10.0 mmol/L) and 70 to 140 mg/dL (3.9 to 7.8 mmol/L); percentage of sensor glucose readings &gt;180 mg/dL (daytime is a co-primary outcome) and &gt;250 mg/dL (10.0 and 13.9 mmol/L, respectively)</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: CGM Derived Indices</title>
          <description>CGM derived indices over the first 84 days of each treatment period for 24 hours. Glucose levels based on sensor glucose data for coefficient of variation; percentage of sensor glucose readings in the range of 70 to 180 mg/dL (3.9-10.0 mmol/L) and 70 to 140 mg/dL (3.9 to 7.8 mmol/L); percentage of sensor glucose readings &gt;180 mg/dL (daytime is a co-primary outcome) and &gt;250 mg/dL (10.0 and 13.9 mmol/L, respectively)</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>percentage of sensor glucose readings</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of Sensor Glucose Readings in the Range of 70-180 mg/dL (3·9-10·0 mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" spread="8"/>
                    <measurement group_id="O2" value="67" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Sensor Glucose Readings in the Range of 70 to 140 mg/dL (3.9 to 7.8 mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40" spread="7"/>
                    <measurement group_id="O2" value="44" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Sensor Glucose Readings &gt;180 mg/dL (10.0 mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34" spread="8"/>
                    <measurement group_id="O2" value="31" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Sensor Glucose Readings &gt;250 mg/dL (13.9 mmol/L)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" spread="6"/>
                    <measurement group_id="O2" value="9" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period</title>
        <description>Amount of total, basal, and bolus daily insulin over the first 84 days of each treatment period (excluding time before auto mode is turned on) for 24 hours. Glucose levels based on sensor glucose data. Sum of daytime and nighttime values may not equal total daily values due to rounding.</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period</title>
          <description>Amount of total, basal, and bolus daily insulin over the first 84 days of each treatment period (excluding time before auto mode is turned on) for 24 hours. Glucose levels based on sensor glucose data. Sum of daytime and nighttime values may not equal total daily values due to rounding.</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>insulin units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Total Insulin Units for 24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50" spread="21"/>
                    <measurement group_id="O2" value="55" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Insulin Units for Daytime</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="18"/>
                    <measurement group_id="O2" value="47" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Insulin Units for Nighttime</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="4"/>
                    <measurement group_id="O2" value="10" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Basal Insulin Units for 24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="11"/>
                    <measurement group_id="O2" value="20" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Basal Insulin Units for Daytime</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="9"/>
                    <measurement group_id="O2" value="14" spread="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Basal Insulin Units for Nighttime</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="3"/>
                    <measurement group_id="O2" value="6" spread="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bolus Insulin Units for 24 Hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="12"/>
                    <measurement group_id="O2" value="36" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bolus Insulin Units for Daytime</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="11"/>
                    <measurement group_id="O2" value="32" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Bolus Insulin Units for Nighttime</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="2"/>
                    <measurement group_id="O2" value="4" spread="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: HbA1c</title>
        <description>Glycated hemoglobin (HbA1c) was measured at a central laboratory (Advanced Research and Diagnostic Laboratory University of Minnesota, MN, USA) at randomization and at the end of each period by use of an International Federation of Clinical Chemistry and Laboratory Medicine aligned method (Tosoh HPLC Glycohemoglobin Analyzer, Tosoh Medics, San Francisco, CA, USA; coefficient of variation range 1.4 1.9%).</description>
        <time_frame>Time Frame: End of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: HbA1c</title>
          <description>Glycated hemoglobin (HbA1c) was measured at a central laboratory (Advanced Research and Diagnostic Laboratory University of Minnesota, MN, USA) at randomization and at the end of each period by use of an International Federation of Clinical Chemistry and Laboratory Medicine aligned method (Tosoh HPLC Glycohemoglobin Analyzer, Tosoh Medics, San Francisco, CA, USA; coefficient of variation range 1.4 1.9%).</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>percentage of HbA1c</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.6" spread="0.6"/>
                    <measurement group_id="O2" value="7.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: BMI for Participants Age ≥18 Years</title>
        <description>Height and weight. Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.</description>
        <time_frame>Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both were included in the analysis for the partial period they completed. An additional two participants from the PID Algorithm group and an additional three participants from the PID + Fuzzy Logic Algorithm group were not included in this outcome due to missing data. Separate BMI outcomes were reported for participants age ≥18 years and age &lt;18 years due to differing units of measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: BMI for Participants Age ≥18 Years</title>
          <description>Height and weight. Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both were included in the analysis for the partial period they completed. An additional two participants from the PID Algorithm group and an additional three participants from the PID + Fuzzy Logic Algorithm group were not included in this outcome due to missing data. Separate BMI outcomes were reported for participants age ≥18 years and age &lt;18 years due to differing units of measure.</population>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
                <count group_id="O2" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Body Mass Index (Age ≥18 years) End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="34"/>
                    <count group_id="O2" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" spread="5"/>
                    <measurement group_id="O2" value="27" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Mass Index (Age ≥18 years) End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="34"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27" spread="5"/>
                    <measurement group_id="O2" value="26" spread="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Efficacy: BMI Percentile for Participants Age &lt;18 Years</title>
        <description>Height and weight based on CDC standards of measurement. Age and gender adjusted.</description>
        <time_frame>Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both were included in the analysis for the partial period they completed. An additional two participants from the PID Algorithm group and an additional three participants from the PID + Fuzzy Logic Algorithm group were not included in this outcome due to missing data. Separate BMI outcomes were reported for participants age ≥18 years and age &lt;18 years due to differing units of measure.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Efficacy: BMI Percentile for Participants Age &lt;18 Years</title>
          <description>Height and weight based on CDC standards of measurement. Age and gender adjusted.</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both were included in the analysis for the partial period they completed. An additional two participants from the PID Algorithm group and an additional three participants from the PID + Fuzzy Logic Algorithm group were not included in this outcome due to missing data. Separate BMI outcomes were reported for participants age ≥18 years and age &lt;18 years due to differing units of measure.</population>
          <units>BMI percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Body Mass Index Percentile (Age &lt;18 years) End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73" spread="19"/>
                    <measurement group_id="O2" value="73" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Body Mass Index Percentile (Age &lt;18 years) End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="22"/>
                    <count group_id="O2" value="20"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="71" spread="22"/>
                    <measurement group_id="O2" value="74" spread="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were &lt;54 mg/dL and &lt;70 mg/dL (3.0 and 3.9 mmol/L, Respectively</title>
        <description>Glucose levels based on sensor glucose data</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were &lt;54 mg/dL and &lt;70 mg/dL (3.0 and 3.9 mmol/L, Respectively</title>
          <description>Glucose levels based on sensor glucose data</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>percentage of time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Percentage of Time &lt;54 mg/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".50" spread=".35"/>
                    <measurement group_id="O2" value=".46" spread=".33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Percentage of Time &lt;70 mg/dL</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="1.4"/>
                    <measurement group_id="O2" value="2.1" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Safety Outcome 2) Number of DKA Events</title>
        <description>DKA as defined by the Diabetes Control and Complications Trial (DCCT) and described below:&#xD;
Symptoms such as polyuria, polydipsia, nausea, or vomiting;&#xD;
Serum ketones &gt;1.5 mmol/L or large/moderate urine ketones;&#xD;
Either arterial blood pH &lt;7.30 or venous pH &lt;7.24 or serum bicarbonate &lt;15; and&#xD;
Treatment provided in a health care facility</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Key Safety Outcome 2) Number of DKA Events</title>
          <description>DKA as defined by the Diabetes Control and Complications Trial (DCCT) and described below:&#xD;
Symptoms such as polyuria, polydipsia, nausea, or vomiting;&#xD;
Serum ketones &gt;1.5 mmol/L or large/moderate urine ketones;&#xD;
Either arterial blood pH &lt;7.30 or venous pH &lt;7.24 or serum bicarbonate &lt;15; and&#xD;
Treatment provided in a health care facility</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Key Safety Outcome 3) Number of Severe Hypoglycemia Events</title>
        <description>Severe hypoglycemia event as defined by the Diabetes Control and Complications Trial (DCCT) and described below:&#xD;
The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or loss of consciousness.</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Key Safety Outcome 3) Number of Severe Hypoglycemia Events</title>
          <description>Severe hypoglycemia event as defined by the Diabetes Control and Complications Trial (DCCT) and described below:&#xD;
The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or loss of consciousness.</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>Events</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Amount of Total Insulin at Daytime, Nighttime and Post-meal</title>
        <description>Based on sensor glucose data</description>
        <time_frame>12 weeks for each arm of the crossover</time_frame>
        <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Amount of Total Insulin at Daytime, Nighttime and Post-meal</title>
          <description>Based on sensor glucose data</description>
          <population>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</population>
          <units>insulin units</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="112"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Post-Meal Total Insulin Delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29" spread="12"/>
                    <measurement group_id="O2" value="29" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Daytime Total Insulin Delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="18"/>
                    <measurement group_id="O2" value="47" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Nighttime Total Insulin Delivery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8" spread="4"/>
                    <measurement group_id="O2" value="10" spread="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires</title>
        <description>Surveys completed by participants. The Glucose Monitoring Satisfaction Survey is 15 items on a 1-5 scale; Total score calculated as mean of all item scores; higher scores indicate greater satisfaction. The Diabetes Distress Scale is 17 items on a 1-6 scale; Total score calculated as mean of all item scores; higher score denotes more distress. The Hypoglycemia Confidence Survey is 8 items on a 1-4 scale; Total score calculated as mean of all item scores; higher score denotes more confidence. The Diabetes Technology Attitudes Survey is 5 items on a 0-4 scale; Total score calculated as sum of all item scores; higher score denotes more satisfaction with diabetes technology. The Adult INSPIRE Survey is 22 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID. The Adolescent INSPIRE Survey is 17 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID.</description>
        <time_frame>Time Frame: Screening visit, at initiation (Day 0); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)</time_frame>
        <population>One participant in the PID Algorithm group and two participants in the PID + Fuzzy Logic Algorithm group did not complete the questionnaires. Questionnaire scores were calculated based on the ends of crossover periods 1 and 2.</population>
        <group_list>
          <group group_id="O1">
            <title>PID Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
          </group>
          <group group_id="O2">
            <title>PID + Fuzzy Logic Algorithm</title>
            <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
          </group>
        </group_list>
        <measure>
          <title>Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires</title>
          <description>Surveys completed by participants. The Glucose Monitoring Satisfaction Survey is 15 items on a 1-5 scale; Total score calculated as mean of all item scores; higher scores indicate greater satisfaction. The Diabetes Distress Scale is 17 items on a 1-6 scale; Total score calculated as mean of all item scores; higher score denotes more distress. The Hypoglycemia Confidence Survey is 8 items on a 1-4 scale; Total score calculated as mean of all item scores; higher score denotes more confidence. The Diabetes Technology Attitudes Survey is 5 items on a 0-4 scale; Total score calculated as sum of all item scores; higher score denotes more satisfaction with diabetes technology. The Adult INSPIRE Survey is 22 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID. The Adolescent INSPIRE Survey is 17 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID.</description>
          <population>One participant in the PID Algorithm group and two participants in the PID + Fuzzy Logic Algorithm group did not complete the questionnaires. Questionnaire scores were calculated based on the ends of crossover periods 1 and 2.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="112"/>
                <count group_id="O2" value="111"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose Monitoring Satisfaction Survey Mean Score - End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.63" spread="0.58"/>
                    <measurement group_id="O2" value="2.89" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose Monitoring Satisfaction Survey Mean Score - End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.67" spread="0.69"/>
                    <measurement group_id="O2" value="2.70" spread="0.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Distress Scale Total Score - End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.62" spread="0.71"/>
                    <measurement group_id="O2" value="1.65" spread="0.68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Distress Scale Total Score - End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.55" spread="0.56"/>
                    <measurement group_id="O2" value="1.63" spread="0.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoglycemia Confidence Survey Mean Score - End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.52" spread="0.56"/>
                    <measurement group_id="O2" value="3.51" spread="0.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoglycemia Confidence Survey Mean Score - End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.53" spread="0.39"/>
                    <measurement group_id="O2" value="3.57" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Technology Attitudes Survey - End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.33" spread="3.00"/>
                    <measurement group_id="O2" value="22.40" spread="3.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes Technology Attitudes Survey - End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.11" spread="3.68"/>
                    <measurement group_id="O2" value="22.71" spread="2.77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INSPIRE Survey Adult Version Total Score - End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.81" spread="1.19"/>
                    <measurement group_id="O2" value="3.79" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INSPIRE Survey Adult Version Total Score - End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.79" spread="1.29"/>
                    <measurement group_id="O2" value="3.98" spread="1.27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INSPIRE Survey Adolescent Version Total Score - End of Period 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="57"/>
                    <count group_id="O2" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.03" spread="0.94"/>
                    <measurement group_id="O2" value="4.38" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INSPIRE Survey Adolescent Version Total Score - End of Period 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="55"/>
                    <count group_id="O2" value="56"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.45" spread="0.55"/>
                    <measurement group_id="O2" value="4.27" spread="0.60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Post-randomization through study completion, an average of 26-weeks</time_frame>
      <desc>All 113 participants completed both arms except for two (one in each arm) who dropped out during period 1; both of whom were included in the analysis for the partial period they completed.</desc>
      <group_list>
        <group group_id="E1">
          <title>PID Algorithm</title>
          <description>Participants received insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
MedtronicMinimed 670G 3.0 hybrid closed loop system: The components of the intervention are the insulin pump with insulin delivery algorithm (PID) and Guardian Sensor (3).</description>
        </group>
        <group group_id="E2">
          <title>PID + Fuzzy Logic Algorithm</title>
          <description>Participants received insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.&#xD;
Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Ruptured Appendix</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Severe Hypoglycemia</sub_title>
                <assessment>Non-systematic Assessment</assessment>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Suicidal Tendencies</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="112"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="112"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperglycemia or Ketosis Related to Insulin Pump Problem (without diabetic ketoacidosis)</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="112"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
              <event>
                <sub_title>Hyperglycemia or Ketosis Events not Related to Insulin Pump Problem (without diabetic ketoacidosis)</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin reactions</sub_title>
                <description>Skin reactions at infusion site and continuous glucose monitor sensor site</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="112"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="112"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Amy Becker LaFrance, Sr. Manager, Research Project Management Office</name_or_title>
      <organization>HealthPartners Institute</organization>
      <phone>952.967.5079</phone>
      <email>Amy.B.LaFrance@healthpartners.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03040414
org study id: UC4DK108611
secondary id: UC4DK108611
nct id: NCT03040414
lead sponsor: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: Yes
Adolescents and young adults with type 1 diabetes often have a difficult time achieving good
      glucose control, which is so important in reducing the risk for diabetes complications.
      Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is
      still a need for many individuals to further improve glucose levels without causing low blood
      glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an
      insulin pump can receive glucose readings from a continuous glucose monitor and adjust the
      insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems
      are called hybrid closed loop (HCL). This means that much of the insulin delivery is
      automated, yet the patient still interacts regularly with the system, particularly to help
      determine the insulin dose to deliver to cover a meal. Results of early studies using HCL
      systems in adolescents and adults with type 1 diabetes are encouraging.

      The objective of this study is to compare the efficacy and safety of the automated insulin
      delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0
      HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced
      Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can
      reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without
      increasing hypoglycemia.

      Up to 124 adolescents and young adults (ages 14-<30) will be recruited to test each system
      for three months in a randomized crossover trial. Investigators will compare how effective
      each hybrid closed loop system is at preventing high blood glucose readings during the day.
      The investigators will also evaluate the safety of each system and how participants adjust to
      the daily use of the technology.
Purpose of the study: A randomized crossover trial involving up to four clinical sites in the
      United States and three sites outside the US (Germany, Israel and Slovenia) will compare the
      efficacy and safety of an AID system with a PID algorithm versus an AID system with a PID
      algorithm enhanced with a fuzzy logic algorithm.

      Study Objectives:

        1. EFFICACY: The co-primary outcomes are difference in continuous glucose monitoring
           (CGM)-measured metrics between periods:

             -  Superiority for percent of time >180 mg/dL (10.0 mmol/L) from 6 AM to 11:59 PM; and

             -  Non-inferiority of percent of time <54 mg/dL (3.0 mmol/L) during the entire 24-hour
                period.

        2. KEY SAFETY OUTCOMES:

             -  Percentage of sensor glucose readings <54 mg/dL (overall is a co-primary outcomes)
                and <70 mg/dL (3.0 and 3.9 mmol/L, respectively)

             -  Diabetic Ketoacidosis (DKA) events

             -  Severe hypoglycemia events

           Study design: Randomized crossover trial with two 12-week crossover periods in automode,
           preceded by a run-in phase.

           Population: A maximum of 124 individuals may be enrolled and start the run-in phase.
           Approximately 112 are expected to enter the crossover trial, with a goal of at least 100
           people completing the trial.

           Maximum duration of a study for a subject: Approximately 28-36 weeks.

           Recruitment: Subjects will be recruited through the clinical sites.

           Consent: Written consent/assent will be obtained for all subjects and/or guardians, in
           accordance with human subjects and regulatory requirements.

           Screening Assessments:

             -  Informed consent will be signed and eligibility will be assessed

             -  Medical history and physical examination

             -  HbA1c measurement

             -  Urine pregnancy test (if applicable)

             -  Surveys investigating participants' quality of life, psychosocial and cognitive
                functioning, and response to their current treatment will be distributed.

           Study Training:

           Run-In Period: (2-8 weeks)

           * Eligible participants will use the study 670G 3.0 HCL pump during the run-in.
           Participants who were pump users at screening may skip the Pump Run-In period (but must
           participate in the Pump+CGM Run-In period) per investigator discretion. 670G auto mode
           users may use the 670G pump in auto mode.

           Screening and start of run-in training visits may occur on the same day or separate
           days, but no more than 14 days apart.

           Standardized pump training will be provided to study participants and their diabetes
           care partners (for participants <18 years old). The study team will assist the
           participant in study pump infusion site initiation and will start the participant on the
           study pump. For current pump users, the study pump will be programmed with the
           participants usual basal rates and pump parameters. The participants personal pump will
           be removed. Participants may continue to use their personal CGM if applicable.

           The pump will be used for at least two weeks during the Pump Run-In, with the option of
           repeating Pump Run-In for an additional two weeks per investigator discretion. Contact
           will be made each week with additional contacts as needed. Prior to each contact,
           participants will be asked to upload device data for study staff to review.

           After completion of Pump Run-In, participants will proceed to use the study CGM along
           with the study 670G HCL pump during the Pump+CGM Run-In period.

           * Pump+CGM Run-In (670G 3.0 HCL + Guardian Sensor (3)) All participants must complete a
           two-week run-in period with the use of the study pump and CGM before being randomized
           into the crossover trial. During Pump+CGM Run-In, the predictive low glucose suspend
           feature will be turned on and auto mode will be off (i.e. manual mode). Participants who
           were 670G auto mode users at screening may use the pump in auto mode.

           Standardized device training will be provided to study participants and their diabetes
           care partners (for participants <18 years old). Personal pumps and CGMs will be removed
           during the Pump+CGM Run-In period as applicable.

           Contact will be made each week with additional contacts as needed. Prior to each
           contact, participants will be asked to upload device data for study staff to review.

           Run-In Assessment Successful completion of Pump Run-In is per investigator discretion.
           Pump Run-In may be repeated once.

           Successful completion of the Pump+CGM Run-In requires CGM data to be collected on at
           least 80% of the possible time in the prior 14 days of use. An average of at least three
           blood glucose meter (BGM) tests per day also will be required. If these are not
           achieved, the Pump+CGM Run-In period may be repeated once.

           Randomization into the Crossover Trial

           Eligible participants who successfully complete the Pump+CGM Run-In will be randomly
           assigned to begin with one Automated Insulin Delivery (AID) system during Period 1 and
           then crossover to the other AID system during Period 2. The two study AID systems
           (treatments) are:

             -  670G 3.0 Hybrid Closed-Loop (HCL) (PID) insulin pump + Guardian Sensor (3) CGM

             -  670G 4.0 Advanced Hybrid Closed-Loop (AHCL) (PID + Fuzzy Logic) insulin pump +
                Guardian Sensor (3) CGM

           Home Use of AID System during the Crossover Trial Period 1 (~13 weeks) Participants and
           their diabetes care partners (for participants <18 years old) will be trained by
           qualified personnel on the use of the assigned pump and on auto mode feature use
           including meal announcement, meal bolusing, and exercise.

           Training will also be provided in performing specific tasks including the following:

             -  Confirming pump parameters

             -  When not to use or rely on auto mode particularly during significant illness or
                acetaminophen use

             -  CGM calibration instructions

             -  Meal bolus procedures

             -  What to do when exercising while using the system

             -  How to react to safety/alert notifications

             -  How to perform fingerstick blood glucose measurements in accordance with the
                labeling of the study CGM device

             -  When and how to contact study staff to ask questions during the study

           Study staff will discuss the visit and contact schedule with the participant and will
           make arrangements for follow-up appointments. Participants will be asked to upload data
           before each contact and at least every two weeks.

           After auto mode training has been completed, participants will proceed with home use of
           the AID system (meaning free-living use at work, home, etc.) during Period 1 with either
           the 670G 3.0 HCL or 670G 4.0 AHCL pump. The predictive low glucose suspend feature will
           be on.

           The system will initially be used with auto mode deactivated (except for 670G auto mode
           users at screening who may activate auto mode if using the 670G 3.0 HCL pump) until
           participants are contacted 6-10 days into Period 1 with instructions to activate auto
           mode. Participants will be instructed to obtain an overnight fingerstick blood glucose
           measurement (between 2-3AM) for 2-3 nights following auto mode initiation and if
           fingerstick blood glucose is <70 mg/dL to treat with carbohydrate. Participants will
           then continue using the AID system for 12 weeks after auto mode is initialized.

           Participants will be expected to use auto mode at all times at home with some exceptions
           (e.g. times of illness, acetaminophen use).

           Participants on the 670G 4.0 AHCL will begin with an auto mode target glucose set point
           of 120 mg/dL (6.7 mmol/L) that may be lowered to 100 mg/dL (5.6 mmol/L) if participant
           meets the safety criteria per protocol and investigator discretion.

           HbA1c, C-peptide, and glucose levels will be collected for central lab analysis at the
           beginning of Study Period 1. Human Factors and Diabetes Technology Attitude Surveys will
           be administered at the end of Study Period 1.

           Period 2 (~13 weeks) At the beginning of Period 2, a urine pregnancy test will be
           completed as applicable. Eligible participants will then use the other AID system during
           Period 2. The procedures in Period 1 will be repeated in Period 2.

           At the end of the 12-weeks of AID use in auto mode at home, the participant will
           complete a final study visit. That visit may be completed in-person in clinic or in an
           alternate location such as the participant's home. The study visit may occur remotely
           via phone or videoconferencing. Certain procedures, such as the measurement of height,
           weight, vitals, and collection of the central HbA1c sample, may be missed if the visit
           is not completed in-person. Participants requiring a remote final visit will be
           transitioned off of the study device during the remote contact and an arrangement will
           be made between site staff and the participant to return all required study devices
           either in-person or via mail.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Randomized crossover trial with two 12-week crossover periods in auto mode preceded by a run-in phase.
primary purpose: Treatment
masking: None (Open Label)
masking description: Open label
measure: Percentage of Time Glucose Levels Were > 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM
time frame: 12 weeks for each arm of the crossover
description: Glucose levels based on sensor glucose data
measure: Non-inferiority for Percent of Time <54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period.
time frame: 12 weeks for each arm of the crossover
description: Glucose levels based on sensor glucose data
measure: Efficacy: CGM Derived Indices: Mean Glucose Only
time frame: 12 weeks for each arm of the crossover
description: Continuous Glucose Monitoring derived indices over the first 84 days of each treatment period for 24 hours (excluding time before auto mode is turned on). Glucose levels based on sensor glucose data for Mean glucose.
measure: Efficacy: CGM Derived Indices
time frame: 12 weeks for each arm of the crossover
description: CGM derived indices over the first 84 days of each treatment period for 24 hours. Glucose levels based on sensor glucose data for coefficient of variation; percentage of sensor glucose readings in the range of 70 to 180 mg/dL (3.9-10.0 mmol/L) and 70 to 140 mg/dL (3.9 to 7.8 mmol/L); percentage of sensor glucose readings >180 mg/dL (daytime is a co-primary outcome) and >250 mg/dL (10.0 and 13.9 mmol/L, respectively)
measure: Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period
time frame: 12 weeks for each arm of the crossover
description: Amount of total, basal, and bolus daily insulin over the first 84 days of each treatment period (excluding time before auto mode is turned on) for 24 hours. Glucose levels based on sensor glucose data. Sum of daytime and nighttime values may not equal total daily values due to rounding.
measure: Efficacy: HbA1c
time frame: Time Frame: End of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)
description: Glycated hemoglobin (HbA1c) was measured at a central laboratory (Advanced Research and Diagnostic Laboratory University of Minnesota, MN, USA) at randomization and at the end of each period by use of an International Federation of Clinical Chemistry and Laboratory Medicine aligned method (Tosoh HPLC Glycohemoglobin Analyzer, Tosoh Medics, San Francisco, CA, USA; coefficient of variation range 1.4 1.9%).
measure: Efficacy: BMI for Participants Age ≥18 Years
time frame: Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)
description: Height and weight. Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.
measure: Efficacy: BMI Percentile for Participants Age <18 Years
time frame: Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)
description: Height and weight based on CDC standards of measurement. Age and gender adjusted.
measure: Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were <54 mg/dL and <70 mg/dL (3.0 and 3.9 mmol/L, Respectively
time frame: 12 weeks for each arm of the crossover
description: Glucose levels based on sensor glucose data
measure: Key Safety Outcome 2) Number of DKA Events
time frame: 12 weeks for each arm of the crossover
description: DKA as defined by the Diabetes Control and Complications Trial (DCCT) and described below:
Symptoms such as polyuria, polydipsia, nausea, or vomiting;
Serum ketones >1.5 mmol/L or large/moderate urine ketones;
Either arterial blood pH <7.30 or venous pH <7.24 or serum bicarbonate <15; and
Treatment provided in a health care facility
measure: Key Safety Outcome 3) Number of Severe Hypoglycemia Events
time frame: 12 weeks for each arm of the crossover
description: Severe hypoglycemia event as defined by the Diabetes Control and Complications Trial (DCCT) and described below:
The event required assistance of another person due to altered consciousness, and required another person to actively administer carbohydrate, glucagon, or other resuscitative actions. This means that the participant was impaired cognitively to the point that he/she was unable to treat himself/herself, was unable to verbalize his/ her needs, was incoherent, disoriented, and/or combative, or experienced seizure or loss of consciousness.
measure: Amount of Total Insulin at Daytime, Nighttime and Post-meal
time frame: 12 weeks for each arm of the crossover
description: Based on sensor glucose data
measure: Human Factors and Diabetes Technology Attitude and Human Factors Questionnaires
time frame: Time Frame: Screening visit, at initiation (Day 0); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending)
description: Surveys completed by participants. The Glucose Monitoring Satisfaction Survey is 15 items on a 1-5 scale; Total score calculated as mean of all item scores; higher scores indicate greater satisfaction. The Diabetes Distress Scale is 17 items on a 1-6 scale; Total score calculated as mean of all item scores; higher score denotes more distress. The Hypoglycemia Confidence Survey is 8 items on a 1-4 scale; Total score calculated as mean of all item scores; higher score denotes more confidence. The Diabetes Technology Attitudes Survey is 5 items on a 0-4 scale; Total score calculated as sum of all item scores; higher score denotes more satisfaction with diabetes technology. The Adult INSPIRE Survey is 22 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID. The Adolescent INSPIRE Survey is 17 items on a 1-5 scale; Total score calculated as mean of all item scores; higher score denotes more satisfaction with AID.
arm group label: PID Algorithm
arm group type: Active Comparator
description: Participants will receive insulin delivered by the Medtronic Minimed 670G 3.0 HCL system using a PID algorithm..
arm group label: PID + Fuzzy Logic Algorithm
arm group type: Experimental
description: Participants will receive insulin delivered by the Medtronic advanced hybrid closed loop system (Minimed 670G 4.0 AHCL) with Guardian Sensor (3) continuous glucose monitoring sensor.
intervention type: Device
intervention name: MedtronicMinimed 670G 3.0 hybrid closed loop system
description: The components of the intervention are the insulin pump with insulin delivery algorithm (PID).
arm group label: PID Algorithm
intervention type: Device
intervention name: Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.
description: The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
arm group label: PID + Fuzzy Logic Algorithm
criteria: 
gender: All
minimum age: 14 Years
maximum age: 30 Years
healthy volunteers: No
last name: Richard Bergenstal, MD
role: Principal Investigator
affiliation: International Diabetes Center, HealthPartners Institute
last name: Moshe Phillip, MD
role: Principal Investigator
affiliation: Schneider Children's Medical Center, Israel
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Israel
country: Slovenia
country: United States
citation: Bergenstal RM, Tamborlane WV, Ahmann A, Buse JB, Dailey G, Davis SN, Joyce C, Peoples T, Perkins BA, Welsh JB, Willi SM, Wood MA; STAR 3 Study Group. Effectiveness of sensor-augmented insulin-pump therapy in type 1 diabetes. N Engl J Med. 2010 Jul 22;363(4):311-20. doi: 10.1056/NEJMoa1002853. Epub 2010 Jun 29. Erratum In: N Engl J Med. 2010 Sep 9;363(11):1092.
PMID: 20587585
citation: Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.
PMID: 23445093
citation: Bergenstal RM, Klonoff DC, Garg SK, Bode BW, Meredith M, Slover RH, Ahmann AJ, Welsh JB, Lee SW, Kaufman FR; ASPIRE In-Home Study Group. Threshold-based insulin-pump interruption for reduction of hypoglycemia. N Engl J Med. 2013 Jul 18;369(3):224-32. doi: 10.1056/NEJMoa1303576. Epub 2013 Jun 22.
PMID: 23789889
citation: Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.
PMID: 25078901
citation: Nimri R, Phillip M. Artificial pancreas: fuzzy logic and control of glycemia. Curr Opin Endocrinol Diabetes Obes. 2014 Aug;21(4):251-6. doi: 10.1097/MED.0000000000000073.
PMID: 24937038
citation: Nimri R, Muller I, Atlas E, Miller S, Kordonouri O, Bratina N, Tsioli C, Stefanija MA, Danne T, Battelino T, Phillip M. Night glucose control with MD-Logic artificial pancreas in home setting: a single blind, randomized crossover trial-interim analysis. Pediatr Diabetes. 2014 Mar;15(2):91-9. doi: 10.1111/pedi.12071. Epub 2013 Aug 15.
PMID: 23944875
citation: Bergenstal RM, Garg S, Weinzimer SA, Buckingham BA, Bode BW, Tamborlane WV, Kaufman FR. Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. JAMA. 2016 Oct 4;316(13):1407-1408. doi: 10.1001/jama.2016.11708. No abstract available.
PMID: 27629148
citation: Nimri R, Bratina N, Kordonouri O, Avbelj Stefanija M, Fath M, Biester T, Muller I, Atlas E, Miller S, Fogel A, Phillip M, Danne T, Battelino T. MD-Logic overnight type 1 diabetes control in home settings: A multicentre, multinational, single blind randomized trial. Diabetes Obes Metab. 2017 Apr;19(4):553-561. doi: 10.1111/dom.12852. Epub 2017 Jan 19.
PMID: 27981804
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No
provided document: 
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 