<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/NCT03767790</url>
  </required_header>
  <id_info>
    <org_study_id>G180011-S001</org_study_id>
    <nct_id>NCT03767790</nct_id>
  </id_info>
  <brief_title>Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting</brief_title>
  <official_title>A Randomized Crossover Comparison of Model Predictive Control (MPC) Artificial Pancreas vs. Sensor Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) With Different Food Choices in the Outpatient Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sansum Diabetes Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sansum Diabetes Research Institute</source>
  <oversight_info>
    <has_dmc>No</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this randomized crossover clinical trial is to 1) assess the efficacy and&#xD;
      safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC)&#xD;
      algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in&#xD;
      people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content&#xD;
      on glucose control when using AID and SAP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to compare the efficacy and safety of an AID system using a MPC&#xD;
      algorithm versus SAP/PLGS therapy with different food choices over a 4 week period.&#xD;
&#xD;
      The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose&#xD;
      monitoring sensor, and a smart phone that contains the algorithm and communicates with the&#xD;
      other devices.&#xD;
&#xD;
      In this study, during each two-week period, subjects will be given pre-weighed portions of&#xD;
      different meals to eat (either regular semolina pasta or extra-long grain white rice) with&#xD;
      detailed cooking instructions, and will eat these meals on 6 different occasions for dinner.&#xD;
      They will bolus as they normally do for these meals. This will allow us to observe the&#xD;
      postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the&#xD;
      importance of nutrition choices with modern technological treatments in T1D.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">June 27, 2019</completion_date>
  <primary_completion_date type="Actual">June 27, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time in target glucose range</measure>
    <time_frame>4 weeks</time_frame>
    <description>Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial glucose peak</measure>
    <time_frame>4 weeks</time_frame>
    <description>Postprandial glucose peak rise (highest measurement in mg/dL) from baseline glucose (mg/dl) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to postprandial glucose peak</measure>
    <time_frame>4 weeks</time_frame>
    <description>Time (minutes) to postprandial glucose (highest measurement in mg/dL) rise from baseline glucose (mg/dl) during the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial Area Under the Curve</measure>
    <time_frame>4 weeks</time_frame>
    <description>Area Under the Curve Glucose (mg/dl x min) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial time for glucose to return to baseline</measure>
    <time_frame>4 weeks</time_frame>
    <description>Time (minutes) for CGM glucose to return to baseline (starting value) after the study meals, during both use of SAP/PLGS and when using the iAPS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &lt; 70 mg/dL</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percent time GGM glucose &lt; 70 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &lt; 54 mg/dL</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percent time GGM glucose &lt; 54 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &gt; 180 mg/dL</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percent time GGM glucose &gt; 180 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucose &gt; 250 mg/dL</measure>
    <time_frame>4 weeks</time_frame>
    <description>Percent time GGM glucose &gt; 250 mg/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events (SAE)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The total number of serious adverse events during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse device events (SADE)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The total number of serious adverse events related to the study device use during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse device effects (ADE)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The total number of adverse device effects (ADE) during the clinical trial</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unanticipated adverse device effects (UADE)</measure>
    <time_frame>4 weeks</time_frame>
    <description>The total number of unanticipated adverse device effects (UADE) during the clinical trial</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Total daily insulin use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Total daily insulin use (units/day) during both use of SAP/PLGS and when using the iAPS</description>
  </other_outcome>
  <other_outcome>
    <measure>Total basal insulin use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Total daily basal insulin use (units/day) during both use of SAP/PLGS and when using the iAPS</description>
  </other_outcome>
  <other_outcome>
    <measure>Total bolus insulin use</measure>
    <time_frame>4 weeks</time_frame>
    <description>Total daily bolus insulin use (units/day) during both use of SAP/PLGS and when using the iAPS</description>
  </other_outcome>
  <other_outcome>
    <measure>Sensor Use Time</measure>
    <time_frame>4 weeks</time_frame>
    <description>Total hours of CGM sensor use time during both use of SAP/PLGS and when using the iAPS</description>
  </other_outcome>
  <other_outcome>
    <measure>Closed-Loop Active Time</measure>
    <time_frame>2 weeks</time_frame>
    <description>Percent time (hours/day) of closed-loop use during the two weeks of iAPS use</description>
  </other_outcome>
  <other_outcome>
    <measure>Device Issues</measure>
    <time_frame>4 weeks</time_frame>
    <description>Total number of devices issues during the clinical trial</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Automated Insulin Delivery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting. During AID use, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAP/PLGS</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting. During these 2 weeks, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iAPS</intervention_name>
    <description>The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.</description>
    <arm_group_label>Automated Insulin Delivery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least&#xD;
             one year and using insulin for at least 1 year.&#xD;
&#xD;
          -  Using an insulin pump for at least 3 months at the time of screening. Insulin pump use&#xD;
             includes use of automated features, to include predictive or threshold low-glucose&#xD;
             suspend or hybrid closed-loop with without a Dexcom sensor.&#xD;
&#xD;
          -  Familiarity and use of a carbohydrate ratio for meal boluses.&#xD;
&#xD;
          -  Age ≥18.0 years old&#xD;
&#xD;
          -  HbA1c &lt; 10.5%, as performed by point of care or central laboratory testing. A1c will&#xD;
             be assessed at the screening visit, or if already completed within 2 weeks of the&#xD;
             screening visit, the prior lab value may be used in lieu of repeating this assessment.&#xD;
&#xD;
          -  For females, not currently known to be pregnant. If female and sexually active, must&#xD;
             agree to use a form of contraception to prevent pregnancy while a participant in the&#xD;
             study. A negative serum or urine pregnancy test will be required for all females of&#xD;
             child-bearing potential. Participants who become pregnant will be discontinued from&#xD;
             the study. Also, participants who during the study develop and express the intention&#xD;
             to become pregnant within the timespan of the study will be discontinued.&#xD;
&#xD;
          -  Willingness to switch home pump to PLGS or full manual mode if using hybrid&#xD;
             closed-loop with an FDA approved system.&#xD;
&#xD;
          -  Have an emergency contact living at home with the subject who will be available to be&#xD;
             contacted by the study staff overnight in the event of an emergency.&#xD;
&#xD;
          -  Investigator has confidence that the participant can successfully operate all study&#xD;
             devices and is capable of adhering to the protocol, to include having basic cooking&#xD;
             equipment at home to prepare the study meals.&#xD;
&#xD;
          -  Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already,&#xD;
             and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the&#xD;
             study.&#xD;
&#xD;
          -  Willingness not to start any new non-insulin glucose-lowering agent during the course&#xD;
             of the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Use of an unapproved closed-loop insulin delivery system within 2 weeks before&#xD;
             screening or during the study is not allowed.&#xD;
&#xD;
          -  Gastrointestinal disease such as celiac disease or multiple food allergies.&#xD;
&#xD;
          -  Any form of gluten sensitivity or wheat allergy.&#xD;
&#xD;
          -  Allergies to any form of nuts or ingredients present in the study meals (tomatoes&#xD;
             etc).&#xD;
&#xD;
          -  History of difficulty digesting food.&#xD;
&#xD;
          -  Concurrent use of Afrezza or any non-insulin glucose-lowering agent other than&#xD;
             metformin (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors,&#xD;
             sulfonylureas).&#xD;
&#xD;
          -  Hemophilia or any other bleeding disorder&#xD;
&#xD;
          -  One or more episodes of hypoglycemia requiring an emergency room visit or&#xD;
             hospitalization in the past 6 months.&#xD;
&#xD;
          -  One or more episodes of hyperglycemia requiring an emergency room visit or&#xD;
             hospitalization in the past 6 months.&#xD;
&#xD;
          -  Self-reported or clinically documented hypoglycemia unawareness.&#xD;
&#xD;
          -  A condition, which in the opinion of the investigator or designee, would put the&#xD;
             participant or study at risk&#xD;
&#xD;
          -  Participation in another pharmaceutical or device trial at the time of enrollment or&#xD;
             during the study&#xD;
&#xD;
          -  Having a direct supervisor at place of employment who is also directly involved in&#xD;
             conducting the clinical trial (as a study investigator, coordinator, etc.); or having&#xD;
             a first-degree relative who is directly involved in conducting the clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eyal Dassau, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>John A. Paulson School of Engineering and Applied Sciences</affiliation>
  </overall_official>
  <overall_official>
    <last_name>David Eisenberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jordan E Pinsker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sansum Diabetes Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sansum Diabetes Research Institute</name>
      <address>
        <city>Santa Barbara</city>
        <state>California</state>
        <zip>93105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>August 7, 2019</last_update_submitted>
  <last_update_submitted_qc>August 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Artificial Pancreas</keyword>
  <keyword>Hyperglycemia</keyword>
  <keyword>Hypoglycemia</keyword>
  <keyword>Nutrition</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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03767790
org study id: G180011-S001
nct id: NCT03767790
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
The objective of this randomized crossover clinical trial is to 1) assess the efficacy and
      safety of an automated insulin delivery (AID) system using a Model Predictive Control (MPC)
      algorithm versus sensor augmented pump therapy (SAP)/Predictive Low Glucose Suspend (PLGS) in
      people with type 1 diabetes, and 2) assess the impact of different meal macronutrient content
      on glucose control when using AID and SAP.
The goal of this study is to compare the efficacy and safety of an AID system using a MPC
      algorithm versus SAP/PLGS therapy with different food choices over a 4 week period.

      The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose
      monitoring sensor, and a smart phone that contains the algorithm and communicates with the
      other devices.

      In this study, during each two-week period, subjects will be given pre-weighed portions of
      different meals to eat (either regular semolina pasta or extra-long grain white rice) with
      detailed cooking instructions, and will eat these meals on 6 different occasions for dinner.
      They will bolus as they normally do for these meals. This will allow us to observe the
      postprandial meal response when using sensor-augmented pump (SAP) or iAPS, showing the
      importance of nutrition choices with modern technological treatments in T1D.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time in target glucose range
time frame: 4 weeks
description: Time in target glucose range 70-180 mg/dL measured by CGM to determine safety and efficacy of the integrated system
measure: Postprandial glucose peak
time frame: 4 weeks
description: Postprandial glucose peak rise (highest measurement in mg/dL) from baseline glucose (mg/dl) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
measure: Time to postprandial glucose peak
time frame: 4 weeks
description: Time (minutes) to postprandial glucose (highest measurement in mg/dL) rise from baseline glucose (mg/dl) during the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
measure: Postprandial Area Under the Curve
time frame: 4 weeks
description: Area Under the Curve Glucose (mg/dl x min) for the 5-hour period after the study meals, during both use of SAP/PLGS and when using the iAPS
measure: Postprandial time for glucose to return to baseline
time frame: 4 weeks
description: Time (minutes) for CGM glucose to return to baseline (starting value) after the study meals, during both use of SAP/PLGS and when using the iAPS
measure: Glucose < 70 mg/dL
time frame: 4 weeks
description: Percent time GGM glucose < 70 mg/dL
measure: Glucose < 54 mg/dL
time frame: 4 weeks
description: Percent time GGM glucose < 54 mg/dL
measure: Glucose > 180 mg/dL
time frame: 4 weeks
description: Percent time GGM glucose > 180 mg/dL
measure: Glucose > 250 mg/dL
time frame: 4 weeks
description: Percent time GGM glucose > 250 mg/dL
measure: Serious adverse events (SAE)
time frame: 4 weeks
description: The total number of serious adverse events during the clinical trial
measure: Serious adverse device events (SADE)
time frame: 4 weeks
description: The total number of serious adverse events related to the study device use during the clinical trial
measure: Adverse device effects (ADE)
time frame: 4 weeks
description: The total number of adverse device effects (ADE) during the clinical trial
measure: Unanticipated adverse device effects (UADE)
time frame: 4 weeks
description: The total number of unanticipated adverse device effects (UADE) during the clinical trial
measure: Total daily insulin use
time frame: 4 weeks
description: Total daily insulin use (units/day) during both use of SAP/PLGS and when using the iAPS
measure: Total basal insulin use
time frame: 4 weeks
description: Total daily basal insulin use (units/day) during both use of SAP/PLGS and when using the iAPS
measure: Total bolus insulin use
time frame: 4 weeks
description: Total daily bolus insulin use (units/day) during both use of SAP/PLGS and when using the iAPS
measure: Sensor Use Time
time frame: 4 weeks
description: Total hours of CGM sensor use time during both use of SAP/PLGS and when using the iAPS
measure: Closed-Loop Active Time
time frame: 2 weeks
description: Percent time (hours/day) of closed-loop use during the two weeks of iAPS use
measure: Device Issues
time frame: 4 weeks
description: Total number of devices issues during the clinical trial
arm group label: Automated Insulin Delivery
arm group type: Experimental
description: Participants will use the Automated Insulin Delivery (AID) iAPS system for 2 weeks in the outpatient setting. During AID use, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.
arm group label: SAP/PLGS
arm group type: No Intervention
description: Participants will use their home pump with a CGM sensor (sensor augmented pump) or in Predictive Low Glucose Suspend (PLGS) mode if their home pump supports this mode, for 2 weeks in the outpatient setting. During these 2 weeks, subjects will consume 6 study meals (3 meals of each meal type in assigned random order, 1-2 portions per meal,) at dinner time over the 2-week period in a pre-assigned random order, and document on the study meal forms when they consume each numbered meal.
intervention type: Device
intervention name: iAPS
description: The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
arm group label: Automated Insulin Delivery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Eyal Dassau, PhD
role: Principal Investigator
affiliation: John A. Paulson School of Engineering and Applied Sciences
last name: David Eisenberg, MD
role: Principal Investigator
affiliation: Harvard School of Public Health (HSPH)
last name: Jordan E Pinsker, MD
role: Principal Investigator
affiliation: Sansum Diabetes Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No