<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/NCT03815487</url>
  </required_header>
  <id_info>
    <org_study_id>PSH-KKB1/ NERP15-028</org_study_id>
    <nct_id>NCT03815487</nct_id>
  </id_info>
  <brief_title>Comparison of Two Management Systems in Patients With Type 1 Diabetes (Pediatric SmartHome)</brief_title>
  <official_title>Comparison of the Efficacy of Sensor-augmented Pump Therapy Versus Hybrid Closed-loop Glucose Management (MiniMed670G™) in Patients With Type 1 Diabetes at Home in a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kinderkrankenhaus auf der Bult</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kinderkrankenhaus auf der Bult</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well&#xD;
      as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of&#xD;
      alerts according to high or low glucose values as well as trend arrows showing actual glucose&#xD;
      trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional&#xD;
      effects compared to SAP therapy: according to actual and predicted sensor glucose values, the&#xD;
      insulin therapy can be adopted automatically by pump: in case of high values (or predicted)&#xD;
      more insulin will be administered, in case of low values (or predicted) the insulin infusion&#xD;
      will be decreased a suspended and resumed again. So the HCL provides a lot more automatic&#xD;
      functions to keep glucose in target compared to SAP.&#xD;
&#xD;
      The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop&#xD;
      glucose management in patients with type 1 diabetes at home.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monocentric, randomized, controlled cross-over safety evaluation study. For the study, 20&#xD;
      subjects per age group (small children 2-&lt;9 years, children/adolescents ≥9-14 years) will be&#xD;
      enrolled (total n=40). The study is anticipated to last no longer than 6 months from&#xD;
      investigational center initiation to completion of all data entry and monitoring procedures.&#xD;
      It is estimated that all subjects will be enrolled into the study within approximately 3&#xD;
      months of study start.&#xD;
&#xD;
        -  Visit 1 - Day 0: (Subjects come to clinic): Consent, Screening (incl. blood sample) and&#xD;
           device training, training to emergency behavior; Pump Start in low glucose suspend mode,&#xD;
           alarm settings&#xD;
&#xD;
        -  Visit 2 - Week 1: Subjects come to clinic; start Run-in Period and start Sensor&#xD;
           Augmented Pump (SAP) therapy without any SmartGuard feature, assessment of AEs; pump&#xD;
           will be read out, data stored; subjects will be trained to use the Auto mode, Auto mode&#xD;
           will be activated. All subjects will participate in a 11-week study period.&#xD;
&#xD;
        -  Visit 3 - Week 2: Subjects are randomized to start with SAP or Hybrid Closed Loop (HCL)&#xD;
           therapy and stay with an assigned therapy for next 4 weeks.&#xD;
&#xD;
        -  Visit 4 - Week 6: End of Period 1 and start of washout period. Subjects stay in this&#xD;
           period with SAP therapy only. Evaluation of past 4 weeks, assessment of AEs&#xD;
&#xD;
        -  Visit 5 - Week 7: Period 2 starts. Evaluation of past week, assessment of AEs. SAP group&#xD;
           will be using 670G with HCL and HCL group will be using SAP therapy for next 4 weeks.&#xD;
&#xD;
        -  Visit 6 - Week 11: End of Study, Subjects come to clinic; evaluation of past 4 weeks,&#xD;
           assessment of AEs, HbA1c; pump will be read out, data stored. All study material will be&#xD;
           given back.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">October 10, 2020</completion_date>
  <primary_completion_date type="Actual">October 10, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of Sensor Glucose</measure>
    <time_frame>6 month</time_frame>
    <description>Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Patient Care</condition>
  <condition>Drug Therapy</condition>
  <arm_group>
    <arm_group_label>Therapy with Hybrid Closed Loop (HCL)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Intervention is the specific function of the Insulin Pump from Medtronic® with the name &quot;MiniMed® 670G (MMT-1780)&quot; to deliver Insulin as medication.&#xD;
This Medtronic MiniMed 670G Insulin Pump in Auto Mode is an Hybrid closed loop (HCL) system including an Auto Mode function. It provides as intervention several additional effects concerning automatically insulin delivery by pump: e.g. in case of high values (or predicted) - more insulin will be administered automatically, in case of low values (or predicted) - the insulin infusion will be decreased a suspended and resumed again. The patients will wear the pump continuously.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sensor Augmented Pump (SAP) therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Intervention is the specific therapy of the Sensor Augmented Insulin Pump &quot;MiniMed® 670G&quot; (MMT-1780) without Auto Mode.&#xD;
This Medtronic MiniMed 670G Insulin Pump without Auto Mode' is a Sensor Augmented Pump (SAP) therapy and means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. The patients will wear the pump also continuously, but have to respond manually after the alarm. There are no automatically steps from the pump.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic MiniMed 670G Insulin Pump in Auto Mode</intervention_name>
    <description>This kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.</description>
    <arm_group_label>Therapy with Hybrid Closed Loop (HCL)</arm_group_label>
    <other_name>Hybrid Closed Loop (HCL) System</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic MiniMed 670G Insulin Pump without Auto Mode</intervention_name>
    <description>Sensor augmented pump therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows.</description>
    <arm_group_label>Sensor Augmented Pump (SAP) therapy</arm_group_label>
    <other_name>Sensor Augmented Pump therapy without Auto Mode</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General Inclusion Criteria&#xD;
&#xD;
          1. At time of screening: Subjects who are 2-14 years are determined by the investigator&#xD;
             to be psychologically sound (e.g. no depression, anxiety disorder, traumatic stress&#xD;
             disorder) in order to successfully participate in this study&#xD;
&#xD;
          2. Subject has been diagnosed with type 1 diabetes ≥ 1 year Study-specific inclusion&#xD;
             criteria&#xD;
&#xD;
             Subjects will be considered for enrollment in the study if they meet all of the&#xD;
             following criteria:&#xD;
&#xD;
          3. Subjects who are 2-14 years are determined by the investigator to have the&#xD;
             appropriate, requisite support (family, caregiver or social network) to successfully&#xD;
             participate in this study&#xD;
&#xD;
          4. Subject is willing to wear the system continuously throughout the study&#xD;
&#xD;
          5. Subject is willing to perform required sensor calibrations&#xD;
&#xD;
          6. Total daily dose of Insulin &gt;8 U&#xD;
&#xD;
          7. Subject has an A1C value &lt; 12.0% (as processed by Laboratory) at time of screening&#xD;
             visit&#xD;
&#xD;
          8. Subject must be on Pump therapy for &gt;3 months prior to Screening&#xD;
&#xD;
          9. Subject may also be on sensor augmented pump therapy.&#xD;
&#xD;
         10. If subject has celiac disease it has been adequately treated as proven by&#xD;
             Transglutamase-Antibodies in normal range&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Event of severe hypoglycemia in past 3 months (as per ISPAD Guideline Definition 2014:&#xD;
             seizure or loss of consciousness.)&#xD;
&#xD;
          2. Subject is unable to tolerate tape adhesive in the area of sensor placement&#xD;
&#xD;
          3. Subject has any unresolved adverse skin condition in the area of sensor placement&#xD;
             (e.g., psoriasis, rash, Staphylococcus infection)&#xD;
&#xD;
          4. Women of child-bearing potential who have a positive pregnancy test at screening or&#xD;
             plan to become pregnant during the course of the study&#xD;
&#xD;
          5. Subject has had any of the following new diagnoses within 1 year of screening:&#xD;
             myocardial infarction, unstable angina, coronary artery bypass surgery, coronary&#xD;
             artery stenting, transient ischemic attack, cerebrovascular accident, angina,&#xD;
             congestive heart failure, ventricular rhythm disturbances or thromboembolic disease&#xD;
&#xD;
          6. Subject has a clinical significant abnormality (out of reference range, as processed&#xD;
             by Laboratory) in thyroid-stimulating hormone (TSH) at time of screening visit&#xD;
&#xD;
          7. Subjects suffering from Morbus Addison, heart failure &gt;NYHA II, chronic pulmonal&#xD;
             disease &gt;GOLD II, chronic arterial insuffiency, known cancer disease, diabetic kidney&#xD;
             disease, diabetic autonom or peropheral neuropathy&#xD;
&#xD;
          8. Subject tests positive in the drug screen&#xD;
&#xD;
          9. Subject has taken any oral, injectable, or IV steroids within 8 weeks prior time of&#xD;
             screening visit, or plans to take any oral, injectable, or IV steroids during the&#xD;
             course of the study; furthermore patients using antipsychotic drugs, antidepressive,&#xD;
             ß-blocking agents are not permitted to participate&#xD;
&#xD;
         10. Subject is actively participating in an investigational study (drug or device) wherein&#xD;
             he/she has received treatment from an investigational study drug or investigational&#xD;
             study device in the last 4 weeks&#xD;
&#xD;
         11. Subject is currently abusing illicit drugs&#xD;
&#xD;
         12. Subject is currently abusing prescription drugs&#xD;
&#xD;
         13. Subject is currently abusing alcohol&#xD;
&#xD;
         14. Subject is using pramlintide (Symlin) at time of screening&#xD;
&#xD;
         15. Subject has a history of visual impairment which would not allow subject to&#xD;
             participate in the study and perform all study procedures safely, as determined by the&#xD;
             investigator&#xD;
&#xD;
         16. Subject has elective surgery planned that requires general anesthesia during the&#xD;
             course of the study&#xD;
&#xD;
         17. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell&#xD;
             transfusion or erythropoietin within 3 months prior to time of screening&#xD;
&#xD;
         18. Subject plans to receive red blood cell transfusion or erythropoietin over the course&#xD;
             of study participation&#xD;
&#xD;
         19. Subject diagnosed with current eating disorder such as anorexia or bulimia&#xD;
&#xD;
         20. Subject has been diagnosed with chronic kidney disease that results in chronic anemia&#xD;
&#xD;
         21. Subject is on dialysis&#xD;
&#xD;
         22. Subjects known for factitial hypoglycemia or possible suicidal tendencies.&#xD;
&#xD;
         23. Patients who are unwilling or unable to perform a minimum of four blood glucose tests&#xD;
             per day.&#xD;
&#xD;
         24. People who are unwilling or unable to maintain contact with their healthcare&#xD;
             professional.&#xD;
&#xD;
        Patients whose vision or hearing does not allow cognition of pump signals and alarms.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Danne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Diabetes Centre for Children and Adolescents, Kinderkrankenhaus AUF DER BULT</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kinder - und Jugendkrankenhaus AUF DER BULT</name>
      <address>
        <city>Hannover</city>
        <zip>30173</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 21, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>June 15, 2021</last_update_submitted>
  <last_update_submitted_qc>June 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pediatrics</keyword>
  <keyword>type 1 diabetes</keyword>
  <keyword>insulin pump</keyword>
  <keyword>closed loop</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Insulin</mesh_term>
    <mesh_term>Insulin, Globin Zinc</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03815487
org study id: PSH-KKB1/ NERP15-028
nct id: NCT03815487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Closed loop technology has been shown to reduce both hypoglycemia and hyperglycemia, as well
      as reduce glycemic variability. Sensor augmented pump (SAP) therapy means the addition of
      alerts according to high or low glucose values as well as trend arrows showing actual glucose
      trends to pump therapy. This Hybrid closed loop (HCL) system provides several additional
      effects compared to SAP therapy: according to actual and predicted sensor glucose values, the
      insulin therapy can be adopted automatically by pump: in case of high values (or predicted)
      more insulin will be administered, in case of low values (or predicted) the insulin infusion
      will be decreased a suspended and resumed again. So the HCL provides a lot more automatic
      functions to keep glucose in target compared to SAP.

      The aim of the current trial is to compare the SAP-therapy with the hybrid closed loop
      glucose management in patients with type 1 diabetes at home.
Monocentric, randomized, controlled cross-over safety evaluation study. For the study, 20
      subjects per age group (small children 2-<9 years, children/adolescents ≥9-14 years) will be
      enrolled (total n=40). The study is anticipated to last no longer than 6 months from
      investigational center initiation to completion of all data entry and monitoring procedures.
      It is estimated that all subjects will be enrolled into the study within approximately 3
      months of study start.

        -  Visit 1 - Day 0: (Subjects come to clinic): Consent, Screening (incl. blood sample) and
           device training, training to emergency behavior; Pump Start in low glucose suspend mode,
           alarm settings

        -  Visit 2 - Week 1: Subjects come to clinic; start Run-in Period and start Sensor
           Augmented Pump (SAP) therapy without any SmartGuard feature, assessment of AEs; pump
           will be read out, data stored; subjects will be trained to use the Auto mode, Auto mode
           will be activated. All subjects will participate in a 11-week study period.

        -  Visit 3 - Week 2: Subjects are randomized to start with SAP or Hybrid Closed Loop (HCL)
           therapy and stay with an assigned therapy for next 4 weeks.

        -  Visit 4 - Week 6: End of Period 1 and start of washout period. Subjects stay in this
           period with SAP therapy only. Evaluation of past 4 weeks, assessment of AEs

        -  Visit 5 - Week 7: Period 2 starts. Evaluation of past week, assessment of AEs. SAP group
           will be using 670G with HCL and HCL group will be using SAP therapy for next 4 weeks.

        -  Visit 6 - Week 11: End of Study, Subjects come to clinic; evaluation of past 4 weeks,
           assessment of AEs, HbA1c; pump will be read out, data stored. All study material will be
           given back.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of Sensor Glucose
time frame: 6 month
description: Time in Range (% of Sensor Glucose 70-180 mg/dL) (SAP period vs Hybrid Closed loop)
arm group label: Therapy with Hybrid Closed Loop (HCL)
arm group type: Experimental
description: The Intervention is the specific function of the Insulin Pump from Medtronic® with the name "MiniMed® 670G (MMT-1780)" to deliver Insulin as medication.
This Medtronic MiniMed 670G Insulin Pump in Auto Mode is an Hybrid closed loop (HCL) system including an Auto Mode function. It provides as intervention several additional effects concerning automatically insulin delivery by pump: e.g. in case of high values (or predicted) - more insulin will be administered automatically, in case of low values (or predicted) - the insulin infusion will be decreased a suspended and resumed again. The patients will wear the pump continuously.
arm group label: Sensor Augmented Pump (SAP) therapy
arm group type: Active Comparator
description: The Intervention is the specific therapy of the Sensor Augmented Insulin Pump "MiniMed® 670G" (MMT-1780) without Auto Mode.
This Medtronic MiniMed 670G Insulin Pump without Auto Mode' is a Sensor Augmented Pump (SAP) therapy and means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. The patients will wear the pump also continuously, but have to respond manually after the alarm. There are no automatically steps from the pump.
intervention type: Device
intervention name: Medtronic MiniMed 670G Insulin Pump in Auto Mode
description: This kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.
arm group label: Therapy with Hybrid Closed Loop (HCL)
other name: Hybrid Closed Loop (HCL) System
intervention type: Device
intervention name: Medtronic MiniMed 670G Insulin Pump without Auto Mode
description: Sensor augmented pump therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows.
arm group label: Sensor Augmented Pump (SAP) therapy
other name: Sensor Augmented Pump therapy without Auto Mode
criteria: 
gender: All
minimum age: 2 Years
maximum age: 14 Years
healthy volunteers: No
last name: Thomas Danne, MD
role: Principal Investigator
affiliation: Diabetes Centre for Children and Adolescents, Kinderkrankenhaus AUF DER BULT
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
mesh term: Insulin
mesh term: Insulin, Globin Zinc