<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/NCT04414280</url>
  </required_header>
  <id_info>
    <org_study_id>S63351</org_study_id>
    <nct_id>NCT04414280</nct_id>
  </id_info>
  <brief_title>The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs</brief_title>
  <acronym>INRANGE</acronym>
  <official_title>The Impact of Hybrid Closed-loop Insulin Delivery (Medtronic MiniMed 670G and 780G System, and Tandem t:Slim X2 Control-IQ) on Glycemic Control and Patient-reported Outcomes in People Living With Type 1 Diabetes: a Multicenter Real-world Observational Study in Belgium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</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_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G&#xD;
      system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies,&#xD;
      the impact of these new kinds of insulin pumps on glycemic control and patient-reported&#xD;
      outcomes (PROMs) is still unclear. Therefore, this study will evaluate the impact of the&#xD;
      Medtronic MiniMed 670G, Medtronic MiniMed 780G and Tandem Control-IQ systems on glycemic&#xD;
      control and PROMs in people living with type 1 diabetes under real-life conditions. In a&#xD;
      multicenter real-world observational study, 350 adults and 100 children with type 1 diabetes&#xD;
      who are treated with each of these systems in one of 17 Belgian centers, will be followed for&#xD;
      a period of 24 months. The primary endpoint is the evolution of time spent in range (defined&#xD;
      as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after&#xD;
      start of hybrid closed-loop therapy.&#xD;
&#xD;
      Since not much is known about the impact of hybrid closed-loop on partners of adults living&#xD;
      with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating&#xD;
      the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop&#xD;
      therapy. More specifically, the substudy will compare the quality of life of partners of type&#xD;
      1 diabetes patients both before and after implementation of hybrid closed-loop therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 12, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time in range</measure>
    <time_frame>12 months</time_frame>
    <description>The evolution of percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time in range</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Percentage of time spent in range (sensor glucose 70-180 mg/dL), with exclusion of the primary endpoint</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in level 2 hypoglycemia</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Percentage of time spent in level 2 hypoglycemia (sensor glucose &lt;54 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in level 1 hypoglycemia</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Percentage of time spent in level 1 hypoglycemia (sensor glucose &lt;70 mg/dL and ≥54 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time below range</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Percentage of time spent below range (sensor glucose &lt;70 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time above range</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Percentage of time spent above range (sensor glucose &gt;180 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time in level 1 hyperglycemia</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Percentage of time spent in level 1 hyperglycemia (sensor glucose &gt;250 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Glycemic variability: coefficient of variation (CV), standard deviation (SD) and mean amplitude of glycemic excursions (MAGE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean glucose concentration</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Mean glucose concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between sex (male/female) and change in HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Correlation between sex (male/female) and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between cohabitation (yes/no) and change in HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Correlation between cohabitation (yes/no) and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between duration of diabetes (years) and change in HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Correlation between duration of diabetes (years) and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between total daily dose of insulin (units per day) and change in HbA1c</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Correlation between total daily dose of insulin (units per day) and change in HbA1c</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of low glucose events</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Number of low glucose events (LGE, defined as sensor glucose values ≤54 mg/dL for at least 15 minutes, preceded by at least 30 minutes with sensor glucose values &gt;54 mg/dL)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults</time_frame>
    <description>Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times &quot;R&quot; or once &quot;U&quot;) or aware (&lt;4 times &quot;R&quot;))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults and children</time_frame>
    <description>Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times &quot;R&quot; or once &quot;U&quot;) or aware (&lt;4 times &quot;R&quot;))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults and children</time_frame>
    <description>Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults</time_frame>
    <description>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults</time_frame>
    <description>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults</time_frame>
    <description>Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for adults</time_frame>
    <description>Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)</measure>
    <time_frame>at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children</time_frame>
    <description>Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for adults</time_frame>
    <description>Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for children</time_frame>
    <description>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for children</time_frame>
    <description>Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Diabetes Quality of Life for Youth (DQOLY) questionnaire</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for children</time_frame>
    <description>The Diabetes Quality of Life for Youth (DQOLY) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for parents</time_frame>
    <description>Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start for parents</time_frame>
    <description>The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Composite endpoint of HbA1c and time in hypoglycemia &lt;70 mg/dl</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Composite endpoint of HbA1c and time in hypoglycemia &lt;70 mg/dl</description>
  </other_outcome>
  <other_outcome>
    <measure>Severe hypoglycemia</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Frequency of severe hypoglycemia</description>
  </other_outcome>
  <other_outcome>
    <measure>Diabetic ketoacidosis</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Frequency of diabetic ketoacidosis</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital visits and/or admissions</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Number of hospital visits and/or admissions because of severe hypoglycemia or diabetic ketoacidosis</description>
  </other_outcome>
  <other_outcome>
    <measure>Work and school absenteeism</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Work and school absenteeism (number of days that a patient was unable to attend work/school due to his/her diabetes (excluding consultation))</description>
  </other_outcome>
  <other_outcome>
    <measure>(Unplanned) contacts with the diabetes team</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Frequency of (unplanned) contacts with the diabetes team</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in total daily dose of insulin (units/day)</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Change in total daily dose of insulin (units/day)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in body weight (kilograms)</measure>
    <time_frame>from before start to 4, 8, 12 and 24 months after start</time_frame>
    <description>Change in body weight (kilograms)</description>
  </other_outcome>
  <other_outcome>
    <measure>Time in Manual Mode</measure>
    <time_frame>only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system</time_frame>
    <description>Percentage of time spent in Manual Mode</description>
  </other_outcome>
  <other_outcome>
    <measure>Time in Auto Mode</measure>
    <time_frame>only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system</time_frame>
    <description>Percentage of time spent in Auto Mode</description>
  </other_outcome>
  <other_outcome>
    <measure>Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))</measure>
    <time_frame>at start</time_frame>
    <description>Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))</description>
  </other_outcome>
  <other_outcome>
    <measure>Patients who stop</measure>
    <time_frame>only measured at stop</time_frame>
    <description>Number of patients who stop with hybrid closed-loop therapy</description>
  </other_outcome>
  <other_outcome>
    <measure>Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)</measure>
    <time_frame>only measured at stop</time_frame>
    <description>Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the DIDP-FM questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the DAWN (Diabetes Attitudes, Wishes and Needs) Impact of Diabetes Profile Family Members (DIDP-FM) questionnaire (scale: 0 (less negative impact) - 100 (more negative impact)) Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the DIDP-FM questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the DIDP-FM questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'quality of life of T1D patients using hybrid closed-loop therapy' and 'quality of life in partners of T1D patients', both measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'quality of life of T1D patients using hybrid closed-loop therapy' and 'quality of life in partners of T1D patients', both measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between composite endpoint 'HbA1c and time in hypoglycemia &lt;70 mg/dL' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2. Note: substudy only</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between composite endpoint 'HbA1c and time in hypoglycemia &lt;70 mg/dL' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between composite endpoint 'HbA1c and time in hypoglycemia &lt;70 mg/dL' and 'quality of life in partners of T1D patients using the hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: substudy only</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between composite endpoint 'HbA1c and time in hypoglycemia &lt;70 mg/dL' and 'quality of life in partners of T1D patients using the hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2. Note: substudy only</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <other_outcome>
    <measure>Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</measure>
    <time_frame>from before start to 12 months after start</time_frame>
    <description>Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy</description>
  </other_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">1150</enrollment>
  <condition>Diabetes Mellitus, Type 1</condition>
  <arm_group>
    <arm_group_label>type 1 diabetes patients using Medtronic MiniMed 670G</arm_group_label>
    <description>Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 670G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>type 1 diabetes patients using Medtronic MiniMed 780G</arm_group_label>
    <description>Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 780G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>type 1 diabetes patients using Tandem Control-IQ</arm_group_label>
    <description>Patients with type 1 diabetes, aged 6 years or older, who start with the Tandem Control-IQ system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic MiniMed 670G</intervention_name>
    <description>The Medtronic Minimed 670G system is a form of hybrid closed-loop insulin delivery. The Medtronic MiniMed 670G system automatically adjusts basal insulin every five minutes based on CGM readings to reach a glucose target of 120 mg/dL, the SmartGuard Auto Mode. Patients still need to enter their carbohydrate intake and administer meal-time and correction boluses. Before Auto Mode is introduced, the Medtronic MiniMed 670G system has to be worn in Manual Mode. In contrast to Auto Mode, Manual Mode features an insulin stop up to 30 minutes before or when reaching preset low limits (suspend before/on low) and an automatic insulin restart when blood sugar levels recover. During Manual Mode the pump 'becomes familiar with' the daily insulin need of the patient. This information will be used when in Auto Mode.</description>
    <arm_group_label>type 1 diabetes patients using Medtronic MiniMed 670G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Medtronic MiniMed 780G</intervention_name>
    <description>The Medtronic Minimed 780G system differs in several aspects from the MiniMed 670G system. In Auto Mode, the user can choose from two target levels for even more stricter glucose control (100 mg/dL and 120 mg/dL) and correction boluses are now automated without the need of user interaction. When administering meal boluses, no capillary blood glucose value is required. The safety feature to exit from Auto Mode to Manual Mode was too strict in the Minimed 670G. In the Minimed 780G this is more flexible to overcome this frequently reported patient frustration.</description>
    <arm_group_label>type 1 diabetes patients using Medtronic MiniMed 780G</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tandem Control-IQ</intervention_name>
    <description>The Tandem t:slim X2 Control-IQ consists of the Tandem t:slim X2 insulin pump with Control-IQ technology, and integrates with the Dexcom G6 CGM-device via Bluetooth. Blood glucose readings for calibration are not required. The Tandem t:slim X2 Control-IQ automatically adjusts basal insulin based on CGM readings to reach a glucose target range between of 112-160 mg/dL. Patients still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically increases the basal insulin dose or gives automated correction boluses in case of high blood glucose levels. The technology offers optional settings for sleep and exercise, with different glucose targets in order to match the insulin need during these activities. New versions of the pump software can be downloaded and installed remotely via the user's own computer.</description>
    <arm_group_label>type 1 diabetes patients using Tandem Control-IQ</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited at the Diabetes departments of 17 diabetes convention&#xD;
        hospitals in Belgium&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with type 1 diabetes&#xD;
&#xD;
          -  patients aged 6 years or older&#xD;
&#xD;
          -  patients starting with hybrid closed-loop therapy (as part of routine clinical&#xD;
             practice) in one of the 17 participating centers. Note: the decision about which&#xD;
             patient to start, is left to the clinical judgement of the treating health care&#xD;
             professional.&#xD;
&#xD;
          -  patients who signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients without type 1 diabetes&#xD;
&#xD;
          -  patients under 6 years of age&#xD;
&#xD;
          -  patients not starting with hybrid closed-loop therapy in one of the 17 participating&#xD;
             centers&#xD;
&#xD;
          -  patients who did not sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pieter Gillard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Margaretha M Visser, MD</last_name>
    <phone>+3216345977</phone>
    <email>margaretha.visser@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sara Charleer, PhD</last_name>
    <phone>+3216342398</phone>
    <email>sara.charleer@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Margaretha M Visser, MD</last_name>
      <phone>+3216345977</phone>
      <email>margaretha.visser@uzleuven.be</email>
    </contact>
    <contact_backup>
      <last_name>Sara Charleer, PhD</last_name>
      <phone>+3216342398</phone>
      <email>sara.charleer@uzleuven.be</email>
    </contact_backup>
    <investigator>
      <last_name>Pieter Gillard, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>OLVZ Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liesbeth van Huffel, MD</last_name>
      <email>liesbeth.van.huffel@olvz-aalst.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>GZA Ziekenhuizen - campus Sint-Vincentius</name>
      <address>
        <city>Antwerpen</city>
        <zip>2018</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pascale Abrams, MD</last_name>
      <email>pascale.abrams@gza.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital d'Arlon</name>
      <address>
        <city>Arlon</city>
        <zip>6700</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eric Weber, MD</last_name>
      <email>eric.weber@vivalia.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Imeldaziekenhuis</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chris Vercammen, MD</last_name>
      <email>chris.vercammen@imelda.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Sint-Jan - campus Sint-Jan</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Youri Taes, MD</last_name>
      <email>youri.taes@azsintjan.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Crenier, MD</last_name>
      <email>laurent.crenier@erasme.ulb.ac.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christophe de Block, MD</last_name>
      <email>christophe.deblock@uza.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>ZOL - campus Sint-Jan</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ine Lowyck, MD</last_name>
      <email>ine.lowyck@zol.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jessa Ziekenhuis - campus Salvator</name>
      <address>
        <city>Hasselt</city>
        <zip>3500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Annelies Mullens, MD</last_name>
      <email>annelies.mullens@jessazh.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>UZ Brussel</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bart Keymeulen, MD</last_name>
      <email>bart.keymeulen@uzbrussel.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge - campus kennedylaan</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gerd Vanhaverbeke, MD</last_name>
      <email>gerd.vanhaverbeke@azgroeninge.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHR de La Citadelle</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marie Strivay, MD</last_name>
      <email>marie.strivay@chrcitadelle.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Liège - site du Sart Tilman</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Régis Radermecker, MD</last_name>
      <email>regis.radermecker@chuliege.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Az Damiaan</name>
      <address>
        <city>Oostende</city>
        <zip>8400</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Linsey Winne, MD</last_name>
      <email>lwinne@azdamiaan.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Delta - campus Wilgenstraat Roeselare</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Katrien Spincemaille, MD</last_name>
      <email>katrien.spincemaille@azdelta.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AZ Nikolaas</name>
      <address>
        <city>Sint-Niklaas</city>
        <zip>9100</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dominique Ballaux, MD</last_name>
      <email>dominique.ballaux@aznikolaas.be</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>GZA Ziekenhuizen - campus Sint-Augustinus</name>
      <address>
        <city>Wilrijk</city>
        <zip>2610</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wouter Vinck, MD</last_name>
      <email>wouter.vinck@gza.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>April 10, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 20, 2022</last_update_submitted>
  <last_update_submitted_qc>December 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitaire Ziekenhuizen KU Leuven</investigator_affiliation>
    <investigator_full_name>prof dr Pieter Gillard</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Hybrid closed-loop</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04414280
org study id: S63351
nct id: NCT04414280
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Since February 2019 the first hybrid closed-loop insulin pump, the Medtronic MiniMed 670G
      system, has been offered to people with type 1 diabetes in Belgium. Despite previous studies,
      the impact of these new kinds of insulin pumps on glycemic control and patient-reported
      outcomes (PROMs) is still unclear. Therefore, this study will evaluate the impact of the
      Medtronic MiniMed 670G, Medtronic MiniMed 780G and Tandem Control-IQ systems on glycemic
      control and PROMs in people living with type 1 diabetes under real-life conditions. In a
      multicenter real-world observational study, 350 adults and 100 children with type 1 diabetes
      who are treated with each of these systems in one of 17 Belgian centers, will be followed for
      a period of 24 months. The primary endpoint is the evolution of time spent in range (defined
      as a sensor glucose value between 70 and 180 mg/dL) from before start to 12 months after
      start of hybrid closed-loop therapy.

      Since not much is known about the impact of hybrid closed-loop on partners of adults living
      with type 1 diabetes, an optional substudy (INRANGE-PARTNER) will be performed investigating
      the quality of life in partners of adults of type 1 diabetes using hybrid closed-loop
      therapy. More specifically, the substudy will compare the quality of life of partners of type
      1 diabetes patients both before and after implementation of hybrid closed-loop therapy.
observational model: Cohort
time perspective: Other
measure: Time in range
time frame: 12 months
description: The evolution of percentage of time spent in range (sensor glucose 70-180 mg/dL) from before start to 12 months after start
measure: Time in range
time frame: from before start to 4, 8, 12 and 24 months after start
description: Percentage of time spent in range (sensor glucose 70-180 mg/dL), with exclusion of the primary endpoint
measure: Time in level 2 hypoglycemia
time frame: from before start to 4, 8, 12 and 24 months after start
description: Percentage of time spent in level 2 hypoglycemia (sensor glucose <54 mg/dL)
measure: Time in level 1 hypoglycemia
time frame: from before start to 4, 8, 12 and 24 months after start
description: Percentage of time spent in level 1 hypoglycemia (sensor glucose <70 mg/dL and ≥54 mg/dL)
measure: Time below range
time frame: from before start to 4, 8, 12 and 24 months after start
description: Percentage of time spent below range (sensor glucose <70 mg/dL)
measure: Time above range
time frame: from before start to 4, 8, 12 and 24 months after start
description: Percentage of time spent above range (sensor glucose >180 mg/dL)
measure: Time in level 1 hyperglycemia
time frame: from before start to 4, 8, 12 and 24 months after start
description: Percentage of time spent in level 1 hyperglycemia (sensor glucose >250 mg/dL)
measure: Glycemic variability
time frame: from before start to 4, 8, 12 and 24 months after start
description: Glycemic variability: coefficient of variation (CV), standard deviation (SD) and mean amplitude of glycemic excursions (MAGE)
measure: Mean glucose concentration
time frame: from before start to 4, 8, 12 and 24 months after start
description: Mean glucose concentration
measure: HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Change in HbA1c
measure: Correlation between sex (male/female) and change in HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Correlation between sex (male/female) and change in HbA1c
measure: Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Correlation between educational attainment (measured by a questionnaire with multiple options) and change in HbA1c
measure: Correlation between cohabitation (yes/no) and change in HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Correlation between cohabitation (yes/no) and change in HbA1c
measure: Correlation between duration of diabetes (years) and change in HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Correlation between duration of diabetes (years) and change in HbA1c
measure: Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Correlation between chronic diabetic complications (measured by a questionnaire with multiple options) and change in HbA1c
measure: Correlation between total daily dose of insulin (units per day) and change in HbA1c
time frame: from before start to 4, 8, 12 and 24 months after start
description: Correlation between total daily dose of insulin (units per day) and change in HbA1c
measure: Number of low glucose events
time frame: from before start to 4, 8, 12 and 24 months after start
description: Number of low glucose events (LGE, defined as sensor glucose values ≤54 mg/dL for at least 15 minutes, preceded by at least 30 minutes with sensor glucose values >54 mg/dL)
measure: Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
time frame: from before start to 4, 8, 12 and 24 months after start for adults
description: Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
measure: Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))
time frame: from before start to 4, 8, 12 and 24 months after start for adults and children
description: Hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey (scale: unaware (≥4 times "R" or once "U") or aware (<4 times "R"))
measure: Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))
time frame: from before start to 4, 8, 12 and 24 months after start for adults and children
description: Hypoglycemia awareness measured by the Gold-scale (scale: 1 (aware) - 7 (unaware))
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
time frame: from before start to 4, 8, 12 and 24 months after start for adults
description: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
time frame: from before start to 4, 8, 12 and 24 months after start for adults
description: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
measure: Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
time frame: from before start to 4, 8, 12 and 24 months after start for adults
description: Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
measure: Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))
time frame: from before start to 4, 8, 12 and 24 months after start for adults
description: Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs. Scale: 0 (low satisfaction) - 36 (high satisfaction))
measure: Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)
time frame: at 4, 8, 12 and 24 months after start of the Medtronic MiniMed 670G and 780G system for adults and children
description: Treatment satisfaction measured by a self-developed questionnaire about expectations towards the use of the Medtronic MiniMed 670G system (multiple choice)
measure: Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))
time frame: from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for adults
description: Impact of diabetes and device satisfaction by the Diabetes Impact and Device Satisfaction Scale (scale: device satisfaction = 7 (not satisfied) - 70 (very satisfied); diabetes impact = 4 (low impact) - 40 (high impact))
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))
time frame: from before start to 4, 8, 12 and 24 months after start of the Tandem Control-IQ for children
description: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, worry (scale: 0 (not worried) - 60 (very worried))
measure: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
time frame: from before start to 4, 8, 12 and 24 months after start for children
description: Fear of hypoglycemia measured by the Hypoglycemia Fear Survey for children (HFS-C) questionnaire, behaviour (scale: 0 (less adapted behaviour) - 40 (more adapted behaviour))
measure: The Diabetes Quality of Life for Youth (DQOLY) questionnaire
time frame: from before start to 4, 8, 12 and 24 months after start for children
description: The Diabetes Quality of Life for Youth (DQOLY) questionnaire
measure: Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)
time frame: from before start to 4, 8, 12 and 24 months after start for parents
description: Questionnaire for parents of children and adolescents with diabetes, a part of the HAPPI-D QOL Protocol (Hvidøre, Adolescent, Parent, Professional, Instrument, Diabetes)
measure: The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents
time frame: from before start to 4, 8, 12 and 24 months after start for parents
description: The Parent's fear of hypoglycemia scale - modified version of the Hypoglycemia Fear Survey for use with parents
measure: Composite endpoint of HbA1c and time in hypoglycemia <70 mg/dl
time frame: from before start to 4, 8, 12 and 24 months after start
description: Composite endpoint of HbA1c and time in hypoglycemia <70 mg/dl
measure: Severe hypoglycemia
time frame: from before start to 4, 8, 12 and 24 months after start
description: Frequency of severe hypoglycemia
measure: Diabetic ketoacidosis
time frame: from before start to 4, 8, 12 and 24 months after start
description: Frequency of diabetic ketoacidosis
measure: Hospital visits and/or admissions
time frame: from before start to 4, 8, 12 and 24 months after start
description: Number of hospital visits and/or admissions because of severe hypoglycemia or diabetic ketoacidosis
measure: Work and school absenteeism
time frame: from before start to 4, 8, 12 and 24 months after start
description: Work and school absenteeism (number of days that a patient was unable to attend work/school due to his/her diabetes (excluding consultation))
measure: (Unplanned) contacts with the diabetes team
time frame: from before start to 4, 8, 12 and 24 months after start
description: Frequency of (unplanned) contacts with the diabetes team
measure: Change in total daily dose of insulin (units/day)
time frame: from before start to 4, 8, 12 and 24 months after start
description: Change in total daily dose of insulin (units/day)
measure: Change in body weight (kilograms)
time frame: from before start to 4, 8, 12 and 24 months after start
description: Change in body weight (kilograms)
measure: Time in Manual Mode
time frame: only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system
description: Percentage of time spent in Manual Mode
measure: Time in Auto Mode
time frame: only measured at month 4, 8, 12 and 24 after start of the Medtronic MiniMed 670G an 780G system
description: Percentage of time spent in Auto Mode
measure: Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))
time frame: at start
description: Indications for use of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple options (non-ordinal))
measure: Patients who stop
time frame: only measured at stop
description: Number of patients who stop with hybrid closed-loop therapy
measure: Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)
time frame: only measured at stop
description: Reasons for discontinuation of hybrid closed-loop therapy measured by a self-developed questionnaire (multiple choice)
measure: Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the DIDP-FM questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Quality of life in partners of T1D patients using hybrid closed-loop therapy measured by the DAWN (Diabetes Attitudes, Wishes and Needs) Impact of Diabetes Profile Family Members (DIDP-FM) questionnaire (scale: 0 (less negative impact) - 100 (more negative impact)) Note: only in case of substudy
measure: Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the DIDP-FM questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Difference in quality of life in partners of T1D patients before and after implementation of hybrid closed-loop therapy, measured by the DIDP-FM questionnaire. Note: only in case of substudy
measure: Correlation between 'quality of life of T1D patients using hybrid closed-loop therapy' and 'quality of life in partners of T1D patients', both measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Correlation between 'quality of life of T1D patients using hybrid closed-loop therapy' and 'quality of life in partners of T1D patients', both measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2. Note: substudy only
time frame: from before start to 12 months after start
description: Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using the hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: substudy only
time frame: from before start to 12 months after start
description: Correlation between composite endpoint 'HbA1c and time in hypoglycemia <70 mg/dL' and 'quality of life in partners of T1D patients using the hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
measure: Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Correlation between 'frequency of severe hypoglycemia' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
measure: Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Correlation between 'frequency of diabetic ketoacidosis' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
measure: Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2. Note: substudy only
time frame: from before start to 12 months after start
description: Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the SF-36 version 2 questionnaire. Note: only in case of substudy
measure: Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
time frame: from before start to 12 months after start
description: Correlation between 'duration of type 1 diabetes of the patient (years)' and 'quality of life in partners of T1D patients using hybrid closed-loop therapy', the latter being measured by the DIDP-FM questionnaire. Note: only in case of substudy
arm group label: type 1 diabetes patients using Medtronic MiniMed 670G
description: Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 670G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.
arm group label: type 1 diabetes patients using Medtronic MiniMed 780G
description: Patients with type 1 diabetes, aged 8 years or older, who start with the Medtronic MiniMed 780G system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.
arm group label: type 1 diabetes patients using Tandem Control-IQ
description: Patients with type 1 diabetes, aged 6 years or older, who start with the Tandem Control-IQ system (as part of routine clinical practice) in one of the 17 participating centers and who signed informed consent are eligible to participate. The decision about which patient to start, is left to the clinical judgement of the treating health care professional.
intervention type: Device
intervention name: Medtronic MiniMed 670G
description: The Medtronic Minimed 670G system is a form of hybrid closed-loop insulin delivery. The Medtronic MiniMed 670G system automatically adjusts basal insulin every five minutes based on CGM readings to reach a glucose target of 120 mg/dL, the SmartGuard Auto Mode. Patients still need to enter their carbohydrate intake and administer meal-time and correction boluses. Before Auto Mode is introduced, the Medtronic MiniMed 670G system has to be worn in Manual Mode. In contrast to Auto Mode, Manual Mode features an insulin stop up to 30 minutes before or when reaching preset low limits (suspend before/on low) and an automatic insulin restart when blood sugar levels recover. During Manual Mode the pump 'becomes familiar with' the daily insulin need of the patient. This information will be used when in Auto Mode.
arm group label: type 1 diabetes patients using Medtronic MiniMed 670G
intervention type: Device
intervention name: Medtronic MiniMed 780G
description: The Medtronic Minimed 780G system differs in several aspects from the MiniMed 670G system. In Auto Mode, the user can choose from two target levels for even more stricter glucose control (100 mg/dL and 120 mg/dL) and correction boluses are now automated without the need of user interaction. When administering meal boluses, no capillary blood glucose value is required. The safety feature to exit from Auto Mode to Manual Mode was too strict in the Minimed 670G. In the Minimed 780G this is more flexible to overcome this frequently reported patient frustration.
arm group label: type 1 diabetes patients using Medtronic MiniMed 780G
intervention type: Device
intervention name: Tandem Control-IQ
description: The Tandem t:slim X2 Control-IQ consists of the Tandem t:slim X2 insulin pump with Control-IQ technology, and integrates with the Dexcom G6 CGM-device via Bluetooth. Blood glucose readings for calibration are not required. The Tandem t:slim X2 Control-IQ automatically adjusts basal insulin based on CGM readings to reach a glucose target range between of 112-160 mg/dL. Patients still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically increases the basal insulin dose or gives automated correction boluses in case of high blood glucose levels. The technology offers optional settings for sleep and exercise, with different glucose targets in order to match the insulin need during these activities. New versions of the pump software can be downloaded and installed remotely via the user's own computer.
arm group label: type 1 diabetes patients using Tandem Control-IQ
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Pieter Gillard, MD
role: Principal Investigator
affiliation: UZ Leuven
last name: Margaretha M Visser, MD
phone: +3216345977
email: margaretha.visser@uzleuven.be
last name: Sara Charleer, PhD
phone: +3216342398
email: sara.charleer@uzleuven.be
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country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: prof dr Pieter Gillard
investigator title: Clinical Professor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Undecided