<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/NCT03772600</url>
  </required_header>
  <id_info>
    <org_study_id>S61830</org_study_id>
    <nct_id>NCT03772600</nct_id>
  </id_info>
  <brief_title>Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes</brief_title>
  <acronym>ALERTT1</acronym>
  <official_title>Comparing Continuous With Flash Glucose Monitoring in Adults With Type 1 Diabetes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>DexCom, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system&#xD;
      (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control&#xD;
      group).&#xD;
&#xD;
      The ALERTT1 trial will have three phases: a baseline, study, and extension phase.&#xD;
&#xD;
      During the baseline phase, eligible patients will be screened for in- and exclusion criteria,&#xD;
      wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and&#xD;
      receive a uniform education moment.&#xD;
&#xD;
      In the study phase, patients will be randomized into two groups (1:1): the experimental group&#xD;
      will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the&#xD;
      FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients&#xD;
      in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their&#xD;
      FreeStyle Libre FGM.&#xD;
&#xD;
      In the extension phase, patients in the initial control group will start using unblinded&#xD;
      Dexcom G6® for 30 months. The initial experimental group will keep using the unblinded Dexcom&#xD;
      G6® for the next 30 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 29, 2019</start_date>
  <completion_date type="Actual">November 30, 2022</completion_date>
  <primary_completion_date type="Actual">October 1, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in time in range (70-180 mg/dL) between the control and experimental group</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Between group difference in time in clinically important hypoglycemia (&lt;54mg/dL)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference of HbA1c</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in time in hypoglycemia (&lt;70 mg/dL)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in time in target (70-140 mg/dL)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in time in hyperglycemia (&gt;180 mg/dL)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in time in clinically important hyperglycemia (&gt;250 mg/dL)</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite endpoint: between group difference in number of patients with HbA1c &lt;7% without episodes of severe hypoglycemia</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in glycemic variability as measured by coefficient of variation [CV]</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in glycemic variability as measured by standard deviation [SD]</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in mean glucose concentration</measure>
    <time_frame>6 months</time_frame>
    <description>measured by Dexcom G6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in number of low glucose events (LGE)</measure>
    <time_frame>6 months</time_frame>
    <description>LGE, measured by Dexcom G6, is 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>Between group difference in number of severe hypoglycemic episodes</measure>
    <time_frame>6 months</time_frame>
    <description>reported by the participant</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in general quality of life measured by the SF-36 questionnaire</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Between group difference in number of patients having allergic reactions to the sensors</measure>
    <time_frame>6 months</time_frame>
    <description>confirmed by a dermatologist</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of diabetes contacts which are not preplanned</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Resource utilization (cost material, use of extra adhesives)</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of severe adverse events</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis)</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Work absenteeism due to diabetes</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients who stop using the Dexcom G6 CGM and the reason to stop</measure>
    <time_frame>6 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in range (70-180 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in target (70-140 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in hypoglycemia (&lt;70 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in clinically important hypoglycemia (&lt;54 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in hyperglycemia (&gt;180 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in clinically important hyperglycemia (&gt;250 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in glycemic variability, defined by coefficient of variation (CV)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in glycemic variability, defined by standard deviation (SD)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in time in number of low glucose events (LGE) (LGE is defined as sensor glucose values ≤54 mg/dL for at least 20 minutes, preceded by at least 30 minutes with sensor glucose values &gt;54 mg/dL)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in HbA1c</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in in emotional distress due to diabetes measured by the PAID questionnaire</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in treatment satisfaction measured by the DTSQ</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in general quality of life measured by the SF-36 questionnaire</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in work absenteeism (expressed as days of work absenteeism per patient year)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients who stop using the Dexcom G6® CGM and the reason to stop</measure>
    <time_frame>36 months (extension phase)</time_frame>
    <description>within-group change</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">269</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Dexcom G6</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use a Dexcom G6 CGM for 36 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FreeStyle Libre</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Keep using their FreeStyle Libre for 6 months. Before the 6 month time point is reached, patients will wear a blinded Dexcom G6 for 28 days, together with their FreeStyle Libre.&#xD;
Cross-over to Dexcom G6 for 30 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dexcom G6 CGM</intervention_name>
    <description>Use of Dexcom G6</description>
    <arm_group_label>Dexcom G6</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  signed ICF&#xD;
&#xD;
          -  diagnosis of type 1 diabetes ≥6 months&#xD;
&#xD;
          -  using FreeStyle Libre FGM system ≥6 months&#xD;
&#xD;
          -  intensified insulin therapy/insulin pump therapy&#xD;
&#xD;
          -  HbA1c ≤10%&#xD;
&#xD;
          -  willing to wear the glucose monitoring device &gt;80% of the time&#xD;
&#xD;
          -  willing to download glucose monitoring data at regular intervals&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-type 1 diabetes participants or diagnosis &lt;6 months&#xD;
&#xD;
          -  participant with T1D not on insulin, or on non-intensified insulin therapy&#xD;
&#xD;
          -  pregnancy or planning pregnancy within next 6 months&#xD;
&#xD;
          -  severe cognitive dysfunction or other disease which makes sensor use difficult&#xD;
&#xD;
          -  current treatment with drugs known to have significant interference with glucose&#xD;
             metabolism, such as systemic corticosteroids, as judged by the investigator&#xD;
&#xD;
          -  abnormal skin at the anticipated glucose sensor insertion sites (excessive hair, burn,&#xD;
             inflammation, infection, rash, and/or tattoo)&#xD;
&#xD;
          -  presence of concomitant pathology that might cause edema at the insertion sites (such&#xD;
             as heart failure, liver failure, kidney failure defined as eGFR &lt;30 mL/min [stage ≥4])&#xD;
&#xD;
          -  beta-cell transplantation and c-peptide positive and/or under immunosuppressive&#xD;
             therapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Onze-Lieve-Vrouw Ziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imeldaziekenhuis Bonheiden</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Brussels</name>
      <address>
        <city>Jette</city>
        <zip>1090</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Groeninge Kortrijk</name>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Antwerp</name>
      <address>
        <city>Wilrijk</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</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>Prof Dr</investigator_title>
  </responsible_party>
  <keyword>Dexcom G6</keyword>
  <keyword>FreeStyle Libre</keyword>
  <keyword>time in range</keyword>
  <keyword>continuous glucose monitoring</keyword>
  <keyword>flash glucose monitoring</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>Yes</sharing_ipd>
    <ipd_description>Anonymous data can be shared with participating centers, based on research questions mentioned in this protocol or based on a new study protocol approved by the relevant ethical committees.</ipd_description>
  </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/NCT03772600
org study id: S61830
nct id: NCT03772600
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study wants to compare the Dexcom G6® continuous glucose monitoring (CGM) system
      (experimental group) with the FreeStyle Libre flash glucose monitoring (FGM) system (control
      group).

      The ALERTT1 trial will have three phases: a baseline, study, and extension phase.

      During the baseline phase, eligible patients will be screened for in- and exclusion criteria,
      wear a blinded Dexcom G6® for 28 days, together with their FreeStyle Libre FGM system, and
      receive a uniform education moment.

      In the study phase, patients will be randomized into two groups (1:1): the experimental group
      will use an unblinded Dexcom G6® CGM for 6 months, the control group will keep using the
      FreeStyle Libre FGM system for 6 months. Before the 6 month time point is reached, patients
      in the control group will wear a blinded Dexcom G6® CGM for 28 days, together with their
      FreeStyle Libre FGM.

      In the extension phase, patients in the initial control group will start using unblinded
      Dexcom G6® for 30 months. The initial experimental group will keep using the unblinded Dexcom
      G6® for the next 30 months.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: multicenter, randomized, double arm, open label, partial cross-over, parallel group clinical trial
primary purpose: Other
masking: None (Open Label)
measure: Difference in time in range (70-180 mg/dL) between the control and experimental group
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in time in clinically important hypoglycemia (<54mg/dL)
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference of HbA1c
time frame: 6 months
measure: Between group difference in fear of hypoglycemia measured by the hypoglycemia fear survey
time frame: 6 months
measure: Between group difference in time in hypoglycemia (<70 mg/dL)
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in time in target (70-140 mg/dL)
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in time in hyperglycemia (>180 mg/dL)
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in time in clinically important hyperglycemia (>250 mg/dL)
time frame: 6 months
description: measured by Dexcom G6
measure: Composite endpoint: between group difference in number of patients with HbA1c <7% without episodes of severe hypoglycemia
time frame: 6 months
measure: Between group difference in glycemic variability as measured by coefficient of variation [CV]
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in glycemic variability as measured by standard deviation [SD]
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in glycemic variability as measured by mean amplitude of glycemic excursions [MAGE]
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in mean glucose concentration
time frame: 6 months
description: measured by Dexcom G6
measure: Between group difference in number of low glucose events (LGE)
time frame: 6 months
description: LGE, measured by Dexcom G6, is 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: Between group difference in number of severe hypoglycemic episodes
time frame: 6 months
description: reported by the participant
measure: Between group difference in emotional distress due to diabetes measured by the problem areas in diabetes (PAID) questionnaire
time frame: 6 months
measure: Between group difference in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
time frame: 6 months
measure: Between group difference in treatment satisfaction measured by the diabetes treatment satisfaction questionnaire (DTSQ)
time frame: 6 months
measure: Between group difference in general quality of life measured by the SF-36 questionnaire
time frame: 6 months
measure: Between group difference in number of patients having allergic reactions to the sensors
time frame: 6 months
description: confirmed by a dermatologist
measure: Number of diabetes contacts which are not preplanned
time frame: 6 months
measure: Resource utilization (cost material, use of extra adhesives)
time frame: 6 months
measure: Number of severe adverse events
time frame: 6 months
measure: Hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis)
time frame: 6 months
measure: Work absenteeism due to diabetes
time frame: 6 months
measure: Number of patients who stop using the Dexcom G6 CGM and the reason to stop
time frame: 6 months
measure: Changes in time in range (70-180 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in target (70-140 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in hypoglycemia (<70 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in clinically important hypoglycemia (<54 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in hyperglycemia (>180 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in clinically important hyperglycemia (>250 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in glycemic variability, defined by coefficient of variation (CV)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in glycemic variability, defined by standard deviation (SD)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in glycemic variability, defined by mean amplitude of glycemic excursions (MAGE)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in time in number of low glucose events (LGE) (LGE is defined as sensor glucose values ≤54 mg/dL for at least 20 minutes, preceded by at least 30 minutes with sensor glucose values >54 mg/dL)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in HbA1c
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in in emotional distress due to diabetes measured by the PAID questionnaire
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in in hypoglycemia awareness measured by the Clarke hypoglycemia awareness survey
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in treatment satisfaction measured by the DTSQ
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in general quality of life measured by the SF-36 questionnaire
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in in fear of hypoglycemia measured by the hypoglycemia fear survey
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in hospitalizations for severe acute diabetes complications (hypoglycemia and ketoacidosis, expressed as admissions per patient year)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in work absenteeism (expressed as days of work absenteeism per patient year)
time frame: 36 months (extension phase)
description: within-group change
measure: Changes in number of severe hypoglycemic episodes (expressed as number of episodes per patient year)
time frame: 36 months (extension phase)
description: within-group change
measure: Number of patients who stop using the Dexcom G6® CGM and the reason to stop
time frame: 36 months (extension phase)
description: within-group change
arm group label: Dexcom G6
arm group type: Experimental
description: Use a Dexcom G6 CGM for 36 months
arm group label: FreeStyle Libre
arm group type: No Intervention
description: Keep using their FreeStyle Libre for 6 months. Before the 6 month time point is reached, patients will wear a blinded Dexcom G6 for 28 days, together with their FreeStyle Libre.
Cross-over to Dexcom G6 for 30 months.
intervention type: Device
intervention name: Dexcom G6 CGM
description: Use of Dexcom G6
arm group label: Dexcom G6
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: Universitaire Ziekenhuizen KU Leuven
investigator full name: prof dr Pieter Gillard
investigator title: Prof Dr
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 1
sharing ipd: Yes
ipd description: Anonymous data can be shared with participating centers, based on research questions mentioned in this protocol or based on a new study protocol approved by the relevant ethical committees.