<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/NCT04506216</url>
  </required_header>
  <id_info>
    <org_study_id>2020-A00147-32</org_study_id>
    <nct_id>NCT04506216</nct_id>
  </id_info>
  <brief_title>Eating Disorders in Type 1 Insulin-dependent Diabetes Patients</brief_title>
  <acronym>Diaboulimia</acronym>
  <official_title>Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Icadom</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AGIR à Dom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Icadom</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to determine the prevalence of eating disorders in type 1&#xD;
      insulin-dependent diabetes patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The risk of developing an eating disorder is increased in type 1 diabetes patients and&#xD;
      associated with a poor prognosis in terms of glycemic control, metabolic complications,&#xD;
      degenerative complications, and mortality.&#xD;
&#xD;
      Therefore the terminology diaboulimia has emerged to characterize an eating disorder specific&#xD;
      to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of&#xD;
      losing or controlling weight and that can contribute to a deterioration of the body&#xD;
      composition.&#xD;
&#xD;
      The purpose of this study is to determine the prevalence of eating disorders in an adult&#xD;
      cohort with type 1 insulin-dependent diabetes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">December 23, 2021</completion_date>
  <primary_completion_date type="Actual">December 23, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>cohort prospective monocentric</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eating disorders in men and women</measure>
    <time_frame>at inclusion</time_frame>
    <description>To determine eating disorder prevalence in differentiated adult men and women with type 1 insulin-dependent diabetes.&#xD;
Patients answer to the SCOFF-F questions :&#xD;
do you make yourself sick because you feel uncomfortably full?&#xD;
do you worry that you have lost control over how much you eat?&#xD;
have you recently lost more than one stone in a 3 month period?&#xD;
do you believe yourself to be fat when others say you are too thin?&#xD;
would you say that food dominates your life?&#xD;
Every &quot;yes&quot; attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating disorders in cohort</measure>
    <time_frame>at inclusion</time_frame>
    <description>To determine eating disorder prevalence in undifferentiated cohort (men and woman) with type 1 insulin-dependent diabetes.&#xD;
Patients answer to the SCOFF-F questions :&#xD;
do you make yourself sick because you feel uncomfortably full?&#xD;
do you worry that you have lost control over how much you eat?&#xD;
have you recently lost more than one stone in a 3 month period?&#xD;
do you believe yourself to be fat when others say you are too thin?&#xD;
would you say that food dominates your life?&#xD;
Every &quot;yes&quot; attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Auto declared insulin under dosage</measure>
    <time_frame>at inclusion</time_frame>
    <description>To Determine the auto declared insulin under dosage prevalence in undifferentiated cohort (men and woman) with type 1 insulin-dependent diabetes.&#xD;
Patients answer to the 5th m-SCOFF question :&#xD;
- do you ever take less insulin than you should?&#xD;
A &quot;yes&quot; answer means that patient underdoses insulin treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall glycemia</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and overall glycemic control, we will look after the last biological value of HbA1c rates</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Basal/Bolus insulin ratio</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and basal/bolus insulin ratio, we will extract and compare to eating disorder presence, this daily data from insulin pump over the 14 days preceding inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Boluses performed per day</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and boluses performed per day, we will extract and compare to eating disorder presence, this daily data from insulin pump over the 14 days preceding inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body composition</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and body composition, we will perform a bio-electric impedance analysis and compare the result to eating disorder presence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous glycemic control</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and continuous glycemic control, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Glycemic control will be determined by the percentage of daily time into the glycemic target (between 70 and 180 mg/dL).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glycemic variability</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and glycemic variability, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Glycemic variability will be determined by the Mean Amplitude of Glycemic Excursions (MAGE) algorithm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence to the sensor</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and the adherence to the continuous glucose monitoring system (CGMS), we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Adherence will be determined by the number of minutes worn per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood glucose monitoring</measure>
    <time_frame>at inclusion</time_frame>
    <description>To identify if there is a link between an eating disorder and blood glucose monitoring, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion The monitoring will be determined by the number of scans done per day.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Type 1 Diabetes</condition>
  <condition>Eating Disorders</condition>
  <arm_group>
    <arm_group_label>cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cohort</intervention_name>
    <description>During a regular follow-up visit, the following data will be collected:&#xD;
questionnaires on lifestyle, eating custom (SCOFF-F, 5th question of the m-SCOFF) and physical activity (IPAQ)&#xD;
bio-electric impedance analysis&#xD;
insulin pump and sensor data collection</description>
    <arm_group_label>cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous&#xD;
             insulin pump&#xD;
&#xD;
          -  Patient followed up for a subcutaneous insulin pump treatment by the healthcare&#xD;
             provider, participating in the study (Agir à Dom group).&#xD;
&#xD;
          -  Beneficiary of social security coverage.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient with type 2 diabetes or MODY diabetes&#xD;
&#xD;
          -  Patient wearing a pacemaker&#xD;
&#xD;
          -  Breastfeeding or pregnant woman&#xD;
&#xD;
          -  Deprived of liberty by judicial or administrative decision&#xD;
&#xD;
          -  Legal guardianship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cécile Bétry, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Grenoble Alpes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>AGIR à dom.</name>
      <address>
        <city>Meylan</city>
        <zip>38240</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>March 31, 2022</last_update_submitted>
  <last_update_submitted_qc>March 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diaboulimia</keyword>
  <keyword>insulin pump treatment</keyword>
  <keyword>DT1</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Feeding and Eating Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Contact icadom@agiradom.com for any data request. The researcher will be invited to complete a form (data sharing agreement) explaining the reasons and the aim of the data requests. The data will be de-identified.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>January 2022 to January 2037</ipd_time_frame>
    <ipd_access_criteria>Researchers requesting the data have to be able to present a scientific reason to get access</ipd_access_criteria>
  </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/NCT04506216
org study id: 2020-A00147-32
nct id: NCT04506216
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine the prevalence of eating disorders in type 1
      insulin-dependent diabetes patients
The risk of developing an eating disorder is increased in type 1 diabetes patients and
      associated with a poor prognosis in terms of glycemic control, metabolic complications,
      degenerative complications, and mortality.

      Therefore the terminology diaboulimia has emerged to characterize an eating disorder specific
      to type 1 insulin-dependent diabetes patients, with insulin under dosage with a view of
      losing or controlling weight and that can contribute to a deterioration of the body
      composition.

      The purpose of this study is to determine the prevalence of eating disorders in an adult
      cohort with type 1 insulin-dependent diabetes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: cohort prospective monocentric
primary purpose: Other
masking: None (Open Label)
measure: Eating disorders in men and women
time frame: at inclusion
description: To determine eating disorder prevalence in differentiated adult men and women with type 1 insulin-dependent diabetes.
Patients answer to the SCOFF-F questions :
do you make yourself sick because you feel uncomfortably full?
do you worry that you have lost control over how much you eat?
have you recently lost more than one stone in a 3 month period?
do you believe yourself to be fat when others say you are too thin?
would you say that food dominates your life?
Every "yes" attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.
measure: Eating disorders in cohort
time frame: at inclusion
description: To determine eating disorder prevalence in undifferentiated cohort (men and woman) with type 1 insulin-dependent diabetes.
Patients answer to the SCOFF-F questions :
do you make yourself sick because you feel uncomfortably full?
do you worry that you have lost control over how much you eat?
have you recently lost more than one stone in a 3 month period?
do you believe yourself to be fat when others say you are too thin?
would you say that food dominates your life?
Every "yes" attributes one point and gives a final score between 0 and 5; a score ≥2 indicates an eating disorder.
measure: Auto declared insulin under dosage
time frame: at inclusion
description: To Determine the auto declared insulin under dosage prevalence in undifferentiated cohort (men and woman) with type 1 insulin-dependent diabetes.
Patients answer to the 5th m-SCOFF question :
- do you ever take less insulin than you should?
A "yes" answer means that patient underdoses insulin treatment.
measure: Overall glycemia
time frame: at inclusion
description: To identify if there is a link between an eating disorder and overall glycemic control, we will look after the last biological value of HbA1c rates
measure: Basal/Bolus insulin ratio
time frame: at inclusion
description: To identify if there is a link between an eating disorder and basal/bolus insulin ratio, we will extract and compare to eating disorder presence, this daily data from insulin pump over the 14 days preceding inclusion
measure: Boluses performed per day
time frame: at inclusion
description: To identify if there is a link between an eating disorder and boluses performed per day, we will extract and compare to eating disorder presence, this daily data from insulin pump over the 14 days preceding inclusion
measure: Body composition
time frame: at inclusion
description: To identify if there is a link between an eating disorder and body composition, we will perform a bio-electric impedance analysis and compare the result to eating disorder presence.
measure: Continuous glycemic control
time frame: at inclusion
description: To identify if there is a link between an eating disorder and continuous glycemic control, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Glycemic control will be determined by the percentage of daily time into the glycemic target (between 70 and 180 mg/dL).
measure: Glycemic variability
time frame: at inclusion
description: To identify if there is a link between an eating disorder and glycemic variability, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Glycemic variability will be determined by the Mean Amplitude of Glycemic Excursions (MAGE) algorithm.
measure: Adherence to the sensor
time frame: at inclusion
description: To identify if there is a link between an eating disorder and the adherence to the continuous glucose monitoring system (CGMS), we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion Adherence will be determined by the number of minutes worn per day.
measure: Blood glucose monitoring
time frame: at inclusion
description: To identify if there is a link between an eating disorder and blood glucose monitoring, we will extract and compare to eating disorder presence, this data from the continuous glucose monitoring system (CGMS) over the 14 days preceding inclusion The monitoring will be determined by the number of scans done per day.
arm group label: cohort
arm group type: Experimental
description: adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes
intervention type: Other
intervention name: cohort
description: During a regular follow-up visit, the following data will be collected:
questionnaires on lifestyle, eating custom (SCOFF-F, 5th question of the m-SCOFF) and physical activity (IPAQ)
bio-electric impedance analysis
insulin pump and sensor data collection
arm group label: cohort
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Cécile Bétry, PhD
role: Principal Investigator
affiliation: CHU Grenoble Alpes
facility: 
country: France
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Feeding and Eating Disorders
sharing ipd: Yes
ipd description: Contact icadom@agiradom.com for any data request. The researcher will be invited to complete a form (data sharing agreement) explaining the reasons and the aim of the data requests. The data will be de-identified.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: January 2022 to January 2037
ipd access criteria: Researchers requesting the data have to be able to present a scientific reason to get access