Eating Disorders in Type 1 Insulin-dependent Diabetes Patients (Diaboulimia)
Primary Purpose
Type 1 Diabetes, Eating Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
cohort
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring diaboulimia, insulin pump treatment, DT1
Eligibility Criteria
Inclusion Criteria:
- Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump
- Patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (Agir à Dom group).
- Beneficiary of social security coverage.
Exclusion Criteria:
- Patient with type 2 diabetes or MODY diabetes
- Patient wearing a pacemaker
- Breastfeeding or pregnant woman
- Deprived of liberty by judicial or administrative decision
- Legal guardianship
Sites / Locations
- AGIR à dom.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
cohort
Arm Description
adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes
Outcomes
Primary Outcome Measures
Eating disorders in men and women
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.
Secondary Outcome Measures
Eating disorders in cohort
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.
Auto declared insulin under dosage
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.
Overall glycemia
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
Basal/Bolus insulin ratio
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
Boluses performed per day
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
Body composition
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.
Continuous glycemic control
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).
Glycemic variability
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.
Adherence to the sensor
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.
Blood glucose monitoring
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.
Full Information
NCT ID
NCT04506216
First Posted
August 5, 2020
Last Updated
March 31, 2022
Sponsor
Icadom
Collaborators
AGIR à Dom
1. Study Identification
Unique Protocol Identification Number
NCT04506216
Brief Title
Eating Disorders in Type 1 Insulin-dependent Diabetes Patients
Acronym
Diaboulimia
Official Title
Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
December 23, 2021 (Actual)
Study Completion Date
December 23, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Icadom
Collaborators
AGIR à Dom
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Eating Disorders
Keywords
diaboulimia, insulin pump treatment, DT1
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cohort prospective monocentric
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cohort
Arm Type
Experimental
Arm Description
adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes
Intervention Type
Other
Intervention Name(s)
cohort
Intervention 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
Primary Outcome Measure Information:
Title
Eating disorders in men and women
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.
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
Eating disorders in cohort
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.
Time Frame
at inclusion
Title
Auto declared insulin under dosage
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.
Time Frame
at inclusion
Title
Overall glycemia
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
Time Frame
at inclusion
Title
Basal/Bolus insulin ratio
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
Time Frame
at inclusion
Title
Boluses performed per day
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
Time Frame
at inclusion
Title
Body composition
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.
Time Frame
at inclusion
Title
Continuous glycemic control
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).
Time Frame
at inclusion
Title
Glycemic variability
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.
Time Frame
at inclusion
Title
Adherence to the sensor
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.
Time Frame
at inclusion
Title
Blood glucose monitoring
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.
Time Frame
at inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient over 18 years of age with type 1 diabetes treated with a subcutaneous insulin pump
Patient followed up for a subcutaneous insulin pump treatment by the healthcare provider, participating in the study (Agir à Dom group).
Beneficiary of social security coverage.
Exclusion Criteria:
Patient with type 2 diabetes or MODY diabetes
Patient wearing a pacemaker
Breastfeeding or pregnant woman
Deprived of liberty by judicial or administrative decision
Legal guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cécile Bétry, PhD
Organizational Affiliation
CHU Grenoble Alpes
Official's Role
Principal Investigator
Facility Information:
Facility Name
AGIR à dom.
City
Meylan
ZIP/Postal Code
38240
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan 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 Sharing Time Frame
January 2022 to January 2037
IPD Sharing Access Criteria
Researchers requesting the data have to be able to present a scientific reason to get access
Learn more about this trial
Eating Disorders in Type 1 Insulin-dependent Diabetes Patients
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