Eating Disorders in Type 1 Insulin-dependent Diabetes Patients

Study Overview
=================
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.

Official Title
-----------------
Prevalence of Eating Disorders in Adult Patients With Type I Diabetes and Insulin Pump Treatment

Conditions
-----------------
Type 1 Diabetes, Eating Disorders

Intervention / Treatment
-----------------
* Other: cohort


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: cohort prospective monocentric
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cohort<br>adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes | Other: cohort<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at inclusion | 
| 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. | at inclusion | 
| 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 | at inclusion | 
| 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 | at 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 | at 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. | at inclusion | 
| 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). | at inclusion | 
| 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. | at inclusion | 
| 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. | at inclusion | 
| 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. | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diaboulimia, insulin pump treatment, DT1