Eating Disorders in Type 1 Insulin-dependent Diabetes Patients
- Conditions
- Eating DisordersType 1 Diabetes
- Interventions
- Other: cohort
- Registration Number
- NCT04506216
- Lead Sponsor
- Icadom
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cohort cohort adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes
- Primary Outcome Measures
Name Time Method Eating disorders in men and women at inclusion 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
Name Time Method Overall glycemia at inclusion 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
Glycemic variability at inclusion 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.
Basal/Bolus insulin ratio at inclusion 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
Adherence to the sensor at inclusion 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.
Boluses performed per day at inclusion 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 at inclusion 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.
Blood glucose monitoring at inclusion 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.
Eating disorders in cohort at inclusion 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.Continuous glycemic control at inclusion 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).
Auto declared insulin under dosage at inclusion 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.
Trial Locations
- Locations (1)
AGIR à dom.
🇫🇷Meylan, France