Eating Disorders in Type 1 Insulin-dependent Diabetes Patients

Type 1 Diabetes Clinical Trial

— Diaboulimia  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506216
• Other study ID #: 2020-A00147-32
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 23, 2021

Study information

• Verified date: March 2022
• Source: Icadom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the prevalence of eating disorders in type 1 insulin-dependent diabetes patients

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 23, 2021
• Est. primary completion date: December 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Eating Disorders
• Feeding and Eating Disorders
• Type 1 Diabetes

Intervention

Other:
• cohort
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

Locations

Country	Name	City	State
France	AGIR à dom.	Meylan

Sponsors (2)

Lead Sponsor	Collaborator
Icadom	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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