Eating Disorders in Type 1 Insulin-dependent Diabetes Patients (Diaboulimia)

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes; Eating Disorders
• Intervention / Treatment: Other: cohort

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Meylan, France, 38240
    • AGIR à dom.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cohort; adult patients with type 1 diabetes and insulin pump treatment . Duration of participation: 30 minutes	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

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

Collaborators and Investigators

• Sponsor: Icadom
• Collaborators: AGIR à Dom
• Investigators: Principal Investigator: Cécile Bétry, PhD, Chu Grenoble Alpes

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): December 23, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 6, 2020
• First Posted (Actual): August 10, 2020

Study Record Updates

• Last Update Posted (Actual): April 8, 2022
• Last Update Submitted That Met QC Criteria: March 31, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: diaboulimia; insulin pump treatment; DT1
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Feeding and Eating Disorders
• Other Study ID Numbers: 2020-A00147-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No