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Clinical Trials/NCT04506216
NCT04506216
Completed
Not Applicable

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

Icadom1 site in 1 country200 target enrollmentSeptember 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes
Sponsor
Icadom
Enrollment
200
Locations
1
Primary Endpoint
Eating disorders in men and women
Status
Completed
Last Updated
4 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
December 23, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Icadom
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Eating disorders in men and women

Time Frame: 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 Outcomes

  • Overall glycemia(at inclusion)
  • Glycemic variability(at inclusion)
  • Basal/Bolus insulin ratio(at inclusion)
  • Adherence to the sensor(at inclusion)
  • Boluses performed per day(at inclusion)
  • Body composition(at inclusion)
  • Blood glucose monitoring(at inclusion)
  • Eating disorders in cohort(at inclusion)
  • Continuous glycemic control(at inclusion)
  • Auto declared insulin under dosage(at inclusion)

Study Sites (1)

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