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Active, not recruiting Observational

Eating Disturbances in Patients With Type 1 Diabetes Initiating Insulin Therapy

NCT07151924 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-09-04
Last updated
2025-09-24

Condition(s) studied

Diabete Type 1

Investigational drug(s) / intervention(s)

Questionnaires answersBiological assessment

Questionnaires answers: Patients will be asked to complete the MScoff and QACD questionnaires during interviews with the dietitian at baseline, 3 months and 6 months.

Biological assessment: Collection of HbA1c level and continuous glucose monitoring data

Study summary

The prevalence of eating disorders is particularly high among people with type 1 diabetes (T1D). These abnormalities, such as "diabulimia," are frequently responsible for poor insulin therapy management and, consequently, chronic glycemic imbalance, exposing them to an increased risk of complications. Their detection and management unfortunately remain insufficient in current practice.

However, to date, no study has addressed the question of the prevalence and impact of eating disorders in this context. Our research hypotheses are therefore as follows:

1. The existence of an eating disorder is likely frequently overlooked and, therefore, not taken into account in patients with T1D initiating semi-automated insulin therapy with BF.
2. The existence of an eating disorder could impair the performance of the BF device in terms of improving glycemic control in patients with T1D initiating this treatment method.

Patients clinical characteristics, glycemic monitoring parameters ad questionnaires answers will be recorded. The prevalence of eating disorders will be calculated, and the association between the presence of these abnormalities and baseline clinical characteristics and glycemic control parameters will be analyzed.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patient diagnosed with type 1 diabetes. * Patient with a CGM device for more than 3 months with \> 80% of data captured in the last month. * Indication for the implementation of a BF device as part of routine care, in the Diabetology, Metabolic Diseases and Nutrition Department of the Toulouse University Hospital (initiating center). Exclusion Criteria: * Pregnant or breastfeeding women, or those planning to become pregnant within 6 months of inclusion. * History of obesity surgery or a preparatory program for obesity surgery planned during the study period. * Pharmacological treatment likely to significantly influence food intake and body weight, whether ongoing or discontinued within the last 3 months (e.g., GLP-1R agonist): Liraglutide (Victoza®, Saxenda®), Semaglutide (Ozempic®, Wegovy®), Dulaglutide (Trulicity®), Tirzepatde (Mounjaro®), Orlistat (Xenical®) * Eating disorder requiring specific treatment in the previous 12 months. * Refusal or inability to consent to participate. * Persons under legal protection (guardianship, curatorship, or court-ordered protection).

Primary outcome measure(s)

  • Prevalence of eating disorders — 6 months after the inclusion
    The primary outcome measure for establishing the prevalence of eating disorders is a composite outcome measure based on determining the existence of eating disorders \[ED\] by analyzing responses to the mSCOFF questionnaire (score ≥ 2) and/or problematic eating behaviors \[PEB\] by analyzing responses to the QACD questionnaire (score ≥ 20).

Trial sites (1)

FacilityCityRegionStatus
Diabetology, Metabolic Diseases and Nutrition Department Rangueil Hospital, Toulouse University Hospital 1 avenue du Pr Jean Poulhès Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07151924 on ClinicalTrials.gov ↗ ← All trials in France