Eating Disturbances in Patients With Type 1 Diabetes Initiating Insulin Therapy

NCT07151924 | Active Not Recruiting

• 2 other identifiers: RC31/24/0571ID-RCB
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Diabete Type 1

Keywords

diabete type 1; eating disorders; eating; insulin; insulin therapy

Outcome Measures

Primary Outcomes (1)

• Prevalence of eating disorders

  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).

  6 months after the inclusion

Secondary Outcomes (14)

• Prevalence of eating disorders (EDs)

  6 months after the inclusion

• Clinical characteristics at inclusion

  6 months after the inclusion

• Clinical characteristics at inclusion

  6 months after the inclusion

• Clinical characteristics at inclusion

  6 months after the inclusion

• Clinical characteristics at inclusion

  6 months after the inclusion

Study Arms (1)

Patients with type 1 diabete

Patients with type 1 diabete with closed-loop therapy

Other: Questionnaires answers; Other: Biological assessment

Interventions

Questionnaires answers OTHER

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

Patients with type 1 diabete

Biological assessment OTHER

Collection of HbA1c level and continuous glucose monitoring data

Patients with type 1 diabete

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with type 1 diabetes for whom closed-loop insulin therapy has been recommended

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Diabetology, Metabolic Diseases and Nutrition Department Rangueil Hospital, Toulouse University Hospital 1 avenue du Pr Jean Poulhès

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Insulin Resistance

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2025
• First Posted: September 3, 2025
• Study Start: September 4, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)