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Recruiting NCT07021456

NCT07021456 Impact of Dietary Knowledge Related to Functional Insulin Therapy in Type 1 Diabetes on the Risk of Eating Disorders

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Clinical Trial Summary
NCT ID NCT07021456
Status Recruiting
Phase
Sponsor University Hospital, Grenoble
Condition Type 1 Diabetes (T1D)
Study Type OBSERVATIONAL
Enrollment 100 participants
Start Date 2025-04-14
Primary Completion 2025-12

Trial Parameters

Condition Type 1 Diabetes (T1D)
Sponsor University Hospital, Grenoble
Study Type OBSERVATIONAL
Phase N/A
Enrollment 100
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-04-14
Completion 2025-12

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Brief Summary

Background: The management of type 1 diabetes (T1D) relies on exogenous insulin administration to compensate for the lack of endogenous insulin production. Optimal glycemic control, essential for preventing long-term complications, requires precise insulin dose adjustments based on carbohydrate intake. Functional insulin therapy (FIT) allows for flexibility in insulin dosing according to carbohydrate consumption, thereby reducing the dietary constraints previously imposed on patients. However, this approach requires increased attention to dietary intake. Individuals with T1D already have a heightened risk of developing eating disorders (EDs). We hypothesize that the dietary knowledge required for FIT may contribute to rigid eating behaviors, thereby increasing the risk of EDs. Objective: This prospective monocentric study aims to determine whether dietary knowledge related to FIT is associated with an increased risk of EDs in individuals with T1D. Methods: The primary outcome measure is the correlation between the Gluciquizz score (a validated tool assessing FIT knowledge) and the risk of EDs, evaluated using the DEPS-R questionnaire (a validated screening tool for ED risk in T1D patients). In addition to this quantitative analysis, a qualitative study will be conducted through semi-structured interviews to explore in greater depth the patients' experiences, their relationship with food, and their perceptions of FIT-related requirements. Perspectives: This study aims to improve the understanding of the impact of FIT on ED risk in T1D. The findings may help identify at-risk patient profiles and enhance therapeutic education and patient management by integrating ED risk considerations. The qualitative approach will provide further insight into patients' individual experiences, facilitating recommendations tailored to their specific needs.

Eligibility Criteria

Inclusion Criteria: * Diagnosis of type 1 diabetes confirmed by a referring physician * Diagnosis received at least three months prior * Adult (18 years or older) * Access to a computer or smartphone capable of videoconferencing * No expressed opposition to participation * Consent for image rights (for Phase 2 qualitative interviews) Exclusion Criteria: * Inability to complete online questionnaires and participate in a 45-minute videoconference interview * Being under legal guardianship or curatorship * Being pregnant or breastfeeding

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