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Recruiting Observational

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

NCT07021456 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-04-14
Last updated
2025-06-15

Condition(s) studied

Type 1 Diabetes (T1D)

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • to determine whether dietary knowledge related to functional insulin therapy (FIT) is associated with the risk of developing eating disorders (EDs) — Day 1
    the correlation between the Gluciquizz score (a validated tool assessing FIT knowledge) and the risk of EDs, as measured by the DEPS-R questionnaire.

Trial sites (1)

FacilityCityRegionStatus
Grenoble Grenoble France Recruiting
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 NCT07021456 on ClinicalTrials.gov ↗ ← All trials in France