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NCT07021456Recruiting

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

Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
24 Feb 2025
Start date
14 Apr 2025
Primary completion date
Dec 2025
Lead sponsor
University Hospital, Grenoble
NCT number
NCT07021456

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 14 Apr 2025 to the primary completion date, Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Inability to complete online questionnaires and participate in a 45-minute videoconference interview
  • Being under legal guardianship or curatorship
  • Being pregnant or breastfeeding

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

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SiteCityCountrySite status
Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.