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

NCT07021456 | Recruiting DMC

• 2 other identifiers: 38RC24.03672024-A02313-44
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes (T1D)

Keywords

eating disorders; functional insulin therapy; type 1 diabetes; dietary knowledge

Outcome Measures

Primary Outcomes (1)

• to determine whether dietary knowledge related to functional insulin therapy (FIT) is associated with the risk of developing eating disorders (EDs)

  the correlation between the Gluciquizz score (a validated tool assessing FIT knowledge) and the risk of EDs, as measured by the DEPS-R questionnaire.

  Day 1

Secondary Outcomes (6)

• To determine whether dietary knowledge related to FIT is associated with the risk of EDs according to the SCOFF-F questionnaire (a validated French screening tool for EDs).

  Day 1

• To assess whether the following factors influence the risk of developing EDs: a. Quality of life

  Day 1

• To identify whether specific patient profiles at risk of developing EDs emerge based on the collected variables.

  Day 1

• To explore the influence of functional insulin therapy on eating behaviors through semi-structured interviews.

  Day 1

• To assess whether the following factors influence the risk of developing EDs: b. Diabetes-related anxiety

  Day 1

Eligibility Criteria

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

Study Population

We aim to include patients with type 1 diabetes (T1D) in France. Participants will be enrolled in the study regardless of their current treatment. We will reach out to French patient associations for individuals with T1D, such as the Fédération Française des Diabétiques, to request the dissemination of our recruitment announcement to their members. The announcement will also be published on social media. Recruitment will be based on an online announcement, attached in Appendix 1. Additionally, we will propose to the Endocrinology Department at CHU Grenoble-Alpes to display the recruitment announcement in their waiting rooms to present it to their patients. If these recruitment channels do not yield a sufficient number of participants, we will expand dissemination to other hospital departments at the national level.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Laboratoire TIMC-IMAG: collaborator

Study Sites (1)

Grenoble

Grenoble, 38000, France

RECRUITING

Related Publications (3)

• De Paoli T, Rogers PJ. Disordered eating and insulin restriction in type 1 diabetes: A systematic review and testable model. Eat Disord. 2018 Jul-Aug;26(4):343-360. doi: 10.1080/10640266.2017.1405651. Epub 2017 Nov 28.

  PMID: 29182474 BACKGROUND

• Palmieri S, Mansueto G, Ruggiero GM, Caselli G, Sassaroli S, Spada MM. Metacognitive beliefs across eating disorders and eating behaviours: A systematic review. Clin Psychol Psychother. 2021 Sep;28(5):1254-1265. doi: 10.1002/cpp.2573. Epub 2021 Feb 23.

  PMID: 33606916 BACKGROUND

• Cheng R, Taleb N, Stainforth-Dubois M, Rabasa-Lhoret R. The promising future of insulin therapy in diabetes mellitus. Am J Physiol Endocrinol Metab. 2021 May 1;320(5):E886-E890. doi: 10.1152/ajpendo.00608.2020. Epub 2021 Mar 15.

  PMID: 33719586 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Cécile BERTY

CONTACT

0476765509; CBetry@chu-grenoble.fr

Laura ALBALADEJO

CONTACT

0476765509; LAlbaladejo@chu-grenoble.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2025
• First Posted: June 15, 2025
• Study Start: April 14, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-04

Locations

FR (1)