Impact of Dietary Knowledge Related to Functional Insulin Therapy in Type 1 Diabetes on the Risk of Eating Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- to determine whether dietary knowledge related to functional insulin therapy (FIT) is associated with the risk of developing eating disorders (EDs)
研究概览
简要总结
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.
详细描述
STUDY DESCRIPTION
This is a Type 3 study under the Jardé law, involving human subjects:
Observational study Prospective design Monocentric National scope
We selected this study design to minimize participant burden (data collection conducted online, by phone, or via videoconference, eliminating the need for patient travel). Recruitment through patient association websites and social media will enable a national reach.
The study will take place in four phases:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Inability to complete online questionnaires and participate in a 45-minute videoconference interview
- •Being under legal guardianship or curatorship
- •Being pregnant or breastfeeding
结局指标
主要结局
to determine whether dietary knowledge related to functional insulin therapy (FIT) is associated with the risk of developing eating disorders (EDs)
时间窗: 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.
次要结局
- 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)
- To assess whether the following factors influence the risk of developing EDs: c. fear of hypoglycemia(Day 1)