The diabEAT Study: Insulin dElivery Technologies And eaTing Behaviours in People With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 106
- 试验地点
- 1
- 主要终点
- Disordered Eating Behaviours
研究概览
简要总结
Type 1 diabetes is an autoimmune health condition that requires daily injections of insulin. Insulin allows the body to use energy from carbohydrates in food. Disordered eating behaviours, like restricting food intake to lose body weight, are more common in women and people with type 1 diabetes, compared to those without because they must practice carbohydrate counting. Carbohydrate counting means identifying, measuring, and planning carbohydrate intake to match insulin dosage. New technologies, such as automated insulin delivery (AID) systems adjust insulin delivery in a blood sugar responsive manner. AID is rapidly replacing conventional insulin delivery like injections or non-automated insulin pumps since it reduces management burden and improves blood sugar levels. It is not known if AID reduces food management and disordered eating behaviours. This study aims to: 1. investigate the relationship between AID and eating behaviours according to gender for youth (12 to 17 years), and adults (18 years and older). 2. Determine the limit of carbohydrate counting inaccuracy to maintain stable blood sugar levels according to insulin delivery method (AID, injections, or pumps). It is hypothesized that those who use AID will have lower disordered eating behaviours and will maintain stable blood sugar levels while allowing for higher carbohydrate counting inaccuracy. This will be a cross-sectional cohort study of people with type 1 diabetes who are 12 years of age or over. Participants will be recruited through the BETTER registry and social medias across Canada. This research is needed to improve nutrition guidelines for type 1 diabetes in the context of new technologies like AID. Evidence from this study may reduce food management burden, lower the risk of disordered eating behaviours, and prevent eating disorders and medical complications.
详细描述
Introduction: Type 1 diabetes occurs when the pancreas cannot produce insulin and a person must be given insulin exogenously. Managing this health condition involves strict diet planning including carbohydrate counting (i.e. identifying and counting carbohydrates to match insulin dose). In addition, to high food management burden, frequent bodyweight monitoring, and weight gain related to insulin usage, makes people living with type 1 diabetes more susceptible to disordered eating behaviours (like intentional food restriction), compared to those without. Automated insulin delivery systems (AID), which automatically adjusts insulin as a response to continuously measured blood glucose levels has shown to improve quality of life, and improve glycemic levels, however it's impact on eating behaviours and diet is unknown. There is also a need to determine the carbohydrate counting inaccuracy threshold to maintain glycemic stability depending on the type of delivery system used (AID vs. Not).
Objectives:
- Determine the relationship between AID and eating behaviours
- Determine the carbohydrate counting inaccuracy threshold to maintain glycemic stability and understand whether AID use modifies this relationship.
Methods: This is an observational cross-section analysis of people with type 1 diabetes.
Eligibility criteria included: those living with type 1 diabetes for more than 1 year, using at least 2 insulin injections per day or using an insulin pump, who were living in Canada, 12 years of age or older, and using their current insulin delivery system for 3 months or more.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •12 years of age or older
- •Living in Canada
- •Living with type 1 diabetes for more than 1 year
- •Using at least 2 insulin injections per day or using an insulin pump
- •Using current insulin delivery system for 3 months or more
排除标准
- •Are pregnant or currently are breastfeeding
- •Don't speak French or English
- •Does not have a smart phone (to download applications)
结局指标
主要结局
Disordered Eating Behaviours
时间窗: Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026.
The primary outcome variable disordered eating behaviours will be measured through the Three Factor Eating Questionnaire-Revised 21 (TFEQ) in adults. The primary outcome for youth (12 to 17y) is the Child Three Factor Eating Questionnaire 17, which is an adapted questionnaire from the TFEQ. TFEQ refers to current dietary practice and measures 3 different aspects of eating behaviour: cognitive dietary restraint (conscious restriction of food intake) score ranges from 6 to 24, uncontrolled eating (tendency to eat more than usual due to loss of control over intake accompanied by subjective feelings of hunger) score ranges from 9 to 36, and emotional eating (inability to resist emotional cues) score ranges from 6 to 24. Higher scores in the respective scales indicate greater level of restrained, uncontrolled, or emotional eating.
Diabetes Disordered Eating Behaviours
时间窗: Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026
The Diabetes Eating Problem Survey (DEPS-R) is a 16-item questionnaire for youth and adults over the age of 12 years. It refers to disordered eating behaviours specific to people with type 1 diabetes. The score ranges from 0 to 80, with a higher score indicating higher risk of disordered eating.
Orthorexia Eating Behaviours
时间窗: Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026
The Teruel Orthorexia Scale is a 17-item questionnaire, that is validated in both English and French. It measures 'healthy orthorexia' behaviours as well as behaviours related to 'orthorexia nervosa'. Healthy orthorexia describes individuals who have a high interest in healthy eating, but in a non-pathological dimension of orthorexia. This sub scales score ranges from 0 to 27. Orthorexia nervosa includes behaviours that are related to healthy eating that may cause malnutrition, emotional distress, and social impairment. This subscale ranges from 0 to 24. A higher score represents more orthorexia symptoms.
次要结局
- Glucose Time In Range (TIR)(Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026.)
- Coefficient of Variation (CV)(Collected at one time point per participant at the time of survey completion. The study has an observational, cross-sectional design from April 2024 to estimated May 2026.)
研究者
Anne-Sophie Brazeau
Associate Professor
McGill University