Suivi en Vie Réelle de l'Activité Physique de Patients Présentant un Diabète de Type 1 Sportifs Equipés d'Une Pompe à Insuline Avec Délivrance Automatisée d'Insuline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 4
- 主要终点
- Time Below Range
研究概览
简要总结
This is a non-interventional, prospective, multi-site study conducted in France among adults with type 1 diabetes mellitus using automated insulin delivery (AID) systems and engaging in at least two exercise sessions per week, each lasting at least 30 minutes. The main objective of this study is to describe the glycemic control of athletic participants with type 1 diabetes mellitus who use an insulin pump with AID and engage in physical exercise under real-life conditions.
Two physician data collection time points are planned: the first occurs at baseline and includes demographic and clinical data, glycemic control during the month preceding inclusion, diabetes management, and information on usual physical exercise (duration, type, sport practiced, competition participation, and adherence to a specific diet). The second occurs at 1-month follow-up and involves downloading insulin pump and glucose sensor data, covering the period from 15 days before the first reported exercise session to 15 days after the last session.
During the 1-month study period, participants will complete a paper logbook after each exercise session to document information such as the type of exercise, self-reported intensity using the modified Borg scale and the WHO physical activity intensity scale, duration, system adjustments, dietary intake, occurrence of hypoglycemia and associated symptoms, snacks consumed, and treatments administered for hypoglycemia.
详细描述
Three hybrid closed-loop systems dedicated to the automated management of type 1 diabetes are currently available in France: the Minimed 780G paired with the Guardian 4 continuous glucose monitoring system, Control-IQ, and mylife CamAPS-FX. Stratification will be performed based on the type of pump used by participants at the time of inclusion, at the national level, in order to obtain groups balanced in size.
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
- •Adult participants with diabetes mellitus type 1
- •User for at least 3 months of one the three automated insulin delivery systems available in France at the time of the study (Minimed 780G pump + Guardian 4 sensor + PID-IFB algorithm; or T:Slim X2 pump + Dexcom G6 sensor + Control-IQ algorithm; or mylife Ypsopump + Dexcom G6 sensor + CamAPS FX app)
- •Engaged in regular physical activity as part of daily life (at least 2 structured sessions per week, each lasting more than 30 minutes)
- •Able to download data from the pump
- •Willing and able to complete the physical activity log and self-questionnaires in French
- •Having received the information sheet and given their oral consent (non-opposition) to participate in the study and for their data processing
排除标准
- •Participants currently enrolled in a clinical trial
- •Pregnancy or breastfeeding women or women planning a pregnancy during the study
- •Adults under legal protection (guardianship, curatorship, or judicial safeguard)
- •Participants with decompensated retinopathy
- •Participants with decompensated cardiac disease
- •History of severe hypoglycemia during physical activity in the past 6 months
- •Participants with unresolved diabetic foot trophic disorders
研究组 & 干预措施
Adults with type 1 diabetes mellitus using AID and engaging in regular physical activity
干预措施: No Intervention: Observational Cohort (Other)
结局指标
主要结局
Time Below Range
时间窗: One month
Percentage of time spent with glucose \<70 mg/dL and \<54 mg/dL before the exercise (within 2 hours prior), during exercise, during early recovery (within 3 hours after exercise), late recovery (from 3 hours after exercise to 8:00 a.m. the following day or until the next pre-exercise window, if closely), and during non-exercise periods
次要结局
- Time-in-Range(One month)
- Time Above Range(One month)
- Ajustement Practices(One month)
- ADDQoL questionnaire(At inclusion)
- DTSQs questionnaire(At inclusion)
- HFS-II questionnaire(At inclusion)