Development of a Closed Loop for the Treatment of Type 2 Diabetes: Collection of Clinical Data at Home for the Creation of an Algorithmic Laboratory Test Bench
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Diabeloop
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Glucose level modification
研究概览
简要总结
The objective of this study is to collect the evolution of blood glucose levels in type 2 diabetes (T2D) patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
详细描述
T2D is a condition that combines insulin resistance and relative insulin deficiency. The T2D naturally progresses towards an increasingly pronounced insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires a complete and immediate substitution of pancreatic insulin secretion. Currently, patients need to be involved in managing their disease by deciding how much insulin to administer based on the results of glucose monitoring. Artificial intelligence, thanks to a self-learning algorithm, enables the automation and customization of insulin administration. These devices, known as closed loops, bring real benefit to the patients included in the studies, by improving glycemic balance, by decreasing the number of hypo- and hyperglycemia but also by decreasing the mental load associated with the disease, improving their quality of life.
These very significant benefits in the T1D treatment open the possibility of obtaining similar benefits in the T2D treated by the basal-bolus type insulin regimen. This study aims to develop a specific algorithm of T2D to meet its particular characteristics.
The objective of this study is to collect the evolution of blood glucose levels in T2D patients under different conditions of their daily life: physical activity, meals, sleep, etc. This data will be used to develop a test bench to evaluate insulin delivery algorithms to treat patients with insulin-resistant T2D using a closed loop.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with T2D treated with insulin pump for at least 6 months
- •Patient with a body mass index (BMI) between 27 and 40 kg/m2
- •Patient treated with a total daily dose of insulin between 40 and 300 U/24 h
- •Patient with CGM
- •Patient with Social security or beneficiary
- •Patient able to read and understand the procedure, and able to express consent for the study protocol
排除标准
- •Patient with T1D
- •Patient currently participating or having participated in the month prior to inclusion in another interventional clinical research that may impact the study, this impact is left to the investigator's discretion
- •Persons referred to in articles L.1121-5 to L.1121-8 of the CSP (corresponds to all the protected persons: pregnant woman (checked by the dosage of β-human chorionic gonadotropin for any woman wishing to participate in the protocol and in childbearing age 60 years), parturient, mother breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)
结局指标
主要结局
Glucose level modification
时间窗: 7 days
Continuous subcutaneous glucose level (measured by continuous glucose sensor (CGM)) for 7 days, compared to the daily activities collected and the insulin doses delivered by the insulin pump.
次要结局
- Medication intake(7 days)
- Schedule and type of food intake(7 days)
- Physical activity(7 days)
- Sleep duration(7 days)
- Patient's chronotype(7 days)