Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Diabeloop
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- Glycemic control evaluation for the 12-week main study
研究概览
简要总结
The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with type 2 diabetes (T2D) treated with insulin pumps.
详细描述
T2D is a condition that combines insulin resistance and relative insulin deficiency. T2D naturally evolves into an increasingly marked insulin deficiency that leads to the need for pancreatic replacement, by administering insulin.
Type 1 diabetes (T1D) requires an integral and immediate substitution of pancreatic insulin secretion. Artificial intelligence, through a self-learning algorithm, enables the automation and personalization of insulin delivery. These devices, called "closed loops" bring a real benefit for the patients included in the studies, by improving the glycemic balance, by reducing the number of hypo- and hyperglycemias but also by reducing the mental load associated with the disease, improving their quality of life.
The objective of this clinical trial is to study the feasibility of using a closed loop and its impact on glycemic control, in patients with T2D treated with insulin pumps.
A 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study is proposed to patients.
Main objective: study of the impact of the closed loop for 6 weeks, compared to 6 weeks in an open loop, on glycemic balance (evaluated by the time in range 70-180 mg/dL).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient > 18 years old
- •Patient with a weight < 150 kg
- •Patient with type 2 diabetes (T2D) treated by insulin pump for at least 6 months
- •Patient with stable pharmacological treatment of diabetes for at least 6 months
- •Patient equipped with a CGM or Flash Glucose Meter (FGM)
- •Patient diagnosed with T2D by a diabetologist
- •Patient treated with a total daily dose of insulin < 160 U/24 h
- •Patient with an HbA1c < 10%.
- •Patient affiliated to the social security system or beneficiary of such a system
- •Patient able to read and understand the procedure, and in a condition to express consent for the study protocol
- •No Inclusion Criteria:
- •Patient with type 1 diabetes
- •Patient receiving less than 8 units of insulin per day
- •Patients suffering from a serious illness or undergoing treatment that may affect the physiology of diabetes, i.e., interactions with glucose and/or insulin that may interfere with the medical device (e.g., steroid treatment)
- •Patient with severe uncorrected hearing and/or visual acuity problems
- •Patient not wishing to use rapid-acting insulin analog 100 U/mL
- •Patient who has undergone pancreatectomy or whose pancreas is severely impaired
- •Patients with severe renal impairment (clearance < 30 mL/min)
- •Patient with reduced sensation of hypoglycemia
- •Patient with highly unstable diabetes
- •Patient who received a pancreas or islet transplant
- •Patient undergoing dialysis
- •Critically ill patient
- •Patient with neuropathy
- •Patient with retinopathy
- •Patient currently participating or having participated in the month prior to inclusion in another clinical interventional research study that may have an impact on the study, this impact is left to the discretion of the investigator
- •Persons referred to in articles L1121-5 to L1121-8 of the CSP: pregnant women, parturients, nursing mothers, persons deprived of liberty by judicial or administrative decision, persons under legal protection
- •Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
排除标准
- 未提供
结局指标
主要结局
Glycemic control evaluation for the 12-week main study
时间窗: Day 84
Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the glycemic balance (time spent in the target 70-180 mg/dL). The data used for the analysis are the last 4 weeks of each 6-week sequence.
次要结局
- Daily amount of insulin administered evaluation for the 12-week main study(Day 84)
- Daily glucose management indicator (GMI) corresponding to the estimated HbA1c(Day 112)
- Diabetes treatment satisfaction evaluation for the 12-week main study(Days 42 and 84 (according to the randomized arm))
- Daily time spent in hypoglycemia evaluation for the 12-week main study(Day 84)
- Daily physical activity evaluation for the 12-week main study(Day 84)
- Sleep quality evaluation for the 12-week main study(Day 84)
- Quality of life questionnaire for the 12-week main study(Days 42 or 84 (according to the randomized arm))
- Daily time spent in hyperglycemia evaluation for the 12-week main study(Day 84)
- Incidence of Adverse events evaluation for the 12-week main study (safety and tolerability)(Day 84)
- Glycemic control evaluation for the 4-week additional study(Day 112)
- Percentage of daily time spent in hypoglycemia(Day 112)
- Average daily amount of insulin administered(Day 112)
- System satisfaction questionnaire evaluation(Day 112)
- Percentage of daily time spent in hyperglycemia(Day 112)
- Diabetes treatment satisfaction(Day 112)
- Daily glycemic variability evaluation for the 12-week main study(Day 84)
- Daily glycemic variability(Day 112)