Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus Type 2 - Insulin-Treated
- Sponsor
- Diabeloop
- Enrollment
- 20
- Locations
- 3
- Primary Endpoint
- Glycemic control evaluation for the 12-week main study
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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). Secondary objectives: study of the impact of the closed loop for 6 weeks, compared to 6 weeks in an open loop, on: * glycemic balance (others parameters) * daily physical activity * quality of sleep * satisfaction with diabetes treatment * quality of life * treatment safety Evaluation of the satisfaction of the use (usability) of the system at the end of the closed loop period.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Glycemic control evaluation for the 12-week main study
Time Frame: 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.
Secondary Outcomes
- 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 glycemic variability evaluation for the 12-week main study(Day 84)
- 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 glycemic variability(Day 112)
- 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)