NCT05369871

Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Diabeloop · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus Type 2 - Insulin-Treated

Interventions

Type	Name	Description
DEVICE	Closed-loop system	Closed-loop system consisting of a terminal including the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the Accu-Chek Insight insulin pump.
DEVICE	Open-loop system	Open-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump.

Timeline

• Start date: 2022-08-29
• Primary completion: 2023-05-09
• Completion: 2023-07-28
• First posted: 2022-05-11
• Last updated: 2023-09-07

Locations

3 sites across 1 country: France