Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2) (Close2target)

Diabeloop

Status: Completed

Conditions: Diabetes Mellitus Type 2 - Insulin-Treated

Treatments: Device: Open-loop system; Device: Closed-loop system

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05369871

RCB 2020-A03429-30

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria :

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Closed-loop system followed by open-loop system

Experimental group

Description:

An interventional cross-over study: * six weeks in closed-loop system with Accu-Chek Insight pump and continuous glucose monitoring (CGM) :consisting of 2 weeks of adaptation where data will not be collected + 4 weeks * followed by six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks , Followed by an optional additional study: 4 weeks in closed-loop system.

Treatment:

Device: Open-loop system

Device: Closed-loop system

Open-loop system followed by closed-loop system

Experimental group

Description:

An interventional cross-over study: * six weeks in open-loop system with usual pump and CGM : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks * followed by six weeks in closed-loop system with Accu-Chek Insight pump and CGM (including two weeks of adaptation) : consisting of 2 weeks of adaptation where data will not be collected + 4 weeks Followed by an optional additional study: 4 weeks in closed-loop system.

Treatment:

Device: Open-loop system

Device: Closed-loop system