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

NCT ID: NCT05369871

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2023-07-28

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.

Conditions

Diabetes Mellitus Type 2 - Insulin-Treated

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed-loop system followed by open-loop system

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.

Group Type: EXPERIMENTAL

Closed-loop system

Intervention Type: DEVICE

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.

Open-loop system

Intervention Type: DEVICE

Open-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump.

Open-loop system followed by closed-loop system

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.

Group Type: EXPERIMENTAL

Closed-loop system

Intervention Type: DEVICE

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.

Open-loop system

Intervention Type: DEVICE

Open-loop system consisting of a terminal without the Diabeloop algorithm that is associated with the Dexcom G6 CGM and the usual insulin pump.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icadom

INDUSTRY

Sponsor Role: collaborator

AGIR à Dom

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: collaborator

Centre Hospitalier Annecy Genevois

OTHER

Sponsor Role: collaborator

Centre Hospitalier Metropole Savoie

OTHER

Sponsor Role: collaborator

Diabeloop

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anne-Laure BOREL, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Grenoble Alpes

Locations

CH Métropole Savoie

Chambéry, , France

CH Annecy-Genevois

Epagny Metz-Tessy, , France

CHU Grenoble Alpes

La Tronche, , France

Countries

France

Other Identifiers

RCB 2020-A03429-30

Identifier Type: -

Identifier Source: org_study_id