Clinical trial NCT05369871: Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)
Official title: Evaluation of a Closed-loop System for the Treatment of Type 2 Diabetes at Home (DT2_2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2 - Insulin-Treated
Lead sponsor: Diabeloop
Sponsor class: INDUSTRY
Collaborators: name: Icadom
name: AGIR à Dom
name: University Hospital, Grenoble
name: Centre Hospitalier Annecy Genevois
name: Centre Hospitalier Metropole Savoie
First posted: 2022-05-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study.
Primary purpose: TREATMENT

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.

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

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

Primary outcomes:
measure: Glycemic control evaluation for the 12-week main study
timeFrame: Day 84
Secondary outcomes:
measure: Daily glycemic variability evaluation for the 12-week main study
timeFrame: Day 84
measure: Daily glycemic variability evaluation for the 12-week main study
timeFrame: Day 84
measure: Daily time spent in hypoglycemia evaluation for the 12-week main study
timeFrame: Day 84
measure: Daily time spent in hyperglycemia evaluation for the 12-week main study
timeFrame: Day 84
measure: Daily amount of insulin administered evaluation for the 12-week main study
timeFrame: Day 84
measure: Daily glucose management indicator (GMI) corresponding to the estimated HbA1c
timeFrame: Day 84
measure: Daily physical activity evaluation for the 12-week main study
timeFrame: Day 84
measure: Sleep quality evaluation for the 12-week main study
timeFrame: Day 84
measure: Diabetes treatment satisfaction evaluation for the 12-week main study
timeFrame: Days 42 and 84 (according to the randomized arm)
measure: Quality of life questionnaire for the 12-week main study
timeFrame: Days 42 or 84 (according to the randomized arm)
measure: Incidence of Adverse events evaluation for the 12-week main study (safety and tolerability)
timeFrame: Day 84
measure: System satisfaction questionnaire evaluation
timeFrame: Days 42 or 84 (according to the randomized arm)
measure: Glycemic control evaluation for the 4-week additional study
timeFrame: Day 112
measure: Daily glycemic variability
timeFrame: Day 112
measure: Daily glycemic variability
timeFrame: Day 112
measure: Percentage of daily time spent in hypoglycemia
timeFrame: Day 112
measure: Percentage of daily time spent in hyperglycemia
timeFrame: Day 112
measure: Average daily amount of insulin administered
timeFrame: Day 112
measure: Daily glucose management indicator (GMI) corresponding to the estimated HbA1c
timeFrame: Day 112
measure: Diabetes treatment satisfaction
timeFrame: Day 112
measure: System satisfaction questionnaire evaluation
timeFrame: Day 112
Other outcomes:
Locations:
city: Chambéry
country: France
facility: CH Métropole Savoie
city: Epagny Metz-Tessy
country: France
facility: CH Annecy-Genevois
city: La Tronche
country: France
facility: CHU Grenoble Alpes
Study officials:
affiliation: CHU Grenoble Alpes
name: Anne-Laure BOREL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: