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

Diabetes Mellitus Type 2 - Insulin-Treated Clinical Trial

— Close2target  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05369871
• Other study ID #: RCB 2020-A03429-30
• Status: Completed
• Phase: N/A
• Start date: August 29, 2022
• Est. completion date: July 28, 2023

Study information

• Verified date: September 2023
• Source: Diabeloop
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 28, 2023
• Est. primary completion date: May 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2 - Insulin-Treated
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CH Métropole Savoie	Chambéry
France	CH Annecy-Genevois	Epagny Metz-Tessy
France	CHU Grenoble Alpes	La Tronche

Sponsors (6)

Lead Sponsor	Collaborator
Diabeloop	AGIR à Dom, Centre Hospitalier Annecy Genevois, Centre Hospitalier Metropole Savoie, Icadom, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic control evaluation for the 12-week main study	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.	Day 84
Secondary	Daily glycemic variability evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the daily glycemic variability measured by the coefficient of variation The data used for the analysis are the last 4 weeks of each 6-week sequence.	Day 84
Secondary	Daily glycemic variability evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the daily glycemic variability measured by the standard deviation.; The data used for the analysis are the last 4 weeks of each 6-week sequence.	Day 84
Secondary	Daily time spent in hypoglycemia evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the percentage of daily time spent in hypoglycemia.; The data used for the analysis are the last 4 weeks of each 6-week sequence.	Day 84
Secondary	Daily time spent in hyperglycemia evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the percentage of daily time spent in hyperglycemia.; The data used for the analysis are the last 4 weeks of each 6-week sequence.	Day 84
Secondary	Daily amount of insulin administered evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the average daily amount of insulin administered.; The data used for the analysis are the last 4 weeks of each 6-week sequence.	Day 84
Secondary	Daily glucose management indicator (GMI) corresponding to the estimated HbA1c	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the Glucose management indicator (GMI) measurement using CGM data.; The data used for the analysis are the last 4 weeks of each 6-week sequence.	Day 84
Secondary	Daily physical activity evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the daily physical activity, measured by actimetry for 7 days.	Day 84
Secondary	Sleep quality evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the sleep quality (duration and fragmentation), measured by actimetry for 7 days.	Day 84
Secondary	Diabetes treatment satisfaction evaluation for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the diabetes treatment satisfaction, measured by the Diabetes Treatment Satisfaction Questionnaire (DTSQ).; The DTSQ questionnaire is composed by a score which has a minimum of zero and a maximum of 36. The higher the score, the more satisfied the patient is with their treatment.	Days 42 and 84 (according to the randomized arm)
Secondary	Quality of life questionnaire for the 12-week main study	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the quality of life, measured by a questionnaire.; This questionnaire is composed of 10 items. For each item, there are 3 possible answers: "less well than before"; "same as before"; "better than before". A score will be calculated from the 10 items by adding 1 point for each improvement answer allowing the calculation of a score varying between 0 and 10. A high score represents a better improvement in quality of life.	Days 42 or 84 (according to the randomized arm)
Secondary	Incidence of Adverse events evaluation for the 12-week main study (safety and tolerability)	Impact of 6 weeks of closed-loop compared to 6 weeks of open-loop on the treatment safety, measured by the number of adverse events	Day 84
Secondary	System satisfaction questionnaire evaluation	Evaluation of the closed loop system satisfaction by an usability questionnaire; This questionnaire is composed of 5 sections. Section 1 evaluates satisfaction with the use of the medical device and will be evaluated through a score varying between 10 and 50. A high score means that satisfaction with the use of the device is high.; Section 3 evaluates the ease of use of the device and will be evaluated through a score varying between 16 and 80. A high score means that the system is easy to use.; Sections 2, 4 and 5 will not be scored and will only be subject to descriptive analysis.	Days 42 or 84 (according to the randomized arm)
Secondary	Glycemic control evaluation for the 4-week additional study	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the glycemic balance (time spent in the target 70-180 mg/dL).	Day 112
Secondary	Daily glycemic variability	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily glycemic variability measured by the coefficient of variation	Day 112
Secondary	Daily glycemic variability	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily glycemic variability measured by the standard deviation	Day 112
Secondary	Percentage of daily time spent in hypoglycemia	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily time spent in hypoglycemia	Day 112
Secondary	Percentage of daily time spent in hyperglycemia	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the daily time spent in hyperglycemia	Day 112
Secondary	Average daily amount of insulin administered	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the average daily amount of insulin administered	Day 112
Secondary	Daily glucose management indicator (GMI) corresponding to the estimated HbA1c	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the Glucose management indicator (GMI) measurement using CGM data.	Day 112
Secondary	Diabetes treatment satisfaction	Impact of 4 weeks of closed-loop without meal declaration compared to 4 weeks of closed-loop with meal declaration on the diabetes treatment satisfaction, measured by the Diabetes Treatment Satisfaction Questionnaire.; The DTSQ questionnaire is composed by a score which has a minimum of zero and a maximum of 36. The higher the score, the more satisfied the patient is with their treatment.	Day 112
Secondary	System satisfaction questionnaire evaluation	Evaluation of the system satisfaction by an usability questionnaire; This questionnaire is composed of 5 sections. Section 1 evaluates satisfaction with the use of the medical device and will be evaluated through a score varying between 10 and 50. A high score means that satisfaction with the use of the device is high.; Section 3 evaluates the ease of use of the device and will be evaluated through a score varying between 16 and 80. A high score means that the system is easy to use.; Sections 2, 4 and 5 will not be scored and will only be subject to descriptive analysis.	Day 112