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| Name | Class |
|---|---|
| Icadom | INDUSTRY |
| AGIR Ã Dom | OTHER |
| University Hospital, Grenoble | OTHER |
| Centre Hospitalier Annecy Genevois |
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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.
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:
Evaluation of the satisfaction of the use (usability) of the system at the end of the closed loop period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop system followed by open-loop system | Experimental | An interventional cross-over study:
Followed by an optional additional study: 4 weeks in closed-loop system. |
|
| Open-loop system followed by closed-loop system | Experimental | An interventional cross-over study:
Followed by an optional additional study: 4 weeks in closed-loop system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop system | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Daily glycemic variability evaluation for the 12-week main study |
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Inclusion Criteria :
No Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne-Laure BOREL, MD, PhD | CHU Grenoble Alpes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH Métropole Savoie | Chambéry | 73300 | France | |||
| CH Annecy-Genevois |
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| OTHER |
| Centre Hospitalier Metropole Savoie | OTHER |
This is a 13-week interventional, randomized, controlled, crossover, open-label, multicenter main study, followed by an optional, open-label, additional 4-week study.
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| Open-loop system | 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. |
|
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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) |
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Epagny Metz-Tessy |
| 74374 |
| France |
| CHU Grenoble Alpes | La Tronche | 38700 | France |