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Our lab has developed an artificial pancreas system called the McGill Artificial Pancreas (MAP) for automating insulin delivery. Using patient's basal-bolus parameters (basal rates and ICRs), the artificial pancreas involves a control algorithm that modulates insulin infusion based on the sensor readings and meal information. However, because basal-bolus parameters are difficult to optimize, proper glycemic control is not always achieved. Therefore, we have developed a learning algorithm that estimates optimal basal-bolus parameters using data over several days. The algorithm examines daily glucose, insulin, and meal data to make changes in patients' basal rates and ICRs.
The objective of this project is to test our artificial pancreas system with and without the learning algorithm using a randomized crossover design in between 31 and 67 children and adolescents at camp Carowanis. We hypothesize that adding a learning algorithm to the artificial pancreas will improve the performance of our artificial pancreas system by increasing the time spent in target glucose range (4mmol/L - 10mmol/L) compared with the artificial pancreas system alone.
This is an open-label, randomized, two-way, cross-over study to compare the glucose control between closed-loop strategy with and without a learning module. Children and adolescent type 1 diabetes patients at Camp Carowanis will be enrolled in the study, where they will undergo two randomly ordered interventions:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Closed-loop therapy | Experimental | Participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be determined by the camp's physicians. The research staff will update the pump's settings to reflect the physician's recommendations at the beginning of the closed-loop therapy, and each time the physicians update the study parameters. The closed-loop therapy will last 2 days (48 hours). |
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| Closed-loop therapy with learning module | Experimental | participants will undergo a closed-loop therapy where insulin delivery is determined by the MAP system. The study parameters (basal rates and ICRs) will be computed by the learning algorithm and updated daily. The learning algorithm runs on a computer of the research staff members and requires patient data to calculate the optimal basal rates and ICR. Each day, the research staff members will upload patient data onto the computer, run the leaning algorithm, and update the pump parameters to reflect the recommendations computed by the learning algorithm. The closed-loop therapy with the learning module will last 8 days (192 hours). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas | Device | The system is composed of 3 main components:
Every 10 minutes, iMAP retrieves the glucose values from the Dexcom G5 CGM via Bluetooth. The application computes an optimal insulin infusion rate based on i) the current glucose reading, ii) the glucose trend (i.e. how quickly the glucose level is rising or falling) and iii) the open-loop basal rates (study parameters). The insulin recommendations are then sent wirelessly via Bluetooth to the insulin pump. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of sensor glucose levels spent in target range | Target range defined to be between 3.9 mmol/L and 10.0 mmol/L | 10-24hour periods |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of sensor glucose levels spent |
| 10-24hour periods |
| Percentage of overnight time (23:00-7:00) of sensor glucose levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Camp Carowanis | Sainte-Agathe-des-Monts | Quebec | Canada |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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This is an open-label, randomized, two-way, cross-over study.
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| 10-24hour periods |
| Percentage of daytime (7:00-23:00) of sensor glucose levels | Percentage of daytime (7:00-23:00) of sensor glucose levels
| 10-24hour periods |
| Standard deviation of glucose levels as a measure of glucose variability. | 10-24hour periods |
| Total insulin delivery. | 10-24hour periods |
| Mean sensor glucose level during: a. the overall study period; b. the daytime period; c. overnight period. | 10-24hour periods |
| Number of participants experiencing hypoglycemia requiring oral treatment during: | 10-24hour periods |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |