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| Name | Class |
|---|---|
| McGill University | OTHER |
| Montreal Children's Hospital of the MUHC | OTHER |
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Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate glucose levels in a 24-hours in-patient study with standardized conditions in adults and adolescents with type 1 diabetes.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.
We aim to conduct the 1st randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. We aim to compare the three interventions for 24 hours in adults and adolescents with type 1 diabetes. Each 24 hours will include a 60-min exercise session, three meals characterizing a full day, activities that mimick real-life conditions and an overnight stay. This study will also allow for multiple comparisons and evaluating the benefits of each component separately (i.e. the benefits of merely closing the loop with insulin alone vs. adding glucagon to the closed-loop strategy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-hormone closed-loop system | Active Comparator | In single-hormone closed-loop system, variable subcutaneous insulin infusion rate will be used to regulate glucose levels. |
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| Dual-hormone closed-loop system | Active Comparator | In dual-hormone closed-loop system, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. |
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| Insulin pump therapy | Active Comparator | Patient's conventional treatment will be implemented. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Closed-loop system | Other | Patients will be admitted at the research clinical facility at 7:00. At 8:00, a mixed meal will be served. At 9:00, patients will be asked to perform two 30-min standardized activities. At 12:00, a mixed meal will be served. At 13:00, patients will be asked to perform two 30-min activities. At 17:00, a mixed meal will be served. At 19:30, patients will perform 60 minutes of aerobic treadmill exercise at an intensity of 60% VO2max. A bedtime snack of 20g carbohydrate will be given at 21:00. Patients will be discharged at 8:00 the next morning |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose levels spent in target range. | Two-hour postprandial target range is between 4.0 and 10.0 mmol/l. Otherwise, target range is defined to be between 4.0 and 8.0 mmol/l. | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose levels spent in the low range | Low range is defined to be a. below 4 mmol/L; b. below 3.5 mmol/L; c. below 3.3 mmol/L. | 24 hours |
| Percentage of overnight time of plasma glucose levels spent in the low range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rémi Rabasa-Lhoret, MD, PhD | Institut de Recherches Cliniques de Montreal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de recherches cliniques de Montréal | Montreal | Quebec | H2W 1R7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25434967 | Derived | Haidar A, Legault L, Messier V, Mitre TM, Leroux C, Rabasa-Lhoret R. Comparison of dual-hormone artificial pancreas, single-hormone artificial pancreas, and conventional insulin pump therapy for glycaemic control in patients with type 1 diabetes: an open-label randomised controlled crossover trial. Lancet Diabetes Endocrinol. 2015 Jan;3(1):17-26. doi: 10.1016/S2213-8587(14)70226-8. Epub 2014 Nov 27. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Low range is defined to be a. < 4 mmol/L; b. < 3.5 mmol/L; c. < 3.3 mmol/L.
| 9 hours |
| Standard deviation of glucose levels | Measure of glucose variability | 24 hours |
| Total insulin delivery | 24 hours |
| Mean plasma glucose level | 24 hours |
| Mean plasma glucose level | 9 hours |
| Mean plasma insulin concentration | 24 hours |
| Mean plasma glucagon concentration | 24 hours |
| Number of subjects experiencing hypoglycemia requiring oral treatment | Number of subjects experiencing hypoglycemia requiring oral treatment during a. the overall study period; b. the exercise; c. the night. | 24 hours |
| Percentage of time of plasma glucose levels spent between 4.0 and 10.0 mmol/L | 24 hours |
| Percentage of overnight time of plasma glucose levels spent between 4.0 and 8.0 mmol/L | 9 hours |
| Percentage of overnight time of plasma glucose levels spent between 4.0 and 10.0 mmol/L | 9 hours |
| Percentage of time of plasma glucose levels spent in the high range | High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L | 24 hours |
| Percentage of overnight time of plasma glucose levels spent in the high range | High range is defined to be above a. 8.0 mmol/L; b. 10.0 mmol/L. | 9 hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |