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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | 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 dosage based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The objective of this project is to assess whether a dual-hormone closed-loop strategy would alleviate the burden of carbohydrate counting from patients with type 1 diabetes (T1D) without a significant degradation in post-meal glucose control.
Our primary hypothesis is that meal-announcement strategy (pre-meal CHO-independent bolus) is equivalent to meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) during closed-loop regulation of glucose levels in adults with T1D. Our secondary hypothesis is that closed-loop strategy with meal-announcement strategy (pre-meal CHO-independent bolus) or meal-and-carbohydrate-announcement strategy (full CHO-matching bolus) is better than conventional pump treatment in regulation of glucose levels in adults with T1D.
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.
Each patient will be admitted three times to a clinical research facility. In the meal-and-carbohydrate-announcement visit, patients will eat 3 meals accompanied with a matching insulin bolus (depending on the carbohydrate content of the meal) and glucose levels will be subsequently regulated using dual-hormone closed-loop system. In the meal-announcement visit, patients will eat the 3 same meals but will inject only a partial insulin bolus (not depending on carbohydrate content of the meal) and the remaining needed insulin will be delivered based on glucose sensor excursions as part of closed-loop operation. In the control visit, patients will use conventional pump therapy to regulate glucose levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHO-dependant bolus | Active Comparator | An insulin bolus dependant of carbohydrate content will be given after each meal. Each subject insulin-to-carbohydrate ratio (U per 10g CHO) will be used to calculate the insulin bolus to be given. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings. |
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| CHO-independent bolus | Active Comparator | An insulin bolus independent of carbohydrate content will be given after each meal. The dual-hormone closed-loop strategy will give the remaining insulin needed based on the sensor readings. |
|
| Conventional treatment | Active Comparator | Patients will use conventional pump therapy to regulate glucose levels |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 14 hours intervention | Other | Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc). |
| Measure | Description | Time Frame |
|---|---|---|
| The positive incremental area under the curve of postprandial glucose excursions | The positive incremental area under the curve (IAUC, as compared to pre-meal glucose value) of the 4-hr postprandial glucose excursions for the breakfast, lunch and dinner meals. | 4 hours after meal intake |
| Measure | Description | Time Frame |
|---|---|---|
| Mean plasma glucose | 8h00 to 21h00 | |
| Incremental two hours postprandial glucose | 2 hours after meal intake | |
| Incremental postprandial peak-glucose values |
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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 | H2W1R7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26072052 | Derived | Gingras V, Rabasa-Lhoret R, Messier V, Ladouceur M, Legault L, Haidar A. Efficacy of dual-hormone artificial pancreas to alleviate the carbohydrate-counting burden of type 1 diabetes: A randomized crossover trial. Diabetes Metab. 2016 Feb;42(1):47-54. doi: 10.1016/j.diabet.2015.05.001. Epub 2015 Jun 10. |
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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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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| 8h00 to 21h00 |
| Percentage of time of plasma glucose levels between 4.0 and 10.0 mmol/L | 8h00 to 21h00 |
| Percentage of time of plasma glucose levels spent above 10.0 mmol/L | 8h00 to 21h00 |
| Percentage of time of plasma glucose levels spent below 4.0 mmol/L | 8h00 to 21h00 |
| Total insulin delivery | 8h00 to 21h00 |
| Total glucagon delivery | 8h00 to 21h00 |
| Standard deviation of glucose levels | 8h00 to 21h00 |
| Percentage of time of plasma glucose concentrations below 3.5 mmol/L | 8h00 to 21h00 |
| Percentage of time of plasma glucose concentrations above 14 mmol/L | 8h00 to 21h00 |
| Mean plasma insulin concentration | 8h00 to 21h00 |
| Mean plasma glucagon concentration | 8h00 to 21h00 |
| Number of patients experiencing hypoglycemia requiring oral treatment | 8h00 to 21h00 |
| Incremental area under the curve of the 4-hr postprandial glucose excursions but the reference glucose is set to 5.0 mmol/L if premeal glucose is less than 5.0 mmol/L. | 4 hours after meal intake |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |