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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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The main objective of this project is to compare the efficacy of single-hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia.
The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.
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 strategy would regulate glucose levels through the infusion of two hormones: insulin and glucagon.
The investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single-hormone closed-loop strategy | Active Comparator |
| |
| Dual-hormone closed-loop strategy | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overnight intervention | Other | Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose levels spent below 4 mmol/L | Up to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L | Up to 8 hours | |
| Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L | Up to 8 hours | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Remi Rabasa-Lhoret | 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 |
|---|---|---|---|
| 29393675 | Derived | Abitbol A, Rabasa-Lhoret R, Messier V, Legault L, Smaoui M, Cohen N, Haidar A. Overnight Glucose Control with Dual- and Single-Hormone Artificial Pancreas in Type 1 Diabetes with Hypoglycemia Unawareness: A Randomized Controlled Trial. Diabetes Technol Ther. 2018 Mar;20(3):189-196. doi: 10.1089/dia.2017.0353. Epub 2018 Feb 2. |
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|
| Percentage of time of plasma glucose levels spent below 3.5 mmol/L |
| Up to 8 hours |
| Percentage of time of plasma glucose levels spent below 3.3. mmol/L | Up to 8 hours |
| Percentage of time of plasma glucose levels spent above 8 mmol/L | Up to 8 hours |
| Percentage of time of plasma glucose levels spent above 10 mmol/L | Up to 8 hours |
| Area under the curve of plasma glucose levels spent below 4 mmol/L | Up to 8 hours |
| Area under the curve of plasma glucose levels spent below 3.5 mmol/L | Up to 8 hours |
| Area under the curve of plasma glucose levels spent below 3.3 mmol/L | Up to 8 hours |
| Area under the curve of plasma glucose levels spent above 8 mmol/L | Up to 8 hours |
| Area under the curve of plasma glucose levels spent above 10 mmol/L | Up to 8 hours |
| Mean plasma glucose levels | Up to 8 hours |
| Standard deviation of plasma glucose levels | Up to 8 hours |
| Total insulin delivery | Up to 8 hours |
| Total glucagon delivery | Up to 8 hours |
| Number of subjects experiencing at least one hypoglycemic event requiring oral treatment | Up to 8 hours |
| Total number of hypoglycemic events requiring treatment | Up to 8 hours |
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
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