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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 closed-loop strategy, dual-hormone closed-loop strategy and conventional insulin pump therapy to regulate glucose levels in a 60-hours in non-standardized conditions in adults with type 1 diabetes.
The investigators hypothesized that 1) Controlling glucose levels using single- or dual-hormone CLS is feasible in free-living conditions for long period of time (60 hours); 2) Dual-hormone CLS is superior to single-hormone CLS as assessed by reducing time spent in hypoglycemic range; 3) Both single-hormone and dual-hormone CLS are superior to conventional pump therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dual-hormone closed-loop strategy | Active Comparator | In dual-hormone closed-loop strategy, variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels |
|
| Single-hormone closed-loop strategy | Active Comparator | In single-hormone closed-loop strategy, variable subcutaneous insulin infusion rate will be used to regulate glucose levels |
|
| Conventional insulin pump therapy | Active Comparator | In control visit, subjects will use conventional pump therapy to regulate glucose levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 60-hours intervention | Other | Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in the hypoglycemic range. | Hypoglycemic range is defined to be between below 4 mmol/L | 60 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of time of glucose levels (as measured by continuous glucose sensor) spent in target range. | Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 8 mmol/L from 22:00 to 7:00. | 60 hours |
| Percentage of time of glucose levels spent below 3.5 mmol/L |
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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 |
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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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|
| 60 hours |
| Percentage of time of glucose levels spent below 3.3 mmol/L | 60 hours |
| Area under the curve of glucose values below 4.0 mmol/L | 60 hours |
| Area under the curve of glucose values below 3.5 mmol/L | 60 hours |
| Area under the curve of glucose values below 3.3 mmol/L | 60 hours |
| Percentage of time of glucose levels spent above 8.0 mmol/L | 60 hours |
| Percentage of time of glucose levels spent above 10.0 mmol/L | 60 hours |
| Mean value of glucose levels | 60 hours |
| Standard deviation of glucose levels | 60 hours |
| Total insulin delivery | 60 hours |
| Number of patients with at least one hypoglycemic event with or without symptoms below 3.0 mmol/L based on glucose sensor reading | 60 hours |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |