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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
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.
Time frame: 24 hours
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.
Time frame: 24 hours
Percentage of overnight time of plasma glucose levels spent in the low range
Low range is defined to be a. \< 4 mmol/L; b. \< 3.5 mmol/L; c. \< 3.3 mmol/L.
Time frame: 9 hours
Standard deviation of glucose levels
Measure of glucose variability
Time frame: 24 hours
Total insulin delivery
Time frame: 24 hours
Mean plasma glucose level
Time frame: 24 hours
Mean plasma glucose level
Time frame: 9 hours
Mean plasma insulin concentration
Time frame: 24 hours
Mean plasma glucagon concentration
Time frame: 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.
Time frame: 24 hours
Percentage of time of plasma glucose levels spent between 4.0 and 10.0 mmol/L
Time frame: 24 hours
Percentage of overnight time of plasma glucose levels spent between 4.0 and 8.0 mmol/L
Time frame: 9 hours
Percentage of overnight time of plasma glucose levels spent between 4.0 and 10.0 mmol/L
Time frame: 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
Time frame: 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.
Time frame: 9 hours
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