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 overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight 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 a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
Mount Sinai Hospital
Toronto, Ontario, Canada
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Montreal Children Hospital
Montreal, Quebec, Canada
Percentage of time in target range
Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range. Target range is defined to be between 4.0 to 8.0 mmol/L
Time frame: 8 hours
Percentage of time in target range for each night separately
Percentage of time for which glucose levels are in target range for each night separately. Target range is defined to be between 4.0 and 8.0 mmol/L.
Time frame: 8 hours
Percentage of time in target range for the pooled data
Percentage of time for which glucose levels are in target range for the pooled data. Target range is defined to be between 4.0 to 8.0 mmol/L.
Time frame: 8 hours
Percentage of time spent below 4.0 mmol/L
Percentage of time for which glucose levels are below 4.0 mmol/L.
Time frame: 8 hours
Percentage of time spent below 3.3 mmol/L
Percentage of time for which glucose levels are spent below 3.3 mmol/L.
Time frame: 8 hours
Area under the curve for glucose levels below 4.0 mmol/L
Time frame: 8 hours
Area under the curve for glucose levels below 3.3 mmol/L
Time frame: 8 hours
Percentage of time spent above 8.0 mmol/L
Percentage of time for which glucose levels are above 8.0 mmol/L
Time frame: 8 hours
Percentage of time spent above 10.0 mmol/L
Percentage of time for which glucose levels are above 10.0 mmol/L.
Time frame: 8 hours
Area under the curve for glucose levels spent above 8.0 mmol/L
Time frame: 8 hours
Area under the curve for glucose levels spent above 10.0 mmol/L
Time frame: 8 hours
Mean glucose levels
Time frame: 8 hours
Standard deviation of glucose levels
Standard deviation of glucose levels as a measure of glucose variability.
Time frame: 8 hours
Total insulin delivery
Time frame: 8 hours
Number of subjects experiencing at least one hypoglycemic event requiring treatment
Time frame: 8 hours
Number of hypoglycemic events requiring treatment
Time frame: 8 hours
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