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. The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect. Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes.
Change in plasma glucose levels 1 hour after the meal
Time frame: 1 hour
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
Time frame: 1 hour
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
Time frame: 2 hours
Plasma glucose level 1 hour after the meal.
Time frame: 1 hour
Plasma glucose level 2 hours after the meal.
Time frame: 2 hours
Glycemic peak in the 3 hours following the meal.
Time frame: 3 hours
Change in plasma glucose levels 2 hours after the meal.
Time frame: 2 hours
Peak time of glucose levels over the 4 hours following the meal.
Time frame: 4 hours
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
Time frame: 4 hours
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels above 10 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels above 10 mmol/L.
Time frame: 11 hours
Percentage of time of plasma glucose levels above 13.9 mmol/L
Time frame: 11 hours
Percentage of time of sensor glucose levels above 13.9 mmol/L
Time frame: 11 hours
Percentage of time of plasma glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Percentage of time of sensor glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels below 3.9 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels below 3.3 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels below 2.8 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels above 10.0 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels above 10.0 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels above 13.9 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels above 13.9 mmol/L.
Time frame: 11 hours
Area under the curve of plasma glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Area under the curve of sensor glucose levels above 16.7 mmol/L.
Time frame: 11 hours
Standard deviation of plasma glucose levels.
Time frame: 11 hours
Standard deviation of sensor glucose levels.
Time frame: 11 hours
Coefficient of variance of plasma glucose levels.
Time frame: 11 hours
Coefficient of variance of sensor glucose levels.
Time frame: 11 hours
Total insulin delivery.
Time frame: 11 hours
Mean plasma glucose level.
Time frame: 11 hours
Mean sensor glucose level.
Time frame: 11 hours
Mean plasma insulin concentration.
Time frame: 11 hours
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
Time frame: 11 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.