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 children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia
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 investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.
Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Percentage of time of glucose levels spent below 4.0 mmol/L.
Time frame: Up to 8 hours
Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L
Time frame: Up to 8 hours
Percentage of time of glucose levels spent below 3.5 mmol/L
Time frame: Up to 8 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Time frame: Up to 8 hours
Percentage of time of glucose levels spent above 8 mmol/L
Time frame: Up to 8 hours
Percentage of time of glucose levels spent above 10 mmol/L.
Time frame: Up to 8 hours
Area under the curve of glucose levels below 4.0 mmol/L
Time frame: Up to 8 hours
Area under the curve of glucose levels below 3.5 mmol/L
Time frame: Up to 8 hours
Area under the curve of glucose levels below 3.3 mmol/L
Time frame: Up to 8 hours
Area under the curve of glucose levels above 8.0 mmol/L
Time frame: Up to 8 hours
Area under the curve of glucose levels above 10.0 mmol/L.
Time frame: Up to 8 hours
Mean glucose levels.
Time frame: Up to 8 hours
Standard deviation of glucose levels
Measure of glucose variability.
Time frame: Up to 8 hours
Total insulin delivery
Time frame: Up to 8 hours
Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L
Time frame: Up to 8 hours
Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L
Time frame: Up to 8 hours
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