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 and dual-hormone closed-loop strategy to regulate overnight glucose levels in a in-patient study in type 1 diabetes adults with hypoglycemia unawareness and documented nocturnal hypoglycemia. The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels compared to single-hormone closed-loop strategy.
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 investigators aim to conduct the 1st randomized cross-over trial comparing single- hormone and dual-hormone closed-loop strategy to regulate overnight glucose levels. The investigators aim to compare the two interventions for 10 hours in two subgroups of adults with type 1 diabètes. Patients from both subgroups will present documented nocturnal hypoglycemia. One subgroup will consist of patients with hypoglycemia unawareness while the other subgroup will consist of patients with hypoglycemia unawareness. This study will allow to determine if there is a greater benefit of a closed-loop strategy in a higher-risk hypoglycemia unaware group.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations.
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Percentage of time of plasma glucose levels spent below 4 mmol/L
Time frame: Up to 8 hours
Percentage of time of plasma glucose levels spent between 4 and 8 mmol/L
Time frame: Up to 8 hours
Percentage of time of plasma glucose levels spent between 4 and 10 mmol/L
Time frame: Up to 8 hours
Percentage of time of plasma glucose levels spent below 3.5 mmol/L
Time frame: Up to 8 hours
Percentage of time of plasma glucose levels spent below 3.3. mmol/L
Time frame: Up to 8 hours
Percentage of time of plasma glucose levels spent above 8 mmol/L
Time frame: Up to 8 hours
Percentage of time of plasma glucose levels spent above 10 mmol/L
Time frame: Up to 8 hours
Area under the curve of plasma glucose levels spent below 4 mmol/L
Time frame: Up to 8 hours
Area under the curve of plasma glucose levels spent below 3.5 mmol/L
Time frame: Up to 8 hours
Area under the curve of plasma glucose levels spent below 3.3 mmol/L
Time frame: Up to 8 hours
Area under the curve of plasma glucose levels spent above 8 mmol/L
Time frame: Up to 8 hours
Area under the curve of plasma glucose levels spent above 10 mmol/L
Time frame: Up to 8 hours
Mean plasma glucose levels
Time frame: Up to 8 hours
Standard deviation of plasma glucose levels
Time frame: Up to 8 hours
Total insulin delivery
Time frame: Up to 8 hours
Total glucagon delivery
Time frame: Up to 8 hours
Number of subjects experiencing at least one hypoglycemic event requiring oral treatment
Time frame: Up to 8 hours
Total number of hypoglycemic events requiring treatment
Time frame: Up to 8 hours
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