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 main objective of this project is to compare the efficacy of single-hormone closed-loop strategy and sensor-augmented pump therapy to regulate glucose levels in outpatient settings for 5 consecutive days in adults with type 1 diabetes. The investigators hypothesized that single-hormone closed-loop strategy will increase the time spent in the target range compared to sensor-augmented pump therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
A sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days.
A sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days. Participants will have been previously shown how to use the study insulin pump.
Institut de recherches cliniques de Montréal
Montreal, Quebec, Canada
Percentage of time of glucose levels spent between 3.9 and 10.0 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent below 3.9 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent below 3.3 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent below 2.8 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent above 10 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent above 13.9 mmol/L
Time frame: 120 hours
Percentage of time of glucose levels spent above 16.7 mmol/L
Time frame: 120 hours
Percentage of time of overnight glucose levels spent below 3.9 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 7.8 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent between 3.9 and 10.0 mmol/L
Time frame: 35 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MiniMed® Paradigm® Veo™, Medtronic
Enlite sensor®, Medtronic
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
Percentage of time of overnight glucose levels spent below 3.3 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent below 2.8 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent above 10 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent above 13.9 mmol/L
Time frame: 35 hours
Percentage of time of overnight glucose levels spent above 16.7 mmol/L
Time frame: 35 hours
Area under the curve of glucose levels below 3.9 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels below 3.3 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels below 2.8 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels above 10 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels above 13.9 mmol/L
Time frame: 120 hours
Area under the curve of glucose levels above 16.7 mmol/L
Time frame: 120 hours
Area under the curve of overnight glucose levels below 3.9 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels below 3.3 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels below 2.8 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels above 10 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels above 13.9 mmol/L
Time frame: 35 hours
Area under the curve of overnight glucose levels above 16.7 mmol/L
Time frame: 35 hours
Mean glucose levels
Time frame: 120 hours
Standard deviation of glucose levels
Time frame: 120 hours
Standard deviation of insulin delivery
Time frame: 120 hours
Coefficient of variance of glucose levels
Time frame: 120 hours
Coefficient of variance of insulin delivery
Time frame: 120 hours
Between-day variability in glucose levels
Time frame: 120 hours
Between-day variability in insulin delivery
Time frame: 120 hours
Total insulin delivery
Time frame: 120 hours
Percentage of time of closed-loop operation
Time frame: 120 hours
Percentage of time of glucose sensor availability
Time frame: 120 hours
Time between failures
Total hours of closed-loop operation over number of failures
Time frame: 120 hours
Number of hypoglycemic events less than 3.1 mmol/L
Time frame: 120 hours
Number of nights with hypoglycemic events less than 3.1 mmol/L
Time frame: 35 hours
Number of days with hypoglycemic events less than 3.1 mmol/L
Time frame: 120 hours