The Artificial Pancreas lab at McGill University has developed an optimization algorithm for adults with Type 1 Diabetes (T1D) on Multiple Daily Injection (MDI) therapy with the adjunctive use of glucose sensor technology, collectively known as sensor-augmented MDI therapy. The algorithm is designed to estimate optimal basal-bolus parameters based on the patient's glucose, insulin and meal data over several days. The investigators hope that this algorithm will be better able to improve long-term glycemic targets by reducing HbA1c levels compared to sensor-augmented MDI therapy alone.
The changes in eligibility criteria indicated below are from a previously approved amendment but were inadvertently omitted in the previous PRS update made in November of 2020. Therefore, this note serves to clarify the order of updates. Inclusion: HbA1c ≥ 7.5% in the last 2 months (modification) Exclusion: * More than 1 slow-acting injection and unwilling to switch to once a day for the study (addition) * Severe hypoglycemic episode within one month of admission (addition) In the subsequent amendment, we modified the timeframe for the HbA1c inclusion criterion to obtain a more accurate representation of their current glucose control at the time of enrollment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator.
Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator. In addition, participants will receive weekly app notifications with personalized recommendations for insulin parameter adjustments made by the optimization algorithm.
CIUSSS West-Central Montreal, Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Change in HbA1c levels
Difference in HbA1c levels from the start to the end of the study
Time frame: Pre-intervention and post-intervention, approximately 12 weeks
The number of patients that achieve an HbA1c at the end-of-study visit of:
a. less than or equal to 7.0%; b. less than or equal to 6.5%
Time frame: Post-intervention, approximately 12 weeks
Percentage of time of sensor glucose levels spent:
a. between 3.9 and 7.8 mmol/L; b.between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d.below 3.3 mmol/L; e.below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Time frame: 12 weeks
Percentage of overnight time (23:00-7:00) of sensor glucose levels:
a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c.below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Time frame: 12 weeks
Percentage of daytime (7:00-23:00) of sensor glucose levels:
a. between 3.9 and 7.8 mmol/L; b. between 3.9 and 10 mmol/L; c. below 3.9 mmol/L; d. below 3.3 mmol/L; e. below 2.8 mmol/L; f. above 7.8 mmol/L; g. above 10 mmol/L; h. above 13.9 mmol/L; i. above 16.7 mmol/L.
Time frame: 12 weeks
Standard deviation of glucose levels.
Standard deviation of glucose levels as a measure of glucose variability.
Time frame: 12 weeks
Total insulin delivery.
Total insulin delivery
Time frame: 12 weeks
Mean sensor glucose level during:
a. the overall study period; b. the daytime period; c. overnight period.
Time frame: 12 weeks
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