NCT04123054

A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users

An Open-Label, Randomized, Two-Way, Parallel Study to Compare the Effectiveness of Multiple Daily Injection Treatment With an Insulin Dose Optimization Algorithm in Free-Living Outpatient Conditions in Patients With Type 1 Diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: McGill University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
DEVICE	Mobile App	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.
DEVICE	Mobile App + Basal-Bolus Optimization Algorithm	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.

Timeline

• Start date: 2020-03-05
• Primary completion: 2023-12-21
• Completion: 2024-01-12
• First posted: 2019-10-10
• Last updated: 2024-05-16

Locations

2 sites across 1 country: Canada