CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 84 enrolled
Drug / intervention
Mobile App +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT04123054
NCT04123054N/ACompleted

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

McGill University·interventional·Posted Oct 10, 2019·Updated May 16, 2024

In Brief

A clinical study evaluating Mobile App and Mobile App + Basal-Bolus Optimization Algorithm for Diabetes Mellitus and Diabetes Mellitus, Type 1. Completed, enrolled 84 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 10, 2019
Enrollment StartMar 5, 2020
Primary CompletionDec 21, 2023
Study CompletionJan 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 6.7 years ago

Interventions

Mobile Appdevice

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.

Mobile App + Basal-Bolus Optimization Algorithmdevice

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.