An interventional study of Mobile App and Mobile App + Basal-Bolus Optimization Algorithm in Diabetes Mellitus and Diabetes Mellitus, Type 1, sponsored by McGill University. Completed at 2 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by McGill University · Not applicable, Interventional, and Treatment
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:
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.
11,090 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 84 is close to the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →McGill University is the lead sponsor of 249 studies on the registry; 51 are open to participants now.
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Exclusion Criteria:
Participants will continue their usual multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data.
Device: Mobile App
Participants will undergo multiple daily injections (MDI) therapy along with the use of Freestyle Libre glucose sensors (Abbott Diabetes Care) and a mobile application that facilitates insulin dose calculations while collecting insulin and meal data. Every week, participants' insulin doses will be updated by the optimization algorithm's recommendations.
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.
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.
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
Mean scores of the survey items on modified versions of the Diabetes Treatment Satisfaction Questionnaire
Scoring for treatment satisfaction ranges from 0-6; higher score = higher satisfaction (patient-reported outcomes)
Time frame: Pre-intervention, then monthly, approximately 12 weeks
Mean scores of the survey items on modified versions of the Mobile Health App Usability Questionnaire
Scoring for the usability of the app ranges from 1-7; higher score = higher usability (patient-reported outcomes)
Time frame: Post-intervention, approximately 12 weeks
Recurrent themes from semi-structured interviews
Qualitative interview data to obtain an understanding of relationships by connecting lived experiences with a) mean survey scores and b) primary and secondary outcomes regarding the use of the study software on quality of life.
Time frame: Post-intervention, approximately 12 weeks
Plan to share: Yes — Participant data - after de-identification.
Supporting information: Study protocol
Time frame: Within one year of publication.
Access criteria: Access provided upon reasonable request.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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