A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
- Conditions
- Diabetes MellitusDiabetes Mellitus, Type 1
- Interventions
- Device: Mobile AppDevice: Mobile App + Basal-Bolus Optimization Algorithm
- Registration Number
- NCT04123054
- Lead Sponsor
- McGill University
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
- Males and females ≥ 18 years of age
- Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- Undergoing multiple daily injection therapy.
- Baseline HbA1c value ≥ 7.5% (up to 7 days before or after screening).
- Serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with the study protocol or with the team's recommendations.
- Injection of isophane insulin (NPH) or any intermediate-acting insulin
- More than 1 slow-acting injection and unwilling to switch to once a day for the study
- Current or ≤ 1-month use of other antihyperglycemic agents (Sodium-Glucose Cotransporter 2 inhibitor (SGLT2), Glucagon-Like Peptide-1 (GLP-1), Metformin, Acarbose, etc....).
- Pregnancy
- Severe hypoglycemic episode within one month of admission.
- Severe diabetic ketoacidosis episode within one month of admission
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Recent (<6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sensor-Augmented MDI + Mobile App (control) Mobile App 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. Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm Mobile App + Basal-Bolus Optimization Algorithm 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.
- Primary Outcome Measures
Name Time Method Change in HbA1c levels Pre-intervention and post-intervention, approximately 12 weeks Difference in HbA1c levels from the start to the end of the study
- Secondary Outcome Measures
Name Time Method Percentage of overnight time (23:00-7:00) of sensor glucose levels: 12 weeks 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.
Percentage of daytime (7:00-23:00) of sensor glucose levels: 12 weeks 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.
Mean sensor glucose level during: 12 weeks a. the overall study period; b. the daytime period; c. overnight period.
The number of patients that achieve an HbA1c at the end-of-study visit of: Post-intervention, approximately 12 weeks a. less than or equal to 7.0%; b. less than or equal to 6.5%
Total insulin delivery. 12 weeks Total insulin delivery
Standard deviation of glucose levels. 12 weeks Standard deviation of glucose levels as a measure of glucose variability.
Percentage of time of sensor glucose levels spent: 12 weeks 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.
Trial Locations
- Locations (2)
McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
CIUSSS West-Central Montreal, Jewish General Hospital
🇨🇦Montreal, Quebec, Canada