A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
Diabetes Mellitus, Diabetes Mellitus, Type 1
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring Multiple Daily Injections,, Type 1 diabetes, Optimization algorithm
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- 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.
Sites / Locations
- CIUSSS West-Central Montreal, Jewish General HospitalRecruiting
- McGill University Health CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Sensor-Augmented MDI + Mobile App (control)
Sensor-Augmented MDI + Mobile App + Basal-Bolus Optimization Algorithm
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.
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.