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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McGill University
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Change in HbA1c levels
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.…).
- •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.
Arms & Interventions
Sensor-Augmented MDI + Mobile App (control)
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.
Intervention: Mobile App (Device)
Sensor-Augmented MDI + 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.
Intervention: Mobile App + Basal-Bolus Optimization Algorithm (Device)
Outcomes
Primary Outcomes
Change in HbA1c levels
Time Frame: Pre-intervention and post-intervention, approximately 12 weeks
Difference in HbA1c levels from the start to the end of the study
Secondary Outcomes
- Percentage of overnight time (23:00-7:00) of sensor glucose levels:(12 weeks)
- Percentage of daytime (7:00-23:00) of sensor glucose levels:(12 weeks)
- Mean sensor glucose level during:(12 weeks)
- The number of patients that achieve an HbA1c at the end-of-study visit of:(Post-intervention, approximately 12 weeks)
- Total insulin delivery.(12 weeks)
- Standard deviation of glucose levels.(12 weeks)
- Percentage of time of sensor glucose levels spent:(12 weeks)