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
- 3
- 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.
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)