Status:
COMPLETED
A Novel mHealth Application Guided by an Optimization Algorithm for T1D Sensor-Augmented Insulin Injection Users
Lead Sponsor:
McGill University
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
NA
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 gluc...
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 se...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 12 2024
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04123054
Start Date
March 5 2020
End Date
January 12 2024
Last Update
May 16 2024
Active Locations (2)
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1
CIUSSS West-Central Montreal, Jewish General Hospital
Montreal, Quebec, Canada
2
McGill University Health Centre
Montreal, Quebec, Canada