Actively Recruiting
Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
Led by McGill University Health Centre/Research Institute of the McGill University Health Centre · Updated on 2024-08-09
46
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
Sponsors
M
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead Sponsor
D
Diabetes Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this 26-week multicenter, randomized, parallel, placebo-controlled trial is to test the effectiveness of empagliflozin use in conjunction with automated insulin delivery (AID) to improve glucose control in individuals with type 1 diabetes who do not meet target recommendations for time in range (3.9-10.0 mmol/L). The main question it aims to answer is: \- Will use of empagliflozin (2.5 mg/day) increase time spent in the target range of 3.9 to 10.0 mmol/L compared to placebo for individuals on an AID system who do not meet glycemic targets? Participants will either take 2.5 mg of empagliflozin or a placebo daily for 26 weeks while remaining on their current AID system.
CONDITIONS
Official Title
Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals 18 years of age or older
- Clinical diagnosis of type 1 diabetes for at least one year
- At least 3 months of use of a commercial advanced automated insulin delivery system
- Less than 70% time in target glucose range (3.9 to 10.0 mmol/L) in the 30 days before screening with at least 70% time spent in closed-loop mode
- Agreement to use highly effective birth control and avoid pregnancy during the trial for individuals of child-bearing potential
- Female participants of child-bearing potential must be post-menarche and not post-menopausal (no menses for 12 months without other cause)
You will not qualify if you...
- Current or within 2 weeks use of any anti-hyperglycemic agents other than insulin (e.g., SGLT2 inhibitors)
- Current or within 1 month use of GLP1-Receptor Agonists
- Current or within 1 month use of high doses of oral or intravenous glucocorticoids
- Planned or ongoing very low carbohydrate diet (less than 50 grams per day)
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2 within the last 12 months
- Use of hydroxyurea
- Planned or ongoing pregnancy
- Breastfeeding
- Active risk of recurrent genito-urinary infections
- Severe hypoglycemic episode within 1 month before screening
- Diabetic ketoacidosis within 6 months before screening
- Any serious medical illness that may interfere with trial completion
- Clinically significant retinopathy
- Recent acute macrovascular event within 3 months
- Prior serious reaction to SGLT2 inhibitors
- Use of Medtronic 670G or 770G system in the last 30 days
- Inability to follow study drug contraindications or study protocol as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
Research Team
A
Adelyn Moore
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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