Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes
Recruiting
Phase 4
Interventional Study
Type 1 Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 46 (estimated)
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre · Other
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About This Trial
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.…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Individuals ≥ 18 years of age.
* A clinical diagnosis of type 1 diabetes for at least one year, as per the investigators' clinical judgment (confirmatory C-peptide and antibodies will not be required).
* Minimum 3-month use of a commercial advanced AID system.
* Time in range …
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