Clinical Trial

Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes

Recruiting Phase 4

Record status

This record was last updated August 9, 2024 (before its estimated May 2025 completion). Its status may not reflect the trial's current state.

Summary

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.

Protocol Amendment History 5 amendments

This ClinicalTrials.gov record has been amended 5 times since 2023-08-31; most recent amendment 2024-08-06.

Status change: Not Yet Recruiting → Recruiting 2024-03-07

Trial Details

NCT Number	NCT06021145
Lead Sponsor	McGill University Health Centre/Research Institute of the McGill University Health Centre Collaborators: Diabetes Canada
Conditions	Type 1 Diabetes
Enrollment	46 participants
Start Date	2024-04-02
Primary Completion	2025-05 (estimated)
Study Completion	2025-05 (estimated)
Updated on ClinicalTrials.gov	2024-08-09