RecruitingPhase 4NCT06021145

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

Effectiveness of Empagliflozin Added to Automated Insulin Delivery (AID) Systems in Adults With Type 1 Diabetes With Sub-optimal Glycemic Outcomes: a Randomized Controlled Parallel Trial


Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrollment

46 participants

Start Date

Apr 2, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether adding empagliflozin (an oral diabetes pill, often used in type 2 diabetes) to an automated insulin delivery system (a smart insulin pump) can improve blood sugar control in adults with type 1 diabetes who are not meeting their glucose goals. **You may be eligible if...** - You are 18 or older with a type 1 diabetes diagnosis of at least 1 year - You have been using a commercial automated insulin delivery (AID) system for at least 3 months - Your time spent in the target blood sugar range is less than 70% in the past 30 days - You agree to use effective birth control if of childbearing potential **You may NOT be eligible if...** - You are currently taking other glucose-lowering medications (like SGLT2 inhibitors or GLP-1 drugs) - You are pregnant, breastfeeding, or planning pregnancy - Your kidney function is severely reduced - You have had diabetic ketoacidosis (DKA) within 6 months or a severe low blood sugar episode requiring emergency care within 1 month - You use the Medtronic 670G or 770G system Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEmpagliflozin

26-week use of automated insulin delivery system with empagliflozin (2.5 mg daily) in individuals with suboptimal time in range.

DRUGPlacebo

26-week use of automated insulin delivery system with placebo (daily) in individuals with suboptimal time in range.


Locations(1)

McGill University Health Centre

Montreal, Quebec, Canada

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NCT06021145


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