RecruitingPhase 2NCT06021158

A Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes

A Randomized, Crossover, Pilot Trial to Compare Automated Lyumjev Delivery With Carbohydrate Counting, Qualitative Meal-size Estimation, and Meal Detection in Type 1 Diabetes


Sponsor

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

Enrollment

12 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this pilot trial is to compare three meal strategies using an ultra-rapid insulin (Lyumjev) and an automated insulin delivery system. The meal strategies to be investigated are carbohydrate counting, qualitative meal announcement (e.g., low-carb meal), and meal detection. The investigators are doing this research to evaluate if carbohydrate counting can be simplified in patients with type 1 diabetes. Participants will test each meal strategy in random order, and each meal strategy will be 21 days long. For the duration of each meal strategy, participants will use an automated insulin delivery system or "artificial pancreas" with an ultra-rapid insulin called Lyumjev.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares three approaches to mealtime insulin dosing in people with type 1 diabetes using an automated insulin delivery system: traditional carbohydrate counting, a simpler meal-size estimation approach, and fully automated meal detection — to see which works best. **You may be eligible if...** - You have had type 1 diabetes for at least 12 months - You have been using an insulin pump for at least 3 months - You are willing to switch to a different fast-acting insulin (Lyumjev) for the duration of the study - You agree to use effective contraception if of childbearing potential **You may NOT be eligible if...** - You are currently taking oral diabetes medications (SGLT2 inhibitors, metformin, GLP-1 drugs) - You are pregnant or breastfeeding - You have had DKA or a severe hypoglycemic episode within the past month - You have significant eye, kidney, or nerve complications from diabetes as judged by your doctor - You have had a recent heart attack or cardiac surgery within 6 months 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

COMBINATION_PRODUCTHybrid automated Lyumjev delivery system with carbohydrate counting

In this system, a Lyumjev insulin bolus is initiated at mealtime based on the total grams of carbohydrates counted. This is the same as commercial hybrid closed-loop insulin therapy (standard treatment).

COMBINATION_PRODUCTHybrid automated Lyumjev delivery system with meal size estimation

In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).

COMBINATION_PRODUCTFully automated Lyumjev delivery system with meal detection

In this system, the patient does not initiate a Lyumjev insulin bolus at mealtime. An algorithm is used to detect a meal and administer a subsequent bolus, rather than requiring a carbohydrate count.


Locations(1)

Research Institute of the McGill University Health Centre (RI-MUHC)

Montreal, Quebec, Canada

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NCT06021158


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