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

McGill University

Status and phase: Enrolling; Phase 2

Conditions: Diabetes Mellitus, Type 1; Type 1 Diabetes

Treatments: Combination Product: Fully automated Lyumjev delivery system with meal detection; Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting; Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation

Study type: Interventional

Funder types: Other

Identifiers

NCT06021158

2024-9583

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of type 1 diabetes for at least 12 months. The diagnosis of type 1 diabetes is based on the investigator's judgment per local and international guideline criteria.
• Insulin pump use for at least 3 months.
• Individuals of childbearing potential must agree to use a highly effective method of birth control.
• Willing to switch to Lyumjev insulin for the duration of the study.

Exclusion criteria

• Use of oral antihyperglycemic agents within 2 weeks of admission (SGLT2i, metformin...); 1 month for GLP1-RA.
• Use of glucocorticoids (except low, stable doses and inhaled steroids).
• Use of hydroxyurea.
• Planned or ongoing pregnancy.
• Breastfeeding.
• Diabetic ketoacidosis and/or severe hypoglycemia episode (defined as requiring the assistance of another person, due to altered consciousness, to administer carbohydrates, glucagon, or other resuscitative actions) within one month of admission.
• Clinically significant retinopathy, nephropathy, or neuropathy as judged by the investigator.
• Recent (<6 months) acute macrovascular event e.g., acute coronary syndrome or cardiac surgery.
• Known hypersensitivity to the study drug or its excipients.
• Other serious medical illness likely to interfere with study participation or with the ability to complete the trial, as judged by the investigator.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

AID-count

Active Comparator group

Treatment:

Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting

AID-estimate

Experimental group

Treatment:

Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation

AID-detect

Experimental group

Treatment:

Combination Product: Fully automated Lyumjev delivery system with meal detection