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

NCT ID: NCT06021158

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-20
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Diabetes Mellitus, Type 1; Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

AID-count

Group Type: ACTIVE_COMPARATOR

Hybrid automated Lyumjev delivery system with carbohydrate counting

Intervention Type: COMBINATION_PRODUCT

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).

AID-estimate

Group Type: EXPERIMENTAL

Hybrid automated Lyumjev delivery system with meal size estimation

Intervention Type: COMBINATION_PRODUCT

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

AID-detect

Group Type: EXPERIMENTAL

Fully automated Lyumjev delivery system with meal detection

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

Hybrid 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).

Intervention Type: COMBINATION_PRODUCT

Hybrid 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).

Intervention Type: COMBINATION_PRODUCT

Fully 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Michael Tsoukas

Associate Professor, Endocrinology & Metabolism

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michael Tsoukas, M.D.

Role: PRINCIPAL_INVESTIGATOR

Royal Victoria Hospital, Belfast

Ahmad Haidar, Ph.D.

Role: STUDY_CHAIR

Research Institute of the McGill University University Health Centre

Laurent Legault, M.D.

Role: STUDY_CHAIR

Montreal Children's Hospital of the MUHC

Melissa-Rosina Pasqua, M.D.

Role: STUDY_CHAIR

Research Institute of the McGill University Health Centre

Locations

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

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Carolyne Schumacher

Role: CONTACT

carolyne.schumacher@mail.mcgill.ca

514-258-5431

Facility Contacts

Carolyne Schumacher

Role: primary

carolyne.schumacher@mail.mcgill.ca

5142585431

Other Identifiers

2024-9583

Identifier Type: -

Identifier Source: org_study_id