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

NCT06021158 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2024-9583
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)

  14 days

Secondary Outcomes (11)

• Percentage of time of glucose levels spent in the following ranges: - between 3.9 and 7.8 mmol/L - below 3.9 mmol/L - below 3.0 mmol/L - above 10.0 mmol/L - above 13.9 mmol/L

  14 days

• Mean glucose levels

  14 days

• Standard deviation of glucose levels

  14 days

• Standard deviation of insulin delivery

  14 days

• Coefficient of variance of glucose levels

  14 days

Study Arms (3)

AID-count

ACTIVE COMPARATOR

Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting

AID-estimate

EXPERIMENTAL

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

AID-detect

EXPERIMENTAL

Combination Product: Fully automated Lyumjev delivery system with meal detection

Interventions

Hybrid automated Lyumjev delivery system with carbohydrate counting 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-count

Hybrid automated Lyumjev delivery system with meal size estimation 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-estimate

Fully automated Lyumjev delivery system with meal detection 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.

AID-detect

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

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

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michael Tsoukas, M.D.

  Royal Victoria Hospital, Belfast

  PRINCIPAL INVESTIGATOR

• Ahmad Haidar, Ph.D.

  Research Institute of the McGill University University Health Centre

  STUDY CHAIR

• Laurent Legault, M.D.

  Montreal Children's Hospital of the MUHC

  STUDY CHAIR

• Melissa-Rosina Pasqua, M.D.

  Research Institute of the McGill University Health Centre

  STUDY CHAIR

Central Study Contacts

Carolyne Schumacher

CONTACT

514-258-5431; carolyne.schumacher@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Endocrinology & Metabolism

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: September 1, 2023
• Study Start: December 20, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)