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

Type 1 Diabetes Clinical Trial

— Lilly-MEALS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021158
• Other study ID #: 2024-9583
• Status: Recruiting
• Phase: Phase 2
• Start date: December 20, 2023
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Carolyne Schumacher
• Phone: 514-258-5431
• Email: carolyne.schumacher[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Combination Product:
• 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).
• 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).
• 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.

Locations

Country	Name	City	State
Canada	Research Institute of the McGill University Health Centre (RI-MUHC)	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)		14 days
Secondary	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
Secondary	Mean glucose levels		14 days
Secondary	Standard deviation of glucose levels		14 days
Secondary	Standard deviation of insulin delivery		14 days
Secondary	Coefficient of variance of glucose levels		14 days
Secondary	Coefficient of variance of insulin delivery		14 days
Secondary	Total insulin delivery (overall, basal, and bolus)		14 days
Secondary	Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after meal insulin boluses		14 days
Secondary	Area under the sensor glucose concentration-time curve (AUC) from 1-2 hours, 2-3 hours, 3-4 hours, and 4-5 hours after meal insulin boluses		14 days
Secondary	Decremental sensor glucose concentration for the duration of announced exercise periods		14 days
Secondary	Area under the sensor glucose concentration-time curve (AUC) from 0-1 hours, 0-2 hours, 0-3 hours, 0-4 hours, and 0-5 hours after the end of announced exercise periods		14 days