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

Phase 2

Recruiting

• Conditions: Diabetes Mellitus, Type 1; Type 1 Diabetes
• Interventions: 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

• Registration Number: NCT06021158
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-24
• Study First Submitted QC: 2023-08-30
• Study First Posted: 2023-09-01
• Study Start: 2023-12-20
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AID-detect	Fully automated Lyumjev delivery system with meal detection	-
AID-count	Hybrid automated Lyumjev delivery system with carbohydrate counting	-
AID-estimate	Hybrid automated Lyumjev delivery system with meal size estimation	-

Primary Outcome Measures

Name	Time	Method
Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L)	14 days

Secondary Outcome Measures

Name	Time	Method
Mean glucose levels	14 days
Standard deviation of glucose levels	14 days
Decremental sensor glucose concentration for the duration of announced exercise periods	14 days
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
Standard deviation of insulin delivery	14 days
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
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
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
Coefficient of variance of glucose levels	14 days
Coefficient of variance of insulin delivery	14 days
Total insulin delivery (overall, basal, and bolus)	14 days

Trial Locations

Locations (1)

Research Institute of the McGill University Health Centre (RI-MUHC); 🇨🇦 Montréal, Quebec, Canada