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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1, Type 1 Diabetes

Intervention / Treatment
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* Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting
* Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation
* Combination Product: Fully automated Lyumjev delivery system with meal detection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AID-count<br> | Combination Product: Hybrid automated Lyumjev delivery system with carbohydrate counting<br>* 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).<br>|
| Experimental: AID-estimate<br> | Combination Product: Hybrid automated Lyumjev delivery system with meal size estimation<br>* In this system, a Lyumjev insulin bolus is initiated at mealtime based on the qualitative amount of carbohydrates estimated (e.g., low-carb meal).<br>|
| Experimental: AID-detect<br> | Combination Product: Fully automated Lyumjev delivery system with meal detection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time of glucose levels spent in the target range (3.9-10.0 mmol/L) |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Coefficient of variance of insulin delivery |  | 14 days | 
| Total insulin delivery (overall, basal, and bolus) |  | 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 | 
| 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 | 
| Decremental sensor glucose concentration for the duration 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 the end of announced exercise periods |  | 14 days |