A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus During Meal Challenges

Lilly

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: AID System; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03848767

F3Z-MC-IORD (Other Identifier)

17177

Details and patient eligibility

About

The Automated Insulin Delivery (AID) System is an investigational insulin delivery device being developed for use for participants with diabetes. The purpose of this study is to assess the safety of the AID system during meal challenges.

Enrollment: 10 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with T1DM for at least 2 years and who have used an insulin delivery system with any rapid-acting insulin analog for the preceding 6 months
• Have a body mass index of 18.5 to 37 kilogram per meter squared
• Have a hemoglobin A1c level ≥6.0% and ≤9.0%

Exclusion criteria

• Have known allergies or history of hypersensitivity to insulin lispro
• Have had an episode of severe hypoglycemia within the past 6 months
• Have had more than 1 episode of diabetic ketoacidosis in the past 6 months

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

AID System Containing Insulin Lispro

Experimental group

Description:

The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component.

Treatment:

Drug: Insulin Lispro

Device: AID System