A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

Lilly

Status and phase: Completed; Phase 1

Conditions: Type1 Diabetes Mellitus

Treatments: Drug: Insulin Lispro; Device: AID System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03367390

16679

F3Z-MC-IOQS (Other Identifier)

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 and to test whether the AID System functions as it was designed to.

This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.

Enrollment: 30 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 for at least 1 year
• Have a body mass index of 18.5 to 35 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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30 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:

Device: AID System

Drug: Insulin Lispro