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

Lilly

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Insulin Lispro; Device: AID System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03849612

17175

F3Z-MC-IORB (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.

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:

Device: AID System

Drug: Insulin Lispro