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

Lilly

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Device: AID System; Drug: Insulin Lispro

Study type: Interventional

Funder types: Industry

Identifiers

NCT03890003

17176

F3Z-MC-IORC (Other Identifier)

Details and patient eligibility

About

The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.

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 automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component.

Treatment:

Drug: Insulin Lispro

Device: AID System