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

Eli Lilly and Company10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus

Interventions

AID SystemDEVICE

AID System

Insulin LisproDRUG

Individualized doses of insulin lispro administered via the AID system to maintain glycemic control except during meal challenges.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Rainier Clinical Research Center

Renton, Washington, United States

Outcomes

Primary Outcomes

Number of Adverse Events (AEs)

Number of AEs

Time frame: In-Patient Period (3 Days)

Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL

CGM measured percentage of time \<70 milligrams per deciliter (mg/dL)

Time frame: In-Patient Period (3 Days)

Data from ClinicalTrials.gov

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