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

Completed · Phase 1

Conditions studied: Type1 Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT03367390

Run by

Eli Lilly and Company

People needed

30

Starts

2017-11-08

Expected to finish

2018-02-09

Last updated by the study team

2018-03-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician. — Renton, Washington, United States

Full record on ClinicalTrials.gov

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