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CompletedNCT03743285Updated Feb 19, 2019

A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)

An interventional study of AID System and Insulin Lispro in Type 1 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-02-19.

Sponsored by Eli Lilly and Company · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Jan 2019, 7 years 8 months ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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 designed. The study will last about 3 months with up to 6 days of inpatient time.

02

Conditions studied

  • Type 1 Diabetes Mellitus
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    AID System Containing Insulin Lispro

    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.

    Device: AID System · Drug: Insulin Lispro

Interventions

  • DeviceAID System

    AID system

    Also known as: LY8888AU

  • DrugInsulin Lispro

    Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.

    Also known as: LY275585

06

What researchers measure

Primary outcomes

  1. Number of Adverse Events (AEs)

    Number of AEs

    Time frame: In-Patient Period (6 Days)

  2. 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 (6 Days)

07

Study locations

1 site
  • Rainier Clinical Research Center
    Renton, Washington 98057, United States
08

References and documents

Publications

  • Christiansen M, Bartee A, Lalonde A, Jones RE, Katz M, Wolpert H, Brazg R. Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies. Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 2020 Oct 5. PubMed 32940537 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03743285
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Nov 16, 2018
Start date
Nov 14, 2018
Primary completion
Jan 28, 2019
Completion
Jan 28, 2019
Last update
Feb 19, 2019

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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