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

April 24, 2019 updated by: Eli Lilly and Company

An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
AID system
Other Names:
  • LY8888AU
Drug: Insulin Lispro
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other Names:
  • LY275585

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Adverse Events (AEs)
Time Frame: In-Patient Period (5 Days)
Number of AEs
In-Patient Period (5 Days)
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
Time Frame: In-Patient Period (5 Days)
CGM measured percentage of time <70 milligrams per deciliter (mg/dL)
In-Patient Period (5 Days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 21, 2019

Primary Completion (Actual)

March 27, 2019

Study Completion (Actual)

March 27, 2019

Study Registration Dates

First Submitted

February 19, 2019

First Submitted That Met QC Criteria

February 20, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17175
  • F3Z-MC-IORB (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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