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

NCT ID: NCT03890003

Last Updated: 2019-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-28

Study Completion Date

2019-05-06

Brief Summary

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

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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AID System Containing Insulin Lispro

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.

Group Type EXPERIMENTAL

AID System

Intervention Type DEVICE

AID system

Insulin Lispro

Intervention Type DRUG

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

Interventions

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AID System

AID system

Intervention Type DEVICE

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.

Intervention Type DRUG

Other Intervention Names

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LY8888AU LY275585

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Sansum Diabetes Research Institute

Santa Barbara, California, United States

Site Status

Countries

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United States

References

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Pinsker JE, Bartee A, Katz M, Lalonde A, Jones R, Dassau E, Wolpert H. Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. Diabetes Technol Ther. 2021 Jul;23(7):512-516. doi: 10.1089/dia.2020.0619. Epub 2021 Feb 18.

Reference Type DERIVED
PMID: 33535013 (View on PubMed)

Other Identifiers

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F3Z-MC-IORC

Identifier Type: OTHER

Identifier Source: secondary_id

17176

Identifier Type: -

Identifier Source: org_study_id

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