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Completed

NCT Number: NCT03848767

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AID System

Device

AID System

Other names: LY8888AU

Insulin Lispro

Drug

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

Other names: LY275585

Primary outcomes

  1. Number of Adverse Events (AEs)

    Time frame: In-Patient Period (3 Days)

    Number of AEs

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

    Time frame: In-Patient Period (3 Days)

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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus During Meal Challenges

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 21, 2019
Registry last updated
Apr 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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