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

NCT03848767 | Completed FDA Device

• 2 other identifiers: 17177F3Z-MC-IORD
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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 during meal challenges.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Number of Adverse Events (AEs)

  Number of AEs

  In-Patient Period (3 Days)

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

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

  In-Patient Period (3 Days)

Study Arms (1)

AID System Containing Insulin Lispro

EXPERIMENTAL

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

AID System DEVICE

AID System

Also known as: LY8888AU

AID System Containing Insulin Lispro

Insulin Lispro DRUG

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

Also known as: LY275585

AID System Containing Insulin Lispro

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 21, 2019
• Study Start: February 20, 2019
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: April 23, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)