A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

NCT03367390 | Completed Phase 1 FDA Drug FDA Device

• 2 other identifiers: 16679F3Z-MC-IOQS
• Study Type: interventional
• Target: 30
• 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 and to test whether the AID System functions as it was designed to. This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.

Conditions

Type1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges

  Up to 4 hours post challenge

• Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge

  Up to 4 hours post challenge

• Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity

  Up to 4 hours post challenge

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 procedures designed to induce hyperglycemia and hypoglycemia.

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 for at least 1 year
• Have a body mass index of 18.5 to 35 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)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Renton, Washington, 98057, United States

Location

Related Links

• A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)

MeSH Terms

Interventions

Insulin Lispro

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: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2017
• First Posted: December 8, 2017
• Study Start: November 8, 2017
• Primary Completion: February 9, 2018
• Study Completion: February 9, 2018
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

US (1)