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NCT03367390 Clinical Trial

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

Type1 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03367390
Other study ID # 16679
Secondary ID F3Z-MC-IOQS
Status Completed
Phase Phase 1
First received December 5, 2017
Last updated March 14, 2018
Start date November 8, 2017
Est. completion date February 9, 2018

Study information
Verified date March 2018
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 9, 2018
Est. primary completion date February 9, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 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%

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 Design

Related Conditions & MeSH terms

Intervention

Device:
• AID System
AID system
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.

Locations
Country Name City State
United States 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

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges Up to 4 hours post challenge
Primary Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge Up to 4 hours post challenge
Primary Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity Up to 4 hours post challenge
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