A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)

Type 1 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: NCT03743285
• Other study ID #: 16681
• Secondary ID: F3Z-MC-IOQW
• Status: Completed
• Phase: N/A
• Start date: November 14, 2018
• Est. completion date: January 28, 2019

Study information

• Verified date: February 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• 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 designed. The study will last about 3 months with up to 6 days of inpatient time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 28, 2019
• Est. primary completion date: January 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

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	Rainier Clinical Research Center	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 Adverse Events (AEs)	Number of AEs	In-Patient Period (6 Days)
Primary	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 (6 Days)