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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849612
• Other study ID #: 17175
• Secondary ID: F3Z-MC-IORB
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: March 27, 2019

Study information

• Verified date: April 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 27, 2019
• Est. primary completion date: March 27, 2019
• 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 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	Diablo Clinical Research	Walnut Creek	California

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 (5 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 (5 Days)