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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

An Early Feasibility Study to Evaluate the Predictive Low Glucose Suspend Functionality and Safety in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03890003
• Other study ID #: 17176
• Secondary ID: F3Z-MC-IORC
• Status: Completed
• Phase: N/A
• Start date: March 28, 2019
• Est. completion date: May 6, 2019

Study information

• Verified date: June 1, 2019
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 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	Sansum Diabetes Research Institute	Santa Barbara	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 (2 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 (2 Days)