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

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Device: AID System; Drug: Insulin Lispro

• Registration Number: NCT03890003
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-22
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-26
• Study Start: 2019-03-28
• Primary Completion: 2019-05-06
• Study Completion: 2019-05-06
• Status Verified: 2019-06-01
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AID System Containing Insulin Lispro	AID System	The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component.
AID System Containing Insulin Lispro	Insulin Lispro	The automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS algorithm, and a continuous glucose monitor (CGM) component.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	In-Patient Period (2 Days)	Number of AEs
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL	In-Patient Period (2 Days)	CGM measured percentage of time \<70 milligrams per deciliter (mg/dL)

Trial Locations

Locations (1)

Sansum Diabetes Research Institute; 🇺🇸 Santa Barbara, California, United States