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

Not Applicable

Completed

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

• Registration Number: NCT03743285
• Lead Sponsor: Eli Lilly and Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-14
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Study First Posted: 2018-11-16
• Primary Completion: 2019-01-28
• Study Completion: 2019-01-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-18
• Last Update Posted: 2019-02-19

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AID System Containing Insulin Lispro	AID System	The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component.
AID System Containing Insulin Lispro	Insulin Lispro	The AID system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a hybrid closed-loop control (HCLC) algorithm, and a continuous glucose monitor (CGM) component.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	In-Patient Period (6 Days)	Number of AEs
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL	In-Patient Period (6 Days)	CGM measured percentage of time \<70 milligrams per deciliter (mg/dL)

Trial Locations

Locations (1)

Rainier Clinical Research Center; 🇺🇸 Renton, Washington, United States