A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
Phase 1
Completed
- Conditions
- Type1 Diabetes Mellitus
- Interventions
- Device: AID System
- Registration Number
- NCT03367390
- 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 it was designed to.
This study will last approximately 12-18 days, not including screening. Screening is required within 28 days prior to the start of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Participants with T1DM for at least 2 years and who have used an insulin delivery system for at least 1 year
- Have a body mass index of 18.5 to 35 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
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 Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges Up to 4 hours post challenge Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge Up to 4 hours post challenge Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity Up to 4 hours post challenge
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
🇺🇸Renton, Washington, United States