Back to resultsA Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
Primary Purpose
Type1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AID System
Insulin Lispro
Sponsored by
About this trial
This is an interventional device feasibility trial for Type1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- 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.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AID System Containing Insulin Lispro
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges
Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge
Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03367390
Brief Title
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
Official Title
An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 8, 2017 (Actual)
Primary Completion Date
February 9, 2018 (Actual)
Study Completion Date
February 9, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes Mellitus
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AID System Containing Insulin Lispro
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
AID System
Other Intervention Name(s)
LY8888AU
Intervention Description
AID system
Intervention Type
Drug
Intervention Name(s)
Insulin Lispro
Other Intervention Name(s)
LY275585
Intervention Description
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Primary Outcome Measure Information:
Title
Number of Participants Who Show a Decrease or Suspension of Basal Insulin Delivery in Response to Hypoglycemia Challenges
Time Frame
Up to 4 hours post challenge
Title
Number of Participants Who Show an Increase of Basal Insulin Delivery in Response to the Hyperglycemia Challenge
Time Frame
Up to 4 hours post challenge
Title
Number of Participants Who Show a Resumption of Auto Mode Following Restored Continuous Glucose Monitoring (CGM) Connectivity
Time Frame
Up to 4 hours post challenge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.lillytrialguide.com/en-US/studies/type-1-diabetes/IOQS#?postal=
Description
A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
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A Study of an Automated Insulin Delivery System in Participants With Type 1 Diabetes Mellitus (T1DM)
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