Back to resultsA Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AID System
Insulin Lispro
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 1 Diabetes Mellitus
Eligibility Criteria
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
Sites / Locations
- Diablo Clinical Research
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 Adverse Events (AEs)
Number of AEs
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
CGM measured percentage of time <70 milligrams per deciliter (mg/dL)
Secondary Outcome Measures
Full Information
NCT ID
NCT03849612
First Posted
February 19, 2019
Last Updated
April 24, 2019
Sponsor
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT03849612
Brief Title
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus
Official Title
An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
February 21, 2019 (Actual)
Primary Completion Date
March 27, 2019 (Actual)
Study Completion Date
March 27, 2019 (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
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate whether an Automated Insulin Delivery (AID) System is safe to use and functions as intended with personalized basal insulin rates and when basal insulin rates are increased.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (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 Adverse Events (AEs)
Description
Number of AEs
Time Frame
In-Patient Period (5 Days)
Title
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
Description
CGM measured percentage of time <70 milligrams per deciliter (mg/dL)
Time Frame
In-Patient Period (5 Days)
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 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
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
Diablo Clinical Research
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32940537
Citation
Christiansen M, Bartee A, Lalonde A, Jones RE, Katz M, Wolpert H, Brazg R. Performance of an Automated Insulin Delivery System: Results of Early Phase Feasibility Studies. Diabetes Technol Ther. 2021 Mar;23(3):187-194. doi: 10.1089/dia.2020.0318. Epub 2020 Oct 5.
Results Reference
derived
Learn more about this trial
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus
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