A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus
An Early Feasibility Study to Evaluate Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
2 other identifiers
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2019
CompletedFirst Posted
Study publicly available on registry
February 21, 2019
CompletedStudy Start
First participant enrolled
February 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 27, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 27, 2019
CompletedApril 25, 2019
April 1, 2019
1 month
February 19, 2019
April 24, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Adverse Events (AEs)
Number of AEs
In-Patient Period (5 Days)
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
CGM measured percentage of time \<70 milligrams per deciliter (mg/dL)
In-Patient Period (5 Days)
Study Arms (1)
AID System Containing Insulin Lispro
EXPERIMENTALThe 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.
Interventions
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Eligibility Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Diablo Clinical Research
Walnut Creek, California, 94598, United States
Related Publications (1)
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.
PMID: 32940537DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2019
First Posted
February 21, 2019
Study Start
February 21, 2019
Primary Completion
March 27, 2019
Study Completion
March 27, 2019
Last Updated
April 25, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will not share