A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)
An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus
2 other identifiers
interventional
10
1 country
1
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.
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 Nov 2018
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
November 14, 2018
CompletedStudy Start
First participant enrolled
November 14, 2018
CompletedFirst Posted
Study publicly available on registry
November 16, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 28, 2019
CompletedFebruary 19, 2019
February 1, 2019
3 months
November 14, 2018
February 18, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Adverse Events (AEs)
Number of AEs
In-Patient Period (6 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 (6 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 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)
Rainier Clinical Research Center
Renton, Washington, 98057, 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
November 14, 2018
First Posted
November 16, 2018
Study Start
November 14, 2018
Primary Completion
January 28, 2019
Study Completion
January 28, 2019
Last Updated
February 19, 2019
Record last verified: 2019-02
Data Sharing
- IPD Sharing
- Will not share