A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes
An Early Feasibility Study to Evaluate the Predictive Low Glucose Suspend Functionality and Safety 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 early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.
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 Mar 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
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
March 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 6, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 6, 2019
CompletedJune 5, 2019
June 1, 2019
1 month
March 22, 2019
June 4, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Adverse Events (AEs)
Number of AEs
In-Patient Period (2 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 (2 Days)
Study Arms (1)
AID System Containing Insulin Lispro
EXPERIMENTALThe automated insulin delivery (AID) system is comprised of a continuous subcutaneous insulin infusion (CSII) pump component with a PLGS 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)
Sansum Diabetes Research Institute
Santa Barbara, California, 93105, United States
Related Publications (1)
Pinsker JE, Bartee A, Katz M, Lalonde A, Jones R, Dassau E, Wolpert H. Predictive Low-Glucose Suspend Necessitates Less Carbohydrate Supplementation to Rescue Hypoglycemia: Need to Revisit Current Hypoglycemia Treatment Guidelines. Diabetes Technol Ther. 2021 Jul;23(7):512-516. doi: 10.1089/dia.2020.0619. Epub 2021 Feb 18.
PMID: 33535013DERIVED
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
March 22, 2019
First Posted
March 26, 2019
Study Start
March 28, 2019
Primary Completion
May 6, 2019
Study Completion
May 6, 2019
Last Updated
June 5, 2019
Record last verified: 2019-06-01
Data Sharing
- IPD Sharing
- Will not share