- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03890003
A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes
June 4, 2019 updated by: Eli Lilly and Company
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
The purpose of this early feasibility study is to assess the predictive low glucose suspend (PLGS) feature's safety, functionality and performance.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Santa Barbara, California, United States, 93105
- Sansum Diabetes Research Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AID System Containing Insulin Lispro
The 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.
|
AID system
Other Names:
Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Adverse Events (AEs)
Time Frame: In-Patient Period (2 Days)
|
Number of AEs
|
In-Patient Period (2 Days)
|
Continuous Glucose Monitor (CGM) Measured Percentage of Time <70 mg/dL
Time Frame: In-Patient Period (2 Days)
|
CGM measured percentage of time <70 milligrams per deciliter (mg/dL)
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In-Patient Period (2 Days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2019
Primary Completion (Actual)
May 6, 2019
Study Completion (Actual)
May 6, 2019
Study Registration Dates
First Submitted
March 22, 2019
First Submitted That Met QC Criteria
March 22, 2019
First Posted (Actual)
March 26, 2019
Study Record Updates
Last Update Posted (Actual)
June 5, 2019
Last Update Submitted That Met QC Criteria
June 4, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17176
- F3Z-MC-IORC (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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