A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes



Status:Not yet recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:4/5/2019
Start Date:April 1, 2019
End Date:April 29, 2019
Contact:This is a single site clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Email:Clinicaltrials.gov@lilly.com
Phone:1-317-615-4559

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Sansum Diabetes Research Institute
Santa Barbara, California 93105
Principal Investigator: Jordan Pinsker
?
mi
from
Santa Barbara, CA
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