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



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:3/21/2019
Start Date:February 20, 2019
End Date:March 21, 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 Basal Initialization Parameters in an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

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.


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
Diablo Clinical Research Inc
Walnut creek, California 94598
Principal Investigator: Mark P Christiansen
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mi
from
Walnut creek, CA
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