A Study of an Automated Insulin Delivery System in Adult Participants With Type 1 Diabetes Mellitus (T1D)



Status:Completed
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 65
Updated:2/21/2019
Start Date:November 14, 2018
End Date:January 28, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

An Early Feasibility Study to Evaluate the Functionality and Safety of an Automated Insulin Delivery System in Adult Patients With Type 1 Diabetes Mellitus

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.


- 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
Rainier Clinical Research Center Inc.
Renton, Washington 98057
Principal Investigator: Ronald L. Brazg
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mi
from
Renton, WA
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