Type 1 Diabetes Mellitus Clinical Trial
Official title:
Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people
with type 1 diabetes who are currently using an insulin pump. During the subject's
participation, the study staff will closely monitor the study subject in a clinical research
center environment for approximately 24 hours, while controller algorithm determined insulin
doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Total subject participation approximately 1 week for screening to completion. This includes
approximately 24 hours usage of the investigation device in the clinical research center
under close medical supervision.
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