Type 1 Diabetes Clinical Trial
Official title:
In-Clinic Feasibility Study to Observe the Overnight Closed Loop System
This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.
Subjects that have met eligibility criteria will undergo treatment with the hybrid closed
loop system under various experimental conditions.There is no statistically powered study
hypothesis testing.
The investigational centers will be encouraged to include subjects of different ethnicities
including Hispanic, Native American, and African-American.
The study is anticipated to last no more than 12 months from investigational center
initiation to finalization of all data entry and monitoring procedures. Subjects are expected
to participate for approximately 1- 2 months.
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