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Clinical Trial Summary

The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.


Clinical Trial Description

The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects. In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c < 7.5%. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02985866
Study type Interventional
Source University of Virginia
Contact
Status Completed
Phase N/A
Start date October 27, 2017
Completion date September 4, 2018

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