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Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense System)

Healthy Subjects Clinical Trial

Official title:
Evaluation of a Percutaneous Optical Fibre Glucose Sensor (FiberSense) Across the Glycemic Range With Rapid Glucose Excursions Using the Glucose Clamp

Clinical Trial Summary

This is a single center prospective study. The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers.

Clinical Trial Description

The FiberSense system is intended to be used by diabetic patients in a home use setting as a CGM system using the interstitial fluid (ISF) glucose as an indicator of blood glucose levels.The purpose of this study is to assess the performance of FiberSense system across the glucose measurement ranges (from hypoglycemia to hyperglycemia) as compared with a gold standard reference laboratory method (YSI glucose) in healthy volunteers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03008044
Study type Interventional
Source Lee's Pharmaceutical Limited
Contact
Status Completed
Phase N/A
Start date August 2016
Completion date June 2017
View Details
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