NCT03008044

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DEVICE	FiberSense system	A novel CGM system based on a FiberSense system placed through the dermis of the patient.

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2017-01-02
• Last updated: 2017-08-11

Locations

1 site across 1 country: Hong Kong