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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
12
A novel CGM system based on a FiberSense system placed through the dermis of the patient.
The Chinese University of Hong Kong
Shatin, Hong Kong
Overall performance of the FiberSense device as compared with YSI
Proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels \>100 mg/dl (5.55 mmol/l), and the proportion of FiberSense readings within ≤15 mg/dl (0.83 mmol/l) of the YSI reading for blood glucose levels ≤100 mg/dl.
Time frame: 1 day
Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
Time frame: 1 day
Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
Time frame: 1 day
Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI)
Time frame: 1 day
Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions
Time frame: 1 day
Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra)
Time frame: 1 day
Percentage of readings that are within 15% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Time frame: 1 day
Percentage of readings that are within 20% of the YSI values
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Time frame: 1 day
Percentage of readings that are within 30% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Time frame: 1 day
Percentage of readings that are within 40% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Time frame: 1 day
Percentage of readings that are greater than 40% of the YSI values
Comparisons of the percentage of readings from Dexcom and Fibersense, and comparisons of the percentage of readings from Bayer Contour Next and Fibersense, will be done separately during analysis.
Time frame: 1 day
Adverse Event Reporting
Time frame: 14 days
Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI)
Time frame: 1 day
Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI)
Time frame: 1 day