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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device: FiberSense system | Experimental | 10 subjects will wear 2 FiberSense system in abdomen and upper arm respectively and Dexcom G4 Platinum CGM sensor for 1 day. |
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| Extension Phase | Experimental | 2 subjects will extend the wearing of the sensors up to 14 days (2 FiberSense systems to Day 14 and Dexcom sensor to Day 7±1) after the glucose clamp study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FiberSense system | Device | A novel CGM system based on a FiberSense system placed through the dermis of the patient. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Mean relative differences in FiberSense measured glucose from the reference laboratory standard (YSI) | 1 day | |
| Mean Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI) | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow, Dr. | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chinese University of Hong Kong | Shatin | Hong Kong |
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For the first 10 subjects, all sensors will be removed after the end of the clamp measurement day.
The last 2 subjects will continue to wear the three sensors after the clamp study. The second clamp study will take place at Day 7±1. After the second clamp study, the commercial CGM sensor will be removed. The two FiberSense sensors will be worn for up to Day 14.
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| Accuracy of glucose rate of change measured by FiberSense sensor compared to glucose rate of change measured using the reference laboratory method (YSI) | 1 day |
| Lag time between FiberSense readings and reference laboratory method (YSI) results during induced glucose excursions | 1 day |
| Precision of FiberSense system readings: Precision Absolute Relative Differences with comparison of FiberSense system locations (inter and intra) | 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. | 1 day |
| Percentage of readings that are within 20% 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. | 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. | 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. | 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. | 1 day |
| Adverse Event Reporting | 14 days |
| Median relative differences in FiberSense measured glucose from the reference laboratory standard (YSI) | 1 day |
| Median Absolute Relative Differences in FiberSense measured glucose from the reference laboratory method (YSI) | 1 day |