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This study evaluates the performance and safety of the fluorescence based fibre optic glucose sensor for home usage.24 subjects will take part in the study, including 4 pre-diabetic subjects, 8 Type I diabetic patients, 8 Type II diabetic patients and 4 diabetic patients who require continuous ambulatory peritoneal dialysis (CAPD). Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subjects.
The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management. The System is intended for use by patients at home and in health care facilities.
The FiberSense system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home glucose monitoring devices.
The FiberSense system aids in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FiberSense sensor | Experimental | Type 1, Type 2 and prediabetic subjects will wear one FiberSense sensor, randomly allocated to either the upper arm (50%) or abdomen (50%) for 28 days. In addition, these subjects will wear a Dexcom sensor on the other side of the abdomen for 7 days in one of the four study weeks. In all 4 CAPD subjects, one FiberSense sensor will be placed in the upper arm for 28 days. No additional comparator sensor will be placed in CAPD subject. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FiberSense sensor | Device | The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood glucose | The primary endpoint is the proportion of FiberSense readings within ≤15% of the reference (YSI) reading for blood glucose levels >100 mg/dl, and the proportion of FiberSense readings within ≤15 mg/dl of the YSI reading for blood glucose levels ≤100 mg/dl, for paired samples taken during the in-clinic sessions. | 28 days |
| Adverse Events reporting | 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Relatives Differences from YSI | 28 days | |
| Median Relatives Differences from YSI | 28 days | |
| Mean Absolute Relative Differences from YSI |
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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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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Dexcom Sensor | Device | Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend. |
|
| 28 days |
| Median Absolute Relative Differences from YSI | 28 days |
| Hypoglycemia detection rates | 28 days |
| Hyperglycemia detection rates | 28 days |
| Accuracy of glucose rate of change of FiberSense sensor compared to glucose rate of change of YSI | 28 days |
| Lag time between FiberSense readings and YSI results during induced glucose excursions | 28 days |
| Agreement and accuracy relative to SMBG readings (same model to be used by all subjects) | 28 days |
| Calibration stability | 28 days |
| Sensor stability | 28 days |
| Sensor life | 28 days |
| User satisfaction questionnaire score | 28 days |
| Blood maltose concentrations | Measured in CAPD subjects during the V1 in-clinic session | 28 days |