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The purpose of this study is to compare glucose measurements from the C8 MediSensors non-invasive Optical Glucose Monitorâ„¢ System to blood glucose measurements from the Yellow Springs Instrument(YSI) blood glucose analyzer.
This is a prospective, non-randomized, open label study to evaluate the performance of the C8 MediSensors non-invasive Optical Glucose Monitorâ„¢ on individuals with diabetes mellitus. Capillary blood samples will be obtained throughout a daily study session; the study session may last for up to 12 hours. Blood glucose will be measured on a YSI blood glucose analyzer. Subjects may adjust food intake and insulin administration so device performance is evaluated across a broad range of glucose concentrations. Glucose measurements will be time matched and paired for comparison. Skin effects and adverse events will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-invasive Optical Glucose Monitorâ„¢ | Experimental | Test device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive Optical Glucose Monitorâ„¢ | Device | Test device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the test device in comparison to the reference device | The primary objective is to characterize the accuracy of the non-invasive glucose measurements from the Optical Glucose Monitorâ„¢ to blood glucose measurements on a sample size of approximately 30 subjects with 1000 time matched, paired data points. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vice President, Clincal, Regulatory, Quality | C8 MediSensors, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C8 MediSensors, Inc. | San Jose | California | 95119 | United States |
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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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| YSI blood glucose analyzer | Device | Reference device |
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