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The study is an open-label, prospective, within-subject comparison of the Bios device readings versus venous blood sample glucose readings, glucose readings from a Dexcom CGM and an SMBG device in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus.
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison between Bios device readings and glucose values | The primary objective of this study is to compare the glucose measurements collected by the Bios device to glucose values measured with a blood glucose lab analyzer (e.g., YSI), glucose values obtained with a self-monitoring blood glucose device (SMBG) and readings from the Dexcom System in subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus. | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Subjects with any physical or behavioral disorder, which, in the opinion of the Principal Investigator, may interfere with the use of the device or compliance with the study protocol;
Subject has any of the following:
History of substance abuse within 6 months of study start;
Use of any illicit drugs during the duration of the study period;
Marijuana use during the duration of the study period;
If female, subject is pregnant or nursing;
Subject is on active dialysis;
Subjects whom the Principal Investigator believes may not be an appropriate candidate for this device.
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Subjects previously diagnosed with Type 1 or Type 2 diabetes mellitus
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Diablo Clinical Research, Inc | Recruiting | Walnut Creek | California | 94598 | United States |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |