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Study was postponed due to manufacturing issues
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The purpose of this clinical study is to optimize the measurement algorithm of the Vital USA VitalDetectTM in measuring the microcirculating blood flow. Further optimization and finally the demonstration of the performance of the VitalDetectTM non-invasive monitoring biosensor in monitoring glucose, and heart rate in patients with type 1 and type 2 diabetes and healthy participants, when operated according to the instructions for use.
The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetectâ„¢ will be individually introduced and assigned. During the experimental study visit, microcirculating blood flow (MBF), heart rate, and SpO2 will be measured using the Vital USA VitalDetectâ„¢ at 2 time points in between approx. 15 min. MBF will be measured in parallel by use of the LEA Medizintechnik O2C also using a finger on the same hand. The YSI glucose measurements will be employed to generate a robust algorithm for glucose measurements using the VitalDetectâ„¢. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetectâ„¢ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VitalDetectTM | Other | Determination of microcirculating blood flow, glucose, SpO2, and heart rate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VitalDetect | Device | measurement of microcirculating blood flow, SpO2 (mmHg or %), heart rate (beats/min) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU) | Accuracy and performance of Vital USA VitalDetectTM for assessment of microcirculation (in AU) by measuring microcirculation using the VitalDetectTM in comparison to the LEA Medizintechnik O2C device. | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Pfuetzner, MD | Pfützner Science & Health Institute GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PSHI Praxis GmbH | Mainz | 55128 | Germany |
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3 groups with the same study procedures in sequential timely series.
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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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