Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Participants
NCT06063759 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2023-10-03
Summary
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.
Conditions
Interventions
- DEVICE
-
VitalDetect
measurement of microcirculating blood flow, SpO2 (mmHg or %), heart rate (beats/min)
Sponsors & Collaborators
-
Sciema UG
lead OTHER
Principal Investigators
-
Andreas Pfuetzner, MD · Pfützner Science & Health Institute GmbH
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-09-25
- Primary Completion
- 2023-10-31
- Completion
- 2023-11-30
Countries
- Germany
Study Locations
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