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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06063759 on ClinicalTrials.gov