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 | Suspended

• 1 other identifier: VIT-NGM-002
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

VitalDetectTM

OTHER

Determination of microcirculating blood flow, glucose, SpO2, and heart rate.

Device: VitalDetect

Interventions

VitalDetect DEVICE

measurement of microcirculating blood flow, SpO2 (mmHg or %), heart rate (beats/min)

VitalDetectTM

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or Type 2 diabetic or healthy subject (25 Type 1, 25 Type 2, 50 healthy subjects)
• Subjects who are able to complete informed consent form (by him/herself or by his/her guardian);
• years old and above;
• Anatomically suitable finger in discretion of the investigator

You may not qualify if:

• Any conditions that may hamper good visual contact between the finger and sensor, such as raised birthmarks, scars, tattoos;
• Pregnancy;
• Nursing mothers;
• Any skin scratch(es), damage, over dry, long nails on the measured finger;
• Unsuitable finger with the device might be excluded if recognized during the trial;
• Medication containing nitrates

Sponsors & Collaborators

• Sciema UG: lead

Study Sites (1)

PSHI Praxis GmbH

Mainz, 55128, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Andreas Pfuetzner, MD

  Pfützner Science & Health Institute GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 groups with the same study procedures in sequential timely series.

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: October 3, 2023
• Study Start: September 25, 2023
• Primary Completion: October 31, 2023
• Study Completion: November 30, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)