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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

Sponsor
Sciema UG (Other)
Overall Status
Suspended
CT.gov ID
NCT06063759
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
2.2
Anticipated Duration (Months)
46.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: VitalDetect
 N/A

Detailed Description

The study procedures will be the same for all three groups during the single visit. In all groups of participants, the Vital USA VitalDetect™ 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 VitalDetect™ 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 VitalDetect™. Parallel measurements of the heart rate and the SpO2 using a patient monitor (Edan iM8b) will be compared to the Vital USA VitalDetect™ device readings. Venous blood will be drawn from every subject to determine proinsulin, insulin and HbA1c values.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
3 groups with the same study procedures in sequential timely series.3 groups with the same study procedures in sequential timely series.
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Comparative Measurement of Microcirculation and Other Parameters With the Vital USA VitalDetect™ in Patients With Diabetes Mellitus Type 1 and Type 2 Versus Healthy Paricipants
Anticipated Study Start Date :
Sep 25, 2023
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Nov 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: VitalDetectTM

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

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

Outcome Measures

Primary Outcome Measures

  1. Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU) [30 minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • 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);

  • 18 years old and above;

  • Anatomically suitable finger in discretion of the investigator

Exclusion Criteria:

  • Does not meet inclusion criteria;

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PSHI Praxis GmbH Mainz Germany 55128

Sponsors and Collaborators

  • Sciema UG

Investigators

  • Principal Investigator: Andreas Pfuetzner, MD, Pfützner Science & Health Institute GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sciema UG
ClinicalTrials.gov Identifier:
NCT06063759
Other Study ID Numbers:
  • VIT-NGM-002
First Posted:
Oct 3, 2023
Last Update Posted:
Oct 3, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 3, 2023