Back to results

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

Primary Purpose

Diabetes Mellitus

Status

Suspended

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

VitalDetect

About this trial

This is an interventional other trial for Diabetes Mellitus

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

PSHI Praxis GmbH

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

VitalDetectTM

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT06063759

First Posted

March 31, 2020

Last Updated

September 25, 2023

Sponsor

Sciema UG

1. Study Identification

Unique Protocol Identification Number

NCT06063759

Brief 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 Participants

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Suspended

Why Stopped

Study was postponed due to manufacturing issues

Study Start Date

September 25, 2023 (Anticipated)

Primary Completion Date

October 31, 2023 (Anticipated)

Study Completion Date

November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sciema UG

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

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

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VitalDetectTM

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

VitalDetect

Intervention Description

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

Primary Outcome Measure Information:

Title

Accuracy of the Vital USA VitalDetectTM for assessment of microcirculation (in AU)

Description

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andreas Pfuetzner, MD

Organizational Affiliation

Pfützner Science & Health Institute GmbH

Official's Role

Principal Investigator

Facility Information:

Facility Name

PSHI Praxis GmbH

City

Mainz

ZIP/Postal Code

55128

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs