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

NCT ID: NCT06063759

Last Updated: 2023-10-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2023-11-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

VitalDetectTM

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

Group Type: OTHER

VitalDetect

Intervention Type: DEVICE

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

Interventions

VitalDetect

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

Intervention Type: DEVICE

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sciema UG

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Pfuetzner, MD

Role: PRINCIPAL_INVESTIGATOR

Pfützner Science & Health Institute GmbH

Locations

PSHI Praxis GmbH

Mainz, , Germany

Countries

Germany

Other Identifiers

VIT-NGM-002

Identifier Type: -

Identifier Source: org_study_id