Measurement Algorithm Control, Optimization, and Performance Evaluation of the Vital USA GlucoseDetect

NCT ID: NCT04340648

Last Updated: 2020-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-03
• Study Completion Date: 2019-11-30

Brief Summary

Measurement Algorithm Control and Optimization with Subsequent Performance Evaluation of the Vital USA GlucoseDetect™ During a Standardized Meal Test in Patients with Diabetes mellitus Type 1 and Type 2

Detailed Description

This study is a combined, open label, prospective, comparative single-center study.

The study is separated in 3 consecutive study parts. The first 2 study parts include 16 patients each. In the third study part 16 additional patients will be enrolled. Study part 1 and 2 will be used for optimization and validation of the measurement algorithms of the Vital USA biosensor. During the third study part with enrolment of 16 additional patients, the precision and accuracy of the final Vital USA biosensor algorithm will be demonstrated. The visit schedule for all participants of all 3 study parts will be exactly the same. In all groups of participants, the Vital USA non-invasive monitoring biosensor will be individually introduced and assigned. During the experimental study visit, a standardized meal will be given to the participants. Before and after the standardized meal, glucose, heart rate, and pO2 will be measured using the Vital USA monitoring biosensor at time-points -30, 0, 15, 30, 45, 60, 75, 90, 120, 150 and 180 min. The glucose measurements will be compared to capillary blood glucose measurements by YSI Stat 2300. Parallel measurements of the heart rate and the pO2 using a patient monitor will be compared to the device readings.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

Vital GlucoseDetect

11 time points for blood glucose measurements over 210 min including the ingestion of a standardized meal 30 min after the first blood glucose measurement.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Type 1 or Type 2 diabetic or healthy subject (50 % from each)
• 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 or wrist 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

Andreas Pfützner

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andreas Pfützner, Prof. Dr. Dr.

Role: PRINCIPAL_INVESTIGATOR

Pfützner Science & Health Institute GmbH

Locations

Pfützner Science & Health Institute GmbH

Mainz, Rhineland-Palatinate, Germany

Countries

Germany

Other Identifiers

VIT-NGM-001

Identifier Type: -

Identifier Source: org_study_id