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

NCT04340648 | Completed

• 1 other identifier: VIT-NGM-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (3)

• Performance and accuracy in glucose monitoring and other parameters

  Performance and accuracy in monitoring glucose levels (in mg/dL) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to the capillary blood glucose reference method YSI STAT 2300 (glucose in mg/dL).

  210 min

• Performance and accuracy in pO2 monitoring

  Performance and accuracy in monitoring pO2 levels (in mmHg) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pO2 (in mmHg).

  210 min

• Performance and accuracy in pulse monitoring

  Performance and accuracy in monitoring the pulse (in beats/min) using the GlucoseDetect during a standardized meal experiment. Measurements (during the meal experiment) of the GlucoseDetectTM will be compared to a patient monitor (pulse (in beats/min).

  210 min

Interventions

Vital GlucoseDetect DEVICE

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.

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 (50 % from each)
• 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 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

Sponsors & Collaborators

• Sciema UG: lead

Study Sites (1)

Pfützner Science & Health Institute GmbH

Mainz, Rhineland-Palatinate, 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 Pfützner, Prof. Dr. Dr.

  Pfützner Science & Health Institute GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: patients are divided in two groups and both groups are enrolled sequential and undergo the same procedures

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: April 9, 2020
• Study Start: June 3, 2019
• Primary Completion: October 31, 2019
• Study Completion: November 30, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)