Non-Invasive Blood Test Cross-Validation Study

Remote Sensing Comprehensive Metabolic Panel

The study considers a cross-validation approach to determine the effectiveness of a non-invasive comprehensive metabolic panel (NICMP), relative to the venipuncture method. The NICMP machine learned powered device utilizes a light sensor to capture readings from either palm. The study (n=90) proves an agreement and strong correlation with respect to the NICMP and venipuncture blood draw.

Study Overview

• Status: Completed
• Conditions: Safety Issues; Reproducibility of Results
• Intervention / Treatment: Device: Non-Invasive Comprehensive Metabolic Panel

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Altru Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Undiagnosed population

Exclusion Criteria:

• Diagnosed population, pregnant women, mental heath/disabled, prisoners, fetus or deceased

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NICMP Spectral Reading; Non-invasive spectral data is collected from this arm to function as the intervention of interest.	Device: Non-Invasive Comprehensive Metabolic Panel; The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.
Active Comparator: Venipuncture CMP; A standard CMP blood draw is performed to function as the "gold standard" reference value. Specifically, the outcome of the experimental arm is cross-validated against the active comparator arm to determine the NICMP accuracy, relative to the venipuncture method.	Device: Non-Invasive Comprehensive Metabolic Panel; The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of Non-Invasive Comprehensive Metabolic Panel	Determine the effectiveness, in terms of accuracy, of the NICMP against the venipuncture CMP (i.e. reference value).	2-minutes

Collaborators and Investigators

• Sponsor: Joseph Allen Jr.
• Collaborators: University of North Dakota

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2018
• Primary Completion (Actual): September 11, 2018
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: June 1, 2019
• First Submitted That Met QC Criteria: June 18, 2019
• First Posted (Actual): June 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 24, 2019
• Last Update Submitted That Met QC Criteria: June 20, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: IRB-201807-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes