A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device

NAUnknownINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

August 2, 2018

Primary Completion Date

June 30, 2019

Study Completion Date

July 31, 2019

Conditions
Diabetes
Interventions
DEVICE

Spectroscopy for Analyte Quantification

Diabetic hospital staff participants subjected to the KBS-1 device (Test Article #01) will have a finger on their left hand pricked with a lancet and their blood glucose level read by a POC glucose monitor (Control Article #02). Next, they will have their interstitial fluid glucose level spectroscopically scanned from the palm of their left hand using the KBS-1 device, and blood (approximately 40µl), collected from their finger prick site, will be spectroscopically scanned using the RBA-1 device (Test Article #02). Hospital patients subjected to the RBA-1 device, who must already be prescribed a hospital lab blood test by their physician, will have approximately 40µl of their blood, collected from the venipuncture site, spectroscopically scanned using the RBA-1 device (Test Article #02).

Trial Locations (1)

33613

RECRUITING

Florida Hospital Tampa, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Kaligia Biosciences, LLC

INDUSTRY

lead

Florida Hospital Tampa Bay Division

OTHER