NCT03607435

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Florida Hospital Tampa Bay Division · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to calibrate the performance of the KBS-1 non-invasive glucose monitoring device with diabetic people when compared to that of the standard method currently used in the clinical setting for prescription point-of-care (POC) blood glucose monitoring. The secondary purpose of this study is to calibrate the performance of the RBA-1 minimally invasive bodily fluid analyte analyzer device when compared to the results from a prescription POC blood glucose monitoring device and/or standard hospital laboratory blood test. The objective of this study is to collect non-invasive in vivo, and potentially in vitro, spectral measurements of interstitial fluid glucose from underneath the skin of the palm of the hand (Test Article #01), and potentially the blood, respectively, from diabetic adult hospital staff participants, and to collect in vitro spectral measurements of venous blood tested from adult hospital patients with or without diabetes (Test Article #02) and compare them to POC blood glucose monitor values and analyte measurements conducted by a hospital laboratory (Control Article #01 procedure), respectively. The comparison of the results obtained from the different analytical methods will be used to calibrate and refine the glucose, and other, analyte level calculation algorithms of the Test Article systems.

Conditions

• Diabetes

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-08-02
• Primary completion: 2019-06-01
• Completion: 2019-07-01
• First posted: 2018-07-31
• Last updated: 2018-08-06

Locations

1 site across 1 country: United States