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

Florida Hospital Tampa Bay Division

Status

Unknown

Conditions

Diabetes

Treatments

Device: Spectroscopy for Analyte Quantification

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03607435

KBS002

Details and patient eligibility

About

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.

Enrollment

300 estimated patients

Sex

All

Ages

21+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Ideally, all enrolled participants will represent an ethnically diverse population with as close to an even ratio of males to females as possible.

Age ≥ 21 years. 2) Willingness and ability to provide informed consent.

Additional inclusion criteria specific to KBS-1 (Test Article #01) testing:
1. Diabetic hospital staff
Additional inclusion criteria specific to RBA-1 (Test Article #02) testing:
1. Hospital patients with a physician prescribed hospital laboratory blood test.
2. Diabetic hospital staff
  
  Exclusion Criteria:
  
  The following exclusion criteria apply to all prospective study participants.

1. A member of a vulnerable population (i.e. children, pregnant women, prisoners, etc.)
2. People with clotting factor disorders and/or currently taking anticoagulation medication.
3. Has any other medical condition that, in the opinion of the Investigator, would interfere with the person's participation in this study (i.e. double arm amputee).
Additional exclusion criteria specific to KBS-1 (Test Article #01) testing:
1. Any skin abnormalities or tattoos located on the palm(s) of the hand(s). The left palm is preferred for this study; however, the right palm can be used if the left palm is excluded.
2. Parkinson's disease, dyskinesia, tremors, or similar that may make it challenging for said person to hold their hand on the device in a still and stable manner.
Additional inclusion criteria specific to RBA-1 (Test Article #02) testing:
1. Patient is in isolation.