A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 8/8/2018 |
| Start Date: | August 2, 2018 |
| End Date: | July 2019 |
| Contact: | Patrick J Stocker, PhD |
| Email: | pstocker@kaligiabiosciences.com |
| Phone: | 727-234-8874 |
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.
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.
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.
1) 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.
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