A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
1 other identifier
interventional
300
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Aug 2018
Shorter than P25 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
August 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2019
CompletedAugust 6, 2018
August 1, 2018
10 months
July 23, 2018
August 2, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Calibration of the KBS-1 Test Article using the POC Control data for comparison.
The data gathered by the Test Article procedures will be compared to the data gathered by the POC Control Article procedure in order to accomplish: * Comparative analysis of the Test data against the Control data. * Test Article calibration and aid in Test Article machine learning. This is being requested to achieve calibration of the test articles, and aid in test article machine learning for glucose level calculations.
The test article and control article procedure together will take approximately 10 - 15 minutes of the research participant's time.
Secondary Outcomes (2)
Research Subject Assessment
The assessment will take place immediately at the conclusion of the KBS-1 and POC glucose monitoring procedure and will take approximately 1 minute of the research participant's time.
Calibration of the RBA-1 Test Article using the hospital lab test Control data and POC blood glucose monitor Control data for comparison.
The test and control article procedure together will take approximately 10 minutes of a research participant's time.
Study Arms (1)
Test Article Scanning
EXPERIMENTALSpectroscopy for Analyte Quantification
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
- \) Diabetic hospital staff
- Hospital patients with a physician prescribed hospital laboratory blood test.
- Diabetic hospital staff
You may not qualify if:
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- A member of a vulnerable population (i.e. children, pregnant women, prisoners, etc.)
- People with clotting factor disorders and/or currently taking anticoagulation medication.
- 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).
- 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.
- 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.
- Patient is in isolation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Florida Hospital Tampa Bay Divisionlead
- Kaligia Biosciences, LLCcollaborator
Study Sites (1)
Florida Hospital Tampa
Tampa, Florida, 33613, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick J Stocker, PhD
Kaligia Biosciences, LLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2018
First Posted
July 31, 2018
Study Start
August 2, 2018
Primary Completion
June 1, 2019
Study Completion
July 1, 2019
Last Updated
August 6, 2018
Record last verified: 2018-08