DiabetesNCT03607435
A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
A study testing Spectroscopy for Analyte Quantification in people with Diabetes, run by Florida Hospital Tampa Bay Division at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Spectroscopy for Analyte Quantification
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2018to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
- Hospital patients with a physician prescribed hospital laboratory blood test.
- Diabetic hospital staff
Who cannot join
- The following exclusion criteria apply to all prospective study participants.
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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).
- Additional exclusion criteria specific to KBS-1 (Test Article #01) testing:
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- 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.
- Additional inclusion criteria specific to RBA-1 (Test Article #02) testing:
- Patient is in isolation.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Florida Hospital Tampa
Tampa, Florida, 33613
Juliet Bala, CCRC, 813-610-8110, juliet.bala@ahss.org
About this study
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
- Being tested
- Spectroscopy for Analyte Quantification
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spectroscopy for Analyte QuantificationDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Test Article Scanning | Experimental | Spectroscopy for Analyte Quantification Receives: Device: Spectroscopy for Analyte Quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 research subjects will be questioned on the presence (Y or N) of any pain or discomfort related to the KBS-1 test article procedure, as well as ease of use and acceptability (1-5 rating scale, 1=bad, 5=excellent).
Measured: 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 data gathered by the Test Article procedure will be compared to the data gathered by the Control Article procedure(s) in order to accomplish:
- Comparative analysis of the Test data against the Control data.
- Test Article calibration and aid in Test Article machine learning. The analyte data from the hospital lab is being requested to achieve calibration of the test article, and aid in test article machine learning, for these analytes.
Measured: The test and control article procedure together will take approximately 10 minutes of a research participant's time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start2 Aug 2018
- Primary completionJun 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida Hospital Tampa Bay Division
- Sponsor type
- University, hospital or other
- Collaborators
- Kaligia Biosciences, LLC
- Responsible party
- Sponsor
- Investigators
- Patrick J Stocker, PhD, Principal investigator, Kaligia Biosciences, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607435
- Sponsor's protocol ID
- KBS002
- Status last verified
- Aug 2018
- First submitted
- 23 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
- ClinicalTrials.gov ID
- NCT03607435
- Acronym / sponsor ID
- KBS002
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Florida Hospital Tampa Bay DivisionUniversity, hospital or other
- Collaborators
- Kaligia Biosciences, LLC
- Study start
- 2 Aug 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 31 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test Article Scanning | Experimental | Device: Spectroscopy for Analyte QuantificationSpectroscopy for Analyte Quantification |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (10 listed)
- The following exclusion criteria apply to all prospective study participants.
- <!-- -->
- Additional exclusion criteria specific to KBS-1 (Test Article #01) testing:
- Additional inclusion criteria specific to RBA-1 (Test Article #02) testing:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spectroscopy for Analyte QuantificationDiabetic 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). | Device | Test Article Scanning |
Primary outcome
Calibration of the KBS-1 Test Article using the POC Control data for comparison.
Time frame: The test article and control article procedure together will take approximately 10 - 15 minutes of the research participant's time.
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.
2 secondary outcomes
Research Subject Assessment
Time frame: 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.
Time frame: The test and control article procedure together will take approximately 10 minutes of a research participant's time.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- American Diabetes AssociationLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Stocker, PhD principal investigator
Kaligia Biosciences, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spectroscopy for Analyte Quantification in people with Diabetes, run by Florida Hospital Tampa Bay Division at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick J Stocker, PhD (727-234-8874, pstocker@kaligiabiosciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calibration of the KBS-1 Test Article using the POC Control data for comparison. (time frame: The test article and control article procedure together will take approximately 10 - 15 minutes of the research participant's time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.