Recruiting

Glucose Monitoring

Sponsor:

Florida Hospital Tampa Bay Division

Code:

NCT03607435

Conditions

Diabetes

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Spectroscopy for Analyte Quantification

Study Details

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.

Conditions

Diabetes

Study ID

NCT03607435

Start date

Aug 2, 2018

Status verified date

Aug, 2018

Completion date

Jul, 2019

Anticipated

Primary completion date

Jun, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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.

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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.

Study Design

Enrollment

300 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Test Article Scanning

Spectroscopy for Analyte Quantification

Interventions

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).

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. ]

Central Contacts and Locations

Central contacts

Patrick J Stocker, PhD

727-234-8874pstocker@kaligiabiosciences.com

Fazal Fazlin, BS

727-234-8877ffazlin@kaligiabiosciences.com

Locations

Florida Hospital Tampa

Recruiting

Tampa, Florida, United States, 33613

Contacts

Juliet Bala, CCRC

813-610-8110juliet.bala@ahss.org

More Information

Sponsor

Florida Hospital Tampa Bay Division

Last update posted

Aug 6, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida Hospital Tampa Bay Division on 2018-08-06.