Clinical trial NCT03607435: A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
Official title: A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Lead sponsor: Florida Hospital Tampa Bay Division
Sponsor class: OTHER
Collaborators: name: Kaligia Biosciences, LLC
First posted: 2018-07-31
Enrollment: 300
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

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.

Primary outcomes:
measure: Calibration of the KBS-1 Test Article using the POC Control data for comparison.
timeFrame: The test article and control article procedure together will take approximately 10 - 15 minutes of the research participant's time.
Secondary outcomes:
measure: Research Subject Assessment
timeFrame: 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.
measure: Calibration of the RBA-1 Test Article using the hospital lab test Control data and POC blood glucose monitor Control data for comparison.
timeFrame: The test and control article procedure together will take approximately 10 minutes of a research participant's time.
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Florida Hospital Tampa
state: Florida
Study officials:
affiliation: Kaligia Biosciences, LLC
name: Patrick J Stocker, PhD
role: PRINCIPAL_INVESTIGATOR
References: