A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-02

Study Completion Date

2019-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Test Article Scanning

Spectroscopy for Analyte Quantification

Group Type EXPERIMENTAL

Spectroscopy for Analyte Quantification

Intervention Type DEVICE

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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.

1\) Diabetic hospital staff

1. Hospital patients with a physician prescribed hospital laboratory blood test.
2. Diabetic hospital staff

1. Patient is in isolation.

Exclusion Criteria

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).

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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes