A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring Device
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Calibration of the KBS-1 Test Article using the POC Control data for comparison.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
- •Additional inclusion criteria specific to KBS-1 (Test Article #01) testing:
- •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
排除标准
- •The following exclusion criteria apply to all prospective study participants.
- •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:
- •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.
研究组 & 干预措施
Test Article Scanning
Spectroscopy for Analyte Quantification
干预措施: Spectroscopy for Analyte Quantification (Device)
结局指标
主要结局
Calibration of the KBS-1 Test Article using the POC Control data for comparison.
时间窗: 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.
次要结局
- 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.)