Noninvasive Glucose Measurements - Database and Calibration Compilation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Calibration models for device predictive purposes
研究概览
简要总结
This study collected spectral raman data from diabetic patients. Data was paired with validated capillary references as well as CGM/FGM readings. Data was used to develop models for glucose prediction.
详细描述
This trial constitutes three subprotocols: "The OUH protocol", "The Home 1 protocol" and "The Home 2 protocol" The investigation was initiated to collect spectral raman data paired with validated blood references. In the OUH protocol, capillary blood was analysed by ABL 800 Flex blood gas analyzer by Radiometer. In the Home 1 protocol, references were obtained by the finger pricking procedure from HemoCue (Radiometer). In the Home 2 protocol, HemoCue measurements were conducted along with continuous monitoring using Dexcom G4/G5 device (Dexcom) or FreeStyle Libre (Abbott) The data was collected from diabetic patients and Optical Coherence Tomography (OCT) readings were obtained from all subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with and without diabetes including pregnant women
排除标准
- •Subject under 18 years of age
- •Subjects not able to understand provided information
- •Subjects without measuring sites
- •Subjects with rash or wound on measuring sites
- •Subjects with stained fingers, such a oil or nicotine
- •Subjects not capable of holding arm/hand steadily on probe
- •Subjects with thrombosis in arm/hand
研究组 & 干预措施
OUH protocol
The protocol constituted two outpatient visits in the clinic within one week. Each visit had a duration of approximately 2,5 hours. Prior to study, optical screenings were conducted:
- Optical Coherence Tomography (OCT)
- Optical screening on measuring site with WM3.4.
Subjects were measured by the following scheme: ABL measurement, two optical measurements on WM3.4 #1 followed by two optical measurements on WM3.4 #2.
干预措施: WM3.4 (Device)
Home 1 protocol
Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital.
WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue was used for reference.
干预措施: WM3.4 (Device)
Home 2 protocol
Optical screening (OCT and device) was conducted at baseline visit in the Department of Endocrinology M at Odense University Hospital.
WM3.4 was subsequently delivered to subject's home and the subject measured 30 days in a 60 days period of time. HemoCue and CGM/FGM was used for reference.
干预措施: WM3.4 (Device)
结局指标
主要结局
Calibration models for device predictive purposes
时间窗: 6 months
Spectral raman data paired with validated references used to develop predictive algorithms with glucose prediction capablities. The preformance was validated using the consensus error grid.
次要结局
未报告次要终点