NCT01745900Unknown不适用
An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Continuing validation of near infrared spectroscopy-based glucose meter algorithm
研究概览
简要总结
Comparison of noninvasive glucose measurement performance versus standard invasive reference measurements.
详细描述
The objectives of this study are
- collect subject data on a near-infrared spectroscopy-based glucose meter
- evaluate existing instrumentation, calibration algorithms and calibration maintenance techniques
- collect data on the physiological and environmental sources of interference and degradation of measurement accuracy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female aged ≥ 18 and ≤ 50 years of age at time of enrollment
- •Females with self reported diagnosis of Type I, Type II or Gestational Diabetes, or no self reported diagnosis of diabetes.
排除标准
- •Severe heart disease as evidenced by peripheral edema (self reported)
- •Currently taking Lasix (self reported)
- •Liver disease as evidenced by jaundice (self reported)
- •Receiving dialysis or having known renal compromise (self reported)
- •Skin damage at optical sampling site
- •Scars, tattoos, rashes or other disruption/discoloration on the right index finger
- •Recent (within past month) or current oral steroid therapy or topical steroids applied to the hands; inhaled steroid therapy (self reported)
- •Current chemotherapy, or chemotherapy within the past 12 months (self reported)
结局指标
主要结局
Continuing validation of near infrared spectroscopy-based glucose meter algorithm
时间窗: 3 months
次要结局
未报告次要终点
研究者
研究点 (1)
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