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临床试验/NCT00433758
NCT00433758Unknown不适用

Evaluation of the Performance and Use of the GlucoTrack(TM), Non-Invasive Glucose Monitoring Device

Integrity Applications Ltd.2 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2006年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
142
试验地点
2
主要终点
Clarke Error Grid

研究概览

简要总结

The purpose of this study is to demonstrate the performance of the GlucoTrack device (non invasive device) in measuring blood glucose levels

详细描述

Diabetes is a leading cause of death in the Western World with medical costs increasing annually. There is no cure for diabetes, and blood glucose monitoring is a key component in diabetes treatment and management. Consistently high blood sugar levels can, over time, lead to complications such as blindness, kidney disease, heart disease, and nerve damage.In addition, low blood sugars may lead to immediate dangers. Self-monitoring of blood glucose levels is essential to the self-management of diabetes and has become widespread over the past decade. Blood glucose determinations are currently done by invasive methods (finger tip pricking), followed by measuring the blood drop characteristics. Currently, there is no commercially available reliable non-invasive glucose measurement device that being marketed.

The GlucoTrack, non-invasive device for determining glucose levels based on the simultaneous measurement of three independent orthogonal parameters.

The rationale for development of the device is to improve the patient's quality of life by providing a device that is easily used and provides a painless measurement method, thereby leading to higher compliance, and to better managed diabetes

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
10 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with Type 1, Type 2, or Gestational Diabetes
  • Above the age of 10

排除标准

  • Does not meet inclusion criteria
  • Patients requiring dialysis
  • Participation in other clinical investigations within the previous month.
  • Pregnancy(excluding patients that intend to participate in the gestational group)

结局指标

主要结局

Clarke Error Grid

时间窗: Clarke Error Grid

次要结局

未报告次要终点

研究者

发起方
Integrity Applications Ltd.
申办方类型
Industry

研究点 (2)

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