此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

2012年2月23日 更新者:InLight Solutions

An Evaluation and Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based method for measuring glucose concentration relative to invasive blood reference measurements. The initial phase of the study will be focused on procurement of the data needed to develop a robust, accurate calibration. The second phase will be focused on performance evaluation of the system.

研究概览

详细说明

Currently, individuals with diabetes must use an invasive finger stick methodology for the determination of their blood glucose levels. Although current technology glucose meters use a smaller amount of blood than older generation meters, the pain and inconvenience associated with this invasive measurement is the number one reason cited for inadequate or infrequent blood glucose monitoring. In fact up to 67% of patients with diabetes fail to routinely monitor their blood glucose levels. A survey of 1895 patients showed that finger soreness was the most common reason given for self-reported noncompliance with testing recommendations, followed by pain, inconvenience, fear of needles, and "other" (including cost), (Diabetes Care August 2001 vol. 24 no. 8 1502-1503). The ability to make a painless blood glucose measurement using only light would address the pain and inconvenience issues associated with current technology glucose meters.

The initial application of the technology is associated with the monitoring of Gestational Diabetes. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recently released recommendations for diagnosing gestational diabetes, as well as clarifying the benefits of treatment (Diabetes Care, 2010;33:676-682). The IADPSG cited research that found significant graded relationships between increasing maternal glucose levels and the frequency of four primary and five secondary outcomes. For example, with a 1-standard deviation increase in maternal fasting, 1-hour, and 2-hour plasma glucose levels, there was a corresponding 38%, 46%, and 38% increased risk, respectively, in the primary outcome of birth weight >90th percentile, and a 5%, 18%, and 16% increased risk, respectively, of the secondary outcome of premature delivery before 37 weeks gestation (N Engl J Med 2008;358:1991-2002).

研究类型

观察性的

注册 (预期的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • New Mexico
      • Albuquerque、New Mexico、美国、87106
        • Lovelace Scientific Resources

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年 至 50年 (成人)

接受健康志愿者

是的

有资格学习的性别

女性

取样方法

概率样本

研究人群

The Human Subject population consists of female subjects between the ages of 20 and 50. Subjects must have been diagnosed with either Type I, Type II, or Gestational diabetes and may utilize healthy individuals for the validation phase. Up to 100 subjects may be recruited to participate in this study. Subjects will be recruited from the community and will be selected to ensure a representative sample of the projected intended use population. Efforts will also be made to ensure a broad and even distribution of ages (between 20 and 50 years old) and ethnicities.

描述

Inclusion Criteria:

  • Female at least 20 years of age but not older than 50 years of age
  • Female with Type I or Gestational diabetes based on ADA criteria
  • Female with Type II diabetes and A1c of greater than 7.0 as measured on a Bayer A1C Now meter
  • May include female healthy volunteers.

Exclusion Criteria:

  • Subject requires hemo-dialysis
  • Severe heart disease as evidenced by peripheral edema
  • Liver disease as evidenced by jaundice
  • Active alcohol or drug abuse
  • Body Mass Index (BMI) > 35 kg/m2
  • Hand size too large to fit in the optical measurement instrumentation
  • Middle finger width of less than 5 mm
  • Skin damage at optical sampling site on hand
  • Currently taking prednisone or other systemic steroids
  • Tattoo at the optical sampling site

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Type 2 Diabetes
Those previously diagnosed with type 2 diabetes
Type 1 Diabetes
Those previously diagnosed with type 1 diabetes
Gestational Diabetes
Those that are currently diagnosed with gestational diabetes
Healthy Human Volunteers
Those that have not been diagnosed with any type of diabetes

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Calibrate near-infrared spectroscopy-based glucose meter
大体时间:1 year
The collection of capillary blood glucose and noninvasive data will allow the calibration of the noninvasive systems and subsequently evaluate performance via a validation study. The paired NIR spectrum and blood reference data acquired during calibration will be processed using multivariate regression techniques to create a calibration model. Results will be compared using a Clark error grid.
1 year

次要结果测量

结果测量
措施说明
大体时间
Compare Noninvasive to invasive techniques
大体时间:1 year
Comparison of noninvasive glucose measurement performance versus standard invasive reference. Invasive measurements are made by obtaining capillary blood glucose measurements and then measuring blood on a Yellow Springs Instrument (YSI). Due to the fact that instrumentation drift and subject physiological changes can adversely influence measurement performance, the study is specifically designed to examine performance over an appropriate period of time with a reasonable distribution of subject variance. Results will be compared using a Clark error grid.
1 year

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Walter Forman, MD、Lovelace Scientific Resources

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年6月1日

初级完成 (预期的)

2012年2月1日

研究完成 (预期的)

2012年2月1日

研究注册日期

首次提交

2011年8月9日

首先提交符合 QC 标准的

2011年8月10日

首次发布 (估计)

2011年8月12日

研究记录更新

最后更新发布 (估计)

2012年2月27日

上次提交的符合 QC 标准的更新

2012年2月23日

最后验证

2012年2月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 10-0020

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅