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临床试验/NCT03405415
NCT03405415已完成不适用

Assessment of Glucose Concentrations in People Without Diabetes Mellitus After Standardized Meals and in Daily Life

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2018年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
2
主要终点
Assessment of glucose concentrations

研究概览

简要总结

Participants will perform blood glucose monitoring (BGM) over the course of 14 days and, in parallel, wear continuous glucose monitoring (CGM) systems. Because current CGM systems typically achieve a lower level of analytical accuracy than BGM systems, participants will perform at least 5 blood glucose (BG) measurements per day. In addition, CGM systems are used to obtain minimally-invasive high-frequency glucose measurements to fill the gaps between BG measurements.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

入选标准

  • At least 18 years of age
  • Written informed consent
  • Subject is legally competent and has the capacity to understand character, meaning and consequences of the study
  • Subject is willing to refrain from intake of salicylic acid and ascorbic acid and medication and/or compounds containing these substances

排除标准

  • Anamnestically known diabetes mellitus
  • Severe acute or chronic disease with potential risk of being adversely affected by the study procedures (at the study physician's discretion)
  • Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion)
  • Pregnancy or lactation period
  • Known severe skin reactions to adhesives
  • Blood donation within the previous two months (according to the subject's statement)
  • Language or other barriers potentially compromising an adequate compliance with study procedures

结局指标

主要结局

Assessment of glucose concentrations

时间窗: 14 days per subject

次要结局

未报告次要终点

研究者

发起方
Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
申办方类型
Other
责任方
Sponsor

研究点 (2)

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