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临床试验/NCT01234727
NCT01234727已完成不适用

Multicentre Performance Comparison Study of Blood Glucose Monitoring Systems in People With Diabetes Randomised to Multiple Devices

Abbott Diabetes Care3 个研究点 分布在 2 个国家目标入组 501 人开始时间: 2010年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
501
试验地点
3

研究概览

简要总结

A Multicentre study comparing 5 different Self-Monitoring Of Blood Glucose (SMBG) system commercially available in Germany & Holland.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects diagnosed with type 1 or type 2 diabetes mellitus
  • Age between 18 and 75 years.
  • Patients with stable blood glucose in judgment of the investigator.
  • Subjects receive intensive insulin therapy (Multiple Daily Injection defined as at least two insulin injections per day)
  • Patients perform blood glucose self measurements on a routine basis
  • Patients must have experience in self measurement blood glucose for at least 6 months.

排除标准

  • Patients with unstable blood glucose in judgment of the investigator.
  • Patient has been diagnosed with progressive / serious diseases that in judgment of the investigator preclude successful completion of the observational period.
  • Lack of compliance or other justifications that, in the discretion of the investigator, precludes satisfactory participation in the study.
  • Subject without legal capacity.
  • Blood donation within the last 30 days.
  • Known pregnancy.
  • Subject has already participated in the study.

研究组 & 干预措施

Diabetes

Patients with Type 1 or Type 2 diabetes requiring insulin.

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (3)

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