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临床试验/ACTRN12614000362695
ACTRN12614000362695
尚未招募
未知

Assessment of a non-invasive system to detect changes in physiological tremor in type 1 diabetes mellitus

Firefly Health Pty Ltd0 个研究点目标入组 10 人2014年4月7日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
Hypoglycaemia in type 1 diabetics
发起方
Firefly Health Pty Ltd
入组人数
10
状态
尚未招募
最后更新
6年前

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2014年4月7日
结束日期
待定
最后更新
6年前
研究类型
Interventional
性别
All

研究者

发起方
Firefly Health Pty Ltd

入排标准

入选标准

  • 1\. Have type 1 diabetes mellitus and are willing to have induced hypoglycaemia under medical supervision
  • 2\. Have adequate venous access to both arms to allow for IV administration of insulin and glucose and for the collection of blood samples
  • 3\. Have adequate surface area on the non dominate arm to allow for the application of all study related monitoring devices
  • 4\. Be willing to fast for up to 14 hours

排除标准

  • 1\. Are unwilling to wear the clinical monitoring devices for the duration of the study.
  • 2\. Have a history of cerebrovascular disease, central or peripheral neurological disease, idiopathic tremors, primary muscle disease, hypokalaemia or a concurrent illness that in the Principal Investigator's opinion would interfere with study procedures.
  • 3\. Have a history of, or current evidence of abuse of alcohol or any illicit drug substances.
  • 4\. Have a positive breath alcohol or urine drug screening on day 1\.
  • 5\. Unable to abstain from alcohol during the 48 hours prior to day 1 and until completion of blood sampling on day 1\.
  • 6\. Tobacco users who are unable to abstain from smoking whilst confined to the clinical facility
  • 7\. Difficulty in abstaining from food and/or beverages that contain caffeine or other xanthenes (eg coffee, tea, cola and chocolate) during the 48 hours prior to day 1 and until completion of blood sampling on day 1\.
  • 8\. Are pregnant or breast feeding.
  • 9\. Has been in receipt of an investigational agent within 4 weeks of screening.
  • 10\. Have given a standard blood donation within the 12 week period prior to day 1\.

结局指标

主要结局

未指定

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