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。
研究者
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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