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 人开始时间: 2014年4月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Diagnosis
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 50 Years（—）
- 性别
- All
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.
- •11. Are currently taking regular prescription or over the counter medications including vitamins and dietary supplements that may induce or mask muscle tremor. Including but not limited to muscle stimulants, muscle relaxants or medications with potential to cause muscle toxicity.
- •12. Have experienced a serious hypoglycaemic episode (requiring the assistance of another person) within the 2 weeks prior to day 1.
- •13. Have a BMI of equal to or greater than 40kg/m2 and weigh equal to or greater than 110kg.
- •14. Are unwilling to remove nail varnish or false nails for the duration of day 1.
- •15. Are currently using an insulin pump.
研究者
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