ACTRN12623000395639尚未招募Unknown
A Pilot Study Evaluating an Education Module Empowering People Living with Type 1 Diabetes to Understand their Continuous Glucose Monitoring Data: The Making Sense Program
St Vincent's Hospital Melbourne0 个研究点目标入组 62 人开始时间: 2023年4月19日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 62
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
- Treatment
入排标准
- 年龄范围
- 19 Years 至 o limit(—)
- 性别
- All
入选标准
- •T1D (diagnosis consistent with American Diabetes Association Classification of Diabetes Mellitus); Age >18Y; HbA1c <9.5%; Fluent in English; using carbohydrate counting; >3 months On MDI or insulin pump therapy (IPT) and safely operating a real time-continuous glucose monitor (RT-CGM) or intermittent scanning glucose monitor (ISGM) device; Willing and able to download and review device data; Living in an area with internet and cellular phone coverage; English speaking. Recruitment will be stratified approximately 1:1 MDI and IPT and at least 40% of all participants will be on either RT-CGM or ISGM. At least 10 days of CGM data between screening and the baseline visit.
排除标准
- •Pregnant or planning pregnancy; Using open-source artificial pancreas system (so-called ‘do-it-yourself’ (DIY) technology); Use of any non-insulin glucose-lowering agent within the past 3 months; Oral or injected steroid use within the past 3 months; active significant nondiabetic illness impacting glucose management (e.g. coeliac disease, thyroid disease, myocardial ischaemia) or any severe or unstable medical or psychological condition which, in the opinion of the investigator, would compromise the ability to meet protocol requirements.
研究者
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