ACTRN12619001295134尚未招募未知
Clinical trial of device to evaluate the accuracy of an experimental continuous glucose monitor (CGM) measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy.
St Vincent's Hospital Melbourne0 个研究点目标入组 12 人开始时间: 2019年9月19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
- 12
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
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 75 Years（—）
- 性别
- All
入选标准
- •1. T1D, of at least 6 months duration.
- •2. Age 21-75
- •3. Insulin pump usage at the time of screening and for at least 3 months prior to screening.
- •4. HbA1c between 5.8 and 10%
- •5. Willingness and ability to follow all study procedures and to attend all clinic visits.
排除标准
- •1. Chronic kidney disease as defined by estimated-GFR < 45 ml/min
- •2. Inadequately-treated proliferative diabetic retinopathy
- •3. Inability to read pump or CGM display due to reduced visual acuity
- •4. Presence of unstable ischaemic heart disease or myocardial infarction within the last 3 months.
- •5. Cerebrovascular disease causing permanent physical or cognitive limitation
- •6. Chronic liver disease with synthetic deficiency (defined as serum albumin of <3.3 g/dl, or serum total bilirubin exceeding 2.5 mg/dl)
- •7. Any active foot ulcer
- •8. Known active infection such as HIV or hepatitis
- •9. Active malignancy, except for basal or squamous cell skin cancer
- •10. Anaemia defined by HCT at least 4 percentage points below lower limit of the reference range
- •11. History of cardiac arrhythmia (note: PVC’s numbering < 6 per minute are not exclusionary)
- •12. Dementia
- •13. Schizophrenia or other untreated mental illness
- •14. Chronic substance abuse
- •15. Seizure disorder
- •16. Major surgical operation within 30 days prior to screening
- •17. Bleeding disorder, or treatment with anticoagulants
- •18. Allergy to Lispro insulin
- •19. Allergy to acrylate-based skin adhesives
- •20. Use of an investigational drug or device in the last 30 days
- •21. Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding, or is not using adequate contraceptive methods.
- •22. Diabetic ketoacidosis or major hypoglycemia within the last 6 months
- •23. Insulin resistance as defined by insulin requirement of more than 200 units per day
- •24. Use of glucose-lowering medications other than insulin
- •25. Need for uninterrupted treatment with acetaminophen
- •26. Any other physical or mental condition judged by the PI as being exclusionary.
研究者
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