ACTRN12623001288617尚未招募Unknown
Clinical trial investigating the efficacy and safety of insulin delivery with a prototype ultra-low-cost insulin pump in adults with type 1 diabetes
niversity of Canterbury0 个研究点目标入组 6 人开始时间: 2023年12月11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
- 6
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
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Type 1 diabetes as classified by the American Diabetes Association
- •2. Aged 18 years or older
- •3. Currently using insulin pump therapy for management of diabetes
- •4. Currently receiving basal insulin at a rate compatible with the investigational ultra-low-cost insulin pump
- •5. HbA1c < 97 mmol/mol (11.0%), based on the mean of all HbA1c results within the 6 months prior to the screening visit, or HbA1c at screening if no results are available
- •within the prior 6 months.
- •6. Willing and able to adhere to the study protocol
排除标准
- •1. A positive pregnancy test at screening is exclusionary
- •2. If female, is currently breastfeeding
- •3. Severe hypoglycaemia or diabetic ketoacidosis in the 6 months prior to study commencement.
- •4. Allergic or intolerant to Humalog® and NovoRapid® insulin
- •5. Alcohol or drug dependence (as reported by participants)
- •6. Any comorbid medical or psychological factors that would, on assessment by the investigators, make the person unsuitable for the study
- •7. A lack of English literacy that would, on assessment by the investigators, make the person unsuitable for the study
研究者
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