NCT03544996已完成不适用
A Comparison of Injected Insulin Replacement Therapy With A Novel Transdermally Delivered Human Insulin Product
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Insulin response
研究概览
简要总结
An Early Feasibility Study of a device formulation to deliver human insulin across intact skin
详细描述
An attempt was made to formulate an insulin product that would complex human insulin in a stable anhydrous solution and when applied to the skin enable the uptake and release of insulin in a brittle T1D patient.
A series of formulations were produced at varing dose strengths and in conjunction with injected insulin products, applied and serum glucose measured to ascertain response and optimize a fomrula to be submitted for IND approval.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 61 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Brittle T1D patient with poor insulin sensitivity requiring more than 3,000 IUs on insulin a day
排除标准
- •High insulin sensitivity
- •well managed serum glucose
结局指标
主要结局
Insulin response
时间窗: 8-24 hours
Measurement of down modulation of serum glucose as measured by a standard blood glucose meter not otherwise attributable to injected insulin
次要结局
未报告次要终点
研究者
研究点 (1)
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