NCT00837512已完成2 期
Insulin Delivery Using Microneedles in Type 1 Diabetes
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Onset Time (Tmax)
研究概览
简要总结
The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 8 years of age
- •<19 years of age
- •Type 1 Diabetes for at least 2 years
- •Uses a conventional, FDA-approved insulin pump for the past year
- •Uses Lispro insulin
- •Mean hemoglobin A1C ≤ 8.5 % for the past year
- •Body mass index ≤ 85th percentile for age
- •Understand and be willing to adhere to the study protocol
排除标准
- •Type 2 Diabetes
- •Acanthosis nigricans
- •Clinically significant major organ system disease
- •On glucocorticoid therapy
- •Insulin requirement ≥ 150 U/day
- •Illness on the day of the study
- •Cognitive impairment (IQ < 85 or > 2 grades behind age-appropriate grade)
- •Pregnant or breast-feeding (if female).
结局指标
主要结局
Onset Time (Tmax)
时间窗: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
Average time to peak insulin concentration
次要结局
未报告次要终点
研究者
Eric Felner, MD, MSCR
Pediatric Endocrinology
Emory University
研究点 (2)
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