Evaluation of the Effect of lnsuPatch on the Pharmacokinetic and Pharmacodynamic Properties of Rapid-Acting Insulin Analogs Given as a Bolus by Continuous Subcutaneous Insulin Infusion (CSII)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
This study is a prospective, single-center, open label, randomized; two-arms cross over study.
This is the test protocol for the InsuPatch device, whose purpose is to improve insulin delivery into the blood when the insulin is infused using an insulin-infusion pump by controlled heating of the area surrounding the point of infusion.
详细描述
Twenty(20) type 1 children with Type 1 Diabetics Mellitus (TIDM) who are meeting the inclusion/exclusion criteria as outlined below and who provide written Informed Consent will be enrolled in the study.
The study will consist of an outpatient enrollment visit and two admissions(One clamps with the InsuPatch and one clamp without the InsuPatch) . Each Subject will thus serve as his/her own control.
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
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 12-17 (inclusive)
- •Clinical diagnosis of T1DM at least one year's duration
- •On CSII therapy for at least three months
- •Hemoglobin A1c(HBA1C) values below 10% and above 6.5%
- •Minimum weight requirements of at least 37.9 Kg.
- •Ability to comprehend written and spoken English
- •Body Mass Index z-score below 90%
排除标准
- •Celiac disease, gastroparesis, or other gastrointestinal disorder associated with alerted carbohydrate absorption or intestinal motility.
- •Medication besides insulin known to alter blood glucose, gastric motility, or intestinal carbohydrate absorption
- •Female subjects of reproductive potential who are pregnant or breast feeding
- •Inability to comprehend written and spoken English
- •Any other condition, which in the judgment of the investigators, would interfere with the subject's or parents' ability to provide informed consent or the investigator's ability to perform the study.
- •Hematocrit below 35 or serum potassium below 3.4 (confirmed by two samples)
结局指标
主要结局
Efficacy
时间窗: one year
Insulin will be taken during the clamp and will be measured for concentration.The concentration of insulin during the first hour will be compared between the two arms for efficacy.
次要结局
未报告次要终点