NCT01594801已完成不适用
Testing the Effect of the InsuPad Device in Daily Life Conditions - The InsuPad in Daily Life Study
Insuline Medical Ltd.17 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 17
- 主要终点
- Efficacy
研究概览
简要总结
This is the test protocol for the InsuPad device. The aim of the study is to show economical benefit when using the InsuPad device, by testing the effect of the InsuPad device on reducing injected insulin dose while keeping the same overall glycaemic control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged 18 to 75 years (including 18 and 75 years old).
- •Type 1 or type 2 diabetes mellitus subjects with daily short-acting prandial insulin intake of > 60 IU/day.
- •HbA1c >=6.0% and =< 8%
- •Use of short-acting prandial insulin analogues with multiple daily injections. The analog insulin brands to be used will be either insulin Lispro (Humalog, Liprolog) or insulin Aspart (NovoRapid) or insulin Glulisin (Apidra).
- •Subject agrees to sign consent form before any study-specific tests or procedures are to be performed.
- •Study subject is willing to perform at least 5 blood glucose measurements per day for at least 3 months, willing to comply with study procedures and to keep a detailed patient log book.
排除标准
- •Excessive fibrosis, lipo-hypertrophy or eczema at injection sites.
- •Known gastro- or enteroparesis.
- •Unstable chronic disease other than diabetes mellitus (e. g. unstable angina pectoris, renal disease) for the last six months before study start.
- •Severe hypoglycaemic events requiring glucagon injection or glucose infusion within the last four weeks prior to study start.
- •Hypoglycaemia unawareness (Score > 4 in the Hypoglycaemia Awareness Questionnaire)
- •Diabetic ketoacidosis (severe, with hospitalization) within the last six months prior to study start
- •Any known life-threatening disease
- •Pregnant women, lactating women or women who intend to become pregnant during the observation period
- •Any other condition or compliance issues that might interfere with study participation or results
- •Subjects with heat sensitivity
- •Subjects involved in or planned to participate in other studies
- •Subjects who are incapable of contracting or under guardianship
结局指标
主要结局
Efficacy
时间窗: 3 months
The primary endpoint of the study is to demonstrate the non-inferiority (margin of 0.4%) for overall glycaemic control defined as HbA1c of a treatment regimen applying InsuPad combined with an insulin dose reduction of \>10% in the test group compared to the control group not using InsuPad.
Safety
时间窗: 3 months
compare the Frequency of mild hypoglycaemia events (Blood Glucose \< 63 mg/dl or 3. 5 mmol/l) with InsuPad and without InsuPad.
次要结局
未报告次要终点
研究者
研究点 (17)
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