NCT01781533已完成不适用
An Open, Single-centre, Non-controlled Feasibility Study Using a Software-algorithm Based Insulin Therapy to Control Blood Glucose in Type 1 Diabetic Patients
Medical University of Graz1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2013年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- the percentage of glucose values obtained every 15 min in predefined glucose ranges
研究概览
简要总结
To investigate the performance of a software-algorithm based insulin therapy to control blood glucose in Type 1 diabetic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Male or female aged 18 to 75 years (both inclusive)
- •Informed consent obtained after being advised of the nature of the study
- •The subject has Type 1 diabetes (as defined by WHO) for at least 24 months
- •The subject's HbA1c <= 10%
- •Body Mass Index (BMI) <= 35 kg/m2
- •The subject is treated with continuous subcutaneous insulin infusion for at least 3 month
排除标准
- •Subject is actively enrolled in another clinical trial or took part in a study within 30 days
- •Experienced recurrent severe hypoglycaemic unawareness
- •Total daily insulin dose >= 1.4 IU/kg
- •Subject is using a medication that significantly impacts glucose metabolism (oral or topical steroids) except if stable for at least the last three months and expected to remain stable for the study duration
- •Allergy against insulin Lispro
- •A history of drug or alcohol dependence
- •Any other significant concomitant disease such as endocrine, cardiac, neurological, malignant, other pancreatic disease or uncontrolled hypertension as judged by the investigator
- •Uncontrolled hypertension with resting blood pressure over 140/90 mmHg
- •Patient is pregnant, or breast feeding during the period of the study
- •Patient donated blood in the last 3 months
研究组 & 干预措施
algorithm
Experimental
干预措施: algorithm (Procedure)
结局指标
主要结局
the percentage of glucose values obtained every 15 min in predefined glucose ranges
时间窗: 15 minutes
次要结局
- Injected insulin dose(24 hours)
- Accuracy of the glucose monitoring unit(24 hours)
研究者
Pieber Thomas, MD
Univ. Prof. Dr. med.
Medical University of Graz
研究点 (1)
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