NCT01932775已完成3 期
An Open, Single-centre, Non-controlled Study of Efficacy, Safety and Usability of the GlucoTab System for Glycaemic Management in Non-critically Ill Patients With Type 2 Diabetes at General Wards
Medical University of Graz2 个研究点 分布在 1 个国家目标入组 99 人开始时间: 2013年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 2
- 主要终点
- Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy
研究概览
简要总结
Objective: To investigate the performance (safety) of the GlucoTab system for glycaemic management in non-critically ill patients with type 2 diabetes at general wards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent obtained after being advised of the nature of the study
- •Male or female aged ≥18 years
- •Type 2 diabetes (treated with diet, oral agents, non-insulin injected anti-diabetic medicine, insulin therapy or any combination of the four) or newly diagnosed hyperglycaemia which requires s.c. insulin therapy
排除标准
- •Type 1 diabetes, gestational diabetes
- •Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the patient
- •Pregnancy
- •Any mental condition rendering the patient incapable of giving his consent
- •Known or suspected allergy to insulin glargine or insulin aspart
- •Continuous parenteral nutrition
- •Participation in another trial which can influence the software algorithm
研究组 & 干预措施
GlucoTab System
Experimental
干预措施: GlucoTab System (Device)
结局指标
主要结局
Mean percentage of blood glucose measurements in the target range 70 to 140 mg/dl, as calculated by all premeal and bedtime glucose values measured ≥ 24 hours after start of therapy
时间窗: duration of hospital stay (maximum three weeks)
次要结局
- Mean daily blood glucose as calculated by premeal and bedtime blood glucose values: Overall and per treatment day(duration of hospital stay (maximum three weeks))
- Number of blood glucose measurements per day(duration of hospital stay (maximum three weeks))
- Adherence to the insulin dose suggestion of the GlucoTab system(duration of hospital stay (maximum three weeks))
研究者
研究点 (2)
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