NCT01715090已完成不适用
Web-based Insulin Titration: Improving Diabetes Care in the Netherlands. An Efficacy Study.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2012年12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
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Mean change in HbA1c
研究概览
简要总结
The main objective of the study is to determine whether an intensive web-based titration system, called PANDIT (Patient Assisting Net-based Diabetes Insulin Titration), is effective in improving glycaemic control in patients with diabetes mellitus type 2 using a basal insulin, compared to standard care.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between 18 and 80 years
- •Type 2 diabetes mellitus (diagnosed clinically) for ≥ 6 months
- •Once daily basal insulin therapy usage
- •No restriction on HbA1c or FPG
- •BMI < 40 kg/m2
- •Ability to read and understand the Dutch language
- •Familiarity with the Internet and use of a mobile phone
- •Ability and willingness to adhere to the protocol
- •Ability and willingness to use a web-based insulin self-titration system
- •Confirmed written consent
排除标准
- •Type 1 diabetes
- •Use of systemic corticosteroid in the last three months
- •Recurrent severe hypoglycaemia or hypoglycaemic unawareness
- •Active proliferative diabetic retinopathy
- •Any clinically significant disease or disorder
- •Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study
- •Working in night shifts
研究组 & 干预措施
Web-based insulin titration
Experimental
An online web-based insulin titration algorithm to guide patients in self-titration
干预措施: Web-based insulin titration (Device)
Standard care
No Intervention
结局指标
主要结局
Mean change in HbA1c
时间窗: Change from baseline after 13 weeks and after 26 weeks
次要结局
- Proportion of subjects who reach the target of HbA1c < 7.0%(After 26 weeks)
- Quality of life and treatment satisfaction(Change from baseline after 13 weeks and after 26 weeks)
- Total contact time with study staff (and the PANDIT system, if applicable)(After 26 weeks)
- Overall incidence and rate of hypoglycaemia (mild hypoglycaemia, probable hypoglycaemia, severe hypoglycaemia and relative hypoglycaemia)(After 26 weeks)
- Mean change in fasting plasma glucose(Change from baseline after 13 weeks and after 26 weeks)
- Frequency of the usage of PANDIT among patients(After 26 weeks)
- Detection of important factors for patient compliance to internet-based self-care interventions(After 26 weeks)
研究者
F Holleman
MD PhD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
研究点 (1)
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