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临床试验/NCT03053336
NCT03053336已完成不适用

App-technology to Enhance Self-care for Patients With Diabetes Type 2 - A Randomized Controlled Trial

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2017年2月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
181
试验地点
1
主要终点
Change in physical activity level (counts/min from accelerometers)

研究概览

简要总结

The aim of this study is to investigate the effect of using new app-based technology to improve self-care, compared to usual care in patients with type 2 diabetes. The hypothesis is that the intervention, i.e. using the new technology, will have a greater positive effect on physical activity levels and outcomes of HbA1c than usual care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
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

入选标准

  • Have a diagnosis of type 2 diabetes
  • 18 years of age or older
  • Ability to communicate in Swedish
  • Have and be able to use a smartphone

排除标准

  • Not being able to walk

结局指标

主要结局

Change in physical activity level (counts/min from accelerometers)

时间窗: baseline and month 3, 6 and 12

次要结局

  • Total cholesterol (mmol/L)(Baseline and month 3, 6 and 12)
  • HbA1c (mmol/mol)(Baseline and month 3, 6 and 12)
  • Steps/day(Baseline and month 3, 6 and 12)
  • Triglycerides (mmol/L)(Baseline and month 3, 6 and 12)
  • HDL-cholesterol (mmol/L)(Baseline and month 3, 6 and 12)
  • Apolipoprotein A1 (g/l)(Baseline and month 3, 6 and 12)
  • Apolipoprotein B (g/l)(Baseline and month 3, 6 and 12)
  • Body weight (kg)(Baseline and month 3, 6 and 12)
  • Body Mass Index (BMI, kg/m2)(Baseline and month 3, 6 and 12)
  • Body composition(Baseline and month 3, 6 and 12)
  • Waist circumference (cm)(Baseline and month 3, 6 and 12)
  • Blood pressure (mmHg)(Baseline and month 3, 6 and 12)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ylva Trolle Lagerros

MD, Associate professor

Karolinska Institutet

研究点 (1)

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