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临床试验/NCT02107326
NCT02107326已完成不适用

Webdia Study: Use of Smartphones to Improve Diabetes Control and Quality of Life in Children With Type 1 Diabetes

Philippe Klee2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2014年5月最近更新:
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
55
试验地点
2
主要终点
Effect of Webdia Software use on HbA1C

研究概览

简要总结

The purpose of this study is to evaluate the impact of a software for smartphones and tablets on type 1 diabetes control and quality of life

详细描述

The hypothesis underlying this project, is that most calculations necessary for flexible intensive insulin therapy for type 1 diabetes in children can be performed using software installed on a smartphone or tablet that nowadays is carried by most parents and children. Smartphones and tablets can easily communicate with each other and with a desktop computer via the Internet, thereby permitting the exchange of information such as blood glucose values or types of meals among family members and physicians. Finally, software collecting blood glucose values and merging values obtained on different devices easily permits reviewing these values by the patient and sending them to the physician's office, thereby avoiding consultations during which no blood glucose values are brought by the patient.

We hypothesize that the Webdia software, that will be tested in this randomized crossover study, will increase treatment compliance and therefore will improve diabetes self-management. We believe, the software will facilitate the adaptation of insulin schemes by physicians and therefore will lead to improved HbA1C values. We also think that this software will improve the patient's quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 10 - 18 years
  • Type 1 diabetes mellitus with positive auto-antibodies against Islet Antigen (IA) 2, insulin, islets, Glutamic Acid Decarboxylase (GAD) 65 or Zink
  • Disease duration equal or more than 6 months
  • Treatment by subcutaneous insulin: by multiple daily injections of pump therapy

排除标准

  • Previous use of Webdia Software
  • Absence of hardware necessary to install the Webdia Software

研究组 & 干预措施

Webdia Software use

Experimental

Use of Webdia Software during 3 months by the patient. Monthly review of blood glucose values by the medical team and automatic adjustment of insulin doses by the team.

干预措施: Webdia Software (Device)

Observation

No Intervention

No use of the software. No intervention.

结局指标

主要结局

Effect of Webdia Software use on HbA1C

时间窗: 0, 3, 6 and 9 months after inclusion

次要结局

  • Effect of Webdia Software use on quality of life(0, 3, 6 and 9 months after inclusion)
  • Effect of Webdia Software use on the incidence of hypoglycaemic events(During 2 weeks at the end of the 3-months period of Webdia Software use)

研究者

发起方
Philippe Klee
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Philippe Klee

MD-PhD

University Hospital, Geneva

研究点 (2)

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