¿Puede Una aplicación móvil Mejorar el Conocimiento y la autogestión de Las Personas Con Diabetes Tipo 1? Evaluación clínica de la App mySugr
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Empowerment
研究概览
简要总结
This project is based on the contribution that an app can offer for improving knowledge and self-management of people with type 1 diabetes.
The main objective of this study is to assess mySugr app as a tool for empowering people with type 1 diabetes.
The study population are type 1 diabetes people, aged more than 18 years old and with more than one year from diagnosis. They will be randomised to standard care or use of mySugr app and will be followed-up during 48 weeks.
Control group will attend 5 face-to-face visits (baseline, 3, 6, 9 and 12 months) with the possibility of telephone contact and hospital assistance if necessary. Intervention group will attend 3 face-to-face visits (baseline, 6 and 12 months) and 2 telematic visits (at 3 and 9 months) and will also have the possibility of telephone contact and hospital assistance if necessary.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years of age
- •People with type 1 diabetes (> 1 year diagnosis)
- •Treatment with insulin in basal-bolus regimen
- •Glucometer that connects automatically with the app
- •HbA1c 7-9%
- •Understanding of carbohydrate counting and concepts of ratio and factor of sensitivity
- •Have a smartphone or tablet
排除标准
- •Use at the time of randomization of another app for diabetes management
- •Use of continuous monitoring or flash glucose systems
- •Pregnancy
- •Any other disease or condition that may interfere with the completion of the protocol or completion of the study
结局指标
主要结局
Empowerment
时间窗: Baseline visit and month 12
Change from baseline score in the Diabetes Empowerment Scale-Short Form Spanish version (DES-SF-S) (8, worse to 40, better) at 12 months
次要结局
- Adherence to glycemic monitoring(Baseline visit and month 3, 6, 9 and 12)
- Adherence to visits(Each follow-up visit (month 3, 6, 9 and 12))
- Adherence to the app(End of the study (month 12) and 3 months after)
- Daily management of diabetes(Baseline visit and month 12)
- Self-efficacy(Baseline visit and month 12)
- Glycemic control(Baseline visit and month 6 and 12)
- Satisfaction with the app(End of the study (month 12))
- Adherence to recommendations(Each follow-up visit (month 3, 6, 9 and 12))
- Quality of life related to diabetes(Baseline visit and month 12)