Effectiveness of Video Consultations in Type 1 Diabetes Patients Treated With Insulin Pumps in the Outpatient Clinic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- Change from baseline of Time in Range (TiR)
研究概览
简要总结
Telemedicine is a solution to overcome distance and ensure the provision of healthcare services. This study aims to investigate the effects of conducting outpatient clinic visits remotely, for patients living with insulin pumps.
详细描述
Telemedicine also has the potential to be a cost-effective solution due to reductions in travelling costs and saved working days, as well as increased patient satisfaction due to the reduction in transportation time.
Several studies have evaluated telemedicine for use in Diabetes Mellitus patients with an insulin pump. In all of these studies, the telemedicine group scheduled more contacts with the health care professionals than in the standard care group. To the investigator's knowledge, no one has investigated telemedicine, compared to standard care with the same number of scheduled contacts. The investigators believe telemedicine should increase the level of service and not increase the workload for health care professionals. A telemedical solution can provide patients with a more flexible alternative for visiting their health care provider rather having the burden of extra telemedicine appointments plus regular treatment.
Patients in rural Denmark may have a travelling time of 70 km (1 hour by car or several hours by public transport) to a specialised Diabetes Mellitus specialist centre. This may result in some patients choosing not to start or not being offered insulin pump treatment despite indications that an insulin pump is an optimal treatment choice. The challenge of distance also poses problems for patients in relation to technical problems or medical issues with the insulin pump. Telemedicine should be a solution for both patients and their Health Care Providers.
In this randomised controlled study, the effects of conducting clinical visits remotely, for patients living with insulin pumps will be investigated. Participants will be allocated to either Intervention (Standard care provide by video consultations) or 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 18 years of age
- •Diagnosed with diabetes Type 1
- •Patient has used insulin pump for at least 6 months
排除标准
- •No internet access
- •Unable to adhere to protocol.
- •Unable to speak or read Danish.
研究组 & 干预措施
No intervention
All appointments, scheduled and non-scheduled are by face-face communication with the health care professionals.
Patients will receive their usual treatment.
Intervention group video consultations
All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals.
Patients will follow their usual treatment.
干预措施: Intervention group video consultations (Other)
结局指标
主要结局
Change from baseline of Time in Range (TiR)
时间窗: 52 weeks
% of TiR (3.9 -10.0 mmol/L)
次要结局
- Change from baseline of time spent below target glucose range (TbR) level 2(52 weeks)
- Change from baseline of Haemoglobin 1Ac(52 weeks)
- Audit of Diabetes Dependent Quality of Life version 19(0 and 52 weeks)
- Diabetes Treatment Satisfaction status(0 and 52 weeks)
- Change from baseline of time spent below target glucose range (TbR ) level 1(52 weeks)
- Diabetes Treatment Satisfaction Questionaire change(52 weeks)
- Change from baseline of Glycaemic variability(52 weeks)
- Change from baseline of time above target glucose range (TaR) level 1(52 weeks)
- Change from baseline of time above target glucose range (TaR) level 2(52 weeks)