Effectiveness of Telemedicine Care Replacing Standard Care in Gestational Diabetes: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Average postprandial glucose concentration
研究概览
简要总结
This is a a single-centre, parallel, randomized controlled trial in women with gestational diabetes mellitus (GDM). Women are randomized to routine monthly prenatal clinic care (standard care group) or a group sending daily glucose readings via an application installed on a smartphone and monthly individual videoconferences replacing in-person visits (telemedicine group). The overall aim is to compare the effectiveness of the combine synchronous and asynchronous telemedicine care with the standard care in women with GDM.
详细描述
In our single-centre, parallel, randomized controlled trial in women with gestational diabetes (GDM) the investigators aim to compare the effectiveness of combined synchonous and asynchronous telemedicine care with the standard care.
In the telemedicine group appointments are performed online via monthly scheduled videoconferences. Women also receive a smartphone with the installed application that enable transfer of the measured capillary glucose concetration at the same time it is performed. The glucose data sent by women are reviewed once per week and after that healthcare professionals contact women if necessary. On the other hand, in the standard care group, visits are scheduled normally on a monthly basis at the diabetes clinic.
Intention-to-treat analysis is going to be performed. The investigators aim to compare glycemic control, gestational weight gain and perinatal data between groups.
Student's t-test or Mann-Whitney U test will be used for normally or non-normally distributed variables. Differences between groups in categorical data will be calcuated by Chi square.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •less then 30 weeks of gestation at enrolement
- •GDM diagnosis
- •at least moderate Slovenian language skills
- •willingness to participate
排除标准
- •more than 30 weeks of pregnancy
- •overt diabetes or fasting glucose >6.9 mmol/l at diagnosis
- •multiple pregnancy
- •poor Slovene language skills
- •history or bariatric surgery or other surgeries that induce malabsorbtion
- •use of systemic steroids prior to enrolment
- •presence of concomitant disease that could affect glucose control or self-management (e.g. uncontrolled psychiatric disorder)
结局指标
主要结局
Average postprandial glucose concentration
时间窗: 1 month
Average postprandial glucose based on participant's SMBG in the 3rd trimester
Percentage of glucose readings in the target range
时间窗: 1 month
average percentage for the 3rd trimester
Compliance with SMBG
时间窗: 1 month
is defined as defined as the number of actual glucose measurements performed divided by the number of recommended glucose measurements\*100
Average fasting glucose concentration
时间窗: 1 month
Average fasting based on participant's SMBG in the 3rd trimester
The percentage of individuals needing insulin treatment
时间窗: once during pregnancy
次要结局
- Incidence of preeclampsia(delivery)
- gestational weight gain(once during pregnancy)
- LGA incidence(delivery)
- Preterm birth(delivery)
- Newborn birth weight(delivery)
- Gestational age at birth(delivery)
- Incidence of caesarean section(delivery)