A Randomised Pilot Trial to Compare Remote Blood Glucose Monitoring With Standard Clinical Care in the Gestational Diabetic Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 2
- 主要终点
- Glycosylated haemogloblin
研究概览
简要总结
Diabetes in pregnancy (gestational diabetes) is becoming more common. It can lead to problems for both mothers-to-be and their babies such as causing a large baby and difficult birth. Gestational diabetes in the mother may also lead to effects on the long term health of the baby.
Most people today use mobile phones. Our research is looking at using a mobile phone app to help with diabetes care in pregnancy. In particular, the investigators are using phones which connect to the standard blood glucose monitoring machines given to all women with gestational diabetes to see if sending the hospital team blood test results between clinic appointments can result in the need for fewer clinic visits. The investigators are also testing to see how acceptable using mobile phones in this way, is to our patients and that the control of the blood glucose and outcomes for the mother and baby are at least as good as standard care.
The investigators are planning to recruit 200 women who receive care for their gestational diabetes at the Oxford University Hospitals NHS (National Health Service) Trust. They will be randomised so that 100 will receive standard care, and 100 will have a mobile phone "app" linked to the blood glucose machines to send blood glucose readings directly to the diabetes care team to review.
Both groups will be asked to test their blood glucose levels at home regularly with a glucometer. All participants will also be given lifestyle advice to reduce the chance they will need medication. Blood glucose control will be measured also by the percentage of glycated hemoglobin (HbA1c) at the time of diagnosis of gestational diabetes and before delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women with an abnormal 75 gram 2 hour glucose tolerance test as defined by the IADPSG (International Association of Diabetes in Pregnancy Study Group)
- •Willingness and able to give informed consent
- •Female aged between 18-40 years
- •Singleton pregnancy
- •Able to travel to hospital independently
排除标准
- •Impaired cognitive function such that she is unable to operate m-health equipment
- •Any evidence of fetal compromise
- •Known risk factors for obstetric complications, other than obesity and diabetes
- •Gestational diabetes requiring immediate pharmacologic treatment
- •Twins or higher order pregnancy
- •OGTT (Oral Glucose Tolerance Test) suggesting preexisting diabetes (fasting blood glucose >= 7.0 or 2 hour >= 11.1 mmol/L
- •Gestation greater than 34+6 at the time of potential recruitment
- •Unable to speak English well enough to explain or use equipment
结局指标
主要结局
Glycosylated haemogloblin
时间窗: 8 weeks from recruitment at 28 weeks gestation to 36 weeks gestation
Glycosylated haemoglobin (HbA1C) will be measured at the time of recruitment (around 28 weeks gestation) and at 36 weeks gestation. This will be approximately 8 weeks after recruitment (time 0).
次要结局
- Effectiveness of monitoring(10 weeks (from 28 weeks gestation to 38 weeks gestation))
- Maternal weight gain,(10 weeks (from 28 weeks gestation to 38 weeks gestation))
- Birth injury(At birth (approximately 10 weeks after trial recruitment))
- Neonatal hypoglycaemia(Approximately 10.5 weeks after recruitment)
- Percentage of 'on target' blood glucose readings(8 weeks (from recruitment at 28 weeks gestation to 36 weeks gestation))
- Maternal outcomes(Approximately 11 weeks after recruitment)
- Birthweight(At birth (approximately 10 weeks after trial recruitment))
- Mean Blood glucose levels for fasting, pre-prandial and post-prandial readings(10 weeks (from 28 weeks gestation to 38 weeks gestation))