Insights Into Glucose Variability Using Continuous Glucose Monitoring in Mothers With Gestational Diabetes Compared to Mothers at High Risk of Gestational Diabetes Who Have a Negative Oral Glucose Tolerance Test.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Time in hyperglycaemia (glucose >10)
研究概览
简要总结
Gestational diabetes (GDM) develops during pregnancy and is becoming increasingly common. The condition is associated with adverse outcomes for mother and baby during both the pregnancy and delivery period. This study compares glucose variability (recorded by a continuous glucose monitoring (CGM) sensor) in pregnant women who have been diagnosed with GDM with pregnant woman who do not have the diagnosis but are at high risk. The sensors will be applied to 400 participants around the time of their standard test for GDM, with a randomly selected 60 of these patients forming a sub-group later in the study to assess for progression of high blood glucose. At present, a positive oral glucose tolerance test (OGTT) is used to confirm the diagnosis of GDM but the test can be unreliable leading to potential diagnostic error. CGM devices are used extensively in the management of Type 1 diabetes and GDM, and have also shown potential to be used in the diagnosis of Type 2 diabetes.
If this study can demonstrate similar trends in glucose variability between OGTT positive patients and those who are OGTT negative but are at high risk for the condition, then further research into the utility of CGM as a diagnostic alternative or supplement to the OGTT would be indicated.
The investigators will recruit 400 patients at high risk for GDM, give them a blinded CGM device, and compare the CGM glucose data with their OGTT result, their initial risk factors for GDM, their pregnancy outcome and their need for treatment. The investigators will use the data to test our hypothesis that a positive OGTT result does not predict hyperglycaemia in pregnancy.
详细描述
Gestational Diabetes (GDM) is associated with higher than normal blood sugar levels in pregnant women which has the potential to harm the baby and mother. The condition resolves with delivery of the baby, but during the pregnancy there is a limited time window for diagnosis and treatment before harm may be caused.
GDM is thought to affect up to 32% of pregnancies and is becoming more common due to rising rates of obesity and maternal age. The current recommended practice in the UK for the diagnosis of GDM is to use the oral glucose tolerance test (OGTT), which is two plasma blood glucose tests (one at baseline and one 2 hours after a glucose load) performed on expectant mothers who have at least one risk factor for GDM at 28 weeks gestation. This method is not standard internationally, with some countries using the test on all woman who fall pregnant, others adhering to different diagnostic thresholds, and others performing the test in a different way. Furthermore, there is no international consensus on the best way to diagnoses GDM. The challenge in diagnosing the condition arises because the results of the OGTT relies upon only two glucose measurements and therefore are not always accurate, meaning that some expectant mothers with GDM are missed, and others who do not have GDM are incorrectly told they have the condition.
Pregnant women who develop GDM but are not identified by the OGTT may suffer complications which could have been avoided with glucose lowering therapy, whilst woman who are incorrectly diagnosed with the condition may have their pregnancies unnecessarily medicalised, both of which places extra burden on the healthcare system. Therefore, improving the accuracy of the diagnosis of GDM has the potential to improve outcomes in pregnancies worldwide (and significantly impact upon current practice).
Recent technological advances in the field of diabetes care have seen the emergence of continuous glucose monitoring (CGM) - digital sensors placed on a patient's skin which constantly read the blood sugar level and communicate with their smart phone. Data from the CGM sensor is sent via Bluetooth to the smart phone, and using software downloaded in an app, is converted into a graphical summary illustration called an 'ambulatory glucose profile' (AGP) allowing for better treatment decisions to be made.
CGM devices are revolutionising the monitoring and treatment of diabetes, including GDM, however they are not utilised for diagnostic purposes. This study examines the challenging task of accurately diagnosing GDM by comparing the CGM data of patients with GDM with the CGM data of individuals at high risk of GDM (who are OGTT negative) to determine if the OGTT result is predictive of high blood glucose.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female aged 18 years of above
- •Between 12-26 weeks gestation
- •Identified by NICE as having one or more independent risk factor for GDM
- •Suitable for the standard care pathway under the joint antenatal clinic for GDM
- •Willing and able to give informed consent.
排除标准
- •Pre-existing diabetes
- •Previous GDM
- •Unsuitable for standard joint antenatal clinic pathway
- •Known allergy to freestyle libre adhesive pad
- •Planning to move geographical area during the study timeframe
- •Participating in a different study that could interfere with glucose levels or affect ability to participate.
结局指标
主要结局
Time in hyperglycaemia (glucose >10)
时间窗: 12 months
Assessed glucose parameters and trends on ambulatory glucose profile provided by continuous glucose monitoring data.
Time in range on CGM data (glucose 3.9-10)
时间窗: 12 months
Assessed glucose parameters and trends on ambulatory glucose profile provided by continuous glucose monitoring data.
Glucose management indicator (GMI) - 'estimated A1c'
时间窗: 12 months
CGM device 'estimated A1c' calculation from the available data. This correlates with average glucose level
Glucose variability
时间窗: 12 months
Measure provided by CGM device referring to the amplitude and frequency of variation from the average glucose level. This does not directly correlate with average glucose level.
次要结局
- A analysis of CGM glucose data for progression of glycaemia in a sub group(12 months)
- Glucose lowering therapy.(12 months)
