Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Women With Gestational Diabetes: A Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
Gestational diabetes mellitus (GDM) is a type of diabetes that is first diagnosed during pregnancy. It causes high blood sugar levels and can increase the risk of health problems for both the mother and the baby. Babies may grow larger than expected (macrosomia), which can make delivery more difficult and increase the risk of birth complications. Mothers with GDM are also more likely to need insulin treatment and may have a higher risk of high blood pressure during pregnancy. Good blood sugar control is important to reduce these risks.
The usual way to monitor blood sugar in women with GDM is by self-monitoring of blood glucose (SMBG). This involves pricking the finger several times a day to measure blood sugar levels. Although this method provides useful information, it only shows glucose levels at specific moments and may miss changes that happen during the night or between measurements.
Continuous glucose monitoring (CGM) is a newer method that uses a small sensor placed under the skin to measure glucose levels throughout the day and night. It provides more detailed information about blood sugar patterns and does not require frequent finger pricks. CGM has been shown to improve blood sugar control in people with type 1 and type 2 diabetes, but its benefits in women with gestational diabetes are not yet fully known.
The purpose of this study is to compare continuous glucose monitoring (CGM) with standard finger-prick monitoring (SMBG) in pregnant women diagnosed with gestational diabetes between 24 and 28 weeks of pregnancy. The study will evaluate whether CGM is practical to use, whether women are satisfied with it, and whether it may help improve blood sugar control and pregnancy outcomes.
A total of 100 pregnant women with gestational diabetes will take part in this study. Participants will be randomly assigned (like flipping a coin) to one of two groups:
One group will use a continuous glucose monitoring device.
The other group will continue with standard finger-prick blood glucose monitoring.
Both groups will receive the same medical care, including dietary advice, physical activity recommendations, and insulin treatment if needed. Participants will attend regular pregnancy visits every 2 to 3 weeks until delivery, as part of usual care. No extra hospital visits are required because of the study. Women using CGM will receive training on how to use the device.
The researchers will compare blood sugar control, the need for insulin, pregnancy complications, and newborn outcomes such as birth weight and episodes of low blood sugar after birth. The study will also assess how satisfied women are with their glucose monitoring method and how it affects their quality of life.
This is a pilot study, which means its main goal is to determine whether a larger study should be carried out in the future. The results will help researchers understand whether continuous glucose monitoring could improve the care of women with gestational diabetes and their babies.
详细描述
Gestational diabetes mellitus (GDM) is a condition in which high blood glucose levels are first detected during pregnancy. It usually develops in the second or third trimester and affects a significant proportion of pregnant women worldwide. Although blood glucose levels often return to normal after delivery, GDM is associated with important short-term and long-term health risks for both the mother and the child.
In the short term, poorly controlled blood glucose levels during pregnancy increase the risk of excessive fetal growth (macrosomia or large for gestational age), shoulder dystocia, birth trauma, neonatal hypoglycemia, respiratory complications, and admission to the neonatal intensive care unit (NICU). For the mother, GDM increases the likelihood of hypertensive disorders of pregnancy, cesarean delivery, and postpartum complications. In the long term, women with GDM have a higher risk of developing type 2 diabetes and cardiovascular disease, and their children are at increased risk of obesity and metabolic disorders later in life.
Achieving and maintaining optimal glycemic control is therefore a central goal in the management of GDM. Standard treatment includes dietary counseling, physical activity recommendations, and regular monitoring of blood glucose levels. If lifestyle measures are not sufficient to reach glycemic targets, insulin therapy is initiated.
Currently, the standard method for glucose monitoring in women with GDM is self-monitoring of blood glucose (SMBG). This involves capillary finger-prick measurements typically performed four to six times per day (fasting and postprandial values). While SMBG provides important information, it has several limitations. It captures glucose levels only at specific time points and may miss significant fluctuations, including nocturnal hyperglycemia and postprandial excursions. It also relies heavily on patient adherence and accurate recording of results. Incomplete monitoring or reporting errors may affect clinical decision-making. Additionally, frequent finger pricks can be uncomfortable and burdensome.
Continuous glucose monitoring (CGM) offers an alternative approach. CGM systems use a small sensor inserted under the skin to measure interstitial glucose levels continuously throughout the day and night. The device provides real-time glucose readings, trend information, and metrics such as time in range, time above range, time below range, and glucose variability. These metrics offer a more comprehensive view of glycemic control than isolated capillary measurements.
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
- Single (Outcomes Assessor)
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
- •Pregnant women aged ≥18 years
- •Singleton pregnancy
- •Diagnosis of gestational diabetes mellitus (GDM) according to local two-step protocol (abnormal 50 g glucose challenge test followed by abnormal 100 g oral glucose tolerance test with at least 2 abnormal values)
- •Gestational age between 24 and 28 weeks at time of GDM diagnosis
- •Access to a compatible smartphone or digital device with internet connection to allow synchronization and remote upload of glucose data (CGM or SMBG)
- •Ability and willingness to provide written informed consent
排除标准
- •Preexisting type 1 or type 2 diabetes mellitus
- •History of bariatric surgery
- •Treatment with metformin during pregnancy
- •Chronic systemic corticosteroid therapy
- •Known contraindications to use of a CGM sensor (e.g., severe dermatologic conditions at insertion site)
- •Inability to comply with study procedures or follow-up
研究组 & 干预措施
Continuous Glucose Monitoring (CGM)
Participants randomized to this arm will use a real-time continuous glucose monitoring system (FreeStyle Libre 2) from randomization (24-28 weeks of gestation) until delivery. The sensor will be placed by trained staff, and participants will receive standardized training on device use and interpretation of glucose trends. Clinical decisions, including dietary adjustments and initiation or titration of insulin therapy, will be based on CGM data according to local gestational diabetes protocols. A capillary glucose meter will be provided for confirmatory measurements if needed. All other aspects of care will follow standard practice.
干预措施: Continuous Glucose Monitoring (FreeStyle Libre 2) (Device)
Self-Monitoring of Blood Glucose (SMBG)
Participants randomized to this arm will perform standard self-monitoring of blood glucose using capillary finger-prick measurements (typically fasting and postprandial values, 4-6 times daily) from randomization until delivery. Participants will receive standardized education on measurement technique and recording. Clinical decisions, including dietary adjustments and insulin initiation or titration, will be based on SMBG values according to local gestational diabetes protocols. All other aspects of care, including obstetric follow-up, will follow standard clinical practice.
干预措施: Self-Monitoring of Blood Glucose (Capillary Glucose Meter) (Device)