Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Composite adverse pregnancy and neonatal outcome
研究概览
简要总结
Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.
详细描述
The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Informed Consent as documented by signature
- •GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
- •Maternal age of 18 to 45 years,
- •Singleton gestation
- •Gestational age ≥ 24 0/7 weeks and <32 0/7 weeks at enrollment.
排除标准
- •Known hypersensitivity or allergy to the sensor
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
- •Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- •Maternal age < 18 years,
- •Multi-fetal gestations,
- •Known fetal structural or chromosomal anomalies
- •Chronic use of medications associated with hyperglycemia (steroids)
- •Planned preterm delivery
- •Overt diabetes mellitus type 1 or 2
- •HbA1c by study entry > 6.5%
- •History of bariatric surgery or other surgeries that induce malabsorption
- •Fetal growth restriction by study entry
研究组 & 干预措施
Dexcom G System
The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app.
干预措施: Dexcom G System (Device)
Standard care of gestational diabetes with self monitoring blood glucose (SMBG)
SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.
干预措施: Self monitoring blood glucose (Device)
结局指标
主要结局
Composite adverse pregnancy and neonatal outcome
时间窗: 2 years
The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight \>90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.
次要结局
- Postpartum disorder(10-14 weeks)
- Neonatal Care(10-14 weeks)
- Respiratory distress syndrome(10-14 weeks)
- Resuscitation(10-14 weeks)
- Neonatal outcome(10-14 weeks)
- Initiated Therapy(10-14 weeks)
- Glycemic Outcomes 1(10-14 weeks)
- Neonatal birth trauma(10-14 weeks)
- Glycemic Outcomes 2(10-14 weeks)
- Glycemic Outcomes 3(10-14 weeks)
- Maternal satisfaction questionnaire(10-14 weeks)
- Glycemic Outcomes 4(10-14 weeks)
- Pregnancy complications(10-14 weeks)
- Mode of Delivery(10-14 weeks)
- Need for induction of labor(10-14 weeks)
- Obstetrical outcome(10-14 weeks)
- Maternal outcomes(10-14 weeks)
- Maternal weight gain(10-14 weeks)
- Maternal Compliance(10-14 weeks)
- Birth age(10-14 weeks)
- Preterm(10-14 weeks)
- Neonatal weight(10-14 weeks)
- Neonatal condition(10-14 weeks)
- Neonatal Morbidity(10-14 weeks)