Effect of Real Time Continuous Glucose Monitoring System on Management of Women With Type 2 Diabetes Mellitus During Pregnancy in a Multidisciplinary Comprehensive System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The difference of Time in Range (TIR)
研究概览
简要总结
The prevalence of type 2 diabetes mellitus (T2DM) in women of childbearing age is increasing rapidly, and low glucose compliance leads to an increased risk of adverse pregnancy outcomes for mothers and infants during pregnancy in women with T2DM. Real-time continuous glucose monitoring (CGM) is an important tool for glucose monitoring and patient education, as it can continuously record blood glucose throughout the day and provide real-time feedback on high and low blood glucose levels. This is a multicenter, open-label, randomized controlled clinical study to investigate the efficacy, safety, and maternal and infant pregnancy outcomes of using real-time CGM monitoring compared with conventional self-monitoring of blood glucose (SMBG) on the basis of multidisciplinary management in pregnant women with T2DM. One hundred and twenty pregnant women with T2DM in early pregnancy who were enrolled in intensive insulin therapy were randomly divided into the real-time CGM group and the conventional SMBG group. The real-time CGM intervention group wore real-time CGM for more than 50% of the pregnancy in addition to regular SMBG; the control group only performed regular SMBG. Both groups wore Medtronic iPro 2 for 3 days in early, mid and late pregnancy, and the time in the target range of blood glucose (TIR) was recorded in a blinded manner. Primary outcome: differences in TIR between the two groups of pregnant women in early, mid, and late pregnancy. Secondary outcomes included differences in glycated hemoglobin, hypoglycemia, insulin dose before delivery, pregnancy weight gain, and maternal and infant pregnancy outcomes.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A clear history of type 2 diabetes, or a history of type 2 diabetes diagnosed in early pregnancy
- •Singleton gestation at 4-26 weeks, with substandard glycemic control (i.e., fasting glucose > 5.3 mmol/L, and or 1 hour postprandial glucose > 7.8 mmol/L, and or 2 hours postprandial glucose > 6.7 mmol/L) after lifestyle intervention ± basal insulin therapy, as assessed by the endocrinology department. Patients who need insulin regimen with basal plus meal or insulin pump regimen.
- •Patients are willing and committed to establish and follow up in the obstetrics and gynecology departments of Peking University Third Hospital, Haidian District Hospital and Yanqing District Hospital during pregnancy, and are willing to provide information on obstetric examination and perinatal medical records if they are transferred to the hospital for special reasons for follow-up or delivery.
- •Voluntarily participate in the study, examine and follow up according to this project and sign informed consent.
- •Able to pass the screening period Adherence evaluation
排除标准
- •Patients with type 1 diabetes, specific type of diabetes or gestational diabetes
- •Pregnancy with severe comorbidities or diabetic complications for which obstetrics does not recommend continuation of pregnancy, including but not limited to the following: proliferative retinopathy, chronic kidney disease (eGFR less than 60 mL/min/1.73± massive proteinuria), known coronary and cerebrovascular disease, autoimmune system disease and receiving exogenous glucocorticoids or immunosuppressive therapy.
- •Patients who have been hospitalized for psychiatric treatment within 6 months prior to enrollment or are still on psychiatric medications.
- •Patients who have received other interventional studies.
研究组 & 干预措施
Intervention group
The intervention group will wear real-time CGM (120 cases) to monitor blood glucose and is required to use real-time-CGM more than 50% of the time every 4 weeks, the more the better.
干预措施: Real-time Continuous Glucose Monitoring System (Device)
Control group
The control group will be followed up with traditional SMBG (120 cases) monitoring.
结局指标
主要结局
The difference of Time in Range (TIR)
时间窗: 24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery)
The iPro2 device was used to calculate TIR(the control range of blood glucose during pregnancy was 3.5-7.8mmol/L), and the average value of TIR obtained from two measurements was used as the main outcome index.
次要结局
- Coefficient of Variation (CV)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Standard difference (SD)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Maternal weight gain(From enrollment to 42 weeks gestation)
- Number of Pregnancy loss(From enrollment to 6 weeks postpartum.)
- Number of macrosomia or fetal growth restriction(During delivery)
- Number of moderate hypoglycemic events(From enrollment to 42 weeks gestation)
- Glycosylated hemoglobin(During delivery)
- Number of newborns with neonatal birth injury, shoulder dystocia, neonatal jaundice, neonatal respiratory distress syndrome (RDS)(From birth to discharge.)
- Gestational age at birth(During delivery)
- Interquartile range(IQR)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Time Above Range(TAR）(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Number of mild hypoglycemic events(From enrollment to 42 weeks gestation)
- Total insulin(At 4 weeks after enrollment, 24, 28, 34 weeks gestation and 6 weeks postpartum.)
- Number of Patients with Adverse pregancy outcome(6 weeks postpartum.)
- Mean Amplitude Of Glycemic Excursion(MAGE)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Mean absolute relative difference (MARD)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Glycosylated albumin(During delivery)
- Apgar score(During delivery)
- Time Below Range(TBR)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- Interdencile range (IDR)(24-28 weeks (second trimester), 34-38 weeks (2 weeks before delivery))
- The length of a newborn is treated in the neonatal intensive care unit (NICU)(6 weeks postpartum.)
- Number of neonatal hypoglycemia(6 weeks postpartum.)
- Patient-reported severe hypoglycemic events(From enrollment to 42 weeks gestation)