Real-time Continuous Glucose Monitoring for the Treatment of Gestational Diabetes: a Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean blood glucose (mg/dL)
研究概览
简要总结
Gestational diabetes (GDM) is a condition of carbohydrate intolerance with onset or first recognition in pregnancy. The prevalence of GDM is as high as 25% in some populations and continues to rise with the increase in obesity and type-2 diabetes. GDM places the pregnancy at great risk to both the mother and the neonate. Recent studies have proven that interventions including dietary and medications lower the risk to the pregnancy. Both the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA) recommend dietary interventions with daily glucose monitoring as the initial treatment of choice. Meanwhile, outside of pregnancy, promising new technologies such as continuous glucose monitors (CGM) are revolutionizing diabetic care. The investigators seek to determine if the constant feedback of a real-time CGM system would improve glycemic control compared to traditional management in GDM
详细描述
The investigators' proposed study will add new information to the emerging use of CGM in pregnant women with GDM. First, most studies only use CGM for 48 - 72hours at a time, while the investigators will be using CGM for 7 day intervals. Both groups will use the same Enlite sensor (Medtronic). The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + transmitter). The real-time CGM group will be using the 530g system (iPro2 (Enlite sensor + transmitter) + inactivated 530g pump set only to display glucose values, no insulin will be administered). This CGM system has been FDA approved to for up to 7 days between sensor changes.26,27 Second, no previous study has used real time CGM in pregnant patients with GDM in the US. The investigators will be the first to describe the use of this technology in this patient population. Third, most of these trials have been performed on populations that are not representative of the investigators' patient population at EVMS. This will be the largest US study of CGM in GDM. Fourth wearable medical and fitness technology is already popular, but as both the technology and the demand continues to grow, it will become the future of diabetes management. Studies have already shown that real time CGM is an effective educational and motivational tool in type-1 and type-2 DM.28,29
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
- •maternal age 18 to 45
- •singleton gestation
- •gestational age less than 32 weeks gestation at study inclusion
- •BMI less than 45
- •50g glucose challenge greater than 135 mg/dL
- •100 g 3 hr oral glucose tolerance test greater than 2 abnormal values using the Carpenter Coustan cut offs (fasting greater than 95 mg/dL, 1 hr greater than 180 mg/dL, 2 hr greater than 155 mg/dL, 3 hr greater than 140 mg/dL)
- •attended the maternal-fetal medicine diabetes education class
排除标准
- •maternal age less than18 or greater than 45
- •multifetal gestation
- •gestational age greater than 32 weeks study inclusion
- •BMI greater than 45
- •pregestational diabetes
- •gestational diabetes diagnosed before 24 weeks
- •did not attend the diabetes education class
- •known fetal anomaly
- •known fetal aneuploidy
- •required ongoing treatment with medications that can exacerbate hyperglycemia (steroids, hydroxyprogesterone caproate injections (Makena), highly active antiretroviral therapy HIV medications)
- •learning disability
- •concern for non compliance with medical care
- •imminent preterm delivery due to maternal disease or fetal conditions
- •is not willing to wear CGM
研究组 & 干预措施
Blinded continuous glucose monitoring
The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter).
干预措施: Continuous glucose monitoring (Device)
Real time continuous glucose monitoring
The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)
干预措施: Continuous glucose monitoring (Device)
结局指标
主要结局
Mean blood glucose (mg/dL)
时间窗: week 1 vs. week 4
Mean blood glucose (mg/dL) in the real-time CGM group compared to self-monitoring of blood glucose (SMBG) group during the 4th week of study from data collected on the 6 day of CGM use during that week.
次要结局
- Failed dietary therapy(week 1 vs. week 4)
- Time spent in normoglycemia(week 1 vs. week 4)
- Time spent in hypoglycemia(week 1 vs. week 4)
- BMI at time of delivery(BMI at time of delivery)
- Gestational hypertension(enrollement vs delivery.)
- Preeclampsia(enrollement vs delivery.)
- HbA1C values(HbA1C values week 1 compared to week 4 (%))
- Polyhydramnios(Through study completion, an average of 9 months)
- Cesarean delivery(Delivery)
- Induction of labor(Delivery)
- Operative vaginal delivery(Delivery)
- Shoulder dystocia(Delivery)
- Fetal macrosomia(Most recent ultrasound before delivery)
- Gestational age at delivery(Delivery)
- Preterm delivery(Delivery)
- Birth weight(Delivery)
- Perinatal morbidity composite outcome(Delivery)
- Large for gestational age(Delivery)
- Small for gestational age(Delivery)
- Admission to neonatal intensive care unit(Delivery)
- 3rd or 4th degree perineal laceration(Delivery)
- Respiratory distress syndrome(Delivery)