Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Large for Gestational Age Infant
研究概览
简要总结
The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.
详细描述
A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology.
The study team therefore propose to perform a randomized controlled trial among 180 pregnant women with T2DM comparing CGM use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Women will be deemed eligible for the study by the following inclusion criteria:
- •1) age greater than or equal to 18 years old
- •2) singleton gestation less than or equal to 14 weeks at initial obstetric visit
- •3) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
- •4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
- •5) able and willing to provide informed consent
排除标准
- •Women will be deemed ineligible for the study based on the following exclusion criteria:
- •1) known diagnosis of type 1 diabetes or gestational diabetes
- •2) plan to receive prenatal care or delivery outside of UMMHC
- •3) inability to provide informed consent
- •4) multifetal gestation
研究组 & 干预措施
Continuous Glucose Monitoring (CGM)
Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.
干预措施: Continuous Glucose Monitor (Device)
Fingerstick Glucose Monitoring
Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.
干预措施: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) (Device)
结局指标
主要结局
Large for Gestational Age Infant
时间窗: Within 2 hours of birth
The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.
次要结局
- Neonatal Respiratory Distress(At delivery)
- Third Trimester Hemoglobin A1c(Between 28 weeks and delivery)
- Neonatal Intensive Care Unit Admission (NICU)(At delivery and within first 2 days of life)
- Mode of Delivery(At delivery)
- Hypertensive Disorders of Pregnancy(After 20 weeks of gestation until delivery)
- Preterm Birth(At delivery)
- Number of participants with a shoulder dystocia(At delivery)
- Gestational age at delivery(At Delivery)
- Maternal Patient Satisfaction Survey with Glucose Monitoring(postpartum day 1 after delivery)
- APGAR less than 7 at 5 minutes of life(5 Minutes after Delivery)
- Number of participants with neonatal hypoglycemia(Within 2 hours of birth)
研究者
Gianna Wilkie
Clinical Fellow in Maternal Fetal Medicine
University of Massachusetts, Worcester