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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
180
Continuous Glucose Monitor
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States
RECRUITINGLarge for Gestational Age Infant
The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.
Time frame: Within 2 hours of birth
Third Trimester Hemoglobin A1c
Third Trimester Hemoglobin A1c
Time frame: Between 28 weeks and delivery
Mode of Delivery
Mode of delivery (vaginal versus cesarean)
Time frame: At delivery
Hypertensive Disorders of Pregnancy
Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation
Time frame: After 20 weeks of gestation until delivery
Preterm Birth
Preterm birth (delivery less than 37 weeks gestation)
Time frame: At delivery
Number of participants with a shoulder dystocia
Number of participants with a shoulder dystocia
Time frame: At delivery
Neonatal Intensive Care Unit Admission (NICU)
Neonatal Intensive Care Unit Admission (NICU)
Time frame: At delivery and within first 2 days of life
Neonatal Respiratory Distress
Neonatal Respiratory Distress requiring respiratory support
Time frame: At delivery
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APGAR less than 7 at 5 minutes of life
APGAR score less than 7 at 5 minutes of life
Time frame: 5 Minutes after Delivery
Number of participants with neonatal hypoglycemia
Number of participants with neonatal hypoglycemia as defined by first neonatal blood sugar obtained within 2 hours of birth
Time frame: Within 2 hours of birth
Gestational age at delivery
Gestational age at delivery
Time frame: At Delivery
Maternal Patient Satisfaction Survey with Glucose Monitoring
This will be assessed by the glucose monitoring satisfaction survey (GMSS) version 2. Participants will complete the survey, which contains 4 subscales and a total score. The subscales assess openness, emotional burden, behavioral burden, and worthwhileness. The higher the score the greater the satisfaction, with a total maximum score 75.
Time frame: postpartum day 1 after delivery