The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Enrollment
1,628
Group I will be comprised of one-hour 50g glucose challenge participants for diagnosis of GDM..Diagnosis will be based on 1-hour glucose challenge test results: 1-hour result ≤ 130 mg/dL, the participant will have passed the challenge test. 1-hour result ≥ 130 mg/dL will complete a three-hour 100g glucose tolerance test. If two out of three values are elevated per Carpenter Coustan criteria , the participant will be diagnosed with GDM and treated according to the standard of care. This group will also receive the CGM.CGM data will not be observed until completion of study and will not be available to provider. Participants will return transmitter at follow up visit after completion of 7 days.Group I will receive routine prenatal care follow-up depending upon one-hour glucose results as written above.
CGM will consist of using the Dexcom G6 Pro device. The device will be placed on the abdomen or the arm.The Dexcom G6/G7 Pro App will be downloaded on the patient's phone. A patient profile will be created on the Dexcom Clarity portal .The patient will receive an email to link their portal to the clinic's portal.The patient will receive a message through Epic electronic medical records to remove the CGM 10 days after placement.The device will be reviewed by the Diabetes team 48 hours after CGM is removed. The recommended range for glucose during pregnancy is defined as 63-140 mg/dL .The time above range has been defined as ≥ 140 mg/dL, greater than 10% of total CGM placement time. The following criteria will currently be used to diagnose gestational diabetes in the CGM group: * Time above range (≥140 mg/dL) ≥ 10% of the time while using CGM or * Average glucose≥130 mg/dL or * Any glucose value ≥200 mg/dL
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Number of Neonates That Show Composite Adverse Neonatal Outcome
Composite adverse neonatal outcome include one or more of the following: * Large for Gestational Age(LGA) is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al) * Shoulder Dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered * Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury * Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy * Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life * Fetal or neonatal death (within 28 days of birth)
Time frame: From birth to about 28 days of life.
Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)
LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
Time frame: at time of birth
Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia
Shoulder dystocia is defined as the need for any extra maneuvers, other than gentle downward traction of the fetal head to deliver the fetal body after the fetal head has been delivered
Time frame: at time of birth
Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
Time frame: at time of birth
Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia
Neonatal hypoglycemia: less than 40 mg/dL in the first 24 hours of life and less than 50 mg/dL after or requiring medical therapy
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Time frame: from birth to discharge (about 3-15 days)
Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress
Respiratory distress is described as the need for at least 4 hours of respiratory support with supplemental oxygen, continuous positive airway pressure, or ventilation at the first 24 hours of life
Time frame: from birth to discharge (about 3-15 days)
Number of Fetal or Neonatal Deaths
Time frame: within 28 days of birth
Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Use Diabetic Medication During Pregnancy
diabetic medication is described as any glycemic control agent
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly
Time frame: From enrollment to delivery
Number of Women That Have Preterm Birth
Pre term birth is described as delivery less than 37 weeks of gestation
Time frame: at time of birth
Number of Women That Undergo Induced Labor
Time frame: at time of birth
Number of Women That Experience Pregnancy Induced Hypertension
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Experience Eclampsia: Seizures
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women Admitted Due to Poor Glucose Control
Time frame: From enrollment up to delivery
Number of Women With Primary Cesarean Section
Time frame: at time of birth
Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Endometritis
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Wound Complications
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Diagnosis of Type 2 Diabetes During Postpartum
Time frame: birth to 6 weeks postpartum
Number of Neonates With Apgar Score Less Than 7
The Apgar score is determined by evaluating the newborn baby on each of five criteria (appearance, pulse, grimace, activity, respiration) on a scale from zero to two, then summing the five values obtained. The total score ranges from zero to 10. A higher score indicates a better outcome.
Time frame: 5 minutes after birth
Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: birth to time of discharge from NICU (about 15 days)
NICU Length of Stay
Time frame: birth to time of discharge from NICU (about 15 days)
Number of Neonates With Hyperbilirubinemia Requiring Phototherapy
Time frame: birth to discharge (about 3-15 days)
Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy
Time frame: birth to discharge (about 3-15 days)
Number of Neonates That Are Small for Gestational Age
Small for gestational age, defined as a weight below 10th percentile of the expected value according to gestational age (using the nomogram published by Duryea EL et al)
Time frame: at time of birth
Number of Participants Who Breastfed Their Babies
Time frame: from birth to 6 weeks postpartum
Number of Participants Who Formula Fed Their Babies
Time frame: from birth to 6 weeks postpartum
Maximum Bilirubin Level - Neonates
Time frame: birth to discharge (about 3 -15 days)
Cord Arterial pH
Time frame: at time of birth
Number of Neonates With Polycythemia
Time frame: birth to discharge (about 3 -15 days)
Number of Women That Experience Preeclampsia With Severe Features
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women That Experience Super Imposed Preeclampsia
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Women With Need for Blood Transfusion
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester
Time frame: Third trimester (≥28 weeks gestation through delivery)
Number of Women That Experience HELLP Syndrome
HELLP syndrome: a group of symptoms in pregnant women characterized by hemolysis (H), elevated liver enzymes (EL), and/or low platelet (LP) count, assessed according to ACOG guidelines.
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Cord Venous pH
Time frame: at time of birth
Total Health System Costs for Mothers and Infants
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks