Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

Study Overview
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Brief Summary
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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

Official Title
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Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy:A Comparative Effectiveness Randomized Control Trial (PRECISE)

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Device: Group 1: one-hour GCT
* Device: Group 2: CGM placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 24-30 weeks gestation undergoing GDM screening Exclusion Criteria: Known diagnosis of Type I and II DM History of bariatric surgery Major fetal anomalies Unwilling to use CGM for GDM screening Incarcerated subjects History of allergic reaction to any of CGM metals or adhesives in contact with the skin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: one-hour Glucose tolerance test (GCT)<br> | Device: Group 1: one-hour GCT<br>* 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.<br>|
| Experimental: CGM screening<br> | Device: Group 2: CGM placement<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of neonates that show Composite Adverse Neonatal Outcome such as 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) | at time of birth | 
| Number of neonates that show Composite Adverse Neonatal Outcome such as 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 | at time of birth | 
| Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury | Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury | at time of birth | 
| Number of neonates that show Composite Adverse Neonatal Outcome such as 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 | from birth to discharge( upto 6 months from birth) | 
| Number of neonates that show Composite Adverse Neonatal Outcome such as 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 | from birth to discharge( upto 6 months from birth) | 
| Number of fetal or neonatal deaths |  | within 28 days of birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility as assessed by the number of participants who complete the CGM diagnostic testing |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women that use diabetic medication during pregnancy | diabetic medication is described as any glycemic control agent | From enrollment to delivery | 
| Number of women that show Polyhydramnios during pregnancy not related to known fetal anomaly |  | From enrollment to delivery | 
| Number of women that have preterm birth | Pre term birth id described as delivery less than 37 weeks of gestation | at time of birth | 
| Number of women that undergo induced labor |  | at time of birth | 
| Number of women that experience pregnancy induced hypertension |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women that experience Eclampsia: seizures |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women admitted due to poor glucose control |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women with Primary cesarean section |  | at time of birth | 
| Number of women with Postpartum hemorrhage: defined as greater then 1000ml or need for blood transfusion |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women with endometritis |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women with wound complications |  | From enrollment to discharge( upto 6 months from birth) | 
| Number of women with diagnosis of type 2 diabetes during postpartum |  | birth to 6 weeks postpartum | 
| Number of neonates with Apgar score less than 7 |  | 5 minutes after birth | 
| Number of neonates that are admitted to the Neonatal intensive care unit (NICU) |  | birth to discharge from NICU(upto 6 months after delivery) | 
| NICU length of stay |  | day of NICU discharge(upto 6 months after delivery) | 
| Number of neonates with hyperbilirubinemia requiring phototherapy |  | birth to discharge( upto 6 months from birth) | 
| Number of neonates with need for intravenous glucose therapy |  | birth to discharge( upto 6 months from birth) | 
| 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) | at time of birth | 
| Number of participants who breastfed their babies |  | upto 6 weeks postpartum | 
| Number of participants who formula fed their babies |  | upto 6 weeks postpartum |