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Completed

NCT Number: NCT05430204

Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy

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

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Group 1: one-hour GCT

Device

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.

Group 2: CGM placement

Device

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

Primary outcomes

  1. Number of Neonates That Show Composite Adverse Neonatal Outcome

    Time frame: From birth to about 28 days of life.

    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)

  2. Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)

    Time frame: at time of birth

    LGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)

  3. Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia

    Time frame: at time of birth

    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

  4. Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury

    Time frame: at time of birth

    Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury

  5. Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia

    Time frame: from birth to discharge (about 3-15 days)

    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

  6. Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress

    Time frame: from birth to discharge (about 3-15 days)

    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

  7. Number of Fetal or Neonatal Deaths

    Time frame: within 28 days of birth

Secondary outcomes

  1. 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

  2. Number of Women That Use Diabetic Medication During Pregnancy

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

    diabetic medication is described as any glycemic control agent

  3. Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly

    Time frame: From enrollment to delivery

  4. Number of Women That Have Preterm Birth

    Time frame: at time of birth

    Pre term birth is described as delivery less than 37 weeks of gestation

  5. Number of Women That Undergo Induced Labor

    Time frame: at time of birth

  6. Number of Women That Experience Pregnancy Induced Hypertension

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  7. Number of Women That Experience Eclampsia: Seizures

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  8. Number of Women Admitted Due to Poor Glucose Control

    Time frame: From enrollment up to delivery

  9. Number of Women With Primary Cesarean Section

    Time frame: at time of birth

  10. Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  11. Number of Women With Endometritis

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  12. Number of Women With Wound Complications

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  13. Number of Women With Diagnosis of Type 2 Diabetes During Postpartum

    Time frame: birth to 6 weeks postpartum

  14. Number of Neonates With Apgar Score Less Than 7

    Time frame: 5 minutes after birth

    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.

  15. 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)

  16. NICU Length of Stay

    Time frame: birth to time of discharge from NICU (about 15 days)

  17. Number of Neonates With Hyperbilirubinemia Requiring Phototherapy

    Time frame: birth to discharge (about 3-15 days)

  18. Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy

    Time frame: birth to discharge (about 3-15 days)

  19. Number of Neonates That Are Small for Gestational Age

    Time frame: at time of birth

    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)

  20. Number of Participants Who Breastfed Their Babies

    Time frame: from birth to 6 weeks postpartum

  21. Number of Participants Who Formula Fed Their Babies

    Time frame: from birth to 6 weeks postpartum

  22. Maximum Bilirubin Level - Neonates

    Time frame: birth to discharge (about 3 -15 days)

  23. Cord Arterial pH

    Time frame: at time of birth

  24. Number of Neonates With Polycythemia

    Time frame: birth to discharge (about 3 -15 days)

  25. Number of Women That Experience Preeclampsia With Severe Features

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  26. Number of Women That Experience Super Imposed Preeclampsia

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  27. Number of Women With Need for Blood Transfusion

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

  28. 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)

  29. Number of Women That Experience HELLP Syndrome

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

    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.

  30. Cord Venous pH

    Time frame: at time of birth

  31. Total Health System Costs for Mothers and Infants

    Time frame: From enrollment to 6 weeks post partum, on average 21 weeks

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 24, 2022
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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