Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: one-hour Glucose tolerance test (GCT)
|
Device: Group 1: one-hour GCT
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.
|
| Experimental: CGM screening
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Device: Group 2: CGM placement
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 one week after placement. The device will be reviewed by the Diabetes team after 7-10 days after CGM placement. 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
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Outcome Measures
Primary Outcome Measures
- Number of neonates that show Composite Adverse Neonatal Outcome such as Large for gestational age(LGA) [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)
- Number of neonates that show Composite Adverse Neonatal Outcome such as shoulder dystocia [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
- Number of neonates that show Composite Adverse Neonatal Outcome such as birth injury [at time of birth]
Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury
- Number of neonates that show Composite Adverse Neonatal Outcome such as Neonatal hypoglycemia [from birth to discharge( upto 6 months from birth)]
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
- Number of neonates that show Composite Adverse Neonatal Outcome such as respiratory distress [from birth to discharge( upto 6 months from birth)]
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
- Number of fetal or neonatal deaths [within 28 days of birth]
Secondary Outcome Measures
- 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 [From enrollment to delivery]
diabetic medication is described as any glycemic control agent
- 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 [at time of birth]
Pre term birth id described as delivery less than 37 weeks of gestation
- 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 [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)
Other Outcome Measures
- Blood sugars using blinded CGM with 1-hour GCT results and composite maternal and neonatal adverse outcomes. [Enrollment to discharge( upto 6 months from birth)]
Blood sugars using blinded CGM with 1-hour GCT
- Evaluation of one-hour screening GCT threshold and composite maternal and adverse outcomes. [Enrollment to discharge( upto 6 months from birth)]
1h GCT results and outcomes
- Evaluation of one abnormal value during 3-hour GTT and composite maternal and adverse outcomes. [Enrollment to discharge( upto 6 months from birth)]
3h OGTT results and outcomes
- Risk factors and adverse outcomes associated with ultrasound diagnosed large for gestational age fetus. [Enrollment to discharge( upto 6 months from birth)]
large for gestational age fetus diagnosis and outcomes
- Fetal growth or amniotic fluid abnormalities during third trimester ultrasound exam among GDM. [Enrollment to discharge( upto 6 months from birth)]
Fetal growth or amniotic fluid abnormalities among people with GDM
- Gestational diabetic outcomes with and without Hypertensive Disorder of Pregnancy. [Enrollment to discharge( upto 6 months from birth)]
GDM and hypertensive disorders of pregnancy
- The racial and ethnic disparity among gestational diabetics screening, diagnosis and treatment . [Enrollment to discharge( upto 6 months from birth)]
GDM and racial/ethnic disparity
- Risk factors associated with neonatal hypoglycemia. [Birth to discharge( upto 6 months from birth)]
neonatal hypoglycemia as defined above
- Evaluation of time above range using CGM and associated neonatal outcomes. [Enrollment to discharge( upto 6 months from birth)]
Time above range using CGM and associated neonatal outcomes.
- Maternal hypoglycemia using CGM and composite maternal and adverse outcomes. [Enrollment to discharge( upto 6 months from birth)]
Maternal hypoglycemia as defined as above
- Incremental cost for prevention of Type II DM in life using a model method. [Birth to 6 weeks postpartum]
cost for prevention of Type II DM in life
- Labor and postpartum evaluation of blood sugars [Labor admission to postpartum discharge(upto 6 weeks after delivery)]
Blood sugars during labor and postpartum using CGM
- Satisfaction with the screening method [Enrollment to discharge( upto 6 months from birth)]
Short anonymized survey after completing their screening test, The survey will take less than five minutes to complete. The survey will be scored in a Likert-type scale allowing for results to undergo descriptive analysis.
- Procedure specific satisfaction surveys [Enrollment to discharge( upto 6 months from birth)]
a satisfaction survey specific to each screening arm: routine care and CGM placement. Participants will be given a short, anonymized survey after completing their screening test. The aim of the survey is to assess participant's experience, perception and satisfaction with the 2-step glucose tests and CGM application. The surveys will take less than five minutes to complete. The surveys will be scored in a Likert-type scale allowing for results to undergo descriptive analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 24-30 weeks gestation undergoing GDM screening
Exclusion Criteria:
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Known diagnosis of Type I and II DM
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History of bariatric surgery
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Major fetal anomalies
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Unwilling to use CGM for GDM screening
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Incarcerated subjects
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History of allergic reaction to any of CGM metals or adhesives in contact with the skin
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Texas Health Science Center at Houston | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- The University of Texas Health Science Center, Houston
- DexCom, Inc.
Investigators
- Principal Investigator: Michal Fishel Bartal, MD, The University of Texas Health Science Center, Houston
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HSC-MS-22-0153