Gestational Diabetes
Conditions
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
Interventions
DEVICEGroup 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.
DEVICEGroup 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 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
Sponsors
DexCom, Inc.
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Neonates That Show Composite Adverse Neonatal Outcome | 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) |
| Number of Neonates That Show Adverse Neonatal Outcome of 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 Adverse Neonatal Outcome of 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 Adverse Neonatal Outcome of Birth Injury | at time of birth | Birth injury: skull, clavicular, humerus fracture, or brachial plexus injury |
| Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia | 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 |
| Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress | 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 |
| Number of Fetal or Neonatal Deaths | within 28 days of birth | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 is described as delivery less than 37 weeks of gestation |
| Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Number of Women With Endometritis | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Number of Women With Wound Complications | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| 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 | 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. |
| Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU) | birth to time of discharge from NICU (about 15 days) | — |
| NICU Length of Stay | birth to time of discharge from NICU (about 15 days) | — |
| Number of Neonates With Hyperbilirubinemia Requiring Phototherapy | birth to discharge (about 3-15 days) | — |
| Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy | birth to discharge (about 3-15 days) | — |
| 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) |
| Number of Women Admitted Due to Poor Glucose Control | From enrollment up to delivery | — |
| Number of Participants Who Formula Fed Their Babies | from birth to 6 weeks postpartum | — |
| Maximum Bilirubin Level - Neonates | birth to discharge (about 3 -15 days) | — |
| Cord Arterial pH | at time of birth | — |
| Number of Neonates With Polycythemia | birth to discharge (about 3 -15 days) | — |
| Number of Women That Experience Preeclampsia With Severe Features | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Number of Women That Experience Super Imposed Preeclampsia | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Number of Women With Need for Blood Transfusion | 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 | Third trimester (≥28 weeks gestation through delivery) | — |
| Number of Women That Experience HELLP Syndrome | 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. |
| Cord Venous pH | at time of birth | — |
| Total Health System Costs for Mothers and Infants | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Number of Participants Who Breastfed Their Babies | from birth to 6 weeks postpartum | — |
| Number of Women With Primary Cesarean Section | 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 6 weeks post partum, on average 21 weeks | — |
| Number of Women That Experience Eclampsia: Seizures | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing | From enrollment to 6 weeks post partum, on average 21 weeks | — |
| Number of Women That Use Diabetic Medication During Pregnancy | From enrollment to 6 weeks post partum, on average 21 weeks | diabetic medication is described as any glycemic control agent |
Countries
United States
Participant flow
Pre-assignment details
A total of 1,628 individuals (814 mother-infant dyads) were enrolled. Each mother was enrolled during pregnancy, prior to the birth of her infant. Following delivery, data collection continued for both mother and infant as part of the same dyad.
Participants by arm
| Arm | Count |
|---|---|
| CGM Screening 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 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 | 405 |
| One-hour Glucose Tolerance Test (GCT) 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. | 409 |
| Total | 814 |
Baseline characteristics
| Characteristic | CGM Screening | Total | One-hour Glucose Tolerance Test (GCT) |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 5.9 | 29 years STANDARD_DEVIATION 6.15 | 29 years STANDARD_DEVIATION 6.4 |
| Gestational age at randomization | 26.0 weeks STANDARD_DEVIATION 1.6 | 25.89 weeks STANDARD_DEVIATION 1.55 | 25.8 weeks STANDARD_DEVIATION 1.5 |
| Number of maternal participants on government assisted insurance | 263 Participants | 532 Participants | 269 Participants |
| Number of maternal participants with Alcohol use during pregnancy | 4 Participants | 9 Participants | 5 Participants |
| Number of maternal participants with body mass index (BMI) greater than 30 at first prenatal visit | 215 Participants | 460 Participants | 245 Participants |
| Number of maternal participants with body mass index (BMI) greater than 40 | 70 Participants | 143 Participants | 73 Participants |
| Number of maternal participants with chronic hypertension | 36 Participants | 74 Participants | 38 Participants |
| Number of maternal participants with family history of diabetes mellitus | 180 Participants | 348 Participants | 168 Participants |
| Number of maternal participants with Gestational diabetes in previous pregnancy | 24 Participants | 53 Participants | 29 Participants |
| Number of maternal participants with Nulliparous | 124 Participants | 260 Participants | 136 Participants |
| Number of maternal participants with Substance use during pregnancy | 8 Participants | 15 Participants | 7 Participants |
| Number of maternal participants with Thyroid disease | 22 Participants | 38 Participants | 16 Participants |
| Number of maternal participants with tobacco use during pregnancy | 8 Participants | 11 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic | 117 Participants | 259 Participants | 142 Participants |
| Race/Ethnicity, Customized Non-Hispanic Black | 144 Participants | 289 Participants | 145 Participants |
| Race/Ethnicity, Customized Non-Hispanic White | 77 Participants | 136 Participants | 59 Participants |
| Race/Ethnicity, Customized Unknown | 67 Participants | 130 Participants | 63 Participants |
| Region of Enrollment United States | 405 participants | 814 participants | 409 participants |
| Sex: Female, Male Female | 405 Participants | 814 Participants | 409 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 405 | 2 / 409 | 0 / 405 | 0 / 409 |
| other Total, other adverse events | 0 / 405 | 0 / 409 | 0 / 405 | 0 / 409 |
| serious Total, serious adverse events | 0 / 405 | 0 / 409 | 0 / 405 | 0 / 409 |
Outcome results
Primary
Number of Fetal or Neonatal Deaths
Time frame: within 28 days of birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Fetal or Neonatal Deaths | 2 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Fetal or Neonatal Deaths | 2 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury | 1 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury | 0 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA) | 32 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA) | 29 Participants |
Primary
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
Time frame: from birth to discharge (about 3-15 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia | 87 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia | 68 Participants |
Primary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress | 45 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress | 47 Participants |
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia | 5 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia | 3 Participants |
Primary
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Show Composite Adverse Neonatal Outcome | 130 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Show Composite Adverse Neonatal Outcome | 114 Participants |
Secondary
Cord Arterial pH
Time frame: at time of birth
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CGM screening | Cord Arterial pH | 7.2 pH |
| one-hour Glucose tolerance test (GCT) | Cord Arterial pH | 7.2 pH |
Secondary
Cord Venous pH
Time frame: at time of birth
Population: Data were not collected or analyzed for Cord Venous pH. The study team determined that collection of cord venous pH was not required based on academic evidence that a different marker, arterial pH, is a reliable marker. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision. Please see outcome #30 for data on arterial pH.
Secondary
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
Population: Data for this outcome measure were only collected for participants in the GCM screening arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing | 388 Participants |
Secondary
Maximum Bilirubin Level - Neonates
Time frame: birth to discharge (about 3 -15 days)
Population: The study team decided that this outcome measure was not going to be collected therefore, the laboratory assays were not performed and no data were collected for this outcome. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision
Secondary
NICU Length of Stay
Time frame: birth to time of discharge from NICU (about 15 days)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| CGM screening | NICU Length of Stay | 100 hours |
| one-hour Glucose tolerance test (GCT) | NICU Length of Stay | 123.5 hours |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU) | 69 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU) | 74 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates That Are Small for Gestational Age | 41 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates That Are Small for Gestational Age | 39 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates With Apgar Score Less Than 7 | 17 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates With Apgar Score Less Than 7 | 18 Participants |
Secondary
Number of Neonates With Hyperbilirubinemia Requiring Phototherapy
Time frame: birth to discharge (about 3-15 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates With Hyperbilirubinemia Requiring Phototherapy | 32 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates With Hyperbilirubinemia Requiring Phototherapy | 33 Participants |
Secondary
Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy
Time frame: birth to discharge (about 3-15 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy | 75 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy | 60 Participants |
Secondary
Number of Neonates With Polycythemia
Time frame: birth to discharge (about 3 -15 days)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Neonates With Polycythemia | 32 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Neonates With Polycythemia | 33 Participants |
Secondary
Number of Participants Who Breastfed Their Babies
Time frame: from birth to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Participants Who Breastfed Their Babies | 121 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Participants Who Breastfed Their Babies | 141 Participants |
Secondary
Number of Participants Who Formula Fed Their Babies
Time frame: from birth to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Participants Who Formula Fed Their Babies | 75 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Participants Who Formula Fed Their Babies | 74 Participants |
Secondary
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester | 5 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester | 4 Participants |
Secondary
Number of Women Admitted Due to Poor Glucose Control
Time frame: From enrollment up to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women Admitted Due to Poor Glucose Control | 1 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women Admitted Due to Poor Glucose Control | 0 Participants |
Secondary
Number of Women That Experience Eclampsia: Seizures
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Experience Eclampsia: Seizures | 0 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Experience Eclampsia: Seizures | 0 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Experience HELLP Syndrome | 0 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Experience HELLP Syndrome | 0 Participants |
Secondary
Number of Women That Experience Preeclampsia With Severe Features
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Experience Preeclampsia With Severe Features | 24 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Experience Preeclampsia With Severe Features | 26 Participants |
Secondary
Number of Women That Experience Pregnancy Induced Hypertension
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Experience Pregnancy Induced Hypertension | 63 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Experience Pregnancy Induced Hypertension | 71 Participants |
Secondary
Number of Women That Experience Super Imposed Preeclampsia
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Experience Super Imposed Preeclampsia | 15 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Experience Super Imposed Preeclampsia | 17 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Have Preterm Birth | 68 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Have Preterm Birth | 65 Participants |
Secondary
Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly
Time frame: From enrollment to delivery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly | 63 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly | 67 Participants |
Secondary
Number of Women That Undergo Induced Labor
Time frame: at time of birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women That Undergo Induced Labor | 194 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Undergo Induced Labor | 207 Participants |
Secondary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CGM screening | Number of Women That Use Diabetic Medication During Pregnancy | Metformin | 7 Participants |
| CGM screening | Number of Women That Use Diabetic Medication During Pregnancy | Insulin | 21 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Use Diabetic Medication During Pregnancy | Metformin | 9 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women That Use Diabetic Medication During Pregnancy | Insulin | 8 Participants |
Secondary
Number of Women With Diagnosis of Type 2 Diabetes During Postpartum
Time frame: birth to 6 weeks postpartum
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women With Diagnosis of Type 2 Diabetes During Postpartum | 2 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women With Diagnosis of Type 2 Diabetes During Postpartum | 1 Participants |
Secondary
Number of Women With Endometritis
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women With Endometritis | 6 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women With Endometritis | 4 Participants |
Secondary
Number of Women With Need for Blood Transfusion
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women With Need for Blood Transfusion | 22 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women With Need for Blood Transfusion | 24 Participants |
Secondary
Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml | 17 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml | 18 Participants |
Secondary
Number of Women With Primary Cesarean Section
Time frame: at time of birth
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women With Primary Cesarean Section | 67 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women With Primary Cesarean Section | 73 Participants |
Secondary
Number of Women With Wound Complications
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CGM screening | Number of Women With Wound Complications | 1 Participants |
| one-hour Glucose tolerance test (GCT) | Number of Women With Wound Complications | 1 Participants |
Secondary
Total Health System Costs for Mothers and Infants
Time frame: From enrollment to 6 weeks post partum, on average 21 weeks
Population: Data were not collected or analyzed for this outcome because there was no standardized cost or charging across participants therefore there was no data to collect or analyze for any participants. This outcome will not be collected in the future. The Study Protocol was not amended to reflect this collective team decision