Trial Outcomes & Findings for Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy (NCT NCT05430204)
NCT ID: NCT05430204
Last Updated: 2025-12-04
Results Overview
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)
COMPLETED
NA
1628 participants
From birth to about 28 days of life.
2025-12-04
Participant Flow
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.
Participant milestones
| Measure |
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
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
405
|
409
|
|
Overall Study
COMPLETED
|
388
|
392
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Baseline characteristics by cohort
| Measure |
CGM Screening
n=405 Participants
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
|
One-hour Glucose Tolerance Test (GCT)
n=409 Participants
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.
|
Total
n=814 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 5.9 • n=9 Participants
|
29 years
STANDARD_DEVIATION 6.4 • n=6 Participants
|
29 years
STANDARD_DEVIATION 6.15 • n=9 Participants
|
|
Sex: Female, Male
Female
|
405 Participants
n=9 Participants
|
409 Participants
n=6 Participants
|
814 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
77 Participants
n=9 Participants
|
59 Participants
n=6 Participants
|
136 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
144 Participants
n=9 Participants
|
145 Participants
n=6 Participants
|
289 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
117 Participants
n=9 Participants
|
142 Participants
n=6 Participants
|
259 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
67 Participants
n=9 Participants
|
63 Participants
n=6 Participants
|
130 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
405 participants
n=9 Participants
|
409 participants
n=6 Participants
|
814 participants
n=9 Participants
|
|
Number of maternal participants on government assisted insurance
|
263 Participants
n=9 Participants
|
269 Participants
n=6 Participants
|
532 Participants
n=9 Participants
|
|
Number of maternal participants with Nulliparous
|
124 Participants
n=9 Participants
|
136 Participants
n=6 Participants
|
260 Participants
n=9 Participants
|
|
Number of maternal participants with body mass index (BMI) greater than 30 at first prenatal visit
|
215 Participants
n=9 Participants
|
245 Participants
n=6 Participants
|
460 Participants
n=9 Participants
|
|
Number of maternal participants with body mass index (BMI) greater than 40
|
70 Participants
n=9 Participants
|
73 Participants
n=6 Participants
|
143 Participants
n=9 Participants
|
|
Number of maternal participants with chronic hypertension
|
36 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
74 Participants
n=9 Participants
|
|
Number of maternal participants with family history of diabetes mellitus
|
180 Participants
n=9 Participants
|
168 Participants
n=6 Participants
|
348 Participants
n=9 Participants
|
|
Number of maternal participants with Gestational diabetes in previous pregnancy
|
24 Participants
n=9 Participants
|
29 Participants
n=6 Participants
|
53 Participants
n=9 Participants
|
|
Gestational age at randomization
|
26.0 weeks
STANDARD_DEVIATION 1.6 • n=9 Participants
|
25.8 weeks
STANDARD_DEVIATION 1.5 • n=6 Participants
|
25.89 weeks
STANDARD_DEVIATION 1.55 • n=9 Participants
|
|
Number of maternal participants with Thyroid disease
|
22 Participants
n=9 Participants
|
16 Participants
n=6 Participants
|
38 Participants
n=9 Participants
|
|
Number of maternal participants with tobacco use during pregnancy
|
8 Participants
n=9 Participants
|
3 Participants
n=6 Participants
|
11 Participants
n=9 Participants
|
|
Number of maternal participants with Alcohol use during pregnancy
|
4 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
9 Participants
n=9 Participants
|
|
Number of maternal participants with Substance use during pregnancy
|
8 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Show Composite Adverse Neonatal Outcome
|
130 Participants
|
114 Participants
|
PRIMARY outcome
Timeframe: at time of birthLGA is described as weight over 90th percentile of the expected value according to gestational age (using the nomogram by Duryea EL et al)
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA)
|
32 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: at time of birthShoulder 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
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: at time of birthBirth injury: skull, clavicular, humerus fracture, or brachial plexus injury
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia
|
87 Participants
|
68 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress
|
45 Participants
|
47 Participants
|
PRIMARY outcome
Timeframe: within 28 days of birthOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Fetal or Neonatal Deaths
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksPopulation: Data for this outcome measure were only collected for participants in the GCM screening arm.
Outcome measures
| Measure |
CGM screening
n=405 Participants
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
|
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.
|
|---|---|---|
|
Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing
|
388 Participants
|
—
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksdiabetic medication is described as any glycemic control agent
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Use Diabetic Medication During Pregnancy
Metformin
|
7 Participants
|
9 Participants
|
|
Number of Women That Use Diabetic Medication During Pregnancy
Insulin
|
21 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: From enrollment to deliveryOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly
|
63 Participants
|
67 Participants
|
SECONDARY outcome
Timeframe: at time of birthPre term birth is described as delivery less than 37 weeks of gestation
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Have Preterm Birth
|
68 Participants
|
65 Participants
|
SECONDARY outcome
Timeframe: at time of birthOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Undergo Induced Labor
|
194 Participants
|
207 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Experience Pregnancy Induced Hypertension
|
63 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Experience Eclampsia: Seizures
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From enrollment up to deliveryOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women Admitted Due to Poor Glucose Control
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at time of birthOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women With Primary Cesarean Section
|
67 Participants
|
73 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women With Endometritis
|
6 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women With Wound Complications
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: birth to 6 weeks postpartumOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women With Diagnosis of Type 2 Diabetes During Postpartum
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 5 minutes after birthThe 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.
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates With Apgar Score Less Than 7
|
17 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: birth to time of discharge from NICU (about 15 days)Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU)
|
69 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: birth to time of discharge from NICU (about 15 days)Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
NICU Length of Stay
|
100 hours
Interval 48.0 to 303.5
|
123.5 hours
Interval 48.0 to 360.0
|
SECONDARY outcome
Timeframe: birth to discharge (about 3-15 days)Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates With Hyperbilirubinemia Requiring Phototherapy
|
32 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: birth to discharge (about 3-15 days)Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy
|
75 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: at time of birthSmall 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)
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates That Are Small for Gestational Age
|
41 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: from birth to 6 weeks postpartumOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Participants Who Breastfed Their Babies
|
121 Participants
|
141 Participants
|
SECONDARY outcome
Timeframe: from birth to 6 weeks postpartumOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Participants Who Formula Fed Their Babies
|
75 Participants
|
74 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at time of birthOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Cord Arterial pH
|
7.2 pH
Interval 7.2 to 7.3
|
7.2 pH
Interval 7.2 to 7.3
|
SECONDARY outcome
Timeframe: birth to discharge (about 3 -15 days)Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Neonates With Polycythemia
|
32 Participants
|
33 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Experience Preeclampsia With Severe Features
|
24 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Experience Super Imposed Preeclampsia
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksOutcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women With Need for Blood Transfusion
|
22 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Third trimester (≥28 weeks gestation through delivery)Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksHELLP 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.
Outcome measures
| Measure |
CGM screening
n=388 Participants
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
|
one-hour Glucose tolerance test (GCT)
n=392 Participants
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.
|
|---|---|---|
|
Number of Women That Experience HELLP Syndrome
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at time of birthPopulation: 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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From enrollment to 6 weeks post partum, on average 21 weeksPopulation: 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
Outcome measures
Outcome data not reported
Adverse Events
CGM screening: Infants
one-hour Glucose tolerance test (GCT): Infants
CGM screening: Mothers
one-hour Glucose tolerance test (GCT): Mothers
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michal Fishel Bartal, MD
The University of Texas Health Science Center at Houston
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place