Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)

• Sponsor: Esa M Davis, MD MPH FAAFP (Other)
• Overall Status: Completed
• CT.gov ID: NCT02309138
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
• Enrollment: 921
• Location: 1
• Arms: 2
• Actual Duration (Months): 57.8
• Patients Per Site Per Month: 15.9

Study Details

Study Description

Brief Summary

This is a single site blinded RCT of 920 pregnant women with singleton gestation designed to compare the Carpenter-Coustan and IADPSG criteria for diagnosing gestational diabetes. Maternal metabolic profiles and infant growth will be assessed at randomization and at one year postpartum.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes; Pregnancy; Glucose Intolerance	Diagnostic Test: Gestational diabetes screening with fasting 3 hour 100 gm; Diagnostic Test: Gestational diabetes screening with fasting 2 hour 75g	N/A

Detailed Description

Impaired glucose metabolism (gestational diabetes (GDM) and mild hyperglycemia) that occurs during pregnancy is associated with an increased risk for pregnancy complications and is also an early indication of long-term metabolic dysfunction leading to diabetes and cardiovascular disease. In the US, GDM is diagnosed using a two-step screening and diagnostic approach. The International Association of Diabetes and Pregnancy Study Group (IADPSG) proposed a one-step diagnostic approach that broadens the definition of GDM by lowering the cutoff values to include women with milder forms of hyperglycemia, who would have screened normal under the current two-step approach. The goal of these recommendations is better identification of women at risk for pregnancy complications and long-term metabolic dysfunction, but it results in a significant increase in the prevalence of GDM. The NIH GDM Consensus Development Conference committee does not recommend changing from the current two-step screening/diagnostic approach to the IADPSG one-step diagnostic approach without trials demonstrating that increasing the number of women diagnosed as having GDM results in better outcomes. We aim to 1) conduct a "real world" randomized controlled trial (RCT) to determine differences in short-term perinatal health outcomes between the two predominant GDM screening approaches, and 2) prospectively follow the mothers to examine their metabolic risk profiles and the growth of their infants at 1 year postpartum. Based on a pilot study, we propose a single site blinded RCT of 920 pregnant women ages 18-45 years without a diagnosis of diabetes, with a singleton pregnancy (18-24 wks gestation). Participants will have a non-fasting 1 hour 50 gm glucose challenge test (GCT) performed between 24-28 weeks' gestation. Women with 50 gm GCT results < 200 mg/dL will be randomized to receive either a fasting 2 hour 75 gm oral glucose tolerance test (OGTT) or a 3 hour 100 gm OGTT. GDM will be diagnosed using the IADPSG criteria for women receiving the 75 gm OGTT and Carpenter-Coustan criteria for women receiving the 100 gm. Participants and their physicians will be informed of the diagnosis of GDM, but blinded to the specific test results and diagnostic criteria. Participants with GDM will receive treatment from their primary provider. Questionnaires will be used to assess participants' and physicians' views on GDM testing. Metabolic profiles will be assessed at randomization and at a year postpartum. The primary outcome measure is large-for-gestational age fetal growth. The rationale for this RCT is that this is a unique opportunity to compare the two methods. At the end of the study, we will know whether women diagnosed at lower glucose levels with the IADPSG criteria are more likely to have adverse perinatal outcomes. We hypothesize that using IADPSG diagnostic criteria will result in greater detection of women with impaired glucose metabolism and treating these women will reduce adverse perinatal outcomes and prevent long-term metabolic dysfunction. This study will provide level A data for endorsing universal screening guidelines for GDM by major organizations and implementation into clinical care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 921 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
• Actual Study Start Date: Aug 11, 2015
• Actual Primary Completion Date: Jul 3, 2019
• Actual Study Completion Date: Jun 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 3 hour 100 gm OGTT (CC Criteria) Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes.	Diagnostic Test: Gestational diabetes screening with fasting 3 hour 100 gm; Participants receive fasting 3 hour 100 gm oral glucose tolerance test
Active Comparator: 2 hr 75 gm OGTT (IADPSG Criteria) Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL.	Diagnostic Test: Gestational diabetes screening with fasting 2 hour 75g; Participants receive fasting 2 hour 75 gm oral glucose tolerance test

Outcome Measures

Primary Outcome Measures

1. Large for Gestational Age (LGA) Infant [at time of delivery]

   birth weight equal to or greater than the 90th percentile for gestational age and sex

Secondary Outcome Measures

1. Cesarean Delivery [at delivery (approximately 40 weeks' gestation)]

   the delivery of a baby through a surgical incision in the mother's abdomen and uterus

2. Maternal Composite Morbidity [at delivery (approximately 40 weeks' gestation)]

   maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage

3. Neonatal Composite Morbidity [7 days after birth]

   1) hypoglycemia: blood glucose < 40mg/dl); 2) hyperbilirubinemia requiring treatment, clinical jaundice; 3)hyperinsulinemia- measured with c peptide level from venous cord blood; 4) still birth- absence of fetal heart tones before delivery, 5) birth trauma= Shoulder dystocia/brachial plexus injuries.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Pregnancy between 18-24 weeks of gestation

• Singleton gestation

• Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania

Exclusion Criteria:

• Preexisting type 1 or 2 diabetes

• Diabetes diagnosed at less than 24 weeks gestational age (GA)

• Multiple gestations ( e.g. twins or triplets)

• Hypertension requiring medications

• Corticosteroid (IM, oral or IV) use in the 30 days prior to enrollment

• Major congenital anomaly with anticipated preterm delivery due to maternal or fetal indications < 28 wks GA

• Inability to complete the glucose testing before 30 completed weeks GA

• Advanced HIV( on medications that cause hyperglycemia), severe liver disease, gastric bypass surgery or other illness/surgeries that preclude them from drinking the glucola solution.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC- Magee Womens Hospital	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Esa M Davis, MD MPH FAAFP
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

• Principal Investigator: Esa M Davis, MD MPH, University of Pittsburgh

Study Documents (Full-Text)

• Statistical Analysis Plan - Apr 29, 2020
• Study Protocol - Dec 1, 2019

More Information

Publications

• Abebe KZ, Scifres C, Simhan HN, Day N, Catalano P, Bodnar LM, Costacou T, Matthew D, Illes A, Orris S, Duell J, Ly K, Davis EM. Comparison of Two Screening Strategies for Gestational Diabetes (GDM(2)) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18.

• Responsible Party: Esa M Davis, MD MPH FAAFP, MD, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT02309138
• Other Study ID Numbers: PRO14070556; R01HD079647
• First Posted: Dec 5, 2014
• Last Update Posted: Jul 20, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by Esa M Davis, MD MPH FAAFP, MD, University of Pittsburgh: gestational diabetes screening; Carpenter Coustan Criteria; IADPSG criteria; Large for gestational age birth weight
• Additional relevant MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Glucose Intolerance

Study Results

Participant Flow

Recruitment Details	Pregnant women were recruited from June 2015 to February 2019 from 10 obstetrical clinics affiliated with Magee Women's Hospital in Pittsburgh,Pennsylvania

Arm/Group Title	3 Hour 100 gm OGTT (CC Criteria)	2 hr 75 gm OGTT (IADPSG Criteria)
Arm/Group Description	Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test	Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the International Association of the Diabetes in Pregnancy Study Group (IADPSG) which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
Period Title: Overall Study
STARTED	460	461
COMPLETED	412	443
NOT COMPLETED	48	18

Baseline Characteristics

Arm/Group Title	3 Hour 100 gm OGTT (CC Criteria)	2 hr 75 gm OGTT (IADPSG Criteria)	Total
Arm/Group Description	Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test	Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test	Total of all reporting groups
Overall Participants	460	461	921
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	28.8 (5.1)	28.6 (5.3)	28.7 (5.2)
Sex: Female, Male (Count of Participants)
Female	460 100%	461 100%	921 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	15 3.3%	15 3.3%	30 3.3%
Not Hispanic or Latino	443 96.3%	445 96.5%	888 96.4%
Unknown or Not Reported	2 0.4%	1 0.2%	3 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.2%	0 0%	1 0.1%
Asian	9 2%	18 3.9%	27 2.9%
Native Hawaiian or Other Pacific Islander	0 0%	2 0.4%	2 0.2%
Black or African American	161 35%	139 30.2%	300 32.6%
White	249 54.1%	261 56.6%	510 55.4%
More than one race	26 5.7%	27 5.9%	53 5.8%
Unknown or Not Reported	14 3%	14 3%	28 3%
pre-pregnancy BMI (kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m2]	26.6 (6.8)	26.9 (7.2)	26.8 (7.0)
Glucose Challenge 50 gm test (mg/dl) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mg/dl]	104.7 (27.7)	107.8 (28.9)	106.2 (28.3)
previous history of gestational diabetes (Count of Participants)
Count of Participants [Participants]	8 1.7%	14 3%	22 2.4%
First degree family history of diabetes (Count of Participants)
Count of Participants [Participants]	97 21.1%	103 22.3%	200 21.7%

Outcome Measures

1. Primary Outcome

Title	Large for Gestational Age (LGA) Infant
Description	birth weight equal to or greater than the 90th percentile for gestational age and sex
Time Frame	at time of delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall IADPSG Arm	Overall Carpenter Coustan	IADPSG With no GDM	Carpenter Coustan With no GDM
Arm/Group Description	Participants randomized into the IADPSG arm	Participants randomized in the the Carpenter Coustan arm	Participants diagnosed as having no GDM by the IADPSG criteria.	Participants diagnosed as having no GDM by the Carpenter Coustan criteria
Measure Participants	443	412	364	377
Count of Participants [Participants]	34 7.4%	35 7.6%	28 3%	34 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall IADPSG Arm, Overall Carpenter Coustan
	Comments	Co-primary hypotheses #1: women diagnosed using the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those diagnosed using the Carpenter-Coustan criteria.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.668
	Comments	Each co-primary hypothesis was tested at the 2.5% significance level.
	Method	Regression, Logistic
	Comments	In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.903
	Confidence Interval	(2-Sided) 97.5%; 0.538 to 1.516
	Parameter Dispersion	Type: Value:
	Estimation Comments	A relative risk < 1 represents a benefit in the direction of the IADPSG group, while a value > 1 represents a benefit towards the CC group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IADPSG With no GDM, Carpenter Coustan With no GDM
	Comments	Co-primary hypothesis #2: women classified as "no gestational diabetes" by the IADPSG criteria will have lower rates of large-for-gestational age infants compared to those classified in the Carpenter-Coustan criteria.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.853
	Comments	Each co-primary hypothesis was tested at the 2.5% significance level.
	Method	Regression, Logistic
	Comments	In the ITT, logistic regression was used to quantify the probability of large-for-gestational age as a function of the study arm and clinic type.
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.853
	Confidence Interval	(2-Sided) 97.5%; 0.493 to 1.475
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Cesarean Delivery
Description	the delivery of a baby through a surgical incision in the mother's abdomen and uterus
Time Frame	at delivery (approximately 40 weeks' gestation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall IADPSG Arm	Overall Carpentar-Coustan Arm	IADPSG Criteria w/ No GDM	CC Criteria w/ No GDM
Arm/Group Description	Participants randomized into the IADPSG arm	Participants randomized in the the Carpenter Coustan arm	Participants randomized in the the IADPSG arm w "No GDM" classification	Participants randomized in the the Carpenter Coustan arm w/ "No GDM" classification
Measure Participants	449	423	365	377
Count of Participants [Participants]	131 28.5%	118 25.6%	101 11%	101 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall IADPSG Arm, Overall Carpenter Coustan
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.6669
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.046
	Confidence Interval	(2-Sided) 95%; 0.847 to 1.291
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IADPSG With no GDM, Carpenter Coustan With no GDM
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.8394
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.033
	Confidence Interval	(2-Sided) 95%; 0.816 to 1.307
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Maternal Composite Morbidity
Description	maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage
Time Frame	at delivery (approximately 40 weeks' gestation)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Overall IADPSG Arm	Overall Carpenter Coustan	IADPSG With no GDM	Carpenter Coustan With no GDM
Arm/Group Description	Participants randomized into the IADPSG arm	Participants randomized in the the Carpenter Coustan arm	Participants diagnosed as having no GDM by the IADPSG criteria.	Participants diagnosed as having no GDM by the CC criteria
Measure Participants	442	425	365	379
Count of Participants [Participants]	77 16.7%	75 16.3%	62 6.7%	63 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall IADPSG Arm, Overall Carpenter Coustan
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9335
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.987
	Confidence Interval	(2-Sided) 95%; 0.740 to 1.318
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IADPSG With no GDM, Carpenter Coustan With no GDM
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.9260
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.022
	Confidence Interval	(2-Sided) 95%; 0.742 to 1.407
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Neonatal Composite Morbidity
Description	1) hypoglycemia: blood glucose < 40mg/dl); 2) hyperbilirubinemia requiring treatment, clinical jaundice; 3)hyperinsulinemia- measured with c peptide level from venous cord blood; 4) still birth- absence of fetal heart tones before delivery, 5) birth trauma= Shoulder dystocia/brachial plexus injuries.
Time Frame	7 days after birth

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	2 hr 75 gm OGTT (IADPSG Criteria)	3 Hour 100 gm OGTT (CC Criteria)	IADPSG Without GDM	Carpenter Coustan Without GDM
Arm/Group Description	Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test	Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test	Participants diagnosed as having no GDM by IADPSG criteria	Participants diagnosed as having no GDM with the Carpenter Coustan criteria
Measure Participants	442	425	365	379
Count of Participants [Participants]	83 18%	57 12.4%	57 6.2%	48 NaN

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Overall IADPSG Arm, Overall Carpenter Coustan
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.0322
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.400
	Confidence Interval	(2-Sided) 95%; 1.027 to 1.909
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	IADPSG With no GDM, Carpenter Coustan With no GDM
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.2643
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.233
	Confidence Interval	(2-Sided) 95%; 0.864 to 1.760
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	Adverse events timeframe in which data were collected was from the time of enrollment of the first participants to the final participant 12 month F/U (~ 5 years). However, adverse event data on each participants was collected within 48 hours of the requirement to fast prior to lab work done for the study and any serious adverse events were collected between study visit 1 and 2 and visit 2and delivery, and determined if related to the study procedures.
Arm/Group Title	3 Hour 100 gm OGTT (CC Criteria)		2 hr 75 gm OGTT (IADPSG Criteria)
Arm/Group Description	Gestational diabetes screening with fasting 3 hour 100 gm. Receive a fasting 3 hour 100 gram oral glucose tolerance test and are diagnosed based on the Carpenter Coustan Criteria: a 50 gm Glucose tolerance test of >130 + fasting 3 hour 100 gram oral glucose tolerance test with two or more values greater than the following diagnostic threshold: Fasting 95, 1-hour 180, 2-hour 155, or 3 hour 140 mg/dL . A positive criteria will be diagnostic for gestational diabetes. Gestational diabetes screening with fasting 3 hour 100 gm: Participants receive fasting 3 hour 100 gm oral glucose tolerance test		Gestational diabetes screening with fasting 2 hour 75g. Receive a fasting 2 hour 75 gm oral glucose tolerance test and diagnosed based on the IADPSG which is if one or more values exceed the following diagnostic threshold: Fasting 92, 1-hour 180, or 2-hour 153 mg/dL. Gestational diabetes screening with fasting 2 hour 75g: Participants receive fasting 2 hour 75 gm oral glucose tolerance test
All Cause Mortality
	3 Hour 100 gm OGTT (CC Criteria)		2 hr 75 gm OGTT (IADPSG Criteria)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/460 (0%)		0/461 (0%)
Serious Adverse Events
	3 Hour 100 gm OGTT (CC Criteria)		2 hr 75 gm OGTT (IADPSG Criteria)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	17/460 (3.7%)		2/461 (0.4%)
Metabolism and nutrition disorders
Hypoglycemia	12/460 (2.6%)	12	1/461 (0.2%)	1
Hypoglycemia	4/460 (0.9%)	4	0/461 (0%)	0
Nervous system disorders
migraine headache	1/460 (0.2%)	1	0/461 (0%)	0
Pregnancy, puerperium and perinatal conditions
heavy vaginal bleeding	0/460 (0%)	0	1/461 (0.2%)	1
Premature rupture of membranes	1/460 (0.2%)	1	0/461 (0%)	0
Other (Not Including Serious) Adverse Events
	3 Hour 100 gm OGTT (CC Criteria)		2 hr 75 gm OGTT (IADPSG Criteria)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	154/460 (33.5%)		56/461 (12.1%)
Gastrointestinal disorders
vomiting	28/460 (6.1%)	30	12/461 (2.6%)	12
General disorders
Malaise	8/460 (1.7%)	8	3/461 (0.7%)	3
Metabolism and nutrition disorders
nausea	58/460 (12.6%)	58	20/461 (4.3%)	20
Hypoglycemia	70/460 (15.2%)	72	19/461 (4.1%)	21
Nervous system disorders
dizziness	22/460 (4.8%)	23	4/461 (0.9%)	4
Headache	4/460 (0.9%)	4	4/461 (0.9%)	4
Pregnancy, puerperium and perinatal conditions
Other	3/460 (0.7%)	3	1/461 (0.2%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.