Gestational DiabetesGDM2NCT02309138
Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
A study testing Gestational diabetes screening with fasting 3 hour 100 gm and Gestational diabetes screening with fasting 2 hour 75g in people with Gestational Diabetes and Pregnancy, run by Esa M Davis, MD MPH FAAFP at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Pregnancy, Glucose Intolerance
- What is being tested?
- Gestational diabetes screening with fasting 3 hour 100 gm and Gestational diabetes screening with fasting 2 hour 75g
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 921 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Aug 2015to 5 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnancy between 18-24 weeks of gestation
- Singleton gestation
- Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC- Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, Pregnancy, Glucose Intolerance
- Being tested
- Gestational diabetes screening with fasting 3 hour 100 gm, Gestational diabetes screening with fasting 2 hour 75g
- Keywords
- gestational diabetes screening, Carpenter Coustan Criteria, IADPSG criteria, Large for gestational age birth weight
- Medical subject headings
- Diabetes, Gestational, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gestational diabetes screening with fasting 3 hour 100 gmDiagnostic test
Participants receive fasting 3 hour 100 gm oral glucose tolerance test
Gestational diabetes screening with fasting 2 hour 75gDiagnostic test
Participants receive fasting 2 hour 75 gm oral glucose tolerance test
| Study group | Role | What they receive |
|---|---|---|
| 3 hour 100 gm OGTT (CC Criteria) | Active comparator | 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. Receives: Diagnostic Test: Gestational diabetes screening with fasting 3 hour 100 gm |
| 2 hr 75 gm OGTT (IADPSG Criteria) | Active comparator | 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. Receives: Diagnostic Test: Gestational diabetes screening with fasting 2 hour 75g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Large for Gestational Age (LGA) Infant
birth weight equal to or greater than the 90th percentile for gestational age and sex
Measured: at time of delivery
Secondary outcomes (3)
Cesarean Delivery
the delivery of a baby through a surgical incision in the mother's abdomen and uterus
Measured: at delivery (approximately 40 weeks' gestation)
Maternal Composite Morbidity
maternal pre-eclampsia, 3rd or 4th degree vaginal lacerations, post-partum hemorrhage
Measured: at delivery (approximately 40 weeks' gestation)
Neonatal Composite Morbidity
- 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.
Measured: 7 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2014 (estimated)
- Study start11 Aug 2015
- Primary completion3 Jul 2019
- Study completion5 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 921 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esa M Davis, MD MPH FAAFP
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor-investigator, Esa M Davis, MD MPH FAAFP, University of Pittsburgh
- Investigators
- Esa M Davis, MD MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02309138
- Sponsor's protocol ID
- PRO14070556
- Other IDs
- R01HD079647
- Acronym
- GDM2
- Status last verified
- Jul 2020
- First submitted
- 25 Nov 2014
- Last updated
- 20 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Once the study is completed and the investigators have published the main manuscripts regarding the outcomes of the trial. De-identified data will be made available by request, review and approval of the investigators and the institution regulatory committee.
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 (GDM2) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18.
PubMed 28823926Scifres CM, Davis EM, Orris S, Costacou T, Lalama C, Abebe KZ, Catalano P. Metabolic factors and perinatal outcomes among pregnant individuals with mild glucose intolerance. Diabetes Res Clin Pract. 2024 Oct;216:111830. doi: 10.1016/j.diabres.2024.111830. Epub 2024 Aug 17.
PubMed 39159865Davis EM, Abebe KZ, Simhan HN, Catalano P, Costacou T, Comer D, Orris S, Ly K, Decker A, Mendez D, Day N, Scifres CM. Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jul 1;138(1):6-15. doi: 10.1097/AOG.0000000000004431.
PubMed 34259458
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Screening Strategies for Gestational Diabetes (GDM2)
- ClinicalTrials.gov ID
- NCT02309138
- Acronym / sponsor ID
- GDM2 / PRO14070556
- Conditions
- Gestational Diabetes, Pregnancy, Glucose Intolerance
- Keywords
- gestational diabetes screening, Carpenter Coustan Criteria, IADPSG criteria, Large for gestational age birth weight
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 921 participants (actual)
- Lead sponsor
- Esa M Davis, MD MPH FAAFPUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Aug 2015 (actual)
- Primary completion
- 3 Jul 2019 (actual)
- Study completion
- 5 Jun 2020 (actual)
- First posted
- 5 Dec 2014 (estimated)
- Results
- Posted 20 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3 hour 100 gm OGTT (CC Criteria) | Active comparator | Diagnostic Test: Gestational diabetes screening with fasting 3 hour 100 gmGestational 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. |
| 2 hr 75 gm OGTT (IADPSG Criteria) | Active comparator | Diagnostic Test: Gestational diabetes screening with fasting 2 hour 75gGestational 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Pregnancy between 18-24 weeks of gestation
- Singleton gestation
- Planning to deliver at Magee-Womens Hospital, Pittsburgh, Pennsylvania
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gestational diabetes screening with fasting 3 hour 100 gmParticipants receive fasting 3 hour 100 gm oral glucose tolerance test | Diagnostic test | 3 hour 100 gm OGTT (CC Criteria) |
| Gestational diabetes screening with fasting 2 hour 75gParticipants receive fasting 2 hour 75 gm oral glucose tolerance test | Diagnostic test | 2 hr 75 gm OGTT (IADPSG Criteria) |
Primary outcome
Large for Gestational Age (LGA) Infant
Time frame: at time of delivery
birth weight equal to or greater than the 90th percentile for gestational age and sex
3 secondary outcomes
Cesarean Delivery
Time frame: at delivery (approximately 40 weeks' gestation)
Maternal Composite Morbidity
Time frame: at delivery (approximately 40 weeks' gestation)
Neonatal Composite Morbidity
Time frame: 7 days after birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28823926Abebe 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 (GDM2) Trial: Design and rationale. Contemp Clin Trials. 2017 Nov;62:43-49. doi: 10.1016/j.cct.2017.08.012. Epub 2017 Aug 18.
- Derived from this study: PubMed 39159865Scifres CM, Davis EM, Orris S, Costacou T, Lalama C, Abebe KZ, Catalano P. Metabolic factors and perinatal outcomes among pregnant individuals with mild glucose intolerance. Diabetes Res Clin Pract. 2024 Oct;216:111830. doi: 10.1016/j.diabres.2024.111830. Epub 2024 Aug 17.
- Derived from this study: PubMed 34259458Davis EM, Abebe KZ, Simhan HN, Catalano P, Costacou T, Comer D, Orris S, Ly K, Decker A, Mendez D, Day N, Scifres CM. Perinatal Outcomes of Two Screening Strategies for Gestational Diabetes Mellitus: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jul 1;138(1):6-15. doi: 10.1097/AOG.0000000000004431.
- Individual participant dataSharing planned: Yes. Once the study is completed and the investigators have published the main manuscripts regarding the outcomes of the trial. De-identified data will be made available by request, review and approval of the investigators and the institution regulatory committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esa M Davis, MD MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gestational diabetes screening with fasting 3 hour 100 gm and Gestational diabetes screening with fasting 2 hour 75g in people with Gestational Diabetes and Pregnancy, run by Esa M Davis, MD MPH FAAFP at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Large for Gestational Age (LGA) Infant (time frame: at time of delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02309138, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2020.