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Gestational DiabetesNCT04521712

Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

A study testing 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor in people with Gestational Diabetes, run by University of Alabama at Birmingham at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for… Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Gestational Diabetes
What is being tested?
2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
17 Sep 2021to 10 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult

Who may be able to join

  • Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
  • Gestational diabetes mellitus identified at < 20 weeks' gestation requiring pharmacologic treatment (class A2)
  • Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
  • Gestational diabetes mellitus identified at >= 24 weeks' gestation requiring pharmacologic treatment (class A2)

Who cannot join

  • History of prediabetes or polycystic ovarian syndrome
  • History of pregestational type 2 diabetes mellitus
  • Skin conditions which prevent wearing a continuous glucose monitor
  • History of prediabetes or polycystic ovarian syndrome
  • History of pregestational type 2 diabetes mellitus
  • Skin conditions which prevent wearing a continuous glucose monitor

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514

Other trials in United States

About this study

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.

Being tested
2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor
Medical subject headings
Diabetes, Gestational

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitorDiagnostic test

    All women enrolled in this study will have a 2-hour 75-g oral glucose tolerance test performed immediately postpartum (within 4 days of delivery), at 4-6 weeks postpartum, and at 6 months postpartum. Enrolled women will also wear a continuous glucose monitor for 10 days at each of these time periods. Both women and their infants will have skin fold thickness measured at each of these 3 study visits to estimate body fat composition. Additionally umbilical cord blood and placental biopsies will be collected at delivery and stored for future research.

Study groups in NCT04521712
Study groupRoleWhat they receive
Postpartum GDMExperimentalWomen with GDM diagnosed early (< 20 weeks gestation) or with routine 3rd trimester screening (>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).
Receives: Diagnostic Test: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pancreatic beta cell function

    Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.

    Measured: 4-6 weeks after delivery

Secondary outcomes (6)

  1. Maternal glycemia measured by CGM

    % time in range

    Measured: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

  2. Maternal hyperglycemia measured by CGM

    % time above range

    Measured: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

  3. Maternal glucose variability

    Coefficient of variation (glucose standard deviation/mean glucose)

    Measured: 10 day wear period starting at 0-4 days, 4-6 weeks, and 6 months after delivery

  4. Pancreatic beta cell function

    Insulin secretion will be estimated using the Stomvall index and insulin sensitivity using the Matsuda index.

    Measured: 0-4 days and 6 months after delivery

  5. Maternal and infant body fat composition

    Percentage body fat calculated from skin fold thickness measurements of upper mid-arm, triceps, subscapular, and flank along with height and weight for the mother and length, birthweight and head circumference for the infant.

    Measured: 0-4 days, 4-6 weeks, and 6 months after delivery

  6. Maternal diabetes mellitus

    Fasting blood glucose >= 126mg/dL or 2-hour blood glucose >=200 mg/dL after 75g oral glucose load.

    Measured: 4-6 weeks and 6 months after delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2020
  2. Study start17 Sep 2021
  3. Primary completion10 Dec 2024
  4. Study completion10 Dec 2024

Resources

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
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521712
Sponsor's protocol ID
300005510
Status last verified
Dec 2024
First submitted
18 Aug 2020
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Benhalima K, Van Crombrugge P, Moyson C, Verhaeghe J, Vandeginste S, Verlaenen H, Vercammen C, Maes T, Dufraimont E, De Block C, Jacquemyn Y, Mekahli F, De Clippel K, Van Den Bruel A, Loccufier A, Laenen A, Minschart C, Devlieger R, Mathieu C. Characteristics and pregnancy outcomes across gestational diabetes mellitus subtypes based on insulin resistance. Diabetologia. 2019 Nov;62(11):2118-2128. doi: 10.1007/s00125-019-4961-7. Epub 2019 Jul 23.

    PubMed 31338546

  • Powe CE, Allard C, Battista MC, Doyon M, Bouchard L, Ecker JL, Perron P, Florez JC, Thadhani R, Hivert MF. Heterogeneous Contribution of Insulin Sensitivity and Secretion Defects to Gestational Diabetes Mellitus. Diabetes Care. 2016 Jun;39(6):1052-5. doi: 10.2337/dc15-2672. Epub 2016 May 13.

    PubMed 27208340

  • Bellamy L, Casas JP, Hingorani AD, Williams D. Type 2 diabetes mellitus after gestational diabetes: a systematic review and meta-analysis. Lancet. 2009 May 23;373(9677):1773-9. doi: 10.1016/S0140-6736(09)60731-5.

    PubMed 19465232

  • Immanuel J, Simmons D. Screening and Treatment for Early-Onset Gestational Diabetes Mellitus: a Systematic Review and Meta-analysis. Curr Diab Rep. 2017 Oct 2;17(11):115. doi: 10.1007/s11892-017-0943-7.

    PubMed 28971305

  • ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

    PubMed 29370047

  • O'SULLIVAN JB. Gestational diabetes. Unsuspected, asymptomatic diabetes in pregnancy. N Engl J Med. 1961 May 25;264:1082-5. doi: 10.1056/NEJM196105252642104. No abstract available.

    PubMed 13730123

  • O'Sullivan JB. Gestational diabetes and its significance. Adv Metab Disord. 1970;1:Suppl 1:339+. doi: 10.1016/b978-0-12-027361-4.50040-5. No abstract available.

    PubMed 5446902

  • Metzger BE, Cho NH, Roston SM, Radvany R. Prepregnancy weight and antepartum insulin secretion predict glucose tolerance five years after gestational diabetes mellitus. Diabetes Care. 1993 Dec;16(12):1598-605. doi: 10.2337/diacare.16.12.1598.

    PubMed 8299456

  • Battarbee AN, Yee LM. Barriers to Postpartum Follow-Up and Glucose Tolerance Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2018 Mar;35(4):354-360. doi: 10.1055/s-0037-1607284. Epub 2017 Oct 11.

    PubMed 29020693

  • Werner EF, Has P, Kanno L, Sullivan A, Clark MA. Barriers to Postpartum Glucose Testing in Women with Gestational Diabetes Mellitus. Am J Perinatol. 2019 Jan;36(2):212-218. doi: 10.1055/s-0038-1667290. Epub 2018 Jul 30.

    PubMed 30060291

  • Stumvoll M, Fritsche A, Haring H. The OGTT as test for beta cell function? Eur J Clin Invest. 2001 May;31(5):380-1. doi: 10.1046/j.1365-2362.2001.00828.x. No abstract available.

    PubMed 11380588

  • Stumvoll M, Van Haeften T, Fritsche A, Gerich J. Oral glucose tolerance test indexes for insulin sensitivity and secretion based on various availabilities of sampling times. Diabetes Care. 2001 Apr;24(4):796-7. doi: 10.2337/diacare.24.4.796. No abstract available.

    PubMed 11315860

  • Pontiroli AE, Pizzocri P, Caumo A, Perseghin G, Luzi L. Evaluation of insulin release and insulin sensitivity through oral glucose tolerance test: differences between NGT, IFG, IGT, and type 2 diabetes mellitus. A cross-sectional and follow-up study. Acta Diabetol. 2004 Jun;41(2):70-6. doi: 10.1007/s00592-004-0147-x.

    PubMed 15224208

  • Chen R, Yogev Y, Ben-Haroush A, Jovanovic L, Hod M, Phillip M. Continuous glucose monitoring for the evaluation and improved control of gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2003 Oct;14(4):256-60. doi: 10.1080/jmf.14.4.256.260.

    PubMed 14738172

  • Moy FM, Ray A, Buckley BS, West HM. Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009613. doi: 10.1002/14651858.CD009613.pub3.

    PubMed 28602020

Questions about this trial

What is this clinical trial studying?

A study testing 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor in people with Gestational Diabetes, run by University of Alabama at Birmingham at 2 sites 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 4 inclusion and 6 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 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pancreatic beta cell function (time frame: 4-6 weeks after 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 NCT04521712, which also lists 20 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 18 Dec 2024.

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