Glucose Tolerance Test + Continuous Glucose Monitoring for Postpartum High Blood Sugar

No longer recruiting at 1 trial location

Overseen By Ashley N Battarbee, MD, MSCR

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must be taking: Pharmacologic treatment

Disqualifiers: Prediabetes, PCOS, Type 2 diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates how women who experienced gestational diabetes (a type of diabetes occurring during pregnancy) manage blood sugar levels after childbirth. The researchers aim to determine if continuous glucose monitoring (a wearable device that tracks sugar levels) can identify those at risk of developing type 2 diabetes later. Participants will undergo a 2-hour 75-g oral glucose tolerance test and wear a Dexcom G6 Pro continuous glucose monitor for several days at different postpartum intervals. Women who had gestational diabetes and required medication during pregnancy may qualify, provided they do not have pre-existing diabetes or certain skin conditions. As an unphased trial, this study offers a unique opportunity to contribute to understanding and potentially improving postpartum care for women at risk of type 2 diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for postpartum women with GDM?

Research shows that both the glucose tolerance test and the Dexcom G6 continuous glucose monitor are safe for people.

The 2-hour 75-gram oral glucose tolerance test commonly assesses how the body handles sugar and often checks women for diabetes after pregnancy. Many studies confirm its safety for women who have recently given birth.

The Dexcom G6 continuous glucose monitor tracks blood sugar levels in real-time. Research indicates it is accurate and safe, even for pregnant women with diabetes. This device allows blood sugar monitoring without frequent finger pricks.

Both methods have undergone thorough testing and are generally well-tolerated, with no major safety issues reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines a glucose tolerance test with continuous glucose monitoring to better understand postpartum high blood sugar. Unlike traditional methods that rely solely on occasional blood tests, the continuous glucose monitor provides real-time data over 10 days, offering a more detailed picture of glucose levels. This approach could potentially help in identifying patterns and issues earlier, leading to more personalized and timely interventions for new mothers experiencing gestational diabetes.

What evidence suggests that the glucose tolerance test and continuous glucose monitoring are effective for postpartum high blood sugar?

In this trial, all participants will undergo both the 2-hour 75-gram oral glucose tolerance test (OGTT) and use the Dexcom G6 Pro continuous glucose monitor (CGM). Research has shown that the OGTT reliably checks for diabetes after childbirth, identifying women who might develop type 2 diabetes post-pregnancy. It has often detected early signs of diabetes or prediabetes just a few months after giving birth. Meanwhile, the CGM provides a detailed view of blood sugar levels, offering accurate, real-time information that reveals patterns over time. This device has helped manage blood sugar in women with gestational diabetes, potentially preventing future health issues. Using both methods together in this trial could enhance understanding and management of blood sugar levels after pregnancy. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for women who had gestational diabetes during a single pregnancy with no fetal anomalies, diagnosed before 20 weeks or at/after 24 weeks and required medication. It's not for those with skin conditions affecting glucose monitor use, history of prediabetes, PCOS, or pregestational type 2 diabetes.

Inclusion Criteria

I was diagnosed with gestational diabetes before 20 weeks of pregnancy and needed medication.

I was diagnosed with gestational diabetes needing medication after 24 weeks of pregnancy.

I am 34-40 weeks pregnant with one healthy baby.

Exclusion Criteria

I cannot wear a glucose monitor due to skin conditions.

I have had type 2 diabetes before becoming pregnant.

I have a history of prediabetes or polycystic ovarian syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment

Participants undergo an oral glucose tolerance test and start wearing a continuous glucose monitor for 10 days

0-4 days

1 visit (in-person)

Follow-up Assessment 1

Participants continue to wear a continuous glucose monitor for 10 days and undergo assessments of insulin secretion and sensitivity

4-6 weeks

1 visit (in-person)

Follow-up Assessment 2

Participants wear a continuous glucose monitor for 10 days and undergo final assessments of insulin secretion and sensitivity

6 months

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests how well two methods can track blood sugar levels after childbirth in women at risk for long-term high blood sugar. One method is a standard oral glucose tolerance test; the other uses a Dexcom G6 Pro continuous glucose monitor.

How Is the Trial Designed?

Group I: Postpartum GDM Experimental Treatment 1 Intervention

Women 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).

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

Published Research Related to This Trial

In a study of 749 women with a history of gestational diabetes, 12.7% were found to have impaired glucose regulation (IGR) postpartum, highlighting the importance of glucose monitoring after delivery.

Key risk factors for postpartum IGR included a family history of type 2 diabetes and having all three glucose values exceed the diagnostic threshold during pregnancy, suggesting targeted monitoring and prevention strategies for these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors associated with postpartum impaired glucose regulation in women with previous gestational diabetes. Bianchi, C., de Gennaro, G., Brocchi, A., et al.[2021]

In a study involving 30 gestational diabetics and 30 metabolically healthy pregnant women, the 75 gm and 100 gm oral glucose tolerance tests showed significant differences in glucose levels for healthy controls, but not for those with gestational diabetes, indicating that the tests may yield similar results in this population.

The findings suggest that for gestational diabetes, 2-hour glucose values from different loading doses should be adjusted by 16 mg/dl for accurate comparison, highlighting the need for careful interpretation of glucose testing in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward universal criteria for gestational diabetes: relationships between seventy-five and one hundred gram glucose loads and between capillary and venous glucose concentrations. Weiss, PA., Haeusler, M., Kainer, F., et al.[2019]

The Continuous Glucose Monitoring System (CGMS) demonstrated a high accuracy in reflecting glucose levels in pregnant women with type 1 diabetes, with a correlation coefficient of 0.94 based on 239 analyzed blood glucose values.

An impressive 93.8% of the non-calibration glucose readings fell within the clinically acceptable range according to the Clarke error grid analysis, indicating that CGMS can be a reliable tool for monitoring glucose in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. Kerssen, A., de Valk, HW., Visser, GH.[2006]

Only 48% of women with gestational diabetes mellitus (GDM) completed postpartum glycemic testing, indicating a low adherence rate to recommended follow-up care.

The fasting plasma glucose (FPG) test was less effective at detecting postpartum glucose intolerance compared to the 75-g oral glucose tolerance test (OGTT), as only 28% of women with abnormal results were identified by FPG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum diabetes screening: adherence rate and the performance of fasting plasma glucose versus oral glucose tolerance test. Kwong, S., Mitchell, RS., Senior, PA., et al.[2022]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545196/

Gestational Diabetes - StatPearls - NCBI Bookshelf Two primary methods for postpartum screening include a fasting plasma glucose test and a 75-g, 2-hour OGTT. While the fasting plasma glucose ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5790595/

Early versus 6–12 week Postpartum Glucose Tolerance ... This was a prospective cohort study. Women received an early 75-gram 2-hour GTT between postpartum days 2–4 and again 6–12 weeks postpartum.

3. diabetesjournals.org diabetesjournals.org/care/article/48/6/874/158304/Rethinking-Postpartum-Glucose-Assessment-Is-One

Rethinking Postpartum Glucose Assessment: Is One-Hour ... At the initial 3-month postpartum test (n = 253 individuals), 70 (19.0%) individuals had prediabetes or diabetes. By 5 years postpartum, 88 ( ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S030121152400544X

Can we do better with postpartum diabetes screening? The American College of Obstetricians and Gynecologists (ACOG) suggests a 75-g, 2-h glucose tolerance test (GTT) to be performed 4–12 weeks after delivery. In ...

5. ohsu.edu ohsu.edu/sites/default/files/2019-06/CWH-21473169-DAPP-Guideline-FINAL-lo-res.pdf

Diabetes and Pregnancy Program Interstitial glucose levels are measured and averaged every five minutes for up to 288 readings, providing blood glucose trends and demonstrating prandial ...

6. diabetesjournals.org diabetesjournals.org/care/article/47/Supplement_1/S282/153948/15-Management-of-Diabetes-in-Pregnancy-Standards

15. Management of Diabetes in Pregnancy: Standards of Care ... ... 75-g oral glucose tolerance test and clinically appropriate nonpregnancy diagnostic criteria. ... testing for women with gestational diabetes.

7. aafp.org aafp.org/pubs/afp/issues/2015/0401/p460.html

Screening for Gestational Diabetes Mellitus Women with GDM should undergo screening at six to 12 weeks postpartum with a fasting glucose measurement or 75-g two-hour glucose tolerance test ...

8. ajog.org ajog.org/article/S0002-9378%2822%2902601-1/fulltext

Quality metric on the rate of postpartum diabetes screening ... A uniform metric that identifies the percentage of persons with gestational diabetes mellitus who completed a 75-g, 2-hour glucose tolerance test within 12 ...

9. mayoclinic.org mayoclinic.org/tests-procedures/glucose-tolerance-test/about/pac-20394296

Glucose tolerance test The glucose tolerance test measures the body's response to sugar, also called glucose. Another name for this test is the oral glucose tolerance test.