Self-Administered Glucose Test for Postpartum Diabetes Screening

Overseen By Alison Kimura, MD, MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Prisma Health-Upstate

Disqualifiers: Pre-pregnancy diabetes, No glucometer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for screening diabetes after childbirth in women who had gestational diabetes, a type of diabetes that develops during pregnancy. The trial aims to determine if a self-administered glucose test at home, combined with a virtual follow-up, increases the number of women completing postpartum diabetes screening within 12 weeks after delivery. Participants will either use this new self-test method, known as the Self-Administered 2-Hour Oral Glucose Tolerance Test, or follow the usual office-based test. Women who had gestational diabetes, delivered at Greenville Memorial Hospital, and have access to the Epic MyChart system may be suitable for the trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance postpartum diabetes care.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on diabetes screening, so it's best to ask the trial coordinators for specific guidance.

What prior data suggests that this self-administered glucose test is safe for postpartum diabetes screening?

Research shows that the 2-hour oral glucose tolerance test, which participants will perform in this trial, is generally safe and easy to manage. This test involves consuming a 75-gram glucose drink, a common method for assessing how the body processes sugar. Widely used to diagnose diabetes, including during pregnancy, this test is a standard procedure in many healthcare settings.

Some individuals might experience mild nausea or discomfort after drinking the glucose solution, but these sensations typically subside quickly and are not serious. The test's safety is well-established due to its regular use in medical practice.

For those considering joining this trial, evidence suggests that the test is unlikely to cause any major side effects. Discussing any concerns with a healthcare provider can help in making the best decision for one's situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to screen for postpartum diabetes that could make life easier for new moms. Unlike the standard in-office glucose tolerance test, this method allows women to self-administer the test at home. This is more convenient and less stressful, especially for those juggling newborn care. Plus, with a virtual follow-up, it could cut down on unnecessary clinic visits and streamline postpartum care.

What evidence suggests that this self-administered glucose test is effective for postpartum diabetes screening?

Research has shown that a 2-hour test, involving a sugary drink, effectively checks for type 2 diabetes after gestational diabetes. This test identifies diabetes or prediabetes in new mothers. In this trial, participants will either self-administer the 2-hour oral glucose tolerance test with a 4-week virtual follow-up or undergo routine postpartum care with an office-based test at 6 weeks postpartum. One study found that self-administered tests might encourage more new mothers to get screened. The Canadian Diabetes Association recommends this test between 6 weeks and 6 months after childbirth. This timing can help detect problems early and ensure more women complete their diabetes screening postpartum. ^{3 6 7 8 9}

Who Is on the Research Team?

Amy Crockett, MD

Principal Investigator

Prisma Health-Upstate

Are You a Good Fit for This Trial?

This trial is for women over 18 who had gestational diabetes during pregnancy, delivered at Greenville Memorial Hospital, and are recommended for postpartum diabetes screening. They must be able to consent, use Prisma Health's MyChart system in English or Spanish, and perform fingerstick glucose monitoring.

Inclusion Criteria

I understand the study and can agree to participate.

I was diagnosed with gestational diabetes and advised to get postpartum screening.

I have never been diagnosed with Type 1 or Type 2 diabetes.

Exclusion Criteria

I don't have a glucometer or can't use one for glucose monitoring.

I am unable to understand and agree to the study's details on my own.

Inability to follow up for routine postpartum care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm receive a 75-gram oral glucose load and instructions for self-administration approximately 4 weeks after delivery, followed by a virtual follow-up visit.

4 weeks

1 virtual visit

Control

Participants in the control arm attend a routine 6-week postpartum visit where the postpartum diabetes glucose screen is ordered.

6 weeks

1 in-person visit

Follow-up

Participants are monitored for completion of the postpartum diabetes screening within 12 weeks of delivery.

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Self-Administered 2-Hour Oral Glucose Tolerance Test

Trial Overview The study tests if a self-administered oral glucose tolerance test with virtual follow-up can increase the rate of postpartum diabetes screening within 12 weeks after giving birth compared to standard methods.

How Is the Trial Designed?

Group I: Self-administered diabetes screen Experimental Treatment 1 Intervention

Self-administered 75-gram oral glucose tolerance test with 4-week virtual follow-up visit. Drug: GlucoCrush

Group II: Routine postpartum care Active Control 1 Intervention

Office based oral glucose tolerance test at 6 weeks postpartum, per normal protocol. Drug: GlucoCrush

Self-Administered 2-Hour Oral Glucose Tolerance Test is already approved in United States, Canada, European Union for the following indications:

Approved in United States as 75-gram Oral Glucose Tolerance Test for:

• Postpartum diabetes screening in patients with gestational diabetes

Approved in Canada as 75-gram Oral Glucose Tolerance Test for:

• Postpartum diabetes screening in patients with gestational diabetes

Approved in European Union as 75-gram Oral Glucose Tolerance Test for:

• Postpartum diabetes screening in patients with gestational diabetes

Who Is Running the Clinical Trial?

Prisma Health-Upstate

Lead Sponsor

Trials

91

Recruited

47,500+

Published Research Related to This Trial

Approximately 50% of women with gestational diabetes mellitus (GDM) underwent postpartum glucose testing within 6 months of delivery, with 46% of those tests occurring during the optimal 6- to 12-week postpartum period.

Among the women tested, 16.3% had impaired fasting glucose or impaired glucose tolerance, and 1.1% were found to have provisional diabetes, indicating a significant risk of persistent glucose intolerance after GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and timing of postpartum glucose testing and sustained glucose dysregulation after gestational diabetes mellitus. Lawrence, JM., Black, MH., Hsu, JW., et al.[2022]

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 of 58 women with abnormal glucose tolerance during pregnancy, those who became impaired in glucose tolerance (IGT) postpartum had higher weights during pregnancy compared to those who normalized their glucose levels, indicating that excessive weight gain is a significant predictor of IGT in obese women.

For non-obese women, the severity of glucose intolerance during pregnancy was linked to poorer outcomes postpartum, suggesting that monitoring glucose levels during pregnancy is crucial for predicting future glucose tolerance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The predictive factor of postpartum impaired glucose tolerance in pregnant women with abnormal glucose tolerance]. Hamasaki, T., Yasuhi, I., Hirai, M., et al.[2011]

In a study of 399 pregnant women undergoing a 75-g oral glucose tolerance test, cold soda water significantly increased glycemic levels at 1 hour after glucose intake compared to room-temperature soda water, suggesting it may not be suitable for diagnosing gestational diabetes mellitus.

While different glucose solution formulas affected taste perception and nausea levels, they did not significantly impact the incidence of gestational diabetes or other side effects like vomiting and headache, indicating that the choice of solution may improve comfort without compromising diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the effects of water temperature and additives in glucose solution on pregnant women's taste, side effects, and glycemic levels during an oral glucose tolerance test: a randomized controlled trial. Wang, P., Chang, PC., Wang, CY., et al.[2023]

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]

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]

In a study of 103 women with gestational diabetes, 22% had abnormal postpartum glucose tolerance, indicating a significant risk for developing diabetes after pregnancy.

Key risk factors for abnormal glucose tolerance included elevated fasting glucose levels and an earlier gestational age at diagnosis of gestational diabetes, highlighting the need for postpartum glucose testing in these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors associated with abnormal postpartum glucose tolerance in women with gestational diabetes. Catalano, PM., Vargo, KM., Bernstein, IM., et al.[2022]

In a study of 246 women with recent gestational diabetes, 19% exhibited abnormal carbohydrate metabolism in the early postpartum period, with 10% showing impaired glucose tolerance and 9% diagnosed with diabetes mellitus.

The prevalence of postpartum diabetes significantly increased with higher fasting serum glucose levels during pregnancy, highlighting the importance of conducting oral glucose tolerance tests after delivery, especially for those with elevated glucose levels during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational diabetes mellitus: the prevalence of glucose intolerance and diabetes mellitus in the first two months post partum. Kjos, SL., Buchanan, TA., Greenspoon, JS., et al.[2022]

Women who have had gestational diabetes mellitus are recommended to undergo an oral glucose tolerance test 6 to 12 weeks after giving birth to monitor their glucose levels.

This follow-up is important for assessing the risk of developing type 2 diabetes in the future, ensuring early intervention if necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gestational diabetes-what comes next? Reidy, J., Chalupka, S.[2010]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2902390/

Screening for type 2 diabetes following gestational diabetes The Canadian Diabetes Association 2008 Clinical Practice Guidelines recommend a 2-hour 75-g oral glucose tolerance test (OGTT) 6 weeks to 6 months post partum.

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06099509/self-administered-2-hour-oral-glucose-tolerance-test

Self-Administered 2-Hour Oral Glucose Tolerance Test This study seeks to evaluate a novel approach to increase uptake of recommended postpartum diabetes screening. The primary objective of this ...

3. journals.lww.com journals.lww.com/ogopen/fulltext/2024/09000/administration_of_the_postpartum_glucose_tolerance.17.aspx

Administration of the Postpartum Glucose Tolerance Test... This meta-analysis demonstrates a lower noncompletion rate for screening for type 2 diabetes in individuals with GDM in the immediate postpartum period.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04972955

Study Details | NCT04972955 | Predicting Dysglycemia in ... Diabetes or prediabetes based on the postpartum 75-gram OGTT will be evaluated as fasting plasma glucose ≥7.0 mmol/L or 2-hour plasma glucose of ≥11.1 mmol/L or ...

5. drc.bmj.com drc.bmj.com/content/10/3/e002726

Uptake of guideline-recommended postpartum diabetes ... We aimed to identify patient factors associated with completed postpartum diabetes screening (2-hour oral glucose tolerance test within 4–12 weeks postpartum)

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06099509

Self-Administered 2-Hour Oral Glucose Tolerance Test The primary objective of this study is to determine if a self-administered postpartum diabetes screen (75-gram oral glucose tolerance test) increases screening ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3221566/

Postpartum Screening for Diabetes Among Women With a ... Rates of postpartum screening among women with a history of GDM are low; only half of women in most populations are screened.

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

Screening for Gestational Diabetes Mellitus Women with GDM should be screened at six to 12 weeks postpartum, and every three years thereafter, for abnormal glucose metabolism.

9. labcorp.com labcorp.com/tests/101200/glucose-tolerance-test-gtt-two-hour-oral-who-protocol

101200: Glucose Tolerance Test (GTT), Two-hour (Oral ... It is used in patients with borderline fasting and postprandial glucose to support or rule out the diagnosis of diabetes mellitus.