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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this randomized controlled trial is to evaluate whether self-administered postpartum diabetes screening tests in patients with gestational diabetes improves screening completion rates. The primary question it aims to answer is: 1. Does a self-administered 75-gram oral glucose tolerance test with virtual follow-up visit increase the rate of postpartum diabetes screening within 12 weeks of delivery?

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 data supports the idea that Self-Administered Glucose Test for Postpartum Diabetes Screening is an effective treatment?

The available research shows that the Self-Administered Glucose Test for Postpartum Diabetes Screening is effective in identifying women who continue to have glucose issues after pregnancy. For example, one study found that 22% of women with gestational diabetes had abnormal results when tested with the 75-gram oral glucose tolerance test after delivery. This indicates that the test is useful in detecting ongoing glucose problems, which is important for preventing future health issues. Additionally, the research suggests that using this test can help improve the rates of postpartum testing, ensuring more women are checked for glucose intolerance after pregnancy. ^{1 2 3 4 5}

What safety data is available for the self-administered glucose test for postpartum diabetes screening?

The safety data for the self-administered glucose test, also known as the 75-gram oral glucose tolerance test, includes information on side effects such as nausea, vomiting, abdominal bloating, and headache. These side effects are common during the oral glucose tolerance test, which is used for diagnosing gestational diabetes mellitus. However, specific safety data for the self-administered version of the test is not detailed in the provided research. ^{1 5 6 7 8}

Is the Self-Administered 2-Hour Oral Glucose Tolerance Test a promising treatment for postpartum diabetes screening?

Yes, the Self-Administered 2-Hour Oral Glucose Tolerance Test is a promising treatment for postpartum diabetes screening. It helps identify women who may have ongoing glucose issues after pregnancy, which is important for early intervention and management. This test is effective in detecting glucose intolerance and diabetes in women who had gestational diabetes, allowing for timely follow-up and care. ^{1 2 3 5 9}

Research Team

Amy Crockett, MD

Principal Investigator

Prisma Health-Upstate

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

References

1. United States 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. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Prevalence and timing of postpartum glucose testing and sustained glucose dysregulation after gestational diabetes mellitus. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Incidence and risk factors associated with abnormal postpartum glucose tolerance in women with gestational diabetes. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Risk factors associated with postpartum impaired glucose regulation in women with previous gestational diabetes. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Postpartum diabetes screening: adherence rate and the performance of fasting plasma glucose versus oral glucose tolerance test. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Gestational diabetes-what comes next? [2010]

7. Japan pubmed.ncbi.nlm.nih.gov

[The predictive factor of postpartum impaired glucose tolerance in pregnant women with abnormal glucose tolerance]. [2011]

8. United States 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Gestational diabetes mellitus: the prevalence of glucose intolerance and diabetes mellitus in the first two months post partum. [2022]