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

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

40 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor for postpartum high blood sugar?

The 2-hour 75-g oral glucose tolerance test is effective in identifying women with glucose intolerance after pregnancy, as it is better at detecting issues than just measuring fasting blood sugar. Continuous glucose monitoring, like the Dexcom G6 Pro, helps track blood sugar patterns closely, which can be useful in managing diabetes during pregnancy. ^{1 2 3 4 5}

Is the 2-hour 75-g oral glucose tolerance test safe for use in humans?

The 2-hour 75-g oral glucose tolerance test has been widely used in pregnancy to assess glucose metabolism, and studies have established reference values for its safe use during different stages of pregnancy. No significant safety concerns have been reported in the studies reviewed. ^{5 6 7 8 9}

How does the treatment using a 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor differ from other treatments for postpartum high blood sugar?

This treatment is unique because it combines a 2-hour 75-g oral glucose tolerance test, which measures how well your body processes sugar, with the Dexcom G6 Pro continuous glucose monitor, which tracks blood sugar levels in real-time. This combination allows for a more comprehensive assessment of glucose tolerance and continuous monitoring, which is not typically offered in standard postpartum glucose testing. ^{1 5 7 10 11}

What is the purpose of this trial?

This trial uses a device to track blood sugar levels in women who had diabetes during pregnancy. These women are at high risk for developing type 2 diabetes later. The study aims to understand their blood sugar patterns after childbirth and improve screening methods for diabetes.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

The importance of a postpartum 75 g oral glucose tolerance test in women with gestational diabetes. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Optimal timing for postprandial glucose measurement in pregnant women with diabetes and a non-diabetic pregnant population evaluated by the Continuous Glucose Monitoring System (CGMS). [2006]

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

The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. [2006]

5. England pubmed.ncbi.nlm.nih.gov

Reference values for 75 g oral glucose tolerance test in pregnancy. [2019]

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

Effect of varying degrees of "normal" glucose metabolism on maternal and perinatal outcome. [2019]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

No deterioration of oral glucose tolerance during pregnancy in rural Tanzania. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Evaluation of the WHO criteria for 75 g oral glucose tolerance test in pregnancy. [2019]

10. England pubmed.ncbi.nlm.nih.gov

The association between an oral glucose tolerance test performed at term pregnancy and obstetric outcomes. [2023]

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

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