Postpartum Diabetes Screening for Gestational Diabetes

Overseen By Kartik Venkatesh, MD, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Gastric bypass, 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

104 Participants Needed

Trial Summary

What is the purpose of this trial?

To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of immediate in-patient postpartum OGTT prior to delivery discharge (intervention) versus 4-12 week outpatient postpartum OGTT (current standard care) to improve the frequency of post-partum diabetes screening among individuals with a pregnancy complicated by GDM.

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.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the idea that Postpartum Diabetes Screening for Gestational Diabetes is an effective treatment?

The available research shows that postpartum diabetes screening using the 75g oral glucose tolerance test (OGTT) is important for women who had gestational diabetes, as it helps identify those at risk of developing type 2 diabetes. One study found that about half of the women who had gestational diabetes were tested postpartum, and among those tested, 16.3% had impaired glucose levels, indicating a risk for diabetes. This suggests that the screening is effective in identifying women who need further monitoring or intervention to prevent type 2 diabetes. Additionally, reminders and automated orders for testing can improve the rates of postpartum testing, making it a more effective approach. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Immediate inpatient postpartum OGTT for postpartum diabetes screening in women with gestational diabetes?

Research shows that women with gestational diabetes are at a higher risk of developing type 2 diabetes after pregnancy. The 75g oral glucose tolerance test (OGTT) is recommended 4-12 weeks postpartum to screen for this risk, and studies indicate that timely postpartum testing can help identify those with impaired glucose regulation, allowing for early intervention. ^{1 2 3 4 5}

What safety data exists for postpartum diabetes screening using OGTT in women with gestational diabetes?

The provided research does not directly address safety data for postpartum diabetes screening using OGTT. The studies focus on the timing and utility of the OGTT for reclassification of glucose tolerance, identifying risk factors for impaired glucose regulation, and evaluating the association with future diabetes risk. However, they do not specifically discuss safety concerns or adverse effects related to the OGTT itself. ^{2 3 6 7 8}

Is the postpartum oral glucose tolerance test (OGTT) safe for humans?

The postpartum oral glucose tolerance test (OGTT) is generally considered safe for humans, as it is a standard procedure recommended for women who had gestational diabetes to assess their risk of developing type 2 diabetes after childbirth. ^{2 3 6 7 8}

Is the treatment 'Immediate inpatient postpartum OGTT' promising for women with gestational diabetes?

Yes, the Immediate inpatient postpartum OGTT is promising because it helps identify women at risk of developing type 2 diabetes early after childbirth. This early screening can lead to timely treatment or prevention, improving health outcomes for women who had gestational diabetes. ^{1 2 3 8 9}

How is the Immediate inpatient postpartum OGTT treatment different from other treatments for gestational diabetes?

The Immediate inpatient postpartum OGTT is unique because it involves conducting the oral glucose tolerance test (OGTT) within 48-72 hours after delivery, rather than the standard 4-12 weeks postpartum. This earlier testing aims to increase screening rates and allow for quicker intervention to prevent or manage type 2 diabetes in women who had gestational diabetes. ^{1 2 3 8 9}

Research Team

Christine Field, MD

Principal Investigator

Ohio State University

Kartik K Venkatesh, MD, PhD

Principal Investigator

Ohio State University

Eligibility Criteria

This trial is for English or Spanish-speaking individuals who were diagnosed with gestational diabetes during pregnancy, are at least 18 years old, and can give informed consent. They must be receiving care at OSU and be immediately postpartum during their delivery hospital stay. Those with a history of gastric bypass or unable to tolerate an OGTT cannot participate.

Inclusion Criteria

You had high blood sugar during pregnancy, as shown by a glucose test.

Receiving prenatal and postpartum care at OSU

You are in the hospital right after having a baby.

Exclusion Criteria

You cannot handle a 2-hour oral glucose tolerance test (OGTT) due to a history of gastric bypass.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Immediate Postpartum OGTT

Participants undergo an immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

Immediate

1 visit (in-person)

Standard Care Postpartum OGTT

Participants undergo a 4-12 week outpatient postpartum OGTT as part of standard care

4-12 weeks

1 visit (in-person)

Follow-up

Participants are monitored for risk perception, lifestyle modification, and diabetes status

12 weeks

Electronic surveys

Long-term Follow-up

Participants are monitored for prediabetes or type 2 diabetes and primary care provider visits

1 year

Treatment Details

Interventions

• Immediate inpatient postpartum OGTT
• Standard of care 4-12 week postpartum OGTT

Trial Overview The DIP trial is testing if doing a glucose tolerance test (OGTT) right after giving birth in the hospital helps more new moms get screened for diabetes compared to waiting for the standard 4-12 weeks after delivery. Participants will either receive this immediate test or follow the usual care plan.

Participant Groups

Group I: Standard of care Experimental Treatment 1 Intervention

Standard of care is 4-12 week outpatient postpartum OGTT

Group II: Immediate inpatient postpartum OGTT Active Control 1 Intervention

The intervention includes immediate inpatient postpartum 2-hour oral glucose tolerance test (OGTT) prior to delivery discharge

Immediate inpatient postpartum OGTT is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Immediate Postpartum OGTT for:

• Postpartum diabetes screening in individuals with gestational diabetes mellitus (GDM)

Approved in Canada as Immediate Postpartum OGTT for:

• Postpartum diabetes screening in individuals with gestational diabetes mellitus (GDM)

Approved in European Union as Immediate Postpartum OGTT for:

• Postpartum diabetes screening in individuals with gestational diabetes mellitus (GDM)

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Findings from Research

A quality improvement project significantly increased postpartum screening for type 2 diabetes in women with gestational diabetes from 39% to 77% by implementing a team-based guideline and education on ACOG recommendations.

The education session improved the clinical team's understanding of diabetes screening, as evidenced by a pretest score of 57% rising to 99% post-intervention, highlighting the importance of team education in enhancing healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Team-Based Approach to Managing Postpartum Screening of Women with Gestational Diabetes for Type 2 Diabetes. Bounds, FL., Rojjanasrirat, W., Martin, MA.[2021]

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 294 women with gestational diabetes mellitus (GDM), 25.5% were found to have impaired glucose tolerance (IGT) and 20.1% were diagnosed with type 2 diabetes mellitus (DM) two months after giving birth, indicating a significant risk of persistent glucose abnormalities post-pregnancy.

The DM group was diagnosed earlier during pregnancy and exhibited higher blood glucose levels and insulin usage compared to those with IGT and normal glucose levels, highlighting the need for close monitoring and management of blood sugar levels in women with GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Postpartum reclassification in women with gestational diabetes and analyzing the high risk factors associated with them]. Wu, LF., Liu, DY., Huang, XH., et al.[2011]

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]

Sending reminders to both patients and their physicians significantly increased the rate of postpartum oral glucose tolerance tests (OGTT) in women with previous gestational diabetes, with 60.5% of women in that group getting screened.

Overall, any form of reminder (to patient, physician, or both) led to higher screening rates compared to no reminders, highlighting the effectiveness of reminders in improving postpartum diabetes screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do postal reminders increase postpartum screening of diabetes mellitus in women with gestational diabetes mellitus? A randomized controlled trial. Clark, HD., Graham, ID., Karovitch, A., et al.[2022]

In a study of pregnant women screened for gestational diabetes, those with an isolated abnormal glucose level at 2 hours during the oral glucose tolerance test had the highest incidence of large for gestational age (LGA) babies (20.3%).

The findings indicate that even mild glucose intolerance can lead to increased risks of LGA and macrosomia, particularly in women with elevated glucose levels at 0 and 2 hours, suggesting the need for monitoring and potential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Isolated abnormal value during the 3-hour glucose tolerance test: which value is associated with macrosomia? Cok, T., Tarim, E., Bagis, T.[2011]

The systematic review included 17 studies and found that both elevated fasting blood glucose and 2-hour OGTT values are significantly associated with an increased risk of developing diabetes in women with gestational diabetes, with odds ratios of 3.62 and 3.96, respectively.

However, these associations were less clear when adjusting for confounding factors, indicating that further research is necessary to establish definitive clinical recommendations regarding the use of antepartum OGTT in predicting diabetes risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between the antepartum oral glucose tolerance test and the risk of future diabetes mellitus among women with gestational diabetes: A systematic review and meta-analysis. Moore, LE., Voaklander, B., Savu, A., et al.[2021]

A study of 152 women with gestational diabetes showed that using a 6-week postnatal fasting plasma glucose test can effectively identify those who need an oral glucose tolerance test (OGTT), with a sensitivity of 100% and specificity of 94%.

Only 10% of women would need to undergo the OGTT if the threshold for testing was set at a fasting glucose level of 6.0 mmol/l or higher, significantly reducing the number of tests performed while still accurately diagnosing postnatal diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A postnatal fasting plasma glucose is useful in determining which women with gestational diabetes should undergo a postnatal oral glucose tolerance test. Holt, RI., Goddard, JR., Clarke, P., et al.[2019]

The 75 g 2-hour oral glucose tolerance test (OGTT) conducted 48-72 hours after delivery is effective in identifying women with gestational diabetes mellitus (GDM) who may develop diabetes, showing a high negative predictive value (97.9%) for ruling out diabetes.

The study found that using specific cutoff values for fasting plasma glucose (78 mg/dl) and 2-hour OGTT (130 mg/dl) can help screen for diabetes with reasonable sensitivity (71.4% and 85.7%, respectively), indicating that early postpartum testing can be a valuable strategy for early intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early diabetes screening in women with previous gestational diabetes: a new insight. Nabuco, A., Pimentel, S., Cabizuca, CA., et al.[2022]

References

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

Team-Based Approach to Managing Postpartum Screening of Women with Gestational Diabetes for Type 2 Diabetes. [2021]

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

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

3. China pubmed.ncbi.nlm.nih.gov

[Postpartum reclassification in women with gestational diabetes and analyzing the high risk factors associated with them]. [2011]

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

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

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

Do postal reminders increase postpartum screening of diabetes mellitus in women with gestational diabetes mellitus? A randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Isolated abnormal value during the 3-hour glucose tolerance test: which value is associated with macrosomia? [2011]

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

Association between the antepartum oral glucose tolerance test and the risk of future diabetes mellitus among women with gestational diabetes: A systematic review and meta-analysis. [2021]

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

A postnatal fasting plasma glucose is useful in determining which women with gestational diabetes should undergo a postnatal oral glucose tolerance test. [2019]

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

Early diabetes screening in women with previous gestational diabetes: a new insight. [2022]