Blood Glucose Monitoring for Gestational Diabetes

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Type 1 diabetes, Type 2 diabetes, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During the intervention

140 Participants Needed

Trial Summary

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. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment for blood glucose monitoring in gestational diabetes?

Research suggests that continuous glucose monitoring (CGM) provides more comprehensive data on blood sugar levels than self-monitoring, especially for identifying high blood sugar levels at night. This could help in better managing gestational diabetes by allowing for more personalized treatment plans. ^{1 2 3 4 5}

Is blood glucose monitoring safe for pregnant women with gestational diabetes?

Blood glucose monitoring, including continuous glucose monitoring, is generally considered safe for pregnant women with gestational diabetes. It helps in managing blood sugar levels, although more research is needed to determine the best monitoring techniques. ^{1 4 5 6 7}

How does 1-hour and 2-hour blood glucose monitoring differ from other treatments for gestational diabetes?

This treatment focuses on monitoring blood glucose levels at specific times after meals (1 hour and 2 hours), which is different from the standard practice of checking blood sugar multiple times a day. This approach may provide more precise insights into how meals affect blood sugar levels, potentially leading to better management of gestational diabetes. ^{1 8 9 10 11}

What is the purpose of this trial?

The purpose of this study is to evaluate if in patients with gestational diabetes (GDM), adherence to postprandial glucose monitoring differs when performed 1-hour versus 2-hours after eating. The primary objective of this study is to evaluate difference in rate of adherence (binary outcome defined as \<80% or ≥80% of glucose log completed) between gestational diabetics who perform 1-hour versus 2-hour postprandial blood glucose testing.

Research Team

Stephen Chasen, MD

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for pregnant women over 18 with a single pregnancy, diagnosed with gestational diabetes (GDM) after 24 weeks using the two-step screening method. It's not for those who had GDM before 24 weeks or have pre-gestational Type 1 or Type 2 diabetes.

Inclusion Criteria

You were diagnosed with gestational diabetes after being 24 weeks pregnant.

I am pregnant with one baby and am 18 years old or older.

You have been diagnosed with gestational diabetes using the screening guidelines from the American College of Obstetrics and Gynecologists.

Exclusion Criteria

I have had Type 1 diabetes before becoming pregnant.

You were diagnosed with gestational diabetes before reaching 24 weeks of pregnancy.

I have type 2 diabetes and had it before getting pregnant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either 1-hour or 2-hour postprandial blood glucose monitoring

During the intervention

Follow-up

Participants are monitored for adherence to glucose monitoring

4 weeks

Treatment Details

Interventions

• 1 hour Blood glucose monitoring
• 2 hour blood glucose monitoring

Trial Overview The study compares how well patients with GDM stick to blood sugar testing if they check it one hour versus two hours after eating. The goal is to see which timing leads to better adherence in completing glucose logs.

Participant Groups

Group I: 2-hour post-prandial blood glucose monitoring Arm Experimental Treatment 1 Intervention

Arm in which participants are randomized to blood glucose monitoring at 2 hours after eating.

Group II: 1-hour post-prandial blood glucose monitoring Arm Experimental Treatment 1 Intervention

Arm in which participants are randomized to blood glucose monitoring at 1 hour after eating.

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

In a study of 40 patients with gestational diabetes, real-time continuous glucose monitoring did not significantly improve mean glucose levels compared to blinded continuous glucose monitoring after 4 weeks of use.

There were no notable differences in glycemic control or maternal and neonatal outcomes between the two monitoring methods, suggesting that real-time feedback may not provide additional benefits over intermittent self-monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial. Lane, AS., Mlynarczyk, MA., de Veciana, M., et al.[2022]

Self-monitoring of blood glucose in women with mild gestational diabetes effectively reduces fetal overgrowth and gestational weight gain, highlighting its importance in managing this condition.

Continuous glucose monitoring systems may benefit pregnant women with insulin-treated diabetes, particularly those with challenging blood sugar control or nocturnal hypoglycemia, but further research through larger randomized trials is needed to confirm their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose monitoring during pregnancy. Hawkins, JS.[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 65 women with various types of diabetes during pregnancy, it was found that the peak postprandial blood glucose levels occur approximately 90 minutes after meals, regardless of the type of diabetes or glycemic control.

About 50% of the participants did not return to their pre-meal glucose levels within 3 hours, highlighting the need for careful monitoring and management of blood glucose in diabetic pregnancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The postprandial glucose profile in the diabetic pregnancy. Ben-Haroush, A., Yogev, Y., Chen, R., et al.[2004]

References

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

Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial. [2022]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Contribution of continuous glucose measurement in the management of gestational diabetes : a pilot study]. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of continuous glucose monitoring compared with self-monitoring of blood glucose in gestational diabetes patients with HbA1c [2023]

4. England pubmed.ncbi.nlm.nih.gov

Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. [2022]

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

Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose to Assess Glycemia in Gestational Diabetes. [2021]

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

Glucose monitoring during pregnancy. [2022]

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

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

8. Canada pubmed.ncbi.nlm.nih.gov

Twice-Daily vs 4-Times-Daily Glucose Testing in Women With Gestational Diabetes Mellitus: A Pilot Study. [2021]

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

The postprandial glucose profile in the diabetic pregnancy. [2004]

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

Is self-monitoring of blood glucose necessary in the management of gestational diabetes mellitus? [2005]

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

Role of continuous glucose monitoring in the management of diabetic pregnancy. [2021]