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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help pregnant women with gestational diabetes determine the best time to check their blood sugar after meals. Researchers seek to understand if testing blood sugar at 1 hour versus 2 hours post-meal affects adherence. The goal is to identify which timing helps more women effectively monitor their blood sugar levels. Pregnant women with a single baby, diagnosed with gestational diabetes after 24 weeks, may qualify for this study. As an unphased trial, it offers a unique opportunity to contribute to important research that could enhance blood sugar management for many pregnant women.

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 prior data suggests that this blood glucose monitoring method is safe for gestational diabetes?

Research has shown that checking blood sugar levels is generally safe for people with gestational diabetes. Continuous glucose monitoring (CGM) provides real-time information about blood sugar levels and is comfortable for most patients. Studies have found that CGM can help manage blood sugar more effectively, leading to better health outcomes.

For the 1-hour blood sugar check, evidence suggests that users favor CGM. It accurately tracks blood sugar levels, which is crucial for managing gestational diabetes.

Similarly, the 2-hour blood sugar check offers detailed information about blood sugar levels. This method aids in better managing gestational diabetes and may prevent negative health effects.

Overall, both methods of checking blood sugar levels appear safe and can assist in managing gestational diabetes. The studies reviewed have reported no major safety issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different blood glucose monitoring times for gestational diabetes, which could lead to more personalized care. Unlike the standard practice of monitoring 2 hours after eating, this trial also evaluates monitoring just 1 hour post-meal. This shorter timeframe might offer more immediate insights into how food affects blood sugar levels, potentially allowing for quicker adjustments to diet or insulin therapy. Ultimately, the trial aims to determine if varying the timing of glucose checks can improve management and outcomes for expectant mothers with gestational diabetes.

What evidence suggests that this trial's blood glucose monitoring methods could be effective for gestational diabetes?

Research shows that tracking blood sugar levels is crucial for managing gestational diabetes. In this trial, participants will be randomized into two arms: one group will monitor blood glucose 1 hour after eating, and the other will monitor 2 hours after meals. Studies have found that continuous glucose monitoring can improve pregnancy outcomes and help maintain healthier blood sugar levels. Checking blood sugar 1 hour after eating effectively detects gestational diabetes early. Checking 2 hours after meals is also effective, with studies supporting its role in treatment. Both methods aim to stabilize blood sugar and reduce the risk of complications for both mother and baby. ^{2 3 4 6 7}

Who Is on the Research Team?

Stephen Chasen, MD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5685869/

Predictive Characteristics of Elevated 1-Hour Glucose ... A value of 216 mg/dL or greater has been associated with100% positive predictive value (PPV) for GDM while a value of 200 mg/dL or greater (for ...

2. diabetesjournals.org diabetesjournals.org/care/article/48/9/1581/163057/Real-Time-Continuous-Glucose-Monitoring-in

Real-Time Continuous Glucose Monitoring in Pregnancies ... We hypothesize that pregnant people with GDM using real-time CGM can achieve higher percent glucose time in range (%TIR; 60–140 mg/dL) compared ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0168822725004036

Continuous glucose monitoring in gestational diabetes ... HAPO, a prospective cohort study, used outcome data to define the IADPSG criteria for GDM, included 23,316 women and excluded women with a fasting glucose ...

4. ajog.org ajog.org/article/S0002-9378(25)00217-0/fulltext

Evidence for improved glucose metrics and perinatal ... Across diabetes in pregnancy, continuous glucose monitoring (vs self-monitoring of blood glucose) decreased hemoglobin A1c (mean difference, −0.22% [95% ...

5. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-025-01854-x

Continuous glucose monitoring system in diabetes in pregnancy The National Pregnancy in Diabetes Audit 2021 and 2022 in England reported that CGM users have improved pregnancy outcomes in women with T1D, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9592228/

Continuous Glucose Monitoring for the Diagnosis of ... CGM was well-tolerated, showing poorer glycaemic control in GDM, and revealing potential misdiagnosis of the OGTT when combined with GDM risk ...

7. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK545196/

Gestational Diabetes - StatPearls - NCBI Bookshelf In patients with a positive 50-g glucose screen, a diagnostic test using a 100-g 3-hour OGTT is necessary.[1] The following values are used as ...