Glucose Monitoring for Gestational Diabetes

Recruiting at 1 trial location

Overseen By Thomas Owens, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Under 18, Multiple gestation, C-section

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research shows that continuous glucose monitoring (CGM) can improve blood sugar control and pregnancy outcomes in women with diabetes, including gestational diabetes. This suggests that frequent glucose monitoring may help manage gestational diabetes effectively. ^{1 2 3 4 5}

Is glucose monitoring safe for pregnant women?

Glucose monitoring, including continuous glucose monitoring, has been studied in pregnant women with diabetes and is generally considered safe, though more research is needed to determine the best practices for its use. ^{1 2 4 5 6}

How is glucose monitoring unique as a treatment for gestational diabetes?

Glucose monitoring for gestational diabetes is unique because it involves regularly checking blood sugar levels to help manage the condition, which can reduce the risk of complications for both mother and baby. Unlike other treatments, it focuses on maintaining specific blood sugar targets through frequent monitoring, which can guide dietary and insulin adjustments. ^{6 7 8 9 10}

What is the purpose of this trial?

The aim of this study is to assess rates of neonatal hypoglycemia with differing intrapartum glucose protocols. Currently at this time there is no guidance from professional medical organizations about when and how frequent to assess maternal glucose levels intrapartum. Several institutions have no protocols in place. The study will be a randomized controlled trial placing patients with Gestational Diabetes Mellitus (GDM) in "frequent" vs "infrequent" glucose monitoring intrapartum and assessing neonatal glucose levels at birth.

Research Team

Thomas Owens, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for pregnant individuals with Gestational Diabetes Mellitus (GDM). It's designed to see if the frequency of checking blood sugar levels during labor affects their newborns' risk of low blood sugar. Participants will be randomly assigned to either 'frequent' or 'infrequent' glucose monitoring groups.

Inclusion Criteria

Patient with singleton gestation presenting in labor or for induction

I am of childbearing age and have been diagnosed with gestational diabetes.

Exclusion Criteria

Multiple gestation pregnancy

Patients undergoing scheduled c-section

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intrapartum Glucose Monitoring

Participants with Gestational Diabetes Mellitus (GDM) undergo either frequent or infrequent glucose monitoring during labor

Duration of labor

Continuous monitoring during labor

Follow-up

Participants are monitored for neonatal hypoglycemia and other outcomes

6 months

Treatment Details

Interventions

• Frequency of Glucose Monitoring

Trial Overview The study tests two different approaches to monitor blood sugar in laboring mothers with GDM: one group will have their glucose checked frequently, while the other less so. The main goal is to observe how these methods impact the baby's blood sugar level at birth.

Participant Groups

Group I: Infrequent testing Experimental Treatment 1 Intervention

Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater)

Group II: Frequent testing Placebo Group 1 Intervention

Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater)

Frequency of Glucose Monitoring is already approved in European Union, United States for the following indications:

Approved in European Union as Glucose Monitoring for:

• Gestational Diabetes Mellitus (GDM)
• Type 1 Diabetes
• Type 2 Diabetes

Approved in United States as Glucose Monitoring for:

• Gestational Diabetes Mellitus (GDM)
• Type 1 Diabetes
• Type 2 Diabetes

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Findings from Research

In a study of 117 pregnant patients with type 1 or 2 diabetes, continuous glucose monitoring (CGM) metrics were linked to neonatal outcomes, showing that higher time in range (TIR) significantly reduces the odds of neonatal morbidity by 28% for every 5 percentage-point increase in TIR.

The optimal TIR for improving neonatal outcomes was found to be between 66-71%, supporting the American Diabetes Association's recommendation of aiming for at least 70% TIR during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes. Sanusi, AA., Xue, Y., McIlwraith, C., et al.[2023]

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]

Continuous glucose monitoring (CGM) is becoming a recommended method for managing blood sugar levels in pregnant women with diabetes, as it is less invasive than traditional blood glucose measurements.

Optimal glycemic control during pregnancy is crucial for improving both maternal and neonatal outcomes, highlighting the importance of effective monitoring strategies like CGM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous Glucose Monitoring in Pregnancy. Horgan, R., Hage Diab, Y., Fishel Bartal, M., et al.[2023]

In a study of 115 pregnant women with diabetes, higher mean glucose levels in the second trimester were linked to an increased risk of having large for gestational age (LGA) babies, particularly in those with type 1 diabetes.

The area under the curve for glucose levels above the target range was significantly associated with LGA in type 2 diabetes and insulin-treated gestational diabetes, but no CGM metrics were found to correlate with other adverse outcomes like neonatal hypoglycemia or preterm birth.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial. Rademaker, D., van der Wel, AWT., van Eekelen, R., et al.[2023]

In a study of 1302 pregnant women with gestational diabetes mellitus (GDM), continuous glucose monitoring (CGM) metrics were found to be associated with an increased risk of adverse pregnancy outcomes, such as preterm birth and NICU admission, indicating the importance of glucose control during pregnancy.

Specific CGM-derived thresholds, such as a time above range (TAR) of 2.5% and a daily mean blood glucose (MBG) of 4.8 mmol/L, could help identify women at higher risk for complications, suggesting that these metrics may be useful targets for interventions to improve pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring-derived glycemic metrics and adverse pregnancy outcomes among women with gestational diabetes: a prospective cohort study. Liang, X., Fu, Y., Lu, S., et al.[2023]

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]

A team approach to diabetes management during pregnancy is crucial for optimizing outcomes for both the mother and baby, requiring intensive insulin therapy and careful glucose monitoring before and during pregnancy.

Universal screening for gestational diabetes at 24 to 28 weeks is essential, and initial dietary management may be supplemented with insulin therapy if glucose levels remain elevated, highlighting the importance of ongoing monitoring and long-term follow-up for women with gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of diabetes in pregnancy. Pasui, K., McFarland, KF.[2005]

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]

Tight glycemic control during pregnancy is crucial, as it significantly reduces risks for both the mother and fetus, with recommended blood glucose targets between 70 to 120 mg/dL.

Effective management of pregestational and gestational diabetes relies on regular blood glucose monitoring, which should be integrated into treatment plans to ensure timely adjustments in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring and managing hyperglycemia in pregnancy: from glycosuria to continuous blood glucose monitoring. Mazze, RS.[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]

References

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

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes. [2023]

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

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

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

Continuous Glucose Monitoring in Pregnancy. [2023]

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

Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial. [2023]

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

Continuous glucose monitoring-derived glycemic metrics and adverse pregnancy outcomes among women with gestational diabetes: a prospective cohort study. [2023]

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

Glucose monitoring during pregnancy. [2022]

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

Management of diabetes in pregnancy. [2005]

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

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

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

Measuring and managing hyperglycemia in pregnancy: from glycosuria to continuous blood glucose monitoring. [2022]

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

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