Glucose Monitoring for Gestational Diabetes
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Icahn School of Medicine at Mount Sinai
Approved in 2 jurisdictions
Trial Summary
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.
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.
12345Do 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.
678910Eligibility 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
I am of childbearing age and have been diagnosed with gestational diabetes.
Exclusion Criteria
I am under 18 years old.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Infrequent testingExperimental Treatment1 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 testingPlacebo Group1 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:
๐ช๐บ Approved in European Union as Glucose Monitoring for:
- Gestational Diabetes Mellitus (GDM)
- Type 1 Diabetes
- Type 2 Diabetes
๐บ๐ธ Approved in United States as Glucose Monitoring for:
- Gestational Diabetes Mellitus (GDM)
- Type 1 Diabetes
- Type 2 Diabetes
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mount Sinai West HospitalNew York, NY
Mount Sinai West HospitalNew york, NY
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
References
Management of diabetes in pregnancy. [2005]A team approach to diabetes management optimizes pregnancy outcomes for mother and baby. Patients with preexisting diabetes require intensive insulin therapy before conception and during pregnancy. Glucose self-monitoring assists in achieving near-normal glucose levels during pregnancy, with the goal of maintaining fasting glucose levels from 60 to 105 mg per dL (3.3 to 5.8 mmol per L) and postprandial levels less than 120 mg per dL (6.7 mmol per L). Universal screening at 24 to 28 weeks of gestation identifies women with gestational diabetes. Dietary measures are used initially in the management of gestational diabetes, with the addition of insulin therapy if glucose levels exceed 105 mg per dL (5.8 mmol per L) in a fasting state or 120 mg per dL (6.7 mmol per L) two hours postprandial. Self-monitoring of blood glucose levels four or more times a day guides insulin and dietary modifications. Women with gestational diabetes have a higher risk of developing non-insulin-dependent diabetes later in life and, thus, warrant long-term follow-up.
Measuring and managing hyperglycemia in pregnancy: from glycosuria to continuous blood glucose monitoring. [2022]The need to accurately detect and monitor hyperglycemia in pregnancy is becoming more apparent as the incidence of pregestational and gestational diabetes is increasing, especially among adolescents. The risk of adverse perinatal outcome is markedly worsened when pregnancy is complicated by elevated blood glucose. The appropriate management of both pregestational and gestational diabetes as it relates to blood glucose targets is clear. In the past 5 years, a number of studies have concluded that tight glycemic control throughout pregnancy significantly reduces both fetal and maternal risk. These studies have proposed blood glucose targets between 70 to 120 mg/dL. They have concluded that blood glucose levels should be the basis of moving rapidly to more effective treatments. The key to this approach is the adoption of blood glucose monitoring as an integral part of the treatment regimen. To assure sufficient data on which clinical decisions are made, the type of device, frequency of monitoring, and interpretation of results need to be carefully considered.
The postprandial glucose profile in the diabetic pregnancy. [2004]A controversy exists regarding the time to monitor blood glucose in the diabetic pregnancy (60 or 120 minutes after meals). Using a novel approach that provides continuous measurement of blood glucose, we sought to determine postprandial glucose profile in the diabetic pregnancy.
The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. [2006]The Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed, Northridge, CA) allows close monitoring of glucose patterns and might be helpful in explaining the persistence of high complication rates in pregnancies of women with type 1 diabetes. It was the aim of this study to determine whether the CGMS accurately reflects glucose levels in pregnant women with type 1 diabetes mellitus.
Glucose monitoring during pregnancy. [2022]Self-monitoring of blood glucose in women with mild gestational diabetes has recently been proven to be useful in reducing the rates of fetal overgrowth and gestational weight gain. However, uncertainty remains with respect to the optimal frequency and timing of self-monitoring. A continuous glucose monitoring system may have utility in pregnant women with insulin-treated diabetes, especially for those women with blood sugars that are difficult to control or who experience nocturnal hypoglycemia; however, continuous glucose monitoring systems need additional study as part of larger, randomized trials.
Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial. [2022]To evaluate whether real-time continuous glucose monitoring improves glycemic control over intermittent self-monitoring of blood glucose in gestational diabetes.
Continuous glucose monitoring metrics and pregnancy outcomes in insulin-treated diabetes: A post-hoc analysis of the GlucoMOMS trial. [2023]To investigate the association between continuous glucose monitoring (CGM) metrics and perinatal outcomes in insulin-treated diabetes mellitus in pregnancy.
Continuous Glucose Monitoring in Pregnancy. [2023]Diabetes mellitus in pregnancy is associated with adverse maternal and neonatal outcomes. Optimal glycemic control is associated with improved outcomes. Continuous glucose monitoring is a less invasive alternative to blood glucose measurements. Two types of continuous glucose monitoring are available in the market: real time and intermittently scanned. Continuous glucose monitoring is gaining popularity and is now recommended by some societies for glucose monitoring in pregnant women. In this review, we discuss the differences between the two types of continuous glucose monitoring, optimal treatment goals, and whether there is an improvement in maternal or neonatal outcomes.
Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes. [2023]Continuous glucose monitoring (CGM) improves maternal glycemic control and neonatal outcomes in type 1 diabetes pregnancies compared with self-monitoring of blood glucose. However, CGM targets for pregnancy are based on expert opinion. We aimed to evaluate the association between CGM metrics and perinatal outcomes and identify evidence-based targets to reduce morbidity.
Continuous glucose monitoring-derived glycemic metrics and adverse pregnancy outcomes among women with gestational diabetes: a prospective cohort study. [2023]Continuous glucose monitoring (CGM) has shown potential in improving maternal and neonatal outcomes in individuals with type 1/2 diabetes, but data in gestational diabetes mellitus (GDM) is limited. We aimed to explore the relationship between CGM-derived metrics during pregnancy and pregnancy outcomes among women with GDM.