Continuous Glucose Monitor for Gestational Diabetes

(VALID Trial)

Recruiting at 1 trial location

Overseen By Nicola F Tavella, MPH

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Steroids

Disqualifiers: Multiple gestation, Preexisting diabetes, others

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

Compensation: Varies

Number of Visits: 3

Duration: 10 days

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for diagnosing gestational diabetes, a type of diabetes that can develop during pregnancy. Researchers aim to determine if a continuous glucose monitor, a device that tracks blood sugar levels, aids in early detection. They seek pregnant individuals between 24 and 32 weeks who receive prenatal care at Mount Sinai Hospital. This trial may suit those not already diagnosed with diabetes and carrying one baby. Participants will wear the monitor for 10 days to gather the necessary data. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance early diagnosis methods for gestational diabetes.

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

The trial does not specify if you need to stop taking your current medications, but it excludes those using steroids. It's best to discuss your specific medications with the trial team.

What prior data suggests that this continuous glucose monitor is safe for diagnosing gestational diabetes?

Research has shown that using a continuous glucose monitor (CGM) is safe during pregnancy. In one study, pregnant women with diabetes who used a CGM experienced better health outcomes compared to those using traditional finger-prick tests. Another study found the CGM safe for pregnant women with gestational diabetes. These studies reported no major safety issues. Overall, the CGM is generally well-tolerated and helps manage blood sugar levels more effectively during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using continuous glucose monitors (CGMs) for managing gestational diabetes because they offer a real-time, dynamic way to track blood sugar levels. Unlike traditional methods that rely on periodic finger-prick tests, CGMs provide continuous data, helping to catch fluctuations that might otherwise go unnoticed. This technology allows for more precise and timely adjustments to diet and insulin therapy, potentially leading to better outcomes for both mother and baby. Additionally, CGMs can enhance the convenience and comfort for pregnant women by reducing the need for frequent manual tests.

What evidence suggests that using a continuous glucose monitor is effective for diagnosing gestational diabetes?

Studies have shown that continuous glucose monitors (CGM) effectively manage gestational diabetes. These devices stabilize blood sugar levels by providing real-time information. Research indicates that CGM use keeps blood sugar levels within the target range more frequently. Additionally, CGM detects high blood sugar and reduces low blood sugar at night better than traditional finger-prick tests. Evidence also suggests that CGM users experience better pregnancy outcomes, such as healthier babies and fewer complications for the mother. Overall, CGM offers a promising method for effectively managing gestational diabetes. ^{1 2 6 7 8}

Who Is on the Research Team?

Angela Bianco, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This clinical trial is for pregnant individuals aged 18-50 receiving prenatal care at Mount Sinai Hospital. They are being considered for participation during their standard prenatal appointments and must consent to the study.

Inclusion Criteria

I am pregnant with one baby, between 24-32 weeks along.

Prenatal care and delivery at Mount Sinai Hospital

Exclusion Criteria

I have diabetes.

Multiple fetal gestation

Insufficient prenatal care (identified as missing half the recommended visits or establishing care after 20 weeks gestation)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants have a 10-day application of a continuous glucose monitor (CGM) to assess blood glucose levels

10 days

1 visit (in-person) for CGM application

Follow-up

Participants are monitored for blood glucose levels postpartum and through glucose tolerance tests

4 hours postpartum and additional follow-up for GTT

1 visit (in-person) for postpartum blood glucose test

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview

The trial is testing the use of a continuous glucose monitor (CGM) to diagnose gestational diabetes mellitus (GDM). It's a prospective pilot study, meaning it's preliminary research looking forward in time from this point.

How Is the Trial Designed?

Group I: Individuals receiving prenatal care at Mount Sinai Hospital Experimental Treatment 1 Intervention

Women receiving prenatal care at Mount Sinai Hospital to have 10-day application of continuous glucose monitor

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

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]

A study involving 130 pregnant women with gestational diabetes showed that using a real-time continuous glucose monitoring system (RT-CGMS) for 3-7 days did not improve overall glycemic control or pregnancy outcomes compared to standard self-monitoring of blood glucose.

However, the RT-CGMS did lead to significant improvements in glucose variability parameters, indicating it may serve as a useful educational tool for managing blood sugar levels, even if it doesn't directly enhance overall control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. Alfadhli, E., Osman, E., Basri, T.[2020]

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 use of continuous glucose monitors (CGM) in pregnancy shows mixed results; one small randomized controlled trial (RCT) indicated that retrospective CGM significantly reduced third-trimester HbA1c levels and neonatal macrosomia, while another RCT on real-time CGM found no impact on glycemic control or pregnancy outcomes.

Overall, the current evidence is limited and contradictory, highlighting the need for more comprehensive RCTs to assess the effectiveness and cost-effectiveness of CGM in improving pregnancy outcomes before it can be widely adopted in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. Voormolen, DN., DeVries, JH., Evers, IM., et al.[2018]

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 2022, there were 281,963 reported adverse events related to continuous glucose monitors (CGMs), highlighting a significant safety concern for people with diabetes.

The analysis of adverse events for four CGM products revealed that common issues included inaccuracy and device malfunctions, indicating a need for improved monitoring and device reliability to enhance user experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Event Causes From 2022 for Four Continuous Glucose Monitors. Krouwer, JS.[2023]

In a study of 340 pregnant women with gestational diabetes, continuous glucose monitoring (CGM) significantly improved glycemic control, leading to lower blood glucose variability compared to routine care.

Women using CGM had a reduced risk of preeclampsia and cesarean delivery, and their infants had lower birth weights, indicating better overall pregnancy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring effects on maternal glycemic control and pregnancy outcomes in patients with gestational diabetes mellitus: a prospective cohort study. Yu, F., Lv, L., Liang, Z., et al.[2015]

Continuous glucose monitoring system (CGMS) is more effective than self-monitoring blood glucose (SMBG) in detecting postprandial hyperglycemia and nocturnal hypoglycemia in pregnant patients with diabetes, as shown in a study of 99 patients over a 72-hour monitoring period.

Both CGMS and SMBG accurately reflect blood glucose levels, but controlling blood glucose is more challenging in patients with type 2 diabetes complicated by pregnancy compared to those with gestational diabetes mellitus (GDM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical use of continuous glucose monitoring system in gestational diabetes mellitus and type 2 diabetes complicated with pregnancy]. Song, Y., Yang, H.[2022]

Citations

1.

diabetesjournals.org

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

Real-Time Continuous Glucose Monitoring in Pregnancies ...

We demonstrated a significantly higher %TIR using real-time CGM compared with CBG glucose monitoring among pregnant people with GDM. Studies are ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12335106/

Continuous glucose monitoring system in diabetes ...

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

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S0002937825002170

Evidence for improved glucose metrics and perinatal ...

Evidence for improved glucose metrics and perinatal outcomes with continuous glucose monitoring compared to self-monitoring in diabetes during pregnancy.

4.

dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.70254?af=R

Continuous glucose monitoring in early gestational diabetes ...

We also found that CGM in pregnant women with GDM may be more effective in detecting hyperglycaemia and reducing nocturnal hypoglycaemia.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12286989/

The Use of Continuous Glucose Monitoring in Comparison ...

Compared with SMBG, CGM demonstrated significant improvements in maintaining TIR and reducing GV, which correlated with favorable maternal and ...

6.

thelancet.com

thelancet.com/journals/landia/article/PIIS2213-8587(25)00063-4/fulltext

an open-label, single-centre, randomised, controlled trial

We aimed to investigate the effect of real-time continuous glucose monitoring (rtCGM) on perinatal outcomes versus self-monitoring of blood glucose (SMBG).

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0168822725004036

Continuous glucose monitoring in gestational diabetes ...

The primary maternal outcome is diagnosis of GDM between 24–28 weeks of gestation, while the primary neonatal outcome is LGA [53]. Both these primary outcomes ...

8.

dom-pubs.onlinelibrary.wiley.com

dom-pubs.onlinelibrary.wiley.com/doi/10.1111/dom.15999

Use of continuous glucose monitoring and hybrid closed‐loop ...

A study in pregnant women with diabetes demonstrated that, compared to SMBG, the Freestyle Libre 1 system is safe to use in pregnancy, with ...