Continuous Glucose Monitor for Gestational Diabetes

(VALID Trial)

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

Trial Summary

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 data supports the effectiveness of the treatment Continuous Glucose Monitor for Gestational Diabetes?

Continuous glucose monitoring (CGM) is shown to help pregnant women with diabetes manage their blood sugar levels better, which can lead to improved outcomes for both mother and baby. It provides continuous information about blood sugar changes, helping women make lifestyle adjustments and manage their condition more effectively. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for use in humans?

Continuous glucose monitors (CGMs) have been used in people with diabetes, but there were 281,963 adverse events reported in 2022, indicating some safety concerns. More research is needed to fully understand their safety, especially in pregnant women. ^{2 4 6 7 8}

How does the continuous glucose monitor treatment differ from other treatments for gestational diabetes?

The continuous glucose monitor (CGM) offers a less invasive and more consistent way to track blood sugar levels compared to traditional self-monitoring methods, which can be burdensome. It provides real-time or intermittently scanned data, potentially improving blood sugar control and reducing complications during pregnancy. ^{1 2 7 9 10}

What is the purpose of this trial?

This is a prospective pilot study to assess the validity of using a continuous glucose monitor (CGM) in diagnosing gestational diabetes mellitus (GDM). Pregnant individuals between the ages of 18-50 years old receiving prenatal care at Mount Sinai Hospital (e..g, E-Level clinic and Faculty Practice Associates) will be enrolled. Potential participants will be approached during their prenatal care appointments. Participants will complete an informed consent form for the study during their standard-of-care prenatal appointments at our institution.

Research Team

Angela Bianco, MD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

References

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

Continuous Glucose Monitoring in Pregnancy. [2023]

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

Glucose monitoring during pregnancy. [2022]

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

The efficacy and effectiveness of continuous glucose monitoring during pregnancy: a systematic review. [2018]

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

Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. [2020]

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

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

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

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

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. United States 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. [2015]

9. China pubmed.ncbi.nlm.nih.gov

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

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

Comparison of an Intermittently Scanned (Flash) Continuous Glucose Monitoring System to Standard Self-Monitoring of Capillary Blood Glucose in Gestational Diabetes Mellitus. [2023]