Continuous Glucose Monitoring for Gestational Diabetes

Recruiting at 9 trial locations

Overseen By Paige N Miller, BS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Jaeb Center for Health Research

Must not be taking: Corticosteroids, Insulin, Metformin, others

Disqualifiers: Gestational diabetes, Gastric bypass, Diabetes, others

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

Compensation: Varies

Number of Visits: 9

6000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a continuous glucose monitor (CGM) can help pregnant women with early signs of high blood sugar manage their condition more effectively. Researchers seek to discover if CGM use can reduce complications for the baby, such as being born too large, and for the mother, such as developing high blood pressure. The trial includes three groups: one using CGM for glucose control, one receiving usual care with some CGM monitoring, and one under observation only. Ideal participants are pregnant women up to 14 weeks along, with no prior gestational diabetes, and able to read English or Spanish. As an unphased trial, this study offers participants the chance to contribute to important research that could improve pregnancy outcomes for many women.

Will I have to stop taking my current medications?

The trial requires that you stop using insulin, metformin, and certain weight-reduction medications that affect glucose levels before starting the study. Specifically, you must not have used metformin within one week or GLP-1 and similar medications within four weeks of starting the glucose monitoring.

What prior data suggests that continuous glucose monitoring is safe for pregnant women?

Previous studies have shown positive results for continuous glucose monitoring (CGM) in pregnant women with diabetes. Research indicates that CGM helps manage blood sugar levels more effectively. One study found that women using CGM experienced healthier pregnancies, with fewer high blood sugar episodes, compared to those who didn't use it.

Another study demonstrated that pregnant women using CGM maintained more stable blood sugar levels, which supports the baby's health and reduces risks like excessive fetal growth. CGM is generally easy to use, with no major safety concerns reported in these studies. Its widespread use among pregnant women with diabetes suggests it is safe for monitoring blood sugar during pregnancy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Glucose Monitoring (CGM) for gestational diabetes because it offers real-time, continuous tracking of blood sugar levels, unlike traditional finger-prick tests. This means moms-to-be can adjust their diets or medications more precisely and quickly, potentially improving outcomes for both mother and baby. Unlike standard care options, such as periodic glucose tests and insulin therapy, CGM provides a comprehensive picture of glucose trends throughout the day and night, which can lead to more personalized and effective management of gestational diabetes.

What evidence suggests that continuous glucose monitoring is effective for gestational diabetes?

Research has shown that continuous glucose monitoring (CGM) can significantly aid pregnant women with gestational diabetes in managing their blood sugar levels. In this trial, participants in the Glucose Lowering Group will use CGM to maintain their blood sugar within the target range. Studies have found that CGM is more effective at keeping blood sugar within the target range compared to traditional methods. Better blood sugar control is linked to healthier outcomes for both the mother and baby, such as reducing the risk of high blood pressure during pregnancy and preventing complications for the newborn, like being too large or having low blood sugar. While more research continues, these findings suggest that CGM is a promising tool for managing gestational diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

Celeste Durnwald, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for pregnant women with a single baby, up to nearly 15 weeks along, without prior gestational diabetes or pre-existing diabetes. Participants must have normal early blood sugar levels (HbA1c <6.5%), be able to read English or Spanish, and be at least 18 years old. They can't join if they're not committed to regular prenatal visits, show signs of abnormal fetal/placental development, are considering pregnancy termination/miscarriage risks, have had gastric bypass surgery, used certain glucose-affecting drugs recently or are on steroids that raise blood sugar.

Inclusion Criteria

Singleton pregnancy

Gestational age up to 14w 6d of pregnancy, determined on ultrasound, for initiation of screening. If ultrasound results are not available at the time of enrollment, participant can have CGM initiated but will be dropped if not eligible after results are available

HbA1c <6.5% (48 mmol/mol) since onset of pregnancy. If HbA1c result not available at time of enrollment, participant can have blinded screening CGM initiated, but results will be needed prior to randomization to verify eligibility

Exclusion Criteria

Unwillingness to attend routine antenatal obstetric appointments

Signs of abnormal fetal or placental development (suspected fetal anomaly or placenta accreta spectrum, low PAPPA) at first routine prenatal visit/ultrasound

Planned termination of pregnancy or any indications of miscarriage

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Initial CGM Assessment

Participants wear a hidden CGM sensor to check for high blood sugar, with assessments at 5 and 10 days

2 weeks

2 visits (in-person)

Randomization and Treatment

Participants meeting criteria are randomized and monitored with CGM, while others form an observational cohort

30 weeks

Periodic visits every 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

15 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• CGM

Trial Overview The study tests whether continuous glucose monitoring (CGM) helps in the early detection and management of high blood sugar during pregnancy. It looks at potential baby health issues like size at birth and NICU needs as well as mother's risk of developing high blood pressure related to pregnancy.

How Is the Trial Designed?

Group I: Glucose Lowering Group Experimental Treatment 1 Intervention

Group II: Observational Active Control 1 Intervention

Group III: Usual Care Group (with periodic blinded CGM) Active Control 1 Intervention

Who Is Running the Clinical Trial?

Jaeb Center for Health Research

Lead Sponsor

Trials

162

Recruited

36,200+

The Leona M. and Harry B. Helmsley Charitable Trust

Collaborator

Trials

69

Recruited

101,000+

DexCom, Inc.

Industry Sponsor

Trials

151

Recruited

35,700+

Kevin Sayer

DexCom, Inc.

Chief Executive Officer since 2015

Bachelor’s and Master’s degrees in Accounting and Information Systems from Brigham Young University

Dr. Shelly Lane

DexCom, Inc.

Chief Medical Officer since 2023

MD from University of California, San Diego

Abbott

Industry Sponsor

Trials

760

Recruited

489,000+

Dr. Etahn Korngold

Abbott

Chief Medical Officer

MD, Harvard Medical School

Robert B. Ford

Abbott

Chief Executive Officer since 2020

Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business

Published Research Related to This Trial

In a study involving 55 pregnant women with diabetes, the continuous glucose monitoring system (CGMS) provided valuable insights that altered clinical management decisions in 62% of cases, helping to identify previously undetected glucose fluctuations.

Patient feedback was largely positive, with 77% of respondents feeling that the benefits of using CGMS outweighed any inconvenience, indicating good tolerability and perceived usefulness in managing diabetes during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. McLachlan, K., Jenkins, A., O'Neal, D.[2009]

In a study of 50 women with insulin-treated gestational diabetes, those using continuous glucose monitoring (CGM) showed a significantly lower increase in HbA1c levels compared to those receiving standard care, indicating better blood sugar control during pregnancy.

The CGM group had a higher percentage of participants achieving target HbA1c levels (92% vs. 68% in the control group) without experiencing severe hypoglycemia, suggesting that CGM is a safe and effective tool for managing gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring results in lower HbA1c in Malaysian women with insulin-treated gestational diabetes: a randomized controlled trial. Paramasivam, SS., Chinna, K., Singh, AKK., et al.[2022]

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]

The study evaluated blood glucose levels in 19 women (7 with diet-controlled GDM, 5 with insulin-controlled GDM, and 7 healthy pregnant women) using a continuous glucose monitoring system (CGMS) over 72 hours, finding that glucose levels were effectively controlled in GDM patients, similar to healthy controls.

Despite effective control of glucose levels through self-monitoring, CGMS revealed significant fluctuations in blood glucose levels, indicating that CGMS could provide valuable insights into asymptomatic periods of hyperglycemia and hypoglycemia in pregnant women with and without GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of metabolic control in women with gestational diabetes mellitus by the continuous glucose monitoring system: a pilot study. Cypryk, K., Pertyńska-Marczewska, M., Szymczak, W., et al.[2021]

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]

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]

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]

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/PMC11486575/

Continuous Glucose Monitoring for Diabetes Management ... Evidence for the role of CGM in pregnant people with T2D and GDM is currently lacking but clinical trials are underway or anticipated soon.

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

Continuous glucose monitoring system in diabetes in pregnancy A retrospective cohort study evaluating 65 pregnant women with T2D and GDM found that both isCGM and rtCGM improved glycemic control. However, ...

5. 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).

6. 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, ...

7. 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 ...

8. drc.bmj.com drc.bmj.com/content/12/3/e003989

Glucose levels measured with continuous ... Mean glucose levels and time 63–120 mg/dL (3.5–6.7 mmol/L) remained nearly stable throughout pregnancy and values above 140 mg/dL (7.8 mmol/L) were rare.