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

Trial Summary

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 data supports the effectiveness of the treatment CGM for gestational diabetes?

Research shows that continuous glucose monitoring (CGM) can improve blood sugar control and reduce complications for pregnant women with gestational diabetes, similar to its benefits in other types of diabetes. ^{1 2 3 4 5}

Is continuous glucose monitoring safe for humans?

Continuous glucose monitoring (CGM) has been studied in pregnant women with gestational diabetes and other types of diabetes, showing it helps manage blood sugar levels. While these studies focus on effectiveness, they do not report significant safety concerns, suggesting CGM is generally safe for use in humans. ^{1 2 4 5 6}

How does continuous glucose monitoring differ from other treatments for gestational diabetes?

Continuous glucose monitoring (CGM) is unique because it provides real-time tracking of blood sugar levels throughout the day and night, allowing for more precise management of gestational diabetes compared to traditional methods like self-monitoring blood glucose (SMBG), which involves periodic finger-prick tests. ^{4 6 7 8 9}

What is the purpose of this trial?

The goal of this clinical trial is to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy. The main questions it aims to answer are: (1) any problems for the baby, such as being too large for their age, shoulder injuries (like broken bones), high bilirubin levels needing light treatment, low blood sugar, or needing to stay in the NICU; (2) any high blood pressure issues for the mother during pregnancy.

Research Team

Celeste Durnwald, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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 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 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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Continuous glucose monitoring results in lower HbA1c in Malaysian women with insulin-treated gestational diabetes: a randomized controlled trial. [2022]

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

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

3. 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]

4. 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]

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

Efficacy of continuous glucose monitoring on maternal and neonatal outcomes in gestational diabetes mellitus: a systematic review and meta-analysis of randomized clinical trials. [2022]

6. 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]

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

Evaluation of metabolic control in women with gestational diabetes mellitus by the continuous glucose monitoring system: a pilot study. [2021]

9. Australia pubmed.ncbi.nlm.nih.gov

The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. [2009]