Continuous Glucose Monitoring for Gestational Diabetes

(CAPO Trial)

Overseen By Audrey Merriam, MD, MS

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Diabetes medications

Disqualifiers: Pregestational diabetes, Fetal anomalies, Lupus, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 40 weeks gestation

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves women with gestational diabetes requiring medication, it seems likely that you will continue your current diabetes treatment.

How is the continuous glucose monitoring treatment different for gestational diabetes?

The continuous glucose monitoring (CGM) system is unique because it provides real-time, continuous tracking of blood sugar levels, allowing for better management of gestational diabetes by helping patients and doctors see glucose trends and make timely adjustments. Unlike traditional methods that require periodic finger-prick tests, CGM offers a more comprehensive view of glucose fluctuations throughout the day, which can improve both maternal and fetal outcomes. ^{1 2 3 4 5}

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

Research shows that using continuous glucose monitoring (CGM) in women with gestational diabetes can lead to better blood sugar control, as indicated by lower HbA1c levels (a measure of average blood sugar over time) and reduced risk of low blood sugar episodes compared to traditional methods. ^{1 3 5 6 7}

Who Is on the Research Team?

Audrey Merriam, MD, MS

Principal Investigator

Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-50 with a single baby and diagnosed with A2 gestational diabetes needing medication, between 24-36 weeks of pregnancy. It's not for those with pregestational diabetes, multiple babies, fetal growth issues, or certain medical conditions like lupus or chronic hypertension.

Inclusion Criteria

I am a woman aged between 18 and 50.

Pregnant with singleton gestation

I have been diagnosed with gestational diabetes needing medication in my current pregnancy between 24-36 weeks.

Exclusion Criteria

The baby has known health problems before birth.

My current pregnancy has been diagnosed with fetal growth restriction.

You missed three or more prenatal visits before being diagnosed with A2 gestational diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily

Up to 40 weeks gestation

Regular monitoring visits as per standard prenatal care

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postpartum outcomes

Up to 7 days postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitor

Trial Overview The study compares the effects of continuous glucose monitoring versus routine fingerstick blood checks four times daily in managing A2 gestational diabetes during pregnancy. The goal is to see if constant monitoring can reduce complications such as high birth weight and neonatal hypoglycemia.

How Is the Trial Designed?

Group I: Continuous Glucose Monitor Experimental Treatment 1 Intervention

Monitoring of control of gestational diabetes with use of a continuous glucose monitor

Group II: Routine Care Active Control 1 Intervention

Monitoring of control of gestational diabetes with routine care and use of a glucometer and fingersticks 4 times a day

Continuous Glucose Monitor is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Insulin-treated Diabetes

Approved in European Union as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes
• Gestational Diabetes

Approved in Canada as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Approved in Japan as Continuous Glucose Monitor for:

• Type 1 Diabetes
• Type 2 Diabetes

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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]

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]

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 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 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]

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]

Citations

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

The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. [2006]

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

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

3. 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]

4. 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]

5. 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]

6. Australia pubmed.ncbi.nlm.nih.gov

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

7. 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]