Continuous Glucose Monitoring for Gestational Diabetes
(CAPO Trial)
Recruiting in Palo Alto (17 mi)
Overseen byAudrey Merriam, MD, MS
Age: 18 - 65
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Yale University
Must be taking: Diabetes medications
Disqualifiers: Pregestational diabetes, Fetal anomalies, Lupus, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
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.
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.
12345How 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.
23567Eligibility Criteria
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.
+6 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Continuous Glucose MonitorExperimental Treatment1 Intervention
Monitoring of control of gestational diabetes with use of a continuous glucose monitor
Group II: Routine CareActive Control1 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, Australia 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
🇦🇺 Approved in Australia as Continuous Glucose Monitor for:
- Type 1 Diabetes
- Type 2 Diabetes
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Yale UniversityNew Haven, CT
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Who Is Running the Clinical Trial?
Yale UniversityLead Sponsor
References
Real-Time Continuous Glucose Monitoring in Gestational Diabetes: A Randomized Controlled Trial. [2022]To evaluate whether real-time continuous glucose monitoring improves glycemic control over intermittent self-monitoring of blood glucose in gestational diabetes.
The Continuous Glucose Monitoring System during pregnancy of women with type 1 diabetes mellitus: accuracy assessment. [2006]The Continuous Glucose Monitoring System (CGMS, Medtronic MiniMed, Northridge, CA) allows close monitoring of glucose patterns and might be helpful in explaining the persistence of high complication rates in pregnancies of women with type 1 diabetes. It was the aim of this study to determine whether the CGMS accurately reflects glucose levels in pregnant women with type 1 diabetes mellitus.
[Clinical use of continuous glucose monitoring system in gestational diabetes mellitus and type 2 diabetes complicated with pregnancy]. [2022]To compare the clinical use of continuous glucose monitoring system (CGMS) and self-monitoring blood glucose (SMBG) when monitoring blood glucose level of patients with gestational diabetes mellitus (GDM) or type 2 diabetes mellitus (DM) complicated with pregnancy.
Continuous glucose monitoring results in lower HbA1c in Malaysian women with insulin-treated gestational diabetes: a randomized controlled trial. [2022]Label="AIMS">To determine if therapeutic, retrospective continuous glucose monitoring (CGM) improves HbA1c with less hypoglycaemia in women with insulin-treated gestational diabetes mellitus (GDM).
Evaluation of metabolic control in women with gestational diabetes mellitus by the continuous glucose monitoring system: a pilot study. [2021]To evaluate the blood glucose concentrations in a group of women with gestational diabetes mellitus (GDM), by the use of a continuous glucose monitoring system (CGMS).
The role of continuous glucose monitoring in clinical decision-making in diabetes in pregnancy. [2009]The continuous glucose monitoring system (CGMS) is a novel tool to assess 24-h glucose fluctuations. In pregnancies complicated by diabetes, where excellent glucose control is desired to improve maternal and fetal outcomes, CGMS may have a role in fine-tuning management.
Use of a real time continuous glucose monitoring system as an educational tool for patients with gestational diabetes. [2020]Women with gestational diabetes mellitus (GDM) are required to control their blood glucose shortly after GDM diagnosis to minimize adverse pregnancy outcomes. A real time-continuous glucose monitoring system (RT-CGMS) provides the patient with continuous information about the alterations in levels of the blood glucose. This visibility may empower the patient to modify her lifestyle and engage in therapeutic management. The aim of this study was to determine whether a single application of RT-CGMS to pregnant women shortly after GDM diagnosis is useful as an educational and motivational tool.