Continuous vs Finger-stick Glucose Monitoring for Type 2 Diabetes in Pregnancy

(PRECIOUS Trial)

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Thomas Jefferson University

Disqualifiers: Type 1 diabetes, Insulin allergy, others

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

Compensation: Varies

Number of Visits: 2

Duration: 20-35 weeks

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how well pregnant women with type 2 diabetes manage their blood sugar using two methods: continuous glucose monitors and finger-stick tests. The researchers aim to determine which method better helps expectant mothers maintain their blood sugar levels, crucial for reducing risks such as larger babies or delivery complications. Participants will either use a small device on their arm that frequently checks blood sugar (continuous glucose monitoring) or test it themselves several times a day with a finger prick (fingerstick glucose monitoring). Ideal participants are pregnant women with type 2 diabetes who began prenatal care before 20 weeks of pregnancy. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance diabetes management for pregnant women.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these glucose monitoring methods are safe for pregnant women with type 2 diabetes?

Research has shown that continuous glucose monitoring (CGM) during pregnancy can lead to better health outcomes for women with diabetes. Studies have found that CGM helps manage blood sugar levels more effectively, benefiting both mother and baby. For example, some studies indicate that women using CGM achieve better blood sugar control compared to those using traditional methods like finger-stick glucose monitoring (FSG).

However, for people with type 2 diabetes, CGM has not always improved outcomes like baby size or conditions such as preeclampsia. Despite this, CGM is generally easy to use. It involves wearing a small sensor on the skin that checks blood sugar levels every few minutes.

In contrast, FSG requires pricking the finger to obtain a blood sample several times a day. While safe and commonly used, this method can be uncomfortable and inconvenient.

Both CGM and FSG are safe for monitoring blood sugar during pregnancy. CGM might provide more continuous information, aiding better management, but both methods have their advantages and disadvantages. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two different ways to monitor glucose levels in pregnant women with Type 2 diabetes. Continuous glucose monitoring (CGM) offers real-time tracking of blood sugar levels through a wearable device, which can provide a more comprehensive picture than traditional methods. This could potentially lead to better glucose control and fewer complications during pregnancy. On the other hand, the fingerstick method requires multiple daily manual checks and logging, which is the current standard. By comparing these two approaches, researchers hope to find out if CGM can offer a more convenient and effective way to manage diabetes during pregnancy.

What evidence suggests that this trial's glucose monitoring methods could be effective for managing type 2 diabetes in pregnancy?

This trial will compare continuous glucose monitoring (CGM) with fingerstick glucose monitoring (FSG) for managing blood sugar in pregnant women with diabetes. Research has shown that CGM can be more effective than FSG, as it better controls blood sugar by lowering hemoglobin A1c levels, which reflect average blood sugar over time. This improvement can lead to better outcomes for both mothers and babies, such as reducing the risk of larger babies or birth complications. In contrast, FSG is a traditional method that involves pricking the finger to check blood sugar several times a day. While effective, it might not provide as complete a picture of blood sugar patterns as CGM does. Overall, CGM offers a more thorough way to monitor blood sugar, potentially leading to better diabetes management during pregnancy. Participants in this trial will be randomized to either the CGM arm or the FSG arm to evaluate these outcomes. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals with pregestational type 2 diabetes. Participants will be monitoring their blood sugar levels throughout pregnancy to manage risks associated with high blood sugars, such as larger babies and higher rates of cesarean delivery.

Inclusion Criteria

Initiation of prenatal care at less than 20 weeks gestation

Singleton pregnancies

Fetuses without anomalies

Exclusion Criteria

Allergy to insulin

I have been diagnosed with Type 1 diabetes.

I cannot use a continuous glucose monitor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants are randomized to either continuous glucose monitoring or finger stick glucose monitoring from enrollment to delivery

20-35 weeks

Every 1-2 weeks (in-person)

Follow-up

Participants are monitored for neonatal and maternal outcomes after delivery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring
• Fingerstick Glucose Monitoring

Trial Overview The study compares two methods of monitoring blood sugar: traditional fingerstick glucose monitoring (FSG) versus continuous glucose monitoring (CGM). Patients are randomly assigned to one method and must adhere to the testing regimen until delivery.

How Is the Trial Designed?

Group I: Continuous glucose monitoring Active Control 1 Intervention

Patients in this arm of the study will use a continuous glucose monitoring device for glucose monitoring throughout their pregnancy, linked with a HIPAA-compliant digital application that will document measurements.

Group II: Finger stick blood glucose monitoring Active Control 1 Intervention

Patients randomized to this arm will perform finger stick blood glucose measurements 4x daily (fasting and 2 hours after each meal) and document their measurements in a glucose log.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Sidney Kimmel Cancer Center at Thomas Jefferson University

Collaborator

Trials

164

Recruited

10,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11563523/

Continuous glucose monitoring in pregnant women with ... Results: Of 34 articles screened, three reported CGM outcomes in T2DM pregnancies compared to self-monitoring of blood glucose (SMBG). Other feasibility and ...

2. 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 ...

3. ajog.org ajog.org/article/S0002-9378(25)00217-0/fulltext

Evidence for improved glucose metrics and perinatal ... Across diabetes in pregnancy, continuous glucose monitoring (vs self-monitoring of blood glucose) decreased hemoglobin A1c (mean difference, −0.22% [95% ...

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/S0002937825002170

Evidence for improved glucose metrics and perinatal ... Across diabetes in pregnancy, continuous glucose monitoring (vs self-monitoring of blood glucose) decreased hemoglobin A1c (mean difference, −0.22% [95% ...

8. diabetesjournals.org diabetesjournals.org/care/article/47/1/89/153675/Association-of-Continuous-Glucose-Monitoring

Association of Continuous Glucose Monitoring Metrics With ... Nearly all CGM metrics were associated with adverse neonatal morbidity and mortality and may aid management of preexisting diabetes in pregnancy.

9. ajog.org ajog.org/article/S0002-9378(22)01433-8/fulltext

Adverse pregnancy outcomes in people with Type 2 ... Among people with T2DM or GDM who utilized CGM during pregnancy, 4 out 10 individuals had TIR < 70% and they are at significantly higher risk of adverse ...

10. clinicaltrials.gov clinicaltrials.gov/study/NCT05947916;

Real Time Continuous Glucose Monitoring System in ... Secondary outcomes included differences in glycated hemoglobin, hypoglycemia, insulin dose before delivery, pregnancy weight gain, and maternal and infant ...