Thomas Jefferson University and the Sidney Kimmel Cancer Center have launched a new clinical trial to evaluate the effectiveness of continuous glucose monitoring (CGM) compared to traditional finger-stick glucose monitoring for managing pregnancies complicated by type 2 diabetes. The study, listed on ClinicalTrials.gov, aims to determine if CGM fosters better adherence to diabetes management protocols and improves outcomes for mothers and babies. Recruitment is expected to begin in late 2025.
Why it matters
Effective diabetes management during pregnancy is critical for reducing maternal and fetal health risks. For patients with type 2 pregestational diabetes, fluctuations in glucose levels can lead to complications such as preterm delivery, preeclampsia, and neonatal hypoglycemia. Accurate and timely blood glucose monitoring is a cornerstone of care, but the best method of monitoring remains an area of ongoing research. This study has the potential to shape future guidelines and technologies for diabetes management in pregnant populations.
Who is conducting the study?
The trial is sponsored by Thomas Jefferson University and the Sidney Kimmel Cancer Center, institutions recognized for their contributions to advancing medical science. As of October 2023, the study is listed as “Not yet recruiting.” Prospective participants and stakeholders are encouraged to follow updates as the study progresses nearer to its recruitment start date, projected for late 2025.
Study details
What is being tested?
Two monitoring devices will be compared:
- Continuous Glucose Monitor: A wearable device that tracks blood glucose levels continuously throughout the day and night, providing real-time data.
- Glucometer: A traditional device used for manual finger-stick blood glucose measurements, typically performed multiple times daily.
How will the study be conducted?
The trial will assess adherence rates and health outcomes among pregnant patients who utilize CGM systems versus those who rely on glucometers. Participants will include individuals with type 2 diabetes diagnosed prior to pregnancy. Researchers aim to establish whether the continuous monitoring method is more effective in supporting glycemic control, informing regulatory decisions on broader implementation of CGM technology.
Expected implications
The results could influence international guidelines for diabetes management during pregnancy. If CGM demonstrates superior adherence and improved clinical outcomes, regulatory bodies might consider updating product labels, indications, or reimbursement policies for CGM systems. This may also shift practices in antenatal care, particularly for women with high-risk pregnancies.
FAQ
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What are the primary aims of the study?
The trial seeks to evaluate whether continuous glucose monitoring improves adherence to glucose monitoring protocols and leads to better maternal and neonatal outcomes compared to traditional finger-stick testing.
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Who can participate in the study?
The study targets pregnant women diagnosed with type 2 pregestational diabetes mellitus. Recruitment details will be announced closer to the launch date.
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What is continuous glucose monitoring?
Continuous glucose monitoring (CGM) involves wearing a device that provides real-time feedback on blood glucose levels, offering a more comprehensive view than periodic finger-stick testing.
Conclusion
This upcoming clinical trial is an important step toward improving diabetes management in pregnancy, with the potential to enhance patient adherence to monitoring protocols and reduce health risks. Stakeholders, including healthcare providers and regulatory bodies, should monitor the evidence as the study unfolds. Outcomes from this research may pave the way for broader adoption of CGM devices in routine prenatal care.
Disclaimer
This article is intended for informational purposes only and does not constitute legal advice. Readers should consult regulatory and healthcare professionals for specific guidance related to medical devices and clinical studies.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07184775?term=medical+device