A new clinical trial focusing on continuous glucose monitors (CGMs) is set to begin soon, promising new insights into their impact on diabetes readmission rates. Conducted by the University of Maryland, Baltimore, with support from DexCom, Inc., this study will utilize CGMs in monitoring diabetes patients. Clinical, quality, and regulatory professionals may find this research pivotal for understanding the role of this medical device in improving patient outcomes.
What changed?
On October 31, 2025, ClinicalTrials.gov published details of an upcoming trial exploring whether CGMs reduce readmission rates for diabetes patients. The use of CGMs in patient management could potentially offer a significant breakthrough in how patients with diabetes are monitored across clinical settings, leading to enhanced care and reduced hospital visits.
Clinical trial details
The study, titled “Continuous Glucose Monitors (CGMs) and Readmission Rates,” is sponsored by the University of Maryland, Baltimore, alongside DexCom, Inc., a recognized leader in glucose monitoring technology. The trial involves two groups of participants:
- The Device Group: Participants using CGMs for glucose management.
- The Control Group: Participants managing diabetes without CGMs.
Although not yet recruiting, this trial aims to examine whether CGMs offer measurable benefits in managing blood glucose levels and minimizing hospital readmissions.
The regulatory significance of such trials lies in their ability to offer robust evidence for healthcare professionals, insurers, and policymakers to reconsider the integration of CGMs into standard diabetic care protocols.
Prospective participants and their respective healthcare navigators should explore the official trial page for eligibility and recruitment updates: NCT07221812.
What is the potential impact?
CGMs have been a transformative technology for diabetes management, offering real-time glucose readings with minimal inconvenience to patients. This study focuses on their efficacy in reducing readmission rates, which is a significant concern for healthcare providers and systems worldwide.
If the study confirms reduction in readmissions, CGMs could become a cornerstone tool in diabetes management strategies. Insurers may adapt coverage policies, and healthcare facilities could incorporate CGM-based protocols to improve patient outcomes. However, any decision to classify CGMs more broadly will require extensive safety and performance evaluations, as defined under current medical device regulations, including MDR and FDA guidance.
Healthcare providers, patients, and regulatory experts should monitor the findings closely as they could influence the trajectory of medical device adoption in diabetes care.
FAQs
1. What is the purpose of this trial?
The study will assess if CGMs reduce hospital readmission rates in diabetes patients.
2. Who is conducting the trial?
The trial is led by the University of Maryland, Baltimore, in collaboration with DexCom, Inc.
3. What are the two intervention groups?
One group uses CGMs for glucose monitoring, while the control group does not.
4. Is the trial currently recruiting?
No, the study is “Not yet recruiting.” Recruitment updates may be available on ClinicalTrials.gov.
Conclusion
The upcoming trial on using continuous glucose monitors to reduce diabetes-related hospital readmissions represents a significant step in assessing the effectiveness of advanced medical devices. Clinical and regulatory professionals should watch this trial closely for potential implications in diabetic care protocols and device regulation. Stakeholders can visit the official announcement link for more information.
Disclaimer
This content is intended for informational purposes and does not serve as legal or regulatory advice. Professionals should consult official guidance or legal advisors when making decisions regarding medical device regulation or integration.
Full announcement
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07221812?term=medical+device