Recent observational and randomized controlled studies in the hospital setting have reported acceptable accuracy and a greater ability to detect hypoglycemia of intermittently scanned and real-time CGM when compared with capillary POC testing. RCTs have also reported on the safety and efficacy of real-time CGM in guiding daily insulin adjustment in hospitalized patients with Type 1 and Type 2 diabetes. CGM provides information about glucose concentration, direction, and rate of change over a period of several days, as well as to guide insulin administration in patients with diabetes.

Continuous glucose monitors (CGMs) are an important technology for improving glycemic outcomes in diabetes. However, in most care settings, CGM data is siloed in manufacturer-specific data platforms, and is not integrated with the electronic health record (EHR). The state of CGM-EHR integration has advanced rapidly in recent years and the 2022 iCoDE report organized by the Diabetes Technology Society laid out a comprehensive and practical approach for integration. New policies, technologies, and funding mechanisms will need to be put in place to ensure broad access to and implementation of CGM-EHR integrations.

The COVID pandemic demanded that the FDA respond in ways that, arguably, it had not done previously, This was especially the case for in vitro diagnostics. That extraordinary effort left in its wake a legacy of positives and negatives for the FDA's regulation of IVDs. This talk will highlight what the industry can expect from the agency going forward, both the good and the challenging. This includes the impact on the FDA personnel, the FDA review process, the IVD industry, and the FDA's willingness to consider broader home testing.

Speed-to-market and controlling costs are critical factors for manufacturers assessing their clinical study strategies. Study design and execution needs to ensure all FDA requirements are met while at the same time limiting over-enrollment and longer study timelines that inevitably increase costs to sponsors. We will present strategies that support fast and efficient study design for a range of POCT devices.

Your end user influences product performance, from market research through clinical trials. Ensuring that you design for these end users, their use environments, capabilities, and biases is vital to product success. Capturing requirements early and iteratively reaffirming them with testing is critical to this goal. This presentation will talk about how to identify end users, generate relevant requirements, and execute necessary usability testing that brings confidence to all stakeholders.

The trend toward increased point-of-care testing was accelerated due to the COVID-19 pandemic. Patients now expect high-quality results with far greater convenience. Point-of-care testing must give the appropriate results in a timely fashion while also being easy enough to be performed by people with different trainings.

The COVID-19 pandemic brought about significant shifts in the diagnostic testing landscape as it pertains to public health outbreaks and emergencies. We witnessed the rapid expansion of both point-of-care testing and self-testing that empowered patients and providers as never before. These advances will continue to impact future public health threats, and we must embrace the role of private sector clinical diagnostics in future public health responses.

The way that Medicare laboratory reimbursement is currently set under PAMA results in uniquely challenging dynamics for point-of-care tests. Understanding how PAMA impacts the Medicare Clinical Laboratory Fee Schedule and how point-of-care testing fits into that system has implications for legislative, regulatory, and coding reform.

Families Fighting Flu will share a personal story on how serious the flu can be and the importance of taking symptoms seriously and seeing a healthcare provider for accurate testing to receive appropriate treatment.