How do you build a better hospital glucose sensor? Very carefully it seems, with lots of input from everyone who could possibly be affected by the effort. At least that's the approach the FDA is taking on the matter.
The regulatory agency is convening a day-long, public meeting on June 25, where they want clinicians, researchers, government regulators, the device industry clinical laboratories and others to chime in on the best way to develop clinical validation studies for such devices and, in turn, judge the performance of them. The free session will be at the FDA's White Oak Campus in Silver Spring, MD, and also be webcast.
Here's why this matters: To no one's surprise at this point, diabetes cases continue to soar in the U.S. and around the world. And hospital glucose monitoring sensors/meters/devices (a different bird from their portable or home monitoring counterparts) are a crucial part of the device ecosystem that helps manage the disease. And companies, including Abbott, are working on developing next-generation hospital glucose monitoring systems as they seek to compete in the space.
As the FDA explains, they see "innovative" hospital glucose sensors as being enormously helpful for patients in the hospital because they'd be inserted and enable continuous monitoring for each patient, but "they are not widely available." Among the obstacles contributing to this: clinical study design, deciding what patients to include in trials and what data would indicate whether the devices are performing like they should. Another struggle from the FDA's perspective: The notion that monitoring systems could come up with differences in glucose concentrations from arteries and veins from the same patient.
Regulators said they simply want every party affected by hospital glucose systems to talk to each other, share information and get some of the affected parties to collaborate more as they develop these devices.
- here's the FDA announcement