Advancements on the accuracy of BGM devices
This year’s focus concerned BGM accuracy in the point-of-care settings compared to home usage. Accuracy in this sense meant devices meeting regulatory standards (e.g., CLIA waived Nova Biomedical StatStrip), but also related to pre-analytical factors that can impact the accuracy of BGM. We heard from, Dr. Leslie Landree, team leader for the FDA’s Diabetes Diagnostics Devices Branch. She noted that the YSI 2900, currently not approved by the FDA, will soon phase out YSI 2300, signifying real change in diabetes treatment.
Harnessing technology to develop smarter CGMs
We also learned that Abbott provided insights on improving the MARD (Mean Absolute Relative Difference) of the 14-day FreeStyle Libre compared to the 10-day version through enhancing factory calibration methods. While, Medtronic presented updates on the development of a potential self-calibrating sensor leveraging Electrochemical Impedance Spectroscopy (EIS) technology.
In addition to well established manufacturers, several emerging developers presented updates on their progress. Waveform showed an internal study demonstrating that its Cascade CGM system, which is scheduled for commercialization in 2019, performed relatively on par with available CGM products.
Biorasis continued the development of its Glucowizzard implantable CGM (measuring 0.75 x 6 mm) that transmits glucose data to a smart watch. Notably, Lifecare showcased how it is leveraging 3D printing technology to develop a CGM device, enabling faster iterations of its designs during the development process. Posters presented by PercuSense, Eyesense, and a research group from the University of North Carolina (led by Dr. Koji Sode) on CGM development, underscore the growing focus in this category.
It was also encouraging to see that Convatec is developing a single on-body product with both a CGM probe and a redesigned insulin cannula, showing that advancements are being made in this area. Pacific Diabetes Technology is also working on a single CGM sensor and insulin infusion product. CapBio presented details on developing a cannula that limits tissue inflammation, enabling greater insulin absorption and potential for greater wear time. Taken together, these technology advances underscore the growing demand for safer and more comfortable on-body devices.
Pushing the development of AID systems
An area that generated strong interest focused on the progress of interoperable devices, leading to advancements in the development of AID systems. Panel sessions led by members of the FDA highlighted the need for establishing quality standards (e.g., iCGM criteria and digital health pre-certification) to ensure the safety of diabetes patients, while simultaneously accelerating the regulatory pathway for AID systems.
While AID systems have certainly improved diabetes management, inherent challenges such as multiple on-body products (separate CGM sensor and insulin infusion set), cannula occlusions, and skin irritations are still key developmental hurdles to overcome.
This event showed that there is growing evidence that wearable AID devices will play a larger role in diabetes management, while accuracy of sensor-based devices is improving.
While this year’s DTM highlighted the varying developments in the field, we look forward to seeing even more progress at the Advanced Technologies and Treatment for Diabetes (ATTD) conference in Berlin, Germany in February 2019, and we hope to see you there.