If Tidepool’s diabetes management app Tidepool Loop gains its 510(k) clearance from the Food and Drug Administration (FDA), it will have a significant impact on patients’ ability to attain glycemic control, says GlobalData, a leading data and analytics company. This is especially prominent as only 20-30% of type 1 diabetes (T1D) patients meet their glycemic targets.
Samisha Khangaonkar, Pharma Analyst at GlobalData, comments: “Innovation in digital platforms and devices will be critical for long-term T1D management. Achieving glycemic control and managing hypoglycemia is still a major issue in T1D, as GlobalData has found that over 90% of T1D patients in the US still experience hypoglycemia.”
T1D patients have been developing their own DIY AIDs through apps such as Loop and OpenAPS, which allows patients to program and calculate their own algorithms to work with their CGM sensors and devices. The DIY loops, compared to the marketed AIDs, have a level of transparency that gives patients more control over how the technology actually works. However, these DIY algorithms are not FDA regulated and rely on an insulin pump loophole that was common in pumps developed prior to 2015.
Khangaonkar adds: “The need for a web/app-based controller is well expressed by the open-source diabetes community. It is critical to emphasize the education and data transparency that Tidepool Loop can provide. An education on CGM and data interpretation is critical to management, as KOLs interviewed by GlobalData have noted. The rise of closed loop systems should not translate to glycemic ignorance. T1D is a disease that needs to be actively managed, and while AID systems may make management easier, patients need the data transparency to continue to maintain T1D awareness.”