Diabetes management startup Tidepool has just locked in a $6 million grant from the Leona M. and Harry B. Helmsley Charitable Trust and JDRF in order to kick off develop an app for hybrid closed-loop automated insulin delivery.
Eventually the company plans to bring the software to market as an FDA-regulated mobile app. Right now the plans are to build an app that is specifically designed to help people living with Type 1 diabetes dose themselves through an algorithm.
Why it matters
Tidepool poses its app as a way to alleviate the burden of people with Type 1 diabetes who must continually check their blood glucose level. The idea is for an algorithm to be able to dose the right amount of insulin at the appropriate time instead of making the user continually check themselves.
"This is exactly what we dreamed of when we launched the JDRF Open Protocol Initiative in 2017 – to accelerate innovation, give users greater control over insulin delivery devices, and expand their ability to choose system components that work best for them," Dr. Aaron Kowalski, chief mission officer for JDRF, said in a statement. "Through the Tidepool Loop project, Tidepool will demonstrate the power and value of an interoperable ecosystem of diabetes devices, giving people with diabetes more options for better control with less burden."
What's the trend
Tidepool is noteworthy as it was one of nine companies selected to participate in the FDA’s Pre-Cert pilot. The program is designed so that companies can work with the agency to prove its overall development processes are reasonable and safe with the possibility of negating the need for product-by-product regulation. The pilot was designed to work with companies of various size but does include some big names like Apple, Samsung, Verily and Johnson&Johnson.
Tidepool President and CEO Howard Look has been publicly supportive of the efforts.
“The FDA is now pulling industry to go faster, but industry has not yet responded,” he wrote in a blog post last January. “Many companies are still being guided by old-school regulatory groups that believe they need to comply with old-school regulatory guidance, much of which was invented before the Internet even existed. This overly conservative approach is causing digital health products to take way too long to get into the public’s hands, and this delay is a detriment to public health and corporate bottom line.”
The company has also been dipping its toes into the sleep space. In August it announced that it has teaming up with Evidation Health to launch a connected device-powered study of nocturnal hypoglycemic events in people with Type 1 diabetes.
On the record
"Tidepool's mission has always been to build and deliver ground-breaking software that helps people living with diabetes," Look said in a statement. "With Tidepool Loop, we are building upon the incredible efforts and innovation of the #WeAreNotWaiting movement, including the work of Nate Racklyeft, Pete Schwamb, Ben West and Katie DiSimone. By taking on Tidepool Loop, we will bring Loop to an even a broader community, make it work with commercial, in-warranty devices, and deliver it through FDA pathways."