FDA Clears Comprehensive Insulin-Titration Software for Clinicians

The U.S. Food & Drug Administration has cleared as a Class II medical device Insulin Algorithms’ decision-support software, which helps clinicians manage every type of insulin for diabetes treatment. Culminating a lifetime of clinical practice and research led by renowned endocrinologist and former American Diabetes Association (ADA) president Mayer B. Davidson, M.D., Insulin Algorithms’ software makes it easy for a clinician to regularly analyze a patient’s blood sugar measurements and quickly optimize their insulin regimen. The software is based on algorithms that are clinically proven to lower HbA1c even in challenging patient populations, no matter what insulin regimen they are on. This makes it possible to achieve better health outcomes, save billions of dollars in annual health care spending, and reduce rates of diabetes-related complications. With FDA clearance and its previous CE registration, Insulin Algorithms’ decision-support software can now be marketed and sold in both the United States and Europe.
 
High blood glucose in people with diabetes is the third highest risk factor for premature mortality. Over half of U.S. diabetic patients fail to reach the ADA’s recommended HbA1c target, and failure rates in reaching HbA1c targets are higher in other countries. While there is significant industry focus on modifying patients’ behavior with apps and self-management of insulin injections, Insulin Algorithms takes a different approach to diabetes care. “Think of the tiny percentage of people who keep their New Year’s resolutions, and then ask yourself how realistic it is to expect millions of diabetic patients to make lifelong behavioral changes,” said Josh Davidson, CEO of Insulin Algorithms. “Because of the shortage of endocrinologists, 90 percent of patients see their primary care provider for diabetes care. This results in a six- to seven-year delay in the initiation of insulin and elevated blood sugar levels once patients are prescribed insulin. We designed our software to close this clinical care gap.”
 
Insulin Algorithms’ chief medical officer, Mayer B. Davidson, M.D., is world-renowned for pioneering algorithm-based insulin titration. A former ADA President and recipient of the ADA’s 2016 Outstanding Physician-Clinician in Diabetes award, Dr. Davidson has spent more than 50 years in clinical practice and research. He has trained thousands of clinicians to achieve dramatic reductions in HbA1c using his algorithms, expanding access to care for the patients who need it most. As an affordable, easily adoptable tool for every sized practice, from large EHR-based systems to individual practices, Insulin Algorithms’ software is the culmination of Dr. Davidson’s work.