Insulin Algorithms said today that its decision-support software, designed to help clinicians manage insulin for patients with diabetes, won FDA clearance.
The company’s software allows clinicians to analyze a patient’s blood sugar measurements regularly and develop an optimized plan for the patient’s insulin regimen. The software was developed with algorithms that are clinically proven to lower blood sugar, according to the company.
Insulin Algorithms’ software also has CE Mark clearance, so it is approved for sale in both the U.S. and Europe.
More than half of patients with diabetes in the U.S. fail to meet the American Diabetes Association’s recommended blood glucose target, the company said.
“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,” CEO Josh Davidson said in prepared remarks. “Because of the shortage of endocrinologists, 90% of patients see their primary care provider for diabetes care. This results in a 6- to 7-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.”