DreaMed Diabetes AI has received US Food and Drug Administration (FDA) clearance to expand its platform’s target population to patients with both type 1 and type 2 diabetes, it said Wednesday in a press release.
The company’s Advisor Pro is the first “decision support system” that has been cleared to assist healthcare providers in the management of diabetes patients who use insulin pumps or injections and monitor their glucose using continuous glucose sensors and/or blood-glucose meters.
“There are simply not enough endocrinologists to provide the expert level of care that all people with diabetes require continuously,” DreaMed founder and CEO Eran Atlas said. “In the US alone, there are over 41,000 adults per endocrinologist, which results in more than 50% of all people with diabetes who are not well managed due to limited access to proper care.
“DreaMed empowers the medical staff to treat significantly more patients by providing access to expert endocrinological advice in primary-care settings.
“We can potentially help avoid thousands of unnecessary hospitalizations and medical complications for the community of people with diabetes and change the overall standards of care in this sector. The FDA clearance puts us on a path to help millions of people with diabetes, and our next step is to develop and extend our solution to cover all injectable or oral medications for diabetes.”
An estimated 463 million adults currently have diabetes, or 9.3% of the world’s adult population, and that number is predicted to rise to 578 million (10.2%) by 2030 and to 700 million (10.9%) by 2045. Annual global health expenditure on diabetes is estimated to be $760 billion and is expected to reach $845b. by 2045.
The health costs of treating the complications of diabetes account for more than 50% of the direct health costs of diabetes. Type 2 diabetes accounts for around 90% of diabetes cases worldwide.
DreaMed Advisor Pro previously received a CE marking for commercial products and was cleared by the FDA for people with type 1 diabetes using insulin-pump therapy with continuous glucose sensors and/or blood-glucose meters. It is already deployed by various diabetes treatment centers, including Yale New Haven Health, Texas Children’s Hospital and the University of Florida, DreaMed said.