Israeli Firm DreamD Receives FDA Approval for Diabetes App

Israeli company DreamD has received approval from the U.S. Food and Drug Administration (FDA) for its app, Modi, designed to recommend insulin dosage adjustments for adults with type 2 diabetes. The app analyzes continuous glucose monitoring data and insulin treatment records to send personalized recommendations directly to the patient's phone. This marks the first FDA-approved solution of its kind for individuals using only long-acting insulin as well as those who combine it with multiple daily injections of rapid-acting insulin.

Modi operates on a prescription basis, but physicians are not required to pre-determine dosage changes or approve each recommendation individually. DreamD developed Modi to bridge the gap between glucose monitoring and treatment adjustments, as patients often wait months between doctor visits for insulin dose modifications. The app aims to provide patients with data-driven recommendations between clinic appointments.

According to the company, approximately 85% of insulin users rely on injections, representing over eight million people in the U.S. alone, many of whom do not achieve recommended blood sugar levels. While advanced dose adjustment solutions have primarily focused on type 1 diabetes patients using insulin pumps, options for injection users have been limited. DreamD previously received FDA approval for a system assisting medical teams with type 2 diabetes treatment, but Modi directly sends recommendations to the patient.

Eran Atlas, co-founder and CEO of DreamD, stated that Modi enables millions of type 2 diabetes patients using injections to receive timely, data-based guidance, bringing advanced diabetes technology benefits to this population. He highlighted the company's history of tackling difficult challenges, noting this as their third leading innovation in the field, achieved through creative, persistent, and patient work.

The app is named in memory of Mordechai "Modi" Amir, a 67-year-old technology professional from Kibbutz Nir Oz who was killed on October 7. The connection between Amir's family and DreamD was established through the "Next October" remembrance initiative, founded by the family of Yaron Shi, who also fell on October 7. The company chose to name the app after Modi Amir with the family's consent, and this name was used for the FDA submission.