DreaMed Receives FDA Clearance for MODI, Bringing Automated Insulin Dose Recommendations to People with Type 2 Diabetes Using Injections

DreaMed Diabetes Ltd., a global leader in personalized diabetes treatment optimization, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to MODI, a medical app that uses continuous glucose monitoring (CGM) and insulin data to recommend insulin dose adjustments directly to adults with type 2 diabetes using insulin injections. The app generates personalized dose recommendations directly to patients, without requiring a healthcare provider to review or approve each individual adjustment.

The clearance opens a major new category in insulin care, bringing automated insulin optimization to 85% of insulin users who rely on injections and have historically had fewer options for automated dosing support. In the United States alone, more than eight million people inject insulin, and most remain above recommended glucose targets, with many patients going months between insulin adjustments. MODI is designed to close this gap by bringing scalable, personalized insulin optimization into everyday injection therapy.

While automated insulin dosing technologies have largely been developed for people with type 1 diabetes using insulin pumps, MODI is the first app to bring dosing automation to people with type 2 diabetes who rely on injections, including those using both long-acting insulin alone or multiple daily injections (MDI).

MODI is indicated for adults 18 and older with type 2 diabetes who use injectable long-acting insulin, with or without rapid-acting insulin. MODI translates a patient's CGM patterns and insulin data into clear insulin dosing recommendations, delivered directly through a mobile application. Unlike traditional insulin titration workflows that depend on repeated clinician review, MODI does not require providers to configure initial insulin settings or approve each recommendation, allowing insulin therapy to be adjusted between appointments while reducing the need for routine clinical team involvement in ongoing insulin management.

DreaMed Diabetes is a diabetes software company turning complex glucose and insulin data into expert-level treatment guidance. Built on more than a decade of clinical, algorithmic, and regulatory experience, DreaMed develops FDA-cleared solutions that support insulin optimization for healthcare providers and patients. Its endo.digital platform brings decision support into clinical workflows, while MODI extends personalized, CGM-informed dose recommendations directly to eligible adults using insulin injections.

The FDA clearance for MODI marks a significant step forward in the management of type 2 diabetes, particularly for those who rely on insulin injections. By automating the insulin dosing process, MODI aims to improve glucose control and reduce the burden of frequent insulin adjustments, which can be a source of stress and inconsistency in diabetes management. As the number of insulin users continues to grow, MODI represents a valuable tool in the arsenal of diabetes care, offering a more personalized and convenient approach to insulin therapy.