First FDA-cleared CGM-informed automatic insulin titration solution for people with type 2 diabetes using both basal-only and multiple daily injection treatment regimens.
PETAH TIKVA, Israel – [MONTH DAY, 2026] – DreaMed Diabetes Ltd. today announced that the U.S. Food and Drug Administration has granted 510(k) clearance to MODI, establishing the first FDA-cleared insulin therapy adjustment medical app that optimizes both basal-only and multiple daily injection (MDI) plans for adults with type 2 diabetes. MODI provides dose recommendations directly to patients without requiring healthcare provider review or approval of each recommendation. The clearance opens a major new category in insulin care. Approximately 85% of people who use insulin rely on injections and have remained outside the benefits of automated titration1. In the United States alone, more than eight million people inject insulin1, 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.
MODI is a prescription, CGM-informed insulin therapy adjustment medical app for adults age 18 and older with type 2 diabetes using injectable long-acting insulin, with or without rapid-acting insulin. Building on DreaMed’s proven algorithmic expertise, MODI translates a patient’s CGM patterns and insulin data into clear insulin dosing recommendations, delivered directly through a mobile application. For the healthcare provider, MODI is designed to take complexity out of insulin adjustment and provide greater confidence that insulin therapy is being actively optimized between visits. The result is an easy-to-deploy tool that enables more consistent self-management between clinic visits.
“Today we can track glucose continuously, but insulin treatment is still only adjusted months apart,” said Eran Atlas, Co-founder and Chief Executive Officer of DreaMed Diabetes. “Data alone does not improve the health of patients; value is created when data is transformed into a timely, personalized recommendation patients can act on. MODI allows people with type 2 diabetes to get ongoing, data-driven guidance between visits. It brings the benefits of advanced diabetes technology to the millions of insulin users who inject, and puts DreaMed at the center of a promising new category in diabetes care.”
About DreaMed Diabetes
DreaMed Diabetes is a diabetes AI 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. For more information, visit www.dreamed.ai.
1 Estimated based on https://diabetes.org/newsroom/american-diabetes-association-announces-support-for-insulin-act-at-senate-press-conference