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FDA clears first app to adjust insulin doses directly for type 2 diabetes patients

DreaMed

Most people who inject insulin still spend months between dose adjustments. That’s not a technology problem. It’s a workflow one. And DreaMed Diabetes may have just solved it.

The Israeli diabetes software company has received FDA 510(k) clearance for MODI, a mobile app that uses continuous glucose monitoring (CGM) and insulin data to generate personalized dose recommendations directly to adults with type 2 diabetes on injectable insulin. No clinician review required for each adjustment.

Why this matters for the 8 million Americans injecting insulin

Automated insulin dosing has mostly been built around insulin pumps and type 1 diabetes. That leaves the vast majority of insulin users, roughly 85% of whom rely on injections, with few options for automated support. MODI is the first app cleared specifically for type 2 patients on injections, including those on long-acting insulin alone or multiple daily injections.

The clinical gap here is real. Many patients remain above recommended glucose targets for extended periods simply because their doses aren’t being adjusted frequently enough. MODI is designed to close that interval between visits.

How the app works

MODI connects CGM patterns with insulin data to produce clear dosing guidance through a smartphone app. It’s indicated for adults 18 and older with type 2 diabetes on injectable long-acting insulin, with or without rapid-acting insulin. Key features include:

The bigger picture

DreaMed CEO Eran Atlas framed it plainly: “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.”

That’s the bet here. Continuous glucose data is already widespread. But the clinical infrastructure to act on it quickly, especially for type 2 patients, hasn’t kept pace. MODI is an attempt to fix that at scale, and it’s entering a market with millions of potential users and very little direct competition.

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