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

Most people who inject insulin go months without a single dose adjustment. That gap, between what the data shows and what actually changes in treatment, is what DreaMed Diabetes is targeting with its newly FDA-cleared app, MODI.

The Israel-based company has received 510(k) clearance for MODI, a mobile app that reads continuous glucose monitoring (CGM) and insulin data to generate personalised insulin dose recommendations, sent directly to adults with type 2 diabetes. No clinician sign-off required for each adjustment. That's the breakthrough here.

How does it work?

MODI is indicated for adults aged 18 and older with type 2 diabetes who use injectable long-acting insulin, with or without rapid-acting insulin. The app analyses a patient's CGM patterns and insulin data, then delivers clear dosing recommendations through their phone. Clinicians do not need to configure initial settings or approve each recommendation, meaning insulin therapy can be adjusted between appointments without routine clinical involvement.

Why does it matter?

More than eight million people in the United States inject insulin. Most remain above recommended glucose targets. Automated dosing technology has existed for years, but almost entirely for type 1 patients using insulin pumps. MODI is the first app to bring that kind of automation to type 2 patients on injections, a group that represents roughly 85% of all insulin users. So the scale of potential impact is significant.

For the GCC, where type 2 diabetes prevalence is among the highest in the world, this matters. Saudi Arabia and the UAE are both investing heavily in digital health infrastructure, and tools that reduce the burden on overstretched clinical teams while improving patient outcomes align directly with national health strategies, including Saudi Vision 2030 and the UAE's broader digital health agenda.

The context

DreaMed Diabetes has spent over a decade building FDA-cleared diabetes software. Its existing endo.digital platform supports clinical decision-making for providers. MODI extends that capability to patients themselves, a meaningful shift in where the intelligence sits in the care pathway. "Data alone does not improve the health of patients," said CEO Eran Atlas. "Value is created when data is transformed into a timely, personalised recommendation patients can act on."