DreaMed Diabetes has received FDA 510(K) clearance for MODI, a tool that uses continuous glucose monitoring data to provide insulin dosing recommendations for people with Type 2 diabetes who need both basal insulin and fast-acting injections.
The company, based in Petah Tikva, Israel, claims that MODI is the first FDA- approved app that can automatically optimize insulin dosing for patients who use both basal-only and multiple daily injection regimens. Current CGM tools typically only work for patients who use a basal-dosing regimen, meaning they get fewer doses of longer-acting insulin to control blood sugars throughout the day and overnight. However, many people also require multiple injections of fast-acting insulin to control blood sugars, particularly around mealtimes. This dosing schedule is harder for both patients and clinicians to manage, but MODI now offers an automated solution.
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More than 8 million people in the U.S. use insulin injections daily. MODI opens up new treatment possibilities for a large segment of that population. Eran Atlas, DreaMed’s co-founder and CEO, said that the company had to account for the added complexity of managing both types of insulin.
“We had the vast know-how on how to solve these challenges because of all of our previous work on FDA-cleared decision support technology and vast clinical knowledge,” Atlas said.
MODI must first be prescribed by a physician. Then, after analyzing a patient’s CGM patterns and monitoring their insulin use, it delivers personalized dose recommendations. The changes can be made without the need for a healthcare provider to review and approve each individual adjustment, which may make it easier for insulin therapy to be modified between appointments.
Type 2 diabetes is typically managed episodically during primary care visits, which can result in up to year-long delays before a patient’s insulin regimen is adjusted to their changing needs. One study estimated the cost of such delays at a staggering $7.3 billion.
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Atlas hopes MODI will address that gap.
“MODI is here to make sure patients will get much more frequent and high-level clinical titration, so people with diabetes will get the right therapy on time,” he said.
Effective blood sugar control is beneficial for health, but too much or too little insulin can cause an emergency in short order, risking symptoms from weakness and nausea to confusion, coma, and in extreme cases, even death.
The risk of error meant that DreaMed took safeguards seriously during MODI’s development. Atlas shared that the company’s clinical team created boundaries within which the system could operate.
“With the help of our clinical team, we were able to define the ‘playground’ for the algorithm to work so that the right balance of safety, autonomy, and efficacy would be preserved.”
Reimbursement and cost could affect access, though Atlas shared that DreaMed is not yet commenting on pricing because they are still early on in the process.
For DreaMed, the MODI clearance marks an expansion of what automated insulin optimization can do for patients and healthcare providers, moving beyond basal insulin management to more complex multiple-injection regimens. The company’s customers include healthcare providers, clinics, hospitals, and medical device companies.
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