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Mobile insulin dosing tool gets FDA clearance

Glooko​'s Mobile Insulin Dosing System for type 2 diabetes evaluates a patient's fasting blood glucose levels and recommends changes to insulin dosage.

The US Food and Drug Administration has OK'd a mobile system meant to help people with type 2 diabetes more easily measure and adjust insulin.

Cropped hand of person checking diabetes

Glooko's Mobile Insulin Dosing System can access a patient's blood glucose data from a glucose meter.


Glooko's Mobile Insulin Dosing System (MIDS) was cleared Wednesday for the titration of long-acting insulin. The system can directly access a patient's blood glucose data from a glucose meter, cutting the need to manually enter fasting blood glucose levels. Health care providers can also access more-accurate diabetes data with the system, and are able to create and send custom treatment plans via Glooko's unified diabetes management app, the company said.

MIDS evaluates fasting blood glucose levels and recommends changes to insulin dosage, based on the health provider's treatment plan or published clinical guidelines. In-app reminders notify patients to take insulin and to check fasting blood glucose.

"Managing long-acting insulin can be a challenge for people with diabetes because it requires patients to regularly change their doses based on their own calculations using fasting glucose values," Dr. Michael Greenfield, chief medical officer at Glooko, said in a statement. "This can be daunting and unreliable." 

More than 100 million adults in the US have diabetes or prediabetes, according to the Centers for Disease Control and Prevention. Less than half of diabetics on long acting insulin are able to achieve recommended glycemic goals. This is due in part to patients not fully understanding or adhering to insulin therapy, but also because of physician resistance to initiating or increasing insulin therapy, according to Glooko.

Other mobile tech is looking to simplify diabetes monitoring and care. Earlier this month, research from Cardiogram and the University of California, San Francisco, found that the heart rate sensors on ordinary wearables can detect diabetes with high accuracy. Apple is rumored to be working on noninvasive diabetes sensors, though reports say the tech won't be available anytime soon.

Glooko spent 18 months conducting research and collecting feedback to ensure the system was market-ready, it said in a statement. A study involving 14 participants found that MIDS helped people with diabetes manage their insulin and glycemic control over a span of one to three weeks. Positive outcomes were associated with titration cycle adherence. A larger clinical trial is also underway.

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