Glooko receives FDA clearance for mobile insulin titration tool

By Dave Muoio
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Digital diabetes care company Glooko announced today that its Mobile Insulin Dosing System (MIDS) — an app-driven tool that recommends insulin dose adjustments using data collected directly from a patient’s blood glucose meter — has been cleared by the FDA.

The MIDS module allows clinicians to create a customized treatment plan and send it to Type 2 diabetes patients directly through the company’s unified mobile diabetes management app. Instead of relying on patients to input their own fasting blood glucose, however, the system pulls readings from the patient’s blood glucose meter.

“We’re the first ones to be leveraging data directly out of blood glucose meters, and a physician can preconfigure a treatment plan. That treatment plan gets loaded into a patient’s phone, then based on the reading of the blood glucose meter they are told how much insulin to dose on a daily basis, and they’re reminded to take their insulin and reminded to test their blood glucose,” Glooko CEO Rick Altinger told MobiHealthnews. “Unlike a lot of the consumer-oriented products that are out there that are wellness focused … this is more of a digital therapeutic-type solution. Because you’re dosing yourself and we’re telling you how much to dose — based on a doctor’s configurative instructions — the safety goes up and therefore it requires FDA clearance.”

Automating titration through MIDS offers a couple of key advantages to patients and their caregivers, Altinger explained. Studies have shown that the majority of self-reported glucose readings are inaccurate, he said, so a tool that draws these readings directly from a blood glucose meter has the potential to reduce the number of acute complications that come from incorrect dosings.

The inconvenience of manually titrating and managing insulin doses has also been a key driver of patient non-adherence, Michelle de Haaff, VP of marketing and customer success at Glooko, added. This issue in particular has made some clinicians hesitant when prescribing long-acting insulin.

“There’s a lot of clinical inertia around prescribing it because clinicians are afraid patients won’t be able to keep the regimen,” she explained. “This new module got cleared because we heard over and over again from clinicians that … insulin adherence was one of the hardest things about managing the condition. We started here, [and] we’ll be doing more of these, but this is where we started because we felt it has the biggest impact on outcomes and, ultimately, cost.”

In a statement, Glooko said their module is the result of 18 months of research and feedback. In a study of the system, which was presented recently at a meeting of the Diabetes Technology Society, researchers found that MIDS appeared to help a small sample of 14 Type 2 diabetes patients manage their insulin and glycemic control within one-to-three weeks, and that positive outcomes among these patients could be linked to better titration cycle adherence. A longer clinical study of the system hoping to enroll 240 patients is currently underway.

Altinger said that Glooko’s diabetes management platform is currently deployed to more than 7,000 provider sites, and integrates over 150 different diabetes devices such as glucose meters, pumps, and continuous glucose monitors. As such, MIDS already has the opportunity impact thousands of patients’ care.

“We’re part of an end-to-end platform,” he said. “This is a module that you can add on to the product offering, but the product has other feature functionality … that makes it more popular with physicians that treat diabetes today.”

Outside of today’s announcement and a $35 million growth round announced last June, Glooko’s numerous partnerships have been making headlines over the past year. The diabetes company’s highest profile collaboration came in July with news that Novo Nordisk would be pitching in on the Conerstones4Care app. Other partnerships included a cloud integration-focused project with Dexcom, a digital coaching program with Fit4D, and integration with Ascensia.