FDA Okays Glooko Insulin Dosing System for Type 2 Diabetes

Miriam E. Tucker

February 16, 2018

The US Food and Drug Administration has cleared the Glooko Mobile Insulin Dosing System for the titration of long-acting (basal) insulin for people with type 2 diabetes.

The system, housed within a mobile app, allows clinicians to create customized treatment plans including insulin titration rules that they then "push" to the patient. The Glooko platform integrates with 95% of the blood glucose meters on the US market, so the verified data can be directly uploaded, rather than manually entered.

The Mobile Insulin Dosing System analyzes fasting plasma glucose levels and recommends insulin dose adjustments based on the clinicians' preprogrammed treatment plan and/or published clinical diabetes management guidelines.

The app also reminds patients to check their fasting glucose levels and to take their insulin.

In a 3-week feasibility study, 14 patients with type 2 diabetes were prescribed personalized long-acting insulin dosage treatment plans, most of them based on the algorithm published by the American Association of Clinical Endocrinologists/American College of Endocrinology.

Average blood glucose levels dropped from 163.9 mg/dL in the prior 14 days to 145.7 mg/dL during the study period (P = .046), and the proportion of readings in-range (80 - 180 mg/dL) increased from 64.2% to 73.2% (P = .048).

At the same time, the percentage of readings above 250 mg/dL dropped from 14.1% to 3.2% (P = .029), whereas levels below 70 mg/dL did not increase significantly (1.3% to 3.7%; P = .830).

The improvements in glycemia were correlated with adherence to the prescribed insulin dose titrations as recorded by the patient (R = 0.65; P = .017). By the end of the study, the recommended dosage of long-acting insulin had increased by 18.7% (P = .013).

"Challenge Will Be Getting Clinicians to Change Prescribing Routine"

Although the Glooko MIPS has some unique features — it is the first insulin titration application accessible through a unified platform that incorporates data from a variety of different devices — it is not the first digital insulin-dosing technology aimed at helping both clinicians and patients.

So-called "clever insulin dosing" is one of the "3Cs" of diabetes technology. One such product, Insulin Algorithms, was cleared by FDA in June 2017. And other products currently helping with insulin-dose titration include Voluntis Insulia, Sanofi My Dose Coach, and Amalgam isage Rx. Another very important part of this category is new "smart" insulin pens and needles, a number of which are in development. These capture injection data and send this information to a cellphone, the cloud, or a healthcare-provider "dashboard."

Commenting on the approval of Insulin Algorithms at the time, University of California, Los Angeles, endocrinologist and diabetes technology expert David Ahn, MD, told Medscape Medical News, "The current practice model of insulin titration is labor-intensive, and as a result [patients are] often delayed in reaching glycemic targets."

Now, digital health tools can help assist diabetes data exchange between provider and patient and simplify treatment decisions, he said, adding: "Automated insulin adjustment is a rapidly growing hot spot for diabetes innovation."

But he noted, "As for many of these products, the challenge will be in getting clinicians to change their routine of prescribing insulin, so streamlining workflow — through electronic medical record integration, for example — might help increase their uptake in clinical practice."

FDA Clears Glooko’s Long-Acting Insulin Titration System. Glooko. February 14, 2018. Full text

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