FDA Clears New Insulin-Dosing Software System

Miriam E Tucker

June 30, 2017

The US Food and Drug Administration has cleared new decision-support software that aids in insulin dosing.

Called Insulin Algorithms (Los Angeles, California), the system "makes it easy for a clinician to regularly analyze a patient's blood sugar measurements and quickly optimize their insulin regimen" with the use of algorithms that optimize both basal and bolus insulin dosing and have been shown to lower HbA1c "even in challenging patient populations," according to a company statement.

In addition, Insulin Algorithms is "an affordable, easily adoptable tool for every-size practice, from large [electronic health record]–based systems to individual practices," it notes.

The product has previously received a CE Mark for marketing in Europe.

Asked to comment, University of California, Los Angeles endocrinologist and diabetes technology expert David Ahn, MD, told Medscape Medical News, "The emergence of digital health tools such as wireless glucose meters and smart insulin pens can help facilitate diabetes data exchange between provider and patient, and products like Insulin Algorithms can simplify treatment decisions for all types of clinicians, including [primary-care providers] and pharmacists."

However, he added, "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."

There are currently several other insulin dosing apps already on the market or in development. They differ in features such as the types of insulins they support (some just adjust basal doses) and whether the interface is designed for interaction with the doctor, the patient, or both.

According to Dr Ahn, "The current practice model of insulin titration is labor-intensive, and as a result [patients are] often delayed in reaching glycemic targets….Automated insulin adjustment is a rapidly growing hot spot for diabetes innovation."

But he cautioned that it's unclear whether Insulin Algorithms would be appropriate for managing type 1 diabetes, because "adjusting insulin in that patient population is exponentially more complex due to the complete absence of endogenous insulin production.

"As a result, I personally feel that most patients with type 1 diabetes should be managed directly by endocrinologists."

The development of artificial-pancreas systems, the first of which was approved in the United States last year, means there will soon be options for those with type 1 diabetes to use a whole system incorporating insulin algorithms, although the initial prototype, the Medtronic MiniMed 670G hybrid closed-loop insulin-delivery system, is not fully automated. It still requires users to tell it when they are exercising or eating (as well as estimating the carbohydrate amount), and they must calibrate the sensor with a minimum of two finger sticks a day.

Dr Ahn, who blogs about diabetes technology for TCOYD, has no relevant financial relationships.

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