The recent flood of diabetes-related apps do everything from track hypoglycemic events to instantly calculate a patient’s insulin doses. But what if a bolus calculator tells a patient to dose 15 units when it should really by five? And what about device compatibility with all these new software options? As apps incorporate more medical recommendations and diabetes devices become more sophisticated data-tracking machines, the FDA grows more concerned over their safety and usability.
To examine these issues, the FDA held a public workshop this past November entitled Regulatory Science Considerations for Software Used in Diabetes Management. The broad scope of opinions discussed— patients, caretakers, clinicians, and industry representatives were all in attendance—will help the FDA construct a more fully informed action plan for regulating these sorts of apps and software.
The daylong conference focused on two main topics: first, Interoperability Between Diabetes Devices and Management Systems, and second, Insulin Bolus Calculators.
Insulin Bolus Calculators
Most of the day was devoted to discussions on bolus calculators. Howard Wolpert, Director of the Insulin Pump and Continuous Glucose Monitoring Programs at Joslin and Associate Professor of Medicine at Harvard Medical School, contributed heavily to the discussion by offering his clinical expertise. “These apps are extremely valuable to people who are using them,” he says in an interview after the conference. “But because there is an unregulated realm, there is no guarantee that they’re operating the way people think they ought to be.”
In his presentation, Dr. Wolpert noted that all bolus dose recommendations – whether from a calculator or other means – are inherently inaccurate, since they don’t adjust for other factors affecting insulin requirements including activity and stress. He outlined the numerous limitations in insulin bolus calculators such as inaccurate carb counting, as well as exclusion of other factors like dietary fat that can markedly affect insulin requirements from consideration in the dose calculation. Continue reading –>
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