FDA Workshop Tackles Bolus Calculators and Device Interoperability
By Adam Brown
by Alexander Wolf and Adam Brown
Twitter summary: FDA holds public workshop to discuss bolus calculators + device interoperability – diverse group of speakers compel FDA to take charge!
On November 13, the Food and Drug Administration (FDA) held a public workshop on bolus calculators (software built into pumps that calculates how much insulin to dose before meals) and interoperability (making it easier for diabetes devices to communicate with each other and with other software). The meeting sought public input on the risks and benefits of bolus calculators; it also wanted to discuss the FDA’s role in advancing device interoperability. The meeting drew about 60 attendees, including FDA leaders, patients/caregivers, healthcare providers, and members of industry. diaTribe Senior Editor Adam Brown also spoke on behalf of The diaTribe Foundation – more on that below, along with a summary of some of the key points raised in the workshop.
How the FDA can better regulate bolus calculators – provider and patient perspectives
For patients, it was encouraging to see that the FDA showed support and awareness for the benefits of bolus calculators. However, the agency is wrestling with the proper balance between safety and innovation. “Too much regulation can slow down innovation, but the risks of not regulating are patient harm,” said Dr. Alberto Gutierrez (Director of the FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety). Very true! The FDA already regulates bolus calculators in pumps and on meters, so a particular challenge concerns the safety of bolus calculators in “stand-alone” mobile apps or software programs that are not part of a regulated device.
Dr. David Klonoff (Mills-Peninsula Health Services) highlighted the risks of insulin and the importance of making sure apps can accurately dose insulin. We certainly need more reliable ways of calculating boluses, as educator Dr. Jane Seley (New York Presbyterian Hospital) pointed out, since the majority of patients have issues manually calculating the correct insulin dosages. Tidepool CEO Howard Look said that even an unapproved bolus calculator app may be better than no calculator at all, given all the math required in mealtime insulin doses.
Providing another perspective, Dr. Howard Wolpert (Joslin Diabetes Center) said that bolus calculators are “inherently inaccurate,” as they don’t take into account all of the factors that affect blood glucose. Dr. Wolpert argued for a middle ground, advocating for an “ecosystem” of bolus calculator apps (Tidepool, Glooko, Livongo, and Telcare) that can help fill the gap between FDA-approved insulin pumps and unregulated smartphone apps that are potentially dangerous.
The diaTribe Foundation’s Adam Brown provided a patient perspective on bolus calculators, saying that they dramatically simplify math that is a burden for most patients. Adam emphasized the complexity of diabetes, noting that more than 22 variables affect blood glucose, and consequently, “bolus calculators cannot be made 100% fool proof.” Adam said that the FDA should be careful not to overregulate bolus calculators, since few patients have access to them right now – only those who are using insulin pumps and those on the Accu-Chek Aviva Expert. He also argued for more innovation in bolus calculators to help patients overcome some of the complexity of mealtime insulin dosing. The slides from his presentation can be found here. All in all, one thing was clear: bolus calculators are highly valuable, as they help simplify complex dose calculations.
Device Interoperability – Making Your Devices Talk Together
Device interoperability is the ability for multiple devices – a CGM, an insulin pump, a fitness tracker – to communicate with each other and/or share data in one co-existing platform. Tidepool’s Howard Look drew a comparison to digital cameras. In the early days, Canon, Olympus, and Kodak each had their own exclusive file format. Eventually, camera manufacturers settled on the .jpeg format. Fast-forward to today, and everyone can view and share pictures despite using a wide range of different cameras, software, computers, and smartphones. In contrast, said Mr. Look, diabetes devices force users to use a company’s own software to both access the data and to view the data. This reduced choice, he said, increases the burden of managing diabetes.
At the meeting, we were pleased to see the FDA’s enthusiasm for improving device interoperability. The FDA laid out three key areas where they see interoperability playing a big role: 1) remote monitoring, 2) device consolidation, and 3) the artificial pancreas. For the latter, one proposal was for different companies to individually produce and sell specific parts of a single system. For example, a patient could buy the pump, CGM, and algorithm from three different companies – just as someone setting up a television set may buy the T.V. from Sony, the DVD player from Samsung, and the cable box from Comcast.
Dr. Alain Silk (FDA reviewer and type 1 patient) summed it up best in his closing argument: Enhanced interoperability = better care = better outcomes. Continua, a non-profit group, has already developed standards for CGMs, blood glucose meters, and insulin pumps to communicate with each other. We hope that the FDA will eventually require such standards, which should result in more patient-friendly devices. In a public comment session, type 1 patient Steven Shaul brilliantly argued, “We’re now talking about cars that can drive themselves, package delivery via drones, yet diabetes devices are still on years-old technology… People with diabetes deserve 21st century technology.”
The FDA has posted a full video and slides of the day here. The agency is also calling for public comments on the topics presented at the workshop – if you have an opinion on any of the above, please make your voice heard by submitting a comment here.