RESUMO
Increasingly, people with diabetes (PWD) are using wearable and other devices to support self-management. During air travel, there are 4 stakeholders involved in maximizing the safety of wireless devices for diabetes care used in flight: (1) manufacturers of the devices, (2) airlines, (3) the Transportation Security Administration, and (4) the U.S. Food and Drug Administration. These stakeholders have all developed technologies and policies that assist PWD who prepare for and take appropriate actions during long-haul flights. This article discusses the performance and use of 6 classes of specific wireless diabetes devices during an airplane flight, including the following: (1) blood glucose monitors, (2) continuous glucose monitors, (3) insulin pumps, (4) smart pens for dosing insulin injections, (5) advanced hybrid closed-loop systems, and (6) spinal cord stimulators for painful diabetic neuropathy. Through the policies and safeguards of the 4 stakeholders and the proper self-care measures that insulin-using PWD can take, it is possible to maintain safe glycemic levels on flights across multiple time zones.
RESUMO
BACKGROUND: Medical device technology is evolving at a rapid pace, with increasing patient expectations to use modern technologies for diabetes management. With the significant expansion of the use of wireless technology and complex, securely connected digital platforms in medical devices, end user needs and behaviors have become essential areas of focus. METHODS: This article provides a detailed description of the user-centered design approach implemented in developing the Omnipod DASH™ Insulin Management System (Insulet Corp., Billerica, MA) Bluetooth®-enabled locked-down Android device handheld controller (Personal Diabetes Manager, PDM). Key methodologies used in the PDM design are described, including how the science of user experience (UX) was integrated into new agile product development. UX methods employed included heuristic evaluations of insulin pumps, iterative formative usability testing, information architecture studies, in-home ethnographic visits, participatory design activities, and interviews. RESULTS: Over 343 users participated in UX research and testing. Key design choices informed by UX research included updating the layout of critical data on the PDM home page, providing access to requested contextual information while a bolus is in progress, and creating an easy-to-understand visual of a 24-hour basal program. Task completion rates for comprehending information on the PDM home page were 87% or greater. The System Usability Scale result for the design prior to limited market release was 84.4 ± 13.4 (out of 100; n = 37). CONCLUSIONS: The UX process described in this article can serve as a blueprint for medical device manufacturers seeking to enhance product development. Adopting UX research methodologies will help ensure that new diabetes devices are safe, easy-to-use, and meet the needs of users.
