- The U.S. Food & Drug Administration has approved the first mHealth device for diabetics that doesn’t require daily user interventions, an important step in improving patient engagement in care management plans.
Abbott’s FreeStyle Libre Flash Glucose Monitoring System continuously monitors a user’s blood glucose levels through a sensor patch attached to the upper arm. Patients wave a dedicated mobile reader over the patch to check their blood sugar levels and look at trends.
Those with diabetes typically prick their finger to draw a drop of blood, then use a small device to measure their blood glucose level. This is typically done several times a day, and is often the biggest reason that diabetics give for not monitoring their condition on a regular basis.
While mHealth devices have become more sophisticated in measuring a user’s blood glucose levels, users still had to perform a finger prick test twice a day to calibrate the system.
“The FDA is always interested in new technologies that can help make the care of people living with chronic conditions, such as diabetes, easier and more manageable,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health and deputy director of new product evaluation in the FDA’s Center for Devices and Radiological Health, said in an FDA press release. “This system allows people with diabetes to avoid the additional step of fingerstick calibration, which can sometimes be painful, but still provides necessary information for treating their diabetes - with a wave of the mobile reader.”
Abbott’s device is already sold in 41 other countries, where it retails for about $69. FDA certification enables Abbott to market the device in the US to those age 18 and older (company officials say they’re working on certification of the device for children).
mHealth and diabetes advocates have long said that digital health technology that can automatically draw blood glucose and other data could make care management much easier for the more than 29 million Americans living with the chronic condition. Studies have shown that a significant percentage of diabetics have shied away from mHealth technology in the past because it’s either too invasive or too uncomfortable.
Earlier this year, a report from digital health analyst Parks Associates found that 27 percent of people with a chronic condition want a mobile health device that tracks their health, but a significant percentage of those now using such devices say they’re too complicated or don’t work well.
"Nearly one-half of type I diabetics and one-third of type II diabetics are interested in health monitoring devices such as glucometers, but a steep learning curve and difficult or counterintuitive directions could inhibit their usage of these devices and also prevent them from buying other connected health devices," Harry Wang, the group’s senior director of research, said in a press release accompanying the report. "Device and application manufacturers would benefit from improving the ease-of-use of these devices."
In its press release, the FDA did caution that users could suffer adverse effects if they didn’t exercise proper care management.
“Risks associated with use of the system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate and used to make treatment decisions, as well as mild skin irritations around the insertion site,” the agency pointed out. “It does not provide real-time alerts or alarms in the absence of a user-initiated action; for example, it cannot alert users to low blood glucose levels while they are asleep.”
Companies like Abbott, Dexcom, Medtronic and Glooko have been working on mHealth technology for years that improves the daily process of diabetes management, developing devices that can be worn or attached to the body to monitor blood sugar levels and transmit that data, through an mHealth app to the cloud, for review by users and their caregivers.
Simultaneously, developers have been working on digital care management platforms that pull information from those devices and combine it with weight, diet, exercise and even moods and environmental factors, all of which can be used to help diabetics manage their health, improve their lifestyle and avoid serious issues.
Other advances include smartwatches, smartglasses and contact lenses to aid in blood-glucose measurements, mHealth messaging platforms that help caregivers connect and collaborate in real time with diabetics, and home-based smart devices and digital personal assistants that can sense mood changes, relay medication and appointment reminders and enable users to access information or call for help.
The advances aren’t without their challenges. In August, an independent study of 18 of the most popular mHealth-based blood glucose monitoring systems by the Diabetes Technology Society found that two-thirds aren’t meeting accuracy standards.