Life recently got easier for the 29 million Americans living with diabetes. In September 2017, the Food and Drug Administration approved the first continuous glucose monitoring system (CGM) for adults that doesn’t require blood sample calibration. The approval marks the latest addition to a list of mobile health technologies making life easier for diabetes patients.
People with diabetes either don’t make enough insulin (type 1 diabetes) or can’t use insulin properly (type 2 diabetes), resulting in sugar building up in the blood. High blood sugar levels are dangerous and can cause heart disease, stroke, blindness, kidney failure and other problems.
To stay in good health, people with diabetes regularly test and monitor their blood sugar to make sure it’s within a safe range. This is often done multiple times a day by taking a finger stick sample and testing it with a blood glucose meter.
Enter CGM
In the last few years, advances in continuous glucose monitoring (CGM) technology have made things easier. CGM is just what it sounds like – a way to monitor glucose levels continuously throughout the day. Until recently, there were just two CGMs approved by the FDA, made by Dexcom and Medtronic.
These two CGMs work using a tiny sensor inserted under the skin that measures glucose levels in tissue fluid, typically every 5 minutes. The sensor sends readings to a device – in Dexcom’s case a smartphone – and the device notifies the user if glucose levels are getting too high or too low.
For many people CGMs are a big quality of life improvement – they provide easy glucose monitoring on-the-go, can suggest which direction glucose levels are going and can alert users if levels are getting off. Basically, they improve accuracy while reducing the number of times you have to check your blood sugar each day.
But CGMs don’t entirely do away with the most annoying part of glucose monitoring: fingerpricks.
A new device reaches customers in the US
While the CGMs made by Dexcom and Medtronic enable routine monitoring with a sensor under the skin, they still required routine fingerpricks to ensure accuracy. Dexcom says “a minimum of 2 finger sticks a day is required for calibration” while Medtronic suggests 3-4 per day.
That’s what makes the devices recently approved by the FDA so exciting. Manufactured by Abbott and available in Europe since 2014, the FreeStyle Libre Flash works differently than the two CGMs currently available in the US. As the company’s website boasts, “You can do it without routine fingersticks.”
As the FDA wrote in a press release, the Libre “reduces the need for fingerstick testing by using a small sensor wire inserted below the skin’s surface that continuously measures and monitors glucose levels.” Users can take a glucose reading by waving a dedicated mobile reader above the quarter-sized sensor, which includes a catheter inserted in the skin. Unlike the previous two CGMs, the Libre doesn’t require daily fingersticks for calibration.
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In addition to eliminating daily fingersticks, the Libre is approved for 10 days of continuous wear, compared to 7 days for the two earlier CGMs. However, the US version of the Libre doesn’t allow for the “share” capability that allows family members and care providers to monitor users’ blood sugar levels remotely via a smartphone app.
Still, the Libre represents another mHealth solution that has experts feeling optimistic about the future for diabetes patients. As Aaron Kowalski, chief mission officer for the Juvenile Diabetes Research Foundation, recently told NPR, “I have tremendous optimism about the future for people with type 1 diabetes. These tools are really starting to … improving blood sugar and making life easier. And that’s a great thing. The more options the better.”
Could life get even easier?
Last year, many mHealth enthusiasts would have predicted a revolution in glucose monitoring technology in the next few years. However, progress seems to have slowed for smart contact lenses.
Originally predicted to be on the market by 2020, excitement about the contact lens to measure glucose levels from Novartis and Google has waned. While the companies haven’t abandoned the project entirely, experts say the lenses may be “technically infeasible.” Long story short, tears have proved less reliable than blood when it comes to measuring glucose levels.