By: Tyler Valente, PharmD Candidate c/o 2016
A growing trend within our progressive society is the advancement of technology. Over the past few years, inventions that were mere fantasies just a decade or two ago have become a reality. Within the medical field, progress can be seen particularly in the development of medical devices. According to the Food and Drug Administration (FDA), medical devices “range from simple tongue depressors and bedpans to complex programmable pacemakers…” and can be defined in part as “an instrument, apparatus, implement, machine or…related article…which is…intended for use in the diagnosis…or in the cure, mitigation, treatment, or prevention of disease in man…”1 One of the most remarkable technological developments amongst medical devices is the revolution of the glucometer.
In treating diabetes, the two most common ways of monitoring blood glucose is with a blood glucose meter or a continuous glucose monitor (CGM). Before the FDA approved MiniMed as the first CGM in 1999, one had no choice but to carry a testing kit and frequently prick their finger in order to draw blood into the glucometer. Although these are still very commonly used among diabetics, standard glucometers are inconvenient and present burdens to patients – inspiring the invention of CGMs.
A CGM is a device that is worn externally and continuously displays an estimate of blood glucose levels via a small, wire-like sensor inserted just under the skin.2 When used in conjunction with a blood glucose meter, a CGM is beneficial because it requires less frequent finger pricks while providing an extensive data set of glucose levels over time. Just earlier this year, the FDA “allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share [medical data].”2
The Dexcom G4® Platinum Receiver with ShareTM is a CGM with Bluetooth capabilities, allowing caretakers to view a diabetic patient’s blood glucose levels in real-time via an app called Dexcom Follow. This technology is particularly useful for young children and elderly patients who need assistance in the management their diabetes. With the ability to access a patient’s glucose levels via the Dexcom Follow app, caretakers can play a larger role in monitoring the patient’s levels, leading to decreased hypoglycemic events and increased medication adherence.3 A possible downside to this technology is that caretakers only have access to levels that the patient chooses to send to the app. Also, although the caretaker can see this information, there is nothing that can be done remotely. The caretaker still has to contact the patient to tell them to either consume something with sugar or inject a rapid acting insulin dose, depending on the levels shown on the app.
Dexcom G4® Platinum Receiver with ShareTM is a monumental first step into the world of medical apps. However in today’s society, one can expect it to be just that, a step. Dexcom’s next product, which will be submitted for FDA approval in Spring 2015, promises to automatically transmit all glucose data directly from the sensor worn on the body to the iPhone app.
- Is The Product A Medical Device? FDA. http://www.fda.gov/medicaldevices/deviceregulationandguidance/overview/classifyyourdevice/ucm051512.htm Updated September 2014. Accessed April 3, 2015.
- Pahon, Eric. FDA permits marketing of first system of mobile medical apps for continuous glucose monitoring. FDA. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm431385.htm Published January 2015. Updated February 2015. Accessed April 3, 2015.
- Sharing your glucose data has never been easier. Dexcom. http://www.dexcom.com/dexcom-cgm-with-share#share-adult Updated 2015. Accessed April 3, 2015.
[pubmed_related keyword1=”technology” keyword2=”medicine” keyword3=”unite”]