Diabetes is a medical condition we are all familiar with. In 2012, the American Diabetes Association reported that 29.1 million Americans had diabetes. This alarmingly high number can only be expected to increase as the incidence of diabetes continues to rise. In 2012, 1.7 million new diagnoses for diabetes were made. Diabetes goes hand-in-hand with daily blood sugar monitoring. Some patients require vigorous monitoring which may result in more than 3 finger sticks a day. Blood sugar monitoring helps physicians determine how effective the patient’s insulin and medication regimen are in the maintenance of diabetes. Certain patients may choose not to regularly monitor their blood sugar or feel it is tedious for the monitoring to be so frequent. This may lead to poor blood sugar control which can lead to further complications of the disease including, but not limited to, hypoglycemia, peripheral neuropathy, retinopathy and diabetic foot ulcers. In 2011, it was reported that a total of 282,000 emergency room visits were due to hypoglycemia.1 The disease was listed as the 7th leading cause of death in the United States in 2010. As a result of these striking statistics, the medical field has responded by working to develop better ways to accurately and effectively monitor blood sugar over a period of time, instead of at a single point in time.
Continuous glucose monitors are medical devices that first entered the market approximately ten years ago. They were met with reluctance from consumers due to being non-user friendly and having unreliable accuracy. DexCom, a San Diego based company, released a new and improved version of the continuous glucose monitor in 2012 which was reported to have improved accuracy. The monitor is composed of three parts; a small radio transmitter, a wire that is inserted under the skin and a handheld receiver. The thin wire goes underneath the skin which allows it to assess the body’s glucose levels in the interstitial fluid (fluid surrounding cells). The device is set to perform a blood sugar reading every five minutes. The wire connects to the small transmitter usually attached at the patient’s waist. After each reading the transmitter sends the information to the handheld receiver allowing the readings to be viewed by the patient. The patient has the option of syncing the receiver up to their smartphone to have all readings sent there instead. In order to improve its convenience, DexCom is in the process of seeking approval from the FDA for a continuous glucose monitor that would use a wireless connection from the sensor to the patient’s smartphone, eliminating the handheld receiver. Upon receiving the continuous glucose monitor for the first time, the user sets a threshold for what blood sugar levels are to be considered low and high. This establishes a range of blood sugars considered safe for the patient, any blood sugar level detected outside of this range will cause the machine to set off an alarm.2 The alarm may also sound if the blood sugar increases or decreases too quickly. Having blood sugar readings at five minute intervals allows for the possibility of being able to identify glucose trends which may lead to more efficient overall glucose control.
While these continuous monitors provide more blood sugar data and are less of a hassle than constant finger sticks, they do have flaws. Each monitor requires that two finger sticks be performed daily in order to calibrate the machine’s effectiveness.2 From a cost perspective, charges can add up quickly when using one of these monitors. The sensor wire requires replacement every 1-2 weeks which adds up to roughly $3,900 annually. The initial expense for the machine is $850. DexCom’s Executive Vice President Steven Pacelli reports that patients with insurance are usually responsible for paying twenty percent of the device’s total costs out of pocket.3 The sensitivity of the alarm function may also be seen as another downfall. It may be an interference with the patient’s daily activities or result in the patient feeling anxious over their blood sugar.
Other manufacturers saw these flaws as an opportunity for their advancement. Abbott Laboratories has a continuous glucose monitor model in the works. Their goal is to provide a lower cost alternative that has a fine tuned alarm mechanism. The Abbott model, Freestyle Libre, consists of a quarter sized sensor designed to be worn on the patient’s arm.3 The sensor is attached to a filament implanted in the skin. The sensor will perform blood sugar readings every minute. To access the readings the patient has to wave the handheld device over the sensor. Unlike the DexCom models, the Freestyle Libre does not require any calibration and it does not trigger an alarm if blood sugar readings are minor deviations outside the established safe range. From a cost perspective, replacing the sensor every 2 weeks as suggested costs $1,800 annually. While the Freestyle Libre is already on the market in Europe, Abbott has not established the expected date it will be available in the United States upon achieving FDA approval.
Google, in conjunction with Alcon, is working to set the bar even higher for the future of glucose monitoring. Brian Otis is currently the head of a project that seeks to develop contact lenses that will use tears to provide a glucose assessment. The lenses would then be able to assess glucose levels every second. This idea is centered on the use of computer microchip technology to make a miniature glucose sensor that will fit inside the lenses.3 To function, a wireless antenna and length-durable battery are required. There may be some concern about how the patient could wear such a device comfortably; Otis has designed the lenses to sit over the iris instead of the pupil.3 While the concept is admirable, this project remains in its early stages of development and continues to work out the kinks. There is hope that the lenses may be available for patients several years down the road. Upon product completion, Alcon would go on to seek device regulation approval via the FDA and would also carry out all manufacturing.
Overall, diabetes is a condition that cannot be taken lightly. Patients face too many potential complications if their disease is not maintained appropriately. These devices discussed may hold potential for the future of diabetic monitoring but it is important to thoroughly review the pros and cons of their use in each patient. We want to improve their quality of life by eventually eliminating the need for constant finger sticks. We also want to prevent placing them in a financial burden or sending them into information overload by expecting them to use a high tech device and smartphone. Each patient will require a training session if they are going to be using a continuous glucose monitor to ensure the device will be used effectively and appropriately.
2016 Pharm.D. Candidate
St. Louis College of Pharmacy
- American Diabetes Association. National Diabetes Statistics Report 2014. 29 June 2015.
- Neithercott T. Continuous Glucose Monitors. Diabetes Forecast. 2014. Web. 29 June 2015.
- Walker J. Easier Blood Sugar Monitoring for Diabetics. Wall Street Journal. 2015. Web. 29 June 2015.