The Boston Marathon’s 26-mile, 385-yard race is grueling for even the fittest athlete, and is made much more daunting with T1D to contend with. Though it can be effectively managed, the disease still requires multiple tests of blood glucose levels throughout the day, often with a painful finger prick test. But recent developments in continuous glucose monitoring (CGM) technology have helped Courtney and others in her situation to train and compete without worrying about interruptions for glucose testing.
Courtney manages her T1D using medical device multinational Abbott Labs’ FreeStyle Libre system, which was launched in the U.S. last September. Now while running, skating, or cheering on the Caps, Courtney is no longer forced to prick a finger—she instead waves a handheld device over a sensor worn on the back of her upper arm roughly the size of two stacked quarters. Her glucose level is displayed on the device reader, along with trends in glucose measurements and forecasted levels.
“After qualifying for and running the Boston Marathon in 2015, I reached out to Abbott as I used their Freestyle Lite blood glucose meter throughout my training,” Courtney explained to Capitals Outsider, a publication that covers happenings involving the team. “Three years later, the Abbott World Marathon Majors team reached out and asked if I would be interested in training for the 2018 Boston Marathon using the Freestyle Libre system. It really didn’t take too long to say yes—1) because the Boston Marathon is one of the most special races in the world and 2) because the Freestyle Libre system was a game-changer in my training.”
Inspired by a supporter who had lived with T1D for 62 years and encouraged by a college mentor, Courtney published “The Marathon We Live: Training for a Personal Best in Life with Type 1 Diabetes” this past January. The book is available on Amazon, and partial proceeds from each sale are donated to the Every Step Counts Scholarship Program (everystepcountst1d.org)
she founded to reward young adults for living their healthiest lives with T1D.
With FreeStyle Libre, Abbott joins the likes of Medtronic and Dexcom in offering CGM technology that allows users to manage their T1D more effectively while in a home environment. Fingerstick glucose testing for type 1 diabetics has been slowly disappearing, and FreeStyle Libre was the first CGM system that did not require a sample—even for user calibration. San Diego-based Dexcom shared this achievement this past March with the FDA approval of its Dexcom G6 CGM. Dexcom G6 is indicated by the FDA for use as both a standalone CGM and integration into automatic insulin dosing systems—the first CGM to receive this type of classification. Following the authorization, FDA is also establishing special controls to outline requirements for ensuring CGM accuracy, reliability, and clinical relevance.
“As a factory-calibrated, real-time CGM system with exceptional accuracy, the Dexcom G6 will be transformative for people with diabetes, who will no longer be required to prick their fingers for diabetes management,” Daniel DeSalvo, M.D., pediatric endocrinologist at Texas Children’s Hospital in Houston, Texas, said in announcing the FDA authorization. “I can tell you as someone who has Type 1 Diabetes myself, with all of its features and benefits, the Dexcom G6 is the CGM device I have been anticipating for the last 20 years. This CGM system will help to alleviate the burden of diabetes management while improving the lives of people with diabetes.”
Last year, the Centers for Medicare & Medicaid Services (CMS) announced coverage for therapeutic CGM for beneficiaries with either type 1 or type 2 diabetes who intensively manage their insulin. CGM has been found to be especially helpful in managing T1D—especially for those using an insulin pump—but many researchers and doctors wonder if CGM technology could help those with type 2 diabetes manage their condition as well.
“In the near term, the diabetes management market will continue to dominate the at-home testing market,” commented Carmelo Volpe, head of clinical diagnostics, global medtech division, at Cambridge Consultants, a product design and development firm with laboratories in Cambridge, United Kingdom, and Boston, Mass. “However, the different approaches for managing type 1 and type 2 diabetes are driving device innovation, which will have a longer-term impact. The conversion of diabetics from the common finger prick and strip ‘batch’ method to a more CGM approach is being driven by the type 1 diabetic.”
CGM has not been well evaluated in those with type 2 diabetes who use insulin, but a 2017 study published in the Annals of Internal Medicine found that a high percentage of adults receiving multiple daily insulin injections for type 2 diabetes who used a CGM on a daily basis for 24 weeks demonstrated improved glycemic control. Few insulin-treated type 2 diabetics currently use a CGM device, but the study’s results supported CGM technology, an additional management tool to benefit those patients. This past March, the FDA also approved Medtronic’s Guardian Connect CGM equipped with the Sugar.IQ assistant to analyze glycemic response to lifestyle factors, another potential option.
“While type 2 diabetes needs a different approach, the CGM solution may eventually find broader adoption with the right product configuration,” Volpe continued. “A logical end goal for CGM is to include ‘intelligence’ to create a closed feedback loop where insulin may be automatically administered at an appropriate dose based on the glucose reading made by the CGM.”
Diabetes management represents a significant portion of the home diagnostic testing market, but the trend of moving tests usually conducted in clinics and hospitals to the home environment is quite attractive to manage a number of other disease states. Other conditions and physiological states have the potential to be monitored in the same way. Potential areas for home testing may include ovulation cycle monitoring to increase conception likelihood, diagnosis of minor infections like UTIs or STIs, or monitoring the dosage of certain medications in order to develop an optimal regimen.
“As health systems seek ways to most effectively and cost efficiently manage patient populations, one trend will continue to be the transition of routine testing and health monitoring out of the costlier acute care environments and closer to the patient,” explained Christopher Grams, product marketing manager, point of care, for Roche Diagnostics North America. Roche Diagnostics, a division of the Basel, Switzerland-based global healthcare company, offers a broad portfolio of tools that help healthcare providers in the prevention, diagnosis, and management of diseases like HPV, HIV, heart failure and diabetes, as well as other medical conditions, such as fertility and blood coagulation.
“The use of retail health clinics, employer on-site clinics, and in-home monitoring should continue to grow and fit-for-purpose technologies should continue to enable this trend,” Grams went on.
For instance, at some point in their lives patients may need to start taking an oral anticoagulant to treat or prevent blood clots that occur in blood vessels. Medicines like warfarin and phenprocoumon are among the pharmaceuticals used for blood clot prevention, and are known as Vitamin K antagonists (VKA). They have been proven to be very effective in reducing stroke risk with minimal side effects.
Taking the correct dose is crucial to efficient and effective anticoagulation treatment. The correct dose is determined by measuring how long it takes the blood to clot, and is called the International Normalized Ratio (INR). It is typically used in combination with a prothrombin (PT) test, which helps to detect and diagnose bleeding or excessive clotting disorder. The INR is calculated from the PT result to monitor how well the blood-thinning medication is working to prevent clots.
In May 2016, responding to the need for accurate, reliable INR test results for warfarin monitoring without the necessity of regularly traveling to a lab or clinic, Roche launched the CoaguChek INRange Bluetooth-enabled PT/INR home health device. CoaguChek lets patients and healthcare providers monitor VKA therapy via self-testing.
“CoaguChek Systems make coagulation testing easy. With the launch of the new CoaguChek Vantus system this year, Roche is further enhancing the patient self-testing experience,” explained Grams. “The graphical user interface of the CoaguChek Vantus meter guides the patient through the test step by step. The code chip accompanying the test strips contains strip lot-specific information and the expiry date for the test strips. The patient only needs to insert the code chip, turn the meter on, insert the test strip, and apply a blood sample.”
According to a British Journal of Haematology study, patients who have a strong link with their healthcare professional demonstrate better adherence to their anticoagulant therapy plan. The CoaguChek system further helps enhance this relationship—patients develop a stronger understanding of their PT/INR results via self-testing, and physicians can be confident that they are optimizing treatment decisions thanks to access to near real-time patient data. The newest CoaguChek model further expedites this process.
“The CoaguChek Vantus meter measures the patient’s coagulation time and displays the result,” Grams continued to explain. “After the test is completed, the meter automatically saves the result to memory. The patient may choose to enable the Bluetooth feature, allowing the INR test result to be reported to their service provider wirelessly and automatically via a smart device application.”
Usually, managing VKA therapy requires frequent hospital or clinic visits for PT/INR testing, which requires an on-site venipuncture. Lab results can also take two to three days for patients to receive. CoaguChek systems require only a fingerstick and 60-second test, allowing patients independence in daily activities and improved quality of life, all while maintaining connections with their healthcare practitioners.
“Changes in healthcare delivery mean that quality and convenient care are becoming more important for patients and their doctors. With our point of care solutions, we aim to meet this growing need,” said Ian Parfrement, lifecycle leader for point of care with Roche Diagnostics. “CoaguChek helps healthcare professionals make more timely treatment decisions with access to their patient’s coagulation data, while empowering patients to better understand their condition.”
The home testing market is an intriguing space for patients, healthcare professionals, and device developers because home-based tests neatly fit into early and late stages of the care pathway. Thanks to a global increase in chronic conditions and healthcare service rationalization, there has been an enormous need for patients to actively manage their own health. This need will undoubtedly increase as life expectancy improves around the world. Following this trend, the range of monitoring and testing devices for both the health-conscious consumer and patient will proliferate.
Pharmacies, supermarkets, retail stores, device manufacturers, and laboratory companies are all pursuing the home-based diagnostics market because of these trends. But when patients become involved in their own testing, designing for human factors becomes a greater concern. And although at-home tests are beginning to mimic the functions of advanced laboratory equipment, their operating environments are vastly different, which must also be accounted for in product design.
“Consumer devices will be used in uncontrolled environments by non-medically trained users, and the device needs to be designed to account for this,” advised Volpe. “In contrast, a device designed for a lab assumes a stable operating environment, highly trained users, and a well-maintained and calibrated device. Understanding the requirements of these different environments allows an integrated product design process to inform the trade-offs between cost, robustness, and ease-of-use. This results in a slick design that works reliably and can be manufactured and sold for a competitive price.”
One benefit of a reliable home diagnostic device is that patients can adjust their treatment and lifestyle based on the immediate feedback it generates. During the time patients are waiting for the results of their lab-based testing, they may behave in a manner that minimizes their condition. Thanks to the quick results and improved perception of control over their condition, patients will be less anxious and more likely to comply with treatment regimens.
However, the potential unreliability of self-reported test results must be addressed—the patient’s interpretation of their result might not be a true reflection of their disease state. And in some cases, it may not be the patient’s fault. Perhaps the device generates an incorrect result, or shows it in a manner that comes across ambiguously. Both are a product of poor design, and home testing device manufacturers must be especially wary of these risks.
“The key to a good non-lab based test is a robust analytical engine which has high diagnostics accuracy, does not need regular maintenance or calibration, and has a user interface which displays the results in an unambiguous way independent of cultural or language bias,” explained Volpe. “Where a ‘sample’ is needed and how it is collected and transferred to the testing device can have a big impact on its reliability.”
It’s important to note that self-testing also does not remove the doctor from the equation. Users should never make lifestyle changes or alter a treatment regimen based purely on a home-based diagnostic test. Most tests are best evaluated together with medical history, a physical exam, and other clinical testing. Using an at-home diagnostic should be supplementary to the complete health picture a clinician is able to provide, meant as a tool for speedier adjustment and real-time disease state monitoring.
That said, the future implications of home diagnostic technology are quite exciting and empowering for patients. Rapid technological advancements are making at-home testing and monitoring devices quicker, more user friendly, safer, and more sensitive, requiring less and less of a sample to make an accurate reading. Blood glucose monitors, drug abuse testing kits, cardiac markers, urinalysis testing kits, hematology testing kits, home pregnancy detection kits and ovulation tests, blood pressure monitoring devices, and HIV test kits are among the technologies now available to consumers.
Continued innovation in consumer devices like smartphones, tablets, and wearable technologies are also working in tandem with diagnostic devices to provide a more complete and speedier picture of a patient’s health and response to treatment. Mobile health applications and digital health devices can help to both increase the speed at which patients receive results and communicate with their healthcare providers. The newer generations of home diagnostic and monitoring devices also collect a wealth of health data, and come equipped with Wi-Fi or Bluetooth connectivity to transmit that data. The phrase “big data” is often used to describe the large volume of data—structured and unstructured—collected by a consumer or medical device and stored in a virtual warehouse.
Though healthcare providers are only just learning how to make sense of the wealth of healthcare data collected by digital health tools, the aggregation and analysis of patient-reported health data can significantly change healthcare delivery. The insights gained via data analysis can help doctors to focus interventions where they are most needed, as well as monitoring the success of those interventions. Predictive analytics can also be applied to make sense of patient-generated data. Artificial intelligence and machine learning strategies may be able to corral all the information into an assessment that a doctor will find more actionable.
“Digital health will take personalized medicine to a whole new level,” predicted Volpe. “Personalized health is currently associated with cancer; however, digital health has the potential to allow patients to collect data on themselves and use analytical techniques to determine their ‘baseline.’ This will allow treatments to be designed specifically for their physiology and condition. The rich data collected at home could be used by the clinician to look at the changing condition over time and inform future treatment decisions.”
This strategy could be particularly useful in the field of women’s health. According to the National Conference of State Legislatures, chronic diseases and conditions like heart disease, cancer, and diabetes are the leading causes of death for women. Thirty-eight percent of women suffer from one or more chronic diseases, compared to 30 percent in men.
“In women’s health, a wide range of medical conditions go undiagnosed due to the variable frequency of symptoms, commonality of symptoms across multiple conditions/diseases, and potential lack of awareness of rare conditions in the medical profession,” said Volpe.
Part of this is due to an unfortunate cultural relic—women are still, on the whole, considered less reliable than men in terms of self-diagnosis. Further issues arise from a general lack of understanding about women’s health issues. Home diagnostic and monitoring devices coupled with predictive analytics may be one avenue to correctly diagnose and gain a stronger understanding of some women’s health issues.
Healthcare providers’ preferred form of health data implementation also takes shape in the electronic health record (EHR). With many EHR systems becoming a foundation for healthcare organizations, their integration is becoming a necessity for those looking to enter the digital health space. Although EHR integration is not a new concept for developers, increased access to health apps and wearables has brought increased attention to integration by medical device companies as well.
For the home diagnostic and monitoring industry, this means integrating health data gathered by apps or devices into an individual’s EHR. EHR integration seeks to assimilate digital health products in terms of both data and clinical workflow. When integrated with an EHR, medical device data can be another avenue to enhance clinical decision support initiatives.
“One key for success in home diagnostics technology will be integration,” said Grams. “In the case of INR monitoring, our customers want the data in just one place—their EHR system. With the introduction of CoaguChek Vantus and CoaguChek Link Mobile this year, Roche has the ability, in partnership with our customers, to deliver INR results from the patient’s meter to the EHR in a seamless fashion.”