Electronic Health Reporter

By Mark Clements, MD, PhD, CPI, FAAP, chief medical officer, Glooko, Inc.

Seemingly overnight, healthcare discovered and fully embraced digital health solutions. Just months after the 2020 nationwide lockdown, telehealth visits, virtual clinical trials and countless remote patient care technologies became the new normal.

Consider:

• Market analysts predict that by 2024 an estimated 30 million Americans will be using remote patient monitoring (RPM) devices, apps and other tools.
• The pandemic has exponentially accelerated the adoption curve for virtual clinical trials; one survey found that 44% of pharma, clinical research and biotech professionals already had or planned to adopt RPM solutions for their trials within a year.
• A nationwide survey of nearly 1,600 physicians and licensed professionals found that 75% said telehealth enabled them to provide quality care.

Most of these technologies addressed what the American Medical Association calls “an epidemic” of chronic diseases. RPM solutions are especially suitable for these complex conditions, which typically require the frequent collection of physiological and/or patient-generated data from self-reporting tools, mobile devices, fitness wearables or other biosensors.

Diabetes has long been a focal point for technological innovations to personalize at-home patient care, beginning with the first glucose meters for patients in 1980. The need for such solutions has never been more urgent. A 2020 CDC report estimates that 122 million U.S. adults – one-third of the population — either have or are at risk of developing diabetes.

Here are three noteworthy recent advances in personalized diabetes care management that show the vast potential of digital health solutions to revolutionize both care management for chronic diseases and clinical research.

Digital Therapeutics (DTx): Real-time Analytics in Action

The Digital Therapeutics Alliance defines a DTx as a solution that delivers “medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.” DTx applications can be used independently or in concert with medications, devices or other therapies. They are especially effective for treating complex disease states that can benefit from frequent self-monitoring and therapeutic adjustments.

For example, a key to managing diabetes care is maintaining blood glucose levels within a desired range. Since these levels can change dramatically numerous times each day, individuals are responsible for self-monitoring as well as for administering appropriate insulin doses. Not surprisingly, many are unable to engage fully with this complicated treatment regimen. In fact, an estimated 50% of people with any chronic disease do not take their medications as prescribed.

To ease this burden and ensure appropriate dosing, healthcare providers and diabetes clinics are combining DTx apps with multiple RPM devices and tools. For example, Glooko’s Mobile Insulin Dosage System (MIDS), an app-based titration tool, automatically prompts, recommends and reminds people using long-acting insulin to adjust their basal insulin doses based on fasting glucose readings and on their personal, clinician-defined titration configurations. In a randomized clinical trial, MIDS significantly improved glycemic control compared to the control treatment.

Connected RPM Platforms: A Collaborative Ecosystem for Personalized Care

As in sports or movie-making, personalized healthcare requires a team effort.  A paradox of the pandemic is that, while people were socially distant, new technologies to accommodate this disruptive change have brought the myriad elements of patient care – persons with diabetes, physicians, health systems, information and communication systems – closer together.

For individuals with diabetes and other chronic conditions, the foundation for more collaborative, timely and data-driven care management is a robust RPM platform that:

• continuously monitors, measures, collects and transmits physiological and patient-reported data, including safety signals (e.g., low blood sugar) that trigger prophylactic or real-time interventions,
• fits seamlessly into patient-centric care delivery models and protocols,
• enables providers, patients and clinical researchers to view all patient information (including EHR data) through a single portal, and
• automates or facilitates actions to initiate therapeutic or behavioral adjustments.

Strong RPM platforms can make it easier for individuals to view, understand, and share their diabetes data with clinicians between clinic visits. Clinicians can also benefit by having much richer data sets for individual patients than they get from just quarterly in-office visits – the standard of care – to guide their clinical decisions.

Healthcare providers, diabetes clinics and pharma companies are using RPM platforms paired with DTx apps and digital companion tools to improve patient engagement, adherence and outcomes. One such modular companion app, for example, syncs a user’s blood glucose and activity data from most diabetes and exercise devices to enable persons with diabetes to easily measure and track their blood glucose, activity and meals.

Hospitals and diabetes clinics also should keep in mind that software platforms that enable RPM services are no longer a budgetary expense but a potential source for new revenues. Since 2018, CMS has been accepting CPT codes to reimburse not only for the RPM activity of collecting patient data but also for providers’ time spent counseling patients to make therapy adjustments.

Real-World Data: A Powerful Engine to Drive Actionable Insights

What happens hour-to-hour in the life of a person with diabetes can have an enormous impact on her health. Activities, food intake, the timing and dosages of insulin administered, medication compliance and behavioral and psychological changes can all affect her ability to maintain glycemic control. Until recently, however, most of this information has been unattainable.

Thanks to the massive amounts of real-world data (RWD) generated by the explosive growth of RPM platforms and tools, this black box is beginning to crack open. In broad terms, RWD refers to any data relating to patient health status and/or the delivery of health care routinely collected from various sources.  Using increasingly sophisticated analytical tools, providers and clinical researchers are leveraging robust sets of deidentified RWD to better understand how various determinants of health outcomes affect not only individuals but also patient populations.

For example, if the glucose data for a person with diabetes suggest a hypoglycemia event, data on her most recent insulin dosing, food intake and activities could shed light on what precipitated the event. By integrating RWD from multiple sources, providers and researchers can gain a deeper understanding of how treatment protocols affect patients’ lives.

RPM diabetes platforms are rapidly accelerating the expansion and value of RWD sets by enabling patients to remotely share glucose trends, insulin usage patterns, medication and other data. As just one example, the Glooko RPM platform offers de-identified RWD for individuals with diabetes from 7,500 clinics in 29 countries.

Recognizing that RWD are playing an increasing role in health care decisions, the FDA is encouraging their use by accepting RWD in its regulatory decisions, including approval of new indications for approved drugs and biologics. As analytical capabilities continually improve, clinician scientists will tap into RWD to investigate the efficacy of a wide range of interventions, including telehealth coaching.

What’s Next?

Spurred by the pandemic, digital health technologies have come a long way in a short time. Connected RPM platforms with DTx apps and digital companion tools already give patients and clinical trial participants greater and more convenient control of their health. Combined with robust and easily accessible RWD, these solutions are planting the seeds for creating ecosystems of holistic, patient-centric care.

However impressive, today’s technologies are only the tip of the iceberg. In the near future, data science will provide a deeper understanding of what motivates people to change, which will drive the development of more effective psychological interventions and tools. As artificial intelligence takes analytics to a whole new level, the healthcare community will have limitless opportunities to harness the power of data and humanize patients’ digital experiences.