SaMD Diabetes Software Experts

Remote Patient Monitoring: Opportunities in Outpatient & Inpatient Settings

Remote patient monitoring is a growing market with applications in outpatient and inpatient hospital settings. For diabetes software and medical device companies, this niche is ripe with opportunities for product development.

The COVID-19 pandemic has boosted the use of remote patient monitoring (RPM) in both outpatient and inpatient hospital settings. It has even brought about guidance that allows for the use of continuous glucose monitors (CGM) in hospitals for the first time. But the uses for RPM in managing hospital patients with diabetes are far from fully realized.

In this article, we look at the current uses for remote patient monitoring for people living with diabetes in hospitals and outpatient programs and the potential for future development within this market.

RPM in Inpatient Hospital Settings

Remote patient monitoring has long been reserved for outpatients and those recently discharged from the hospital. But guidance released by the FDA in the midst of the COVID-19 pandemic changed that.

This emergency use authorization allows for hospital use of non-invasive remote or wearable patient devices. This action is meant to reduce the contact time between doctors and COVID-19 patients and preserve PPE. For the diabetic community, specifically, it has opened the doors to CGM use in hospitals for the first time.

While this use has been limited to COVID-19 patients within ICU settings, it has offered some incredible data on the potential use of these devices in more general hospital settings. Much of this, we discussed in our recent article on CGM use in hospitals

Current Uses

While RPM is mainly used for ambulatory patients, current constraints on the healthcare system caused by short staffing and an increase in patients have made RPM more valuable for inpatients. For patients living with diabetes, CGMs and connected finger-stick POC devices are the most common RPMs used in hospitals.

CGMs

CGMs are limited to use in the ICU for the treatment of COVID-19 patients. Here, they have proven valuable. Research has shown they provide no additional benefits in terms of procuring better outcomes than hourly finger-stick POC. But when used in place of POC, they do an incredible amount to reduce the time needed for glucose checks and the supplies required, and allow for reactive treatment to real-time remote glucose data.

Most importantly, CGMs have proven to be just as accurate in reading glucose numbers as standard blood glucose meters when compared to lab readings.

While their use is highly restricted at this point, most experts agree that we will see full approval for CGM use in hospitals within the year.

Connected POC

Outside of the COVID unit, most patients with diabetes are monitored using standard POC protocols. These call for finger stick glucose readings before meals and before bed. Traditionally, these readings were taken with standard blood glucose readers. More recently, many hospitals have transitioned to cellular-connected remote glucose monitors.

These meters work and function the same as traditional meters, but offer the added benefit of cellular connectivity. With this, the meters automatically transfer results to the connected Electronic Healthcare Record (EHR). These tools eliminate the possibility of mistranscribed measurements, reduce testing time, and keep records up to date at all times.

Opportunities

With such limited current use in inpatient settings, it should come as no surprise that the opportunities for improvement and innovation in RPM in inpatient settings are vast. Here are a few open areas in this market that experts agree show the most promise for future RPM use.

Widespread CGM Use

Research has found that current CGM devices are just as accurate in reporting glucose levels in diabetic patients as finger sticks(1). In the ICU, their benefits are limited by the strict POC standards for hourly blood glucose checks. But in the general hospital setting where POC standards only recommend four blood glucose checks per day, CGMs have the potential to offer many benefits.

Continuous glucose monitors are more likely to catch hypoglycemia and hyperglycemia than intermittent finger sticks(2). Since non-ICU patients suffer high blood sugars at the same rate as those in the ICU, having a system in place to better monitor non-ICU patients for abnormal blood sugars is a must(3).

CGMs have also been proven to be effective in guiding insulin treatment of inpatients. In a randomized trial, patients treated based on CGM spent similar time in range compared to those treated based on POC and had similar numbers of hyperglycemic episodes. Where CGMs outperformed POC was in preventing hypoglycemia(4).

Since both hypo and hyperglycemia are known to cause increased complications in hospital settings, CGMs could greatly reduce complication risks for these patients. 

Automated Insulin Dosing

Automated insulin dosing (AID), which relies on a CGM, insulin pump, and connected algorithm, has proven highly beneficial for reducing critical events and preventing complications in people living with diabetes. To this point, using it as a method for insulin treatment in hospital patients has not been attempted. 

However, experts agree that current technology allows for the safe use of AID in patients already using these systems outside of the hospital(5). Moreover, some focused improvements in this tech could easily render it useful as a fallback hospital tool for long-term patients who did not use AID before entering the hospital.

Current AID systems take time to establish baselines for patients before they can effectively normalize glucose levels. Improvements in this area could drastically increase the useability of these systems in hospital patients. 

Many factors in the hospital environment have the potential to interrupt normal glucose patterns. The advanced algorithms of AID systems have the potential to provide better reactive treatment to these changing factors than busy hospital staff with limited knowledge of diabetes care. The remote monitoring of these systems also allows for the oversight of an endocrinologist that may not otherwise be available for treatment advice.

Integrated CGM and POC tools

Currently, there are a handful of cellular-connected remote glucose monitors used in hospitals. These smart devices are compatible with most EHRs. This is in contrast to current CGMs, which are not compatible with common EHR systems.

Developing CGMs that can connect directly to hospital records and central monitoring systems is vital for hospital-wide use of these devices. More importantly, these CGMs need to be interoperable with current and future remote glucose monitors since these tools will be needed for calibration. CGMs, blood glucose monitors, and other POC tools optimized for connectivity (that feature easy-to-use software development kits) will have major advantages over those that are not when considered for use in the inpatient hospital environment. 

RPM In Outpatient Settings

Remote patient monitoring in outpatient settings is far more common than it is inside the hospital. But even here, we see that current uses of RPM in outpatients living with diabetes are limited to CGMs and remote glucose meters. This leaves plenty of opportunities for innovative companies to fill gaps in care to reduce the occurrence of complications and hospital admittance.

Current Uses

Many people living with diabetes undergo outpatient procedures for wound care associated with their condition. Nerve damage, cardiac issues, and other common complications of the disease account for an additional chunk of outpatient cases. In the remaining instances, the reason for treatment is unrelated to diabetes, but, inevitably, still affected by it since this condition raises the risk of complications from most types of medical intervention.

For these reasons, many outpatient programs will follow up with blood glucose reporting after the procedure. This is made quite a bit easier when RPM tools are used. The most common are remote glucose monitors like the cellular-enabled meters discussed above. CGMs may also be prescribed for patients with recurring complications or those requiring longer term follow-up.

Opportunities

Nonattendance of diabetes-related outpatient appointments is a major problem across the world(6). This is especially true of repeated appointments necessary for continuous monitoring or wound cleaning. RPM tools can be helpful for doctors to track patients’ health and control even when appointments are missed. But these tools must be noninvasive, require little input from the user, and be easy to use. Otherwise, like the missed appointments, they are likely to be abandoned.

Beyond diabetes-specific tech, opportunities also exist in RPM tools that report metrics on conditions and complications common to those living with this disease.

Sepsis Risk Monitoring

People living with diabetes are at an increased risk of sepsis following many inpatient and outpatient procedures(7). Tools that allow doctors to monitor signs, symptoms, and progression of sepsis could be highly valuable in monitoring discharged and ambulatory patients following these kinds of visits.

Many solutions for such a device have been proposed(8). Producing one that could not only accomplish this type of monitoring for early intervention but do so noninvasively and in a form that allows for interoperability with other common RPMs would be highly useful.

Cardiac Monitoring

Heart failure, heart disease, and many other cardiopulmonary conditions are common in people living with diabetes. Both outpatient procedures and more complex inpatient surgeries require long-term monitoring of the patient once they get home.

Studies have shown that current single-center RPM programs do not do enough to reduce instances of hospitalization following discharge. However, dual-platform programs have a proven ability to reduce emergency room visits and readmittance following these procedures(9). More research is needed in this area in order to develop promising cardiac-centric RPM that can be used along with common diabetes monitoring devices.

Diseases with Known High Risk of Complications

COVID-19 has highlighted the importance of extra and continuing care for ill patients at high risk for complications. This is true even for those whose symptoms are not serious enough to warrant hospitalization. 

One study looking at cancer patients (who are also at high risk for complications) after outpatient treatment for COVID found that those who received RPM following discharge were 78% less likely to be readmitted to the hospital(10). Those that were hospitalized tended toward shorter stays and saw fewer ICU admissions and deaths than those who did not receive RPM.

Whether the illness in question is COVID, the flu, RSV, or other common viruses with known increased complications for people living with diabetes, RPM is vital for positive outcomes. The more comprehensive this monitoring, the better. But, since monitoring needs will change based on the illness and the potential complications, versatility will also be important. This means that tools built using component architecture that can be easily fit together and taken apart will be the most valuable.

Moving Forward with Remote Patient Monitoring

Remote patient monitoring is a growing market with vast opportunities for innovative software and medical device companies. Those with the skills to build highly adaptable, interoperable, and scalable solutions will have a major advantage over competitors.

Achieving these features in SaMD, mobile medical applications, and connected devices requires not just an understanding of potential gaps in the market, but of global regulations and optimized software development practices. For diabetes hardware companies looking to expand into the SaMD niche, it is vital to have a partner who understands these areas and is experienced in helping companies develop their product in line with them.

Here at Sequenex, we have decades of experience building software for the medical technology market. We specialize in diabetes tech and have helped dozens of companies design, develop, and launch their product. If you think we can help you, connect with us today.

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