Fitbits Are So Last Decade

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By Mary Carpenter

INSOLE MONITORS from Paris-based FeetMe offer real-time gait assessment of variables, such as pressure distribution across the bottom of the foot —making them an exciting new digital health tracker for people with ongoing foot problems. After an endless search for helpful orthotics, real-time evaluations sound like a huge advance over current methods.

“The way people walk under observation in a short amount of time [in the clinic] is not how they walk in real life,” FeetMe co-founder and CEO Alexis Mathieu told ClinicalOMICs news.  The insoles also collect and store data for “home-based assessments” of the efficacy of rehabilitation programs and drug treatment in patients with conditions like diabetes and osteoporosis —as well as multiple sclerosis, for which the device is now in clinical trials.

In the “Quantified Self” movement—which includes terms like bio-hacking, self-quantifying, lifelogging —digital devices can offer crucial real-time monitoring of  “biomarkers,” defined as indicators of biological events that provide information or clues about current or future health issues. Biomarkers measurable by digital devices provide information on everything from sleep quality, inflammation levels and drug effectiveness, to mental health issues—a big step forward from first-generation health trackers that assessed steps and mileage. (Most of these devices are not yet commercially available in the U.S.)

As early as 2019, 44% of respondents in a digital-health consumer-adoption report tracked some aspect of their health using digital tools and shared that information with their health care providers, according to Rock Health, a seed fund supporting startups focused on digital health technology. “One in three respondents owned a wearable, and one in four wearable owners used it to manage a diagnosis.”

Among the newest options, the CompanionMx app can evaluate four variables relevant to mental health—interest, social isolation, mood and energy levels—by collecting data to find patterns in an individual’s speech as well as in the frequency, diversity and timing of their cell phone use. Studies using the app for suicide prevention are now underway with the U.S. Department of Defense.

The Sweatronics platform from Eccrine Systems analyzes sweat for rapid assessments of drug effects, with the goal of “precision dosing,” especially for medications with a “narrow therapeutic range, like some blood thinners,” explains Eccrine CEO Gavi Begtrup. “The big picture… is to get away from one size fits all dosing and get everyone on the right drug faster.”

Sweat testing also offers rapid adherence-monitoring for opioids, compared to traditional urine tests which take time. And sweat detectors can perform non-invasive testing for inflammation and glucose levels to help monitor diseases like diabetes; and for cortisol levels that indicate stress levels and can be crucial in cases of Addison’s and Cushing’s diseases.

In the case of sweat testing— as with many assessments from wearable devices —the most avid users may be athletes desiring real-time performance data, especially those in serious training for marathon and Olympic competitions.

To determine how hard she can train and whether she can practice her most competitive moves, competitive skater Jeanette Cajide aims for a “good recovery day,” based on her Oura ring’s assessments of resting heart and respiratory rates; continuous glucose monitoring from Levels; and help from a mattress pad programmed to lower middle-of the night temperature for improved heart functioning.

Cajide also wears an Elite monitor to keep track of heart-rate variability (HRV), variance in the length of time between heart beats (greater variance is considered a key real-time indicator of fitness); and an overnight high variance score, an indicator of restorative sleep. The Apollo Neuro, another bio-hacking device, can increase HRV to optimize performance.

Programming the Neuro to “recalibrate the nervous system” using varying-frequency vibrations may speed recovery after physical exertion as well as increase alertness and focus. In an early test, however, endurance mountain biker Chris Bailey concluded that “it helps with focus a little bit, maybe.”

The Covid pandemic has created more interest in tracking biomarkers, Stanford University geneticist Michael Snyder told the Wall Street Journal.” In Snyder’s research, smart watch data on heart rate, steps and sleep have helped detect Covid-19 up to nine days before symptoms appeared. “The seriousness of the pandemic has made people realize that, gosh, isn’t it a good idea to have a sensor?” Snyder said.

Also associated with the pandemic, remote-physician options are upping interest in personal biomarker tracking— as is accumulating evidence that supports better individualizing of health care. Do-it-yourself blood and urine tests and body-fat scans can also help reveal underlying health conditions.

Smartphone and big-data companies like Apple and Google have been developing digital health programs, ushering in a “new class of… software-as-medical-device (SaMD), according to ClinicalOmics, which considers the Apple watch the “the iconic symbol of a SaMD.”

When the Apple Watch Series 4 received FDA clearance for its ECG (electrocardiogram)-monitoring functionality —with the ability to detect elevated heart rates and atrial fibrillation— it became one of the first direct-to-consumer ECG devices on the market. Accuracy of the Apple Watch, however, can vary among individuals; and some find it impossible to get a heart-rate reading at all.

In one study, the Apple Watch detected atrial fibrillation about 40% of the time—considered “fairly good” sensitivity for abnormal arrhythmia—and was more accurate in older patients than younger, according to Morristown, NJ cardiologist and sports medicine specialist Matthew Martinez. Warnings from some doctors, however, concern the risk of overdiagnosis with this function, especially in younger wearers—with a high frequency of false alarms leading to the risk of over-treatment.

“The Apple Watch is in no way a replacement for medical devices,” said Martinez, who instead recommends the AliveCor “medical-grade ECG without the extras of the Apple Watch.”  “Medical grade” and “clinical usefulness” are major goals of SaMD’s developers.

Creator of “The Quantified Self” podcast” Laura McClellan—real estate lawyer, self-described “productivity enthusiast” and tech geek—summarizes the advantages of digital biomarker monitors: raising awareness, gathering data about what our bodies and minds are doing; accountability, creating the motivation to be more active; crowdsourced aggregated data; seeing how others are functioning in ways we might like to work on; and improved medical care, using data for better treatment designs.

Among downsides, McClellan describes “cyberchondria,” undue anxiety about health resulting from intense self-tracking. Also: obsession, “unhealthy focus, wasted time;” loss of perspective, forgetting what really matters due to over-focus on numbers; self-criticism, “beating ourselves up or judging ourselves by the results of what we track;” and privacy concerns — “what do the app/website owners do with that data?”

Deeper questions arise about whether the body-hacking movement portends the end of “narrative health” — and “the beginning of examining patients exclusively through data rather than through their personal, needs, worries, expectations or stories,” writes digital health journalist Artur Olesch. “The question ‘how do you feel’ is being replaced by ‘what are the results?’”

Olesch also warns about the new digital divide that could arise as biotracking wearables, most of which are not reimbursable by health insurers, are available only to “digital natives with a higher economic status.” The result: measurement of life signs would be available “not for those who really need it, but for those who can afford it.”

Meanwhile, ongoing questions about the accuracy of wearable monitors extend even to the simplest measurements. But the Apple Watch has come a long way from the early Fitbit—with which one user managed to increase her number of steps by moving her forearm up and down while lying on her bed. And advanced calibrations can now vastly improve the accuracy of data collected by wearable devices, especially by the Apple Watch.

If I could bundle the most appealing lifelogging offerings —only for a few days or nights and mostly out of curiosity rather than medical need — I would choose the following: a continuous blood-glucose monitor, such as the Sweati patch, to find out which favorite foods spike my blood glucose; an HRV monitor to assess the restorative effects of my nighttime sleep; and the Apollo Neuro for staying more alert and focused during Zoom meetings.

Before any of these, however, I’d want to use those FeetMe insole monitors—with the longed-for real-time gait assessments of walking speed, cadence and load—in the hope of acquiring terrific new orthotics that balance my body and end foot pain.

—Mary Carpenter regularly reports on topical issues in health and medicine.