Health-Related Wearables Can Track Data for Your Doctors

“Whether it’s a wearable or not, just collecting data from home, I’m making my patients healthier,” says Richard Milani, M.D., chief clinical transformation officer at Ochsner Health System in New Orleans. “The question is, how can I collect more information than these isolated events when you show up in my office — that can provide us a better way to keep you in good health and avoid you from getting into trouble?”

Abbott

Other health wearables on the cusp

During the recent CES trade show (formerly called the Consumer Electronics Show) in Las Vegas, Swiss start-up firm Aktiia announced plans to bring its automated wrist-worn 24/7 blood pressure device to the United States. The company has about 15,000 customers in Europe. In the United Kingdom, it sells for 200 pounds, or about $275. CEO Michael Kisch says Aktiia’s goal is to get FDA clearance in the next 12 months.

“In the U.S., maybe 30 percent of people who have high blood pressure will measure their blood pressure in a month. That’s it,” Kisch says. “With our product … people on average will check their blood pressure 15 to 20 times a week. The coolest thing to come out of that … is for the first time ever, you can present to the consumer what percentage of your day or week or month you are in a target range.”

Omron Healthcare, a global electronics firm based in Japan, already sells an FDA-approved HeartGuide wristwatch for $499 that can monitor blood pressure. A key difference: You must initiate pressure readings manually, which you can then send via Bluetooth to an app on your smartphone.

Health care giant Abbott announced a new line of consumer “biowearables” at CES under the Lingo brand name, designed to continuously track signals in the body for glucose, ketones, lactate and eventually alcohol levels. These latest biowearables are an extension of Abbott’s FreeStyle Libre 2 continuous glucose monitoring system that has been in the U.S. market since 2017 and is used by nearly 4 million people globally.

Worn on the back of the arm, FreeStyle Libre is about the size of two stacked quarters. A tiny sensor filament, about the width of three human hairs, is placed just below the surface of the skin, where it measures molecular biomarkers. Data is sent via Bluetooth to an app on your smartphone every minute, giving users insights into what’s going on in real time. It’s available by prescription and lasts 14 days. Then the user peels it off and applies a new one.

Lingo devices won’t require a prescription. They are “about learning your body’s unique language — a language that most of us have not yet learned how to speak. What if we could decode the message our body is trying to send us as a way to maintain and improve our health?” Abbott chairman and CEO Robert Ford said during remarks at CES.

Abbott plans to sell the Lingo ketone biowearable in Europe this year but hasn’t said anything about U.S. availability.

Nor has Tokyo-based health care start-up Quantum Operation, which says it has developed a noninvasive glucometer wristband that can sense glucose in the bloodstream without having to stick in a needle. Now a prototype, the device hasn’t yet gone through the required medical certifications in Japan, the U.S and elsewhere.  

Getting data from the foot

San Francisco-based Siren is producing a wearable for your feet: machine-washable socks for people living with diabetes and neuropathy. The socks come with a Bluetooth hub that plugs in the wall and lets a team of nurses monitor the temperature of the foot, which Siren says has been shown to reduce diabetic foot ulcers by up to 87.5 percent.

These socks have been around for about five years, and Medicare can cover the cost. You need a prescription, but you don't need a smartphone.

“Everybody in our team is dedicating all of their time to prevention and using data and easy-to-use tools to prevent the complications caused by chronic disease and aging,” says Henk Jan Scholten, Siren's chief operating officer. “If people can use a very simple intervention — just putting on socks — I think it’s worth pursuing. We see really good outcomes with our patients.”

Patients receive five pairs of socks at a time. The embedded electronics do not have to be charged, and the socks, which come in black or white, are replaced after normal wear and tear. Medicare patients who have secondary insurance typically have no copay, Scholten says. Those who don't have insurance pay about $20 a month.

While experts celebrate the boom in health-care-related wearables, such devices can leave consumers with several questions, especially among older folks who may be a bit less trustful when it comes to technology.

Aktiia

Is the information generated accurate?

There are no guarantees, but you generally can put more faith in a device that your doctor prescribes or recommends, or that has the blessing of the FDA. You’ll also want to investigate the science whenever possible: Were clinical studies done, and did respected peer reviews validate the device?

It isn’t always clear if a device has medical-grade bona fides, which is not to suggest that a wearable that lacks them is without merit. And not every feature on a single device may be regulated. While the EKG feature on the Apple Watch did require FDA clearance, its fall detection — Apple will call emergency services if you take a hard spill and need help — and blood oxygen features did not.

Aktiia's Kisch draws the dividing line between a consumer wellness device and clinical wearable by asking this question: Is the device producing data that a physician is willing to base a medical decision on? Aktiia plans to make its blood pressure watch available through doctors rather than as a direct-to-consumer offering, at least initially. The company is engaged in clinical partnerships and pilots in the U.S., including a study with hypertension patients at Brigham and Women's Hospital.

Can I understand what the data is telling me?

You don’t want to overreact or get too weirded out by a single reading or temporary blip. At the same time, you shouldn’t ignore serious warning signs. When in doubt, reach out to your doctor.

 The onus is on the makers of the wearable to explain in plain language not only what the data means, but also potentially what can you do about it. It's equally important to spell out how to properly take measurements. You should also be informed on a devices's limitations. When you launch the ECG app on the Apple Watch, for example, a note appears that says "Apple Watch never checks for heart attacks."

It's equally important to spell out how to properly take measurements. For example, you need to stay as still as possible when counting down the 15 seconds the Apple Watch requires to measure your blood oxygen, a point Apple makes clear.

Omron’s HeartGuide watch is meant to be worn snugly, but not too snugly, about an inch above the wristbone. “We’ve got a reminder every time someone goes to use HeartGuide that you have to hold the device at heart level, almost like a reverse pledge of allegiance,” says Carol Lucarelli, the Illinois-based executive director of marketing and e-commerce at Omron Healthcare.

Omron also tries to add context behind the numbers. You may receive notifications along the lines of, “We also noticed that your average blood pressure reading yesterday was higher than your typical average for a Thursday,” Lucarelli says.

Is your information private and secure?

Ask the device makers and medical providers you share data with how they plan to safeguard the information and keep it confidential. Where is the data stored? How is it protected in transit? Read privacy policies carefully.

The Federal Trade Commission affirmed in September 2021 that health apps and connected devices that collect or hold fertility, glucose level, heart health and other health data must notify consumers in the event of a breach.

“There’s promise in all of this technology, but also peril,” says Patrice Harris, chief executive officer and cofounder of digital health care company eMed and former president of the American Medical Association. “I always say proceed with caution and have some curiosity.”

This story, originally published Jan. 20, 2022, has been updated with information from the Apple Heart and Movement Study.