Advances in wearable technology are opening the door for a new generation of disease treatments that leverage remote monitoring and therapeutics delivered via devices worn on the body.
Wearable devices and sensors, also known as wearables, are a growing area of focus for healthcare organizations and technology companies alike.
In the past three months alone Amazon has released plans to distribute its new health tracking wristband to patients at Sharp HealthCare; Fitbit—awaiting regulatory approval for an acquisition by Google—earned Food and Drug Administration clearance for an electrocardiogram app; and Apple kicked off research using the Apple Watch to study asthma, heart failure and respiratory conditions.
The FDA, which for years has been working to develop new regulatory models for digital health separate from traditional medical devices, in September launched the Digital Health Center of Excellence to coordinate those efforts.
But as the technology offerings grow, hospitals and health systems are still figuring out the best way to integrate wearables into care delivery, if at all. “Wearable adoption for chronic care management, for continuous monitoring (and) for discharge … remains low,” at least before the pandemic began, said Arielle Trzcinski, a senior analyst at market research firm Forrester.
It’s yet to be seen whether increased remote monitoring practices adopted during the pandemic, such as using wearables, are sustained.
Some may be hurting health long term. Experts have raised concerns about whether devices developed as consumer fitness trackers provide data as accurate as traditional medical devices, and have questioned whether the often costly devices will widen health disparities if not deployed in an accessible way or subsidized by a provider or insurer.
There’s a “need to continue to grow clinical evidence,” said Brian Kalis, managing director of digital health at consulting firm Accenture. But generally, growing comfort with wearables and evolving regulatory models are pushing more widespread adoption, he said.
Anthem is one of the healthcare organizations that has partnered with Apple. Along with the University of California at Irvine, they are recruiting volunteers for a randomized, controlled trial to assess whether tracking heart rate, blood oxygen, sleep patterns and other characteristics with the Apple Watch and Apple’s sleep monitoring device Beddit will help members manage their asthma and decrease emergency department utilization.
Depending on the trial’s results, Anthem may integrate digital tools for asthma management into its programs long term, said Dr. Warris Bokhari, vice president of digital care delivery and leader of Anthem’s work on the study.
Many healthcare organizations see potential in wearable therapeutics designed specifically for medicine, too.
Snapshots of health systems integrating wearables into care for cardiac health, diabetes and migraines follow.
Wake Forest Baptist Health in Winston-Salem, N.C., this spring began trying out a new use for wearable continuous glucose monitors: to give care teams more information when adjusting insulin doses for inpatients. It’s an example of a health system repurposing medical wearables.
Continuous glucose monitoring, or CGM, has been a part of outpatient diabetes management and treatment for years. Dr. Joseph Aloi, section chief for endocrinology and metabolism at Wake Forest Baptist Health, said he’s seen outpatient adoption tick up in the past three to five years in particular, as needles have gotten smaller, sensors can be worn longer and the technology has become more affordable.
However, the technology is still considered investigational in the inpatient setting, where inpatient glycemic management teams tend to rely on traditional finger-stick tests to determine whether they need to adjust a patient’s insulin.
That’s changed, at least temporarily, at Wake Forest Baptist Health during the pandemic.
Inpatients with diabetes are offered the option to use a CGM sensor from Abbott Laboratories; it’s about the size of a quarter and worn on the upper arm for 14 days. Abbott donated the wearable sensors in April, after the Food and Drug Administration approved the system for use in the hospital setting during the COVID-19 emergency.
Traditionally, nurses check a patient’s blood sugar with finger-stick tests before each meal and at bedtime. “So that’s four finger-stick blood sugars a day,” Aloi said. “With the sensor, we’re getting more than 100 data points a day,” something he thinks will provide a more comprehensive way to tailor patients’ insulin needs.
During the pandemic, continuous glucose monitoring has helped reduce infection risks, since nurses don’t need to enter a patient’s room several times a day for bedside finger-stick tests, Aloi said.
A study published by TouchEndocrinology concluded that cost differences vary by volume. If a Type 1 diabetes patient is using eight finger sticks per day, the annual cost is $4,380; six finger sticks/day, the annual cost is $3,285; for three finger sticks/day, the annual cost is $1,643. CGM costs $1,712 annually, lower than six to eight tests per day, but comparable to three daily tests.
“This is all (an) emerging change in practice,” Aloi said. But “my personal bias is that this is going to replace finger-stick testing in the hospital.”
In the wake of the COVID-19 pandemic, Children’s Mercy Kansas City (Mo.) launched a program to deliver physical education to local elementary school students remotely.
The research project, still in its early stages, seeks to encourage kids to engage in physical activity while at home and to help Children’s Mercy better understand the role wearables can play in doing so.
“School is a huge source of kids’ physical activity,” said Jordan Carlson, associate professor of pediatrics at the Center for Children’s Healthy Lifestyles & Nutrition at Children’s Mercy, citing a 2015 study he led that found roughly half of kids’ daily physical activity comes from time spent at school. Carlson is leading the project, which is dubbed the Stay Active Program.
“With the impact of the pandemic, and kids not physically being at school … we know physical activity is taking a huge hit,” he said.
Children’s Mercy in the fall launched the research project—funded by a grant from the Claire Giannini Fund—in fourth- and fifth-grade classrooms in six schools. Stay Active involves an instructor from Children’s Mercy delivering physical activity lessons via video conferencing twice a week, with short sessions of five to 10 minutes. To encourage kids to exercise, the program also supplies participating classrooms with smartwatch fitness trackers from Garmin, which students wear to track daily step counts and minutes of physical activity. Parents get an email newsletter twice a month with advice on encouraging their kids to be active during the pandemic.
Garmin donated 250 smartwatches for the program; so far, roughly 75 devices have been distributed to participating students. The smartwatches retail for around $80.
Students’ data is sent to a Garmin mobile app for parents to view, as well as to Children’s Mercy, as part of the health system’s research and to inform automatic pre-scripted text messages that are sent to parents. Physical education teachers can also request to see aggregated class-level data, but not information on individual children, Carlson said.
Carlson said it’s a voluntary program, and kids have seemed excited, in part because they keep the device. “Are kids going to wear it for the long term? Are they going to keep wearing it across the semester?” he said, citing examples of questions his research seeks to answer. “Those are questions that we don’t have much experience with so far.”
Migraine treatment is tricky. Treatment options range from lifestyle changes and prescription medications to Botox injections that block pain pathways associated with the chronic neurological disorder. No single treatment works for everyone—meaning physicians often have to try different methods to tailor care for each patient.
Dr. Hida Nierenburg, director of headache medicine at LaGrangeville, N.Y.-based Nuvance Health system, has added a new therapeutic option to her arsenal. Since late last year, she’s been prescribing some patients a wearable arm patch from Theranica, a company that last year gained Food and Drug Administration clearance as an acute treatment applied during a migraine episode to stop pain symptoms.
The Theranica patch is an electrical neuromodulation device, which means it uses electrical pulses to stimulate the wearer’s nerves. It “feels like tentacles and electricity,” said Nierenburg, who’s tried the device. The whole idea is to prevent the migraine pain signal from spreading.
To determine whether a prescription for the arm patch is a fit for patients, Nierenburg said she considers factors like how frequent and severe their migraines are, their comorbidities and their treatment preferences, such as whether they’d prefer to try a device instead of a medication. “My job would be a lot easier if everything was the same for everybody,” Nierenburg noted. “But I have to adapt. … Everybody reacts differently.”
Nierenburg last year led a three-month clinical trial, testing the device in about 40 patients with chronic migraines, or patients who report at least 15 days each month with headaches, at least eight of which have features of migraines.
Today, the wearable device is only cleared by the FDA for patients with episodic migraine, a condition with fewer migraines per month than chronic migraine.
In the trial, an estimated 74% of participants with chronic migraine reported pain relief two hours after using the device; 84% had sustained pain relief after 24 hours in at least half of their migraine episodes, according to study results published in the journal Pain and Therapy in July.
Patients don’t wear the arm patch all the time. It’s an acute treatment, which means a patient dons the patch when they feel an episode starting. Patients use an associated app to control the degree of electrical stimulation received through the patch for each session, which lasts 45 minutes.
One drawback is that insurance generally doesn’t cover the device, so patients are paying out of pocket, Nierenburg said. The disposable device costs $99 and lasts for 12 treatments.
Traditionally after a patient suffers a heart attack, their physician would encourage them to enroll in a multiweek on-site cardiac rehab program. There the patient receives health counseling, as well as prescribed exercise and diet that decrease the likelihood of a secondary cardiac event. The patient would visit a facility for medically supervised exercises.
Enrollment in such programs tends to be “quite low,” in part because it’s inconvenient, said Dr. Tad Funahashi, an orthopedic surgeon and chief innovations and transformation officer at Kaiser Permanente in Southern California.
So, about three years ago, the Oakland, Calif.-based health system and health insurer began trying an eight-week virtual program for patients stable enough to complete the program at home.
It’s since been scaled across medical centers in Southern California and Georgia, and Kaiser is working to expand it across its seven regions. Participants wear a Samsung smartwatch to monitor activity levels and heart rate while completing prescribed exercises; they also answer questions through an app about exercise patterns, symptoms and medication adherence. The data is shared with Kaiser’s electronic health record system to populate a dashboard that care teams review to inform adjustments to their treatment plan.
Patients also complete weekly check-ins via phone call or video visit with care managers.
More than 80% of patients who enrolled in Kaiser’s virtual program complete it, compared with less than 50% on average for the system’s in-clinic cardiac rehab program. Less than 2% of patients who enrolled in Kaiser’s virtual cardiac rehab program experienced a cardiac-related hospital readmission, according to findings published in NEJM Catalyst last year.
Kaiser provides the smartwatches to patients for free, and they’re returned when the program ends. Kaiser has a contract with Samsung for the smartwatches. They aren’t purchased off the shelf, Funahashi said, since they’re outfitted with software specifically developed to link with Kaiser’s systems.
Funahashi declined to share financial details of the contract. He said running the virtual program is more cost-effective than traditional in-person cardiac rehab at a facility.
Kaiser expects 4,000 to 5,000 Southern California patients to go through the virtual program annually, Funahashi said. Kaiser continues to tweak the program, such as looking into whether using a wearable device with a longer battery life could improve outcomes by also monitoring patients’ sleep patterns.