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DSTXXX10.1177/1932296818768618Journal of Diabetes Science and TechnologyBasatneh et al
Symposium/Special Issue
Health Sensors, Smart Home Devices,
and the Internet of Medical Things: An
Opportunity for Dramatic Improvement
in Care for the Lower Extremity
Complications of Diabetes
Journal of Diabetes Science and Technology
2018, Vol. 12(3) 577­–586
© 2018 Diabetes Technology Society
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https://doi.org/10.1177/1932296818768618
DOI: 10.1177/1932296818768618
journals.sagepub.com/home/dst
Rami Basatneh, BSc, MA1, Bijan Najafi, PhD, MSc2 ,
and David G. Armstrong, DPM, MD, PhD3
Abstract
Objective: The prevalent and long-neglected diabetic foot ulcer (DFU) and its related complications rank among the
most debilitating and costly sequelae of diabetes. With the rise of the Internet of medical things (IoMT), along with smart
devices, the med-tech industry is on the cusp of a home-care revolution, which could also create opportunity for developing
effective solutions with significant potential to reduce DFU-associated costs and saving limbs. This article discusses potential
applications of IoMT to the DFU patient population and beyond.
Methods: To better understand potential opportunities and challenges associated with implementing IoMT for management
of DFU, the authors reviewed recent relevant literatures and included their own expert opinions from a multidisciplinary
point of view including podiatry, engineering, and data security.
Results: The IoMT has opened digital transformation of home-based diabetic foot care, as it enables promoting patient
engagement, personalized care and smart management of chronic and noncommunicable diseases through individual datadriven treatment regimens, telecommunication, data mining, and comprehensive feedback tailored to individual requirements.
In particular, with recent advances in voice-activated commands technology and its integration as a part of IoMT, new
opportunities have emerged to improve the patient’s central role and responsibility in enabling an optimized health care
ecosystem.
Conclusions: The IoMT has opened new opportunities in health care from remote monitoring to smart sensors and medical
device integration. While it is at its early stage of development, ultimately we envisage a connected home that, using voicecontrolled technology and Bluetooth-radio-connected add-ons, may augment much of what home health does today.
Keywords
Internet of things (IOT), Internet of medical things (IoMT), diabetic foot care, diabetic foot ulcers, diabetes, telehealth,
remote care, voice-driven technologies, Amazon Alexa, data security
Diabetic foot ulcers (DFUs) are common and costly conditions both to people with diabetes and to health systems.1-3
Subsequent complications such as infection, gangrene,
amputation, and early mortality further add to the seriousness of this sinister syndrome.4-6 Today, diabetes is the most
common cause of nontraumatic limb amputation.4
Up to one-third of people with diabetes will develop a
DFU in their lifetime.4,6 Diabetic foot complications constitute up to one-third of the direct costs of diabetes. Up to three
quarters of these costs are borne by inpatient care.2 A study
on the economic burden of DFUs and amputations showed
that patients with a DFU were seen in outpatient facilities 14
1
School of Podiatric Medicine, Temple University, Philadelphia, PA, USA
Interdisciplinary Consortium for Advanced Motion Performance
(iCAMP), Michael E. DeBakey Department of Surgery, Baylor College of
Medicine, Houston, TX, USA
3
Southwestern Academic Limb Salvage Alliance (SALSA), Department of
Surgery, Keck School of Medicine of University of Southern California,
Los Angeles, CA, USA
2
Corresponding Author:
Bijan Najafi, PhD, Interdisciplinary Consortium on Advanced Motion
Performance (iCAMP), Michael E. DeBakey Department of Surgery,
Baylor College of Medicine, One Baylor Plaza, MS: BCM390, Houston, TX
77030, USA.
Email: [email protected]
578
times per year and hospitalized about 1.5 times per year, for
a total of about $33 000 in Medicare reimbursements per
year.7
There is evidence that DFU rates can be reduced using
screening and appropriate intervention.6,8 In light of the
impending diabetes epidemic the need for enhanced prevention of DFUs is clear.6,8-10 Thanks to the new “smart” information and communications technology available today,
new opportunities have opened to smartly manage DFUs
with personalized screening and timely intervention.9-15 With
the help of automation, patients can even be prompted to
check their feet, glucose level or weight, and enter results
into mobile patient portals. Even better: They can transmit
the results to their doctors in real time. These fast-growing,
low-cost, and widely available resources can help predict
one’s risk for foot ulcers, infections, peripheral arterial disease, frailty, and other diabetes associated complications,
ultimately saving limbs and lives.
One of the fast developing infrastructures promising to
revolutionize the diabetic foot care industry is the Internet of
things (IoT).16 It is expected that 50% of health care over the
next few years will be delivered through virtual platforms.
This has accelerated development of a new market named
“digital wellness,” which combines digital technology and
health care.16 Digital-technology-based health care is
regarded as a natural and ultimate choice for remote, homebased, and long-term care of patients with chronic conditions
due to its low cost, high accuracy, and continuous monitoring
and tracking capabilities.
To better understand potential opportunities and challenges associated with implementing IoT for management of
DFUs, authors reviewed recent relevant literatures and
included their own expert opinions from a multidisciplinary
point of view including podiatry, engineering, and data security. More specifically, this article discusses the latest
advancements in the Internet of medical things (IoMT),
smart home devices, digital wellness, and health sensors and
their potential uses for the purpose of DFU prevention.
What Is the IoMT?
The IoT covers many areas ranging from enabling technologies and components to several mechanisms that
effectively integrate these low-level components. However,
its definition still remains vague and too broad. In an effort
to give a sound definition for IoT that addresses all the
IoT’s features and facilitates, “IEEE Internet Initiative”
has published a report titled “Towards a Definition of the
Internet of Things (IoT).”17 This report provided a short
definition for IoT as “an application domain that integrates
different technological and social fields.” However, this
report acknowledged that the definition of IoT is often
biased toward the assets and particular vision of the proponent entity with respect to the assets of IoT that are deemed
more relevant to the proponent entity. Regardless of which
Journal of Diabetes Science and Technology 12(3)
definition is used, an IoT system always involves a system
of devices, machines, or anything with the ability to transfer data without the need for a human to implement the
communication.18 Furthermore, the complexity of the IoT
system could be changed depending on specific application. For example, for small environment scenarios, an IoT
system is a uniquely identifiable “thing” connected to the
Internet, perhaps with static data stored in a wearable
device, so that these data can be accessed from anywhere,
at any time, by anything.17 In the large environment scenario, the IoT system could include a large amount of
“things” that can be interconnected to deliver a complex
service and support an execution of a complex process.
With this scenario, the definition of an IoT device can
grow to a self-configuring, adaptive, complex network that
interconnects “things” to the Internet and provide services
through intelligent interfaces, with or without human intervention, through the exploitation of unique identification,
data capture, data mining, communication, and actuation
capability.17
The major features of an IoT system include (1) interconnection of “things” (eg, wearables or any other physical
objects relevant to a targeted application); (2) connection of
“things” to the Internet (intranet or extranet); (3) uniquely
identifiable “things” (eg, RIFD tag, physical object with
unique virtual and readable serial number, etc); (4) ubiquity
(a network that is available anywhere and anytime); (5)
sensing/actuation capability (eg, wearables, glucose monitoring system, etc); (6) embedded intelligence (eg, artificial
intelligence, machine learning, or other data modeling); (7)
interoperable communication capability; (8) self-configurability (eg, service discovery, network organization, and
resource provisioning); and (9) programmability (eg, adjustable threshold for triggering an alert).17,19
Fueled by the recent adaptation of a variety of enabling
wireless technologies such as RFID tags and wearable sensors and actuator nodes, the IoT has stepped out of its infancy
and is the next revolutionary stage, transforming the Internet
into a fully integrated “Future Internet.”18 As we move from
www (static pages web) to web2 (social networking web) to
web3 (ubiquitous computing web), the need for data on
demand using sophisticated intuitive queries increases
significantly.
What has made IoT the “next big thing” is not just its
machine-to-machine component, but the potential of sensorto-machine interaction. With the increasing development of
health sensors, there is a growing opportunity to utilize IoT
for medical data collection and analysis. It is expected that
integration of these tools into the health care model has the
potential of lowering annual costs of chronic disease management by close to one-third.20
The cross-sectionality of smart home devices and portable diagnostic sensors has paved way for an IoT byproduct
called the Internet of medical things. IoMT may be defined
as medical device connectivity to a health care system
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Basatneh et al
Smart Home Devices and New
Opportunities From Voice-Driven
Technologies for Better Health Care
Delivery and Outcomes
Figure 1. The Internet of medical things lies at the intersection
of sensors, cloud computing, and medical monitoring.
through an online network, such as a cloud, often involving
machine to machine communication (Figure 1).15
The use of IoT for medical applications and in particular for wound and diabetic foot care is however still in
infancy. Currently, IoMT is frequently used for activities
such as remote patient monitoring for chronic illnesses,
tracking medication orders, and wearable mobile health
devices.11,21 However, our systematic search did not identify any study related to application of IoT for management
of DFUs. However, significant business decisions have
been taken recently by major information and communication technology (ICT) players like Google, Apple, Cisco,
and Amazon to position themselves in the IoT landscape.
For example, in 2014 Novartis began working with Google
on sensor-technologies, such as the smart lens, and a wearable device to measure blood glucose levels.22 In 2017,
Amazon teamed up with Merck and Luminary Labs on an
effort called the Alexa Diabetes Challenge, with the goal
of finding the ultimate way to monitor diabetes using
voice-enabled solutions.23As the IoT continues to develop,
there is increased potential to facilitate management of
chronic conditions at home including effective and timely
management of diabetic foot at risk as well as facilitating
the delivery of care for speed up wound healing. In addition, most medical devices that connect to analytics dashboards can be developed into IoMT technology.24 As
sensors that can measure DFU predictive markers are
being developed, there is a need to explore how these new
devices can be integrated into an IoMT model for the DFU
patient.
IoT is a concept reflecting a connected set of anyone, anything, anytime, anyplace, any service, and any network.17,25
This enables making the environment around us smart,
potentially giving rise to many medical applications such as
remote health monitoring to engage in intervention/prevention programs and improvement of adherence with treatment
and medication at home and by health care providers.
Thanks to recent advances in voice-driven technologies,
voice-activated commands are evolving into an integral
component of the IoT. Voice-controlled IoT is already ubiquitous and is getting more ranging from intelligent personal
assistance such as Apple’s Siri, Amazon Alexa, Google’s
Google Now, and Microsoft’s Cortana to the devices that
learn each individual person’s unique voice and create an
interface where that voice can reliably interact with a variety
of applications, such as a physician speaking directly to the
electronic medical record and hearing it back or voice
enabled medical transcription allowing doctors and nurses to
record what they say as text, rather than having to type or
handwrite forms.26,27 It is estimated that 40%-60% of
American adults already use voice search in their everyday
lives, and that 50% of all queries will be voice searches by
2020.28,29 This figure will only grow as voice-enabled assistant devices like the Amazon Echo and Google Home become
more commonplace and interactions more normal.
Recent improvements in voice-enabled assistant devices
not only reduce their cost (at time of writing of this review,
popular devices such as Amazon Echo are available for under
$50) but also include many interactive features allowing
users to connect to the world and facilitate self-care. For
instance, these voice-enabled devices can help users order
pizza, call an on-demand transportation service (eg, Uber,
Lyft, etc), control home appliances (eg, lights), tell the TV
what show to put on, request media playback, ask what the
weather will be like next week, order groceries for tomorrow’s dinner, and much more.30-32 As described in the following, these features could also provide opportunities to create
self-care solutions as it pertains to the goals of seeking timely
health care information, ordering medications, encouraging
adherence to care management plan, easing communication
between doctors and patients, and many more.
There are several efforts taking place to utilize these smart
speaker systems for better health care delivery and outcomes
ranging from drug delivery to voice-activated technology for
home-based exercise systems and caregiver engagement.29,33
Much recently, some efforts have been initiated to translate
the application of voice-enabled technologies for diabetes
care. But these efforts are still in infancy and we couldn’t
identify any clinical trial demonstrating the feasibility,
580
acceptability, and/or effectiveness of such technologies for
the purpose of diabetic foot management. Recently, few
industrially supported initiatives have encouraged researchers to explore solutions for the use of voice-enabled technologies for managing diabetes. For example, in 2017
Amazon paired with Merck and Luminary Labs to launch the
“Alexa Diabetes Challenge”, calling on innovators to create
Alexa voice-enabled solutions to improve lives of those with
type 2 diabetes. On its first call on April 2017, the challenge
received 96 submissions from a variety of innovators, including research institutions, software companies, start-ups, and
health care providers. On October 2017, Sugarpod application by Wellpepper34 was announced as the winner. The winner of the challenge suggested to build a voice-enabled IOT
scale and diabetic foot scanner, and also a voice-powered
interactive care plan. Sugarpod is a comprehensive diabetes
care plan solution that provides tailored tasks based on
patient preferences. It delivers patient experiences via SMS,
email, web, and a mobile application—and one day, through
voice interfaces thanks to the grant awarded by the “Alexa
Diabetes Challenge”. The major focus of this platform is to
improve patient engagement with treatment plans.
Could Voice-Enabled Home Assistants
Change the Management of DFU?
The management of DFUs largely entails a home approach.
When patients visit a podiatrist or any other specialist, they
are counseled on any number of important self-inspection or
self-measurement-based tips. For example, in 2017, a company named Orbita (Boston, MA, USA) designed the Orbita
Voice platform (Orbita Voice™),35 which enables health
care organizations and service providers to create and maintain interactive apps for voice-assistants and conversational
artificial intelligent platforms like Amazon Alexa and
Google Assistant. According to the company webpage,35
Orbita Voice is currently used to engage patients in clinical
trials and remain compliant with their treatment. For example, the clinical trial study coordinators can create and manage care plans by setting care goals, tasks, and rules over a
specified timeline, including completion of daily pain
assessment surveys, wellness tasks, or vitals measurements.
Patients and family members can review and manage care
tasks via voice as well as in mobile phone and web environments. Based on the indicated features in the company websites, authors believe a similar concept could be used for
managing DFUs at home. For instance, the technology could
be programed to instruct the patient or his/her caregivers on
how to change their dressings daily, valuate their foot temperatures for a preulcerative lesion, control their blood sugar
by adhering to certain dietary restrictions and taking their
diabetic medications, and perform daily foot checks to prevent any further ulcerations. Some of these potential features have been illustrated in Figure 2. In addition, based on
our expert opinions, several potential examples and features
Journal of Diabetes Science and Technology 12(3)
Figure 2. Schema of potential application of smart speaker
commands for management of DFU.
for a voice-enabled device for managing the diabetic foot
have been summarized in Table 1. In summary, we believe
that such technology could have 5 different feature categories. First is the patient-doctor interface—to facilitate scheduling appointments, refiling medications, informing the care
provider about any signs of health deterioration (eg, wound
smelling, painful wound, too much drainage, etc), and
obtaining additional clarification about care management
plan (eg, frequency of wound dressing change). Second is
the patient-caregiver interface—this interface can support
the communication between patients and their formal and
informal caregivers including families, friends, and others
affected by the illness. For instance, it could be instructed to
deliver a message from the caregiver to the patient at a specific time (eg, “Remind my mom at noon to take her medication”). Similarly, it could record a message from the
patient and send it to the caregiver via a text message or
voicemail (eg, “Please tell my nurse that I feel too much
wetness in my wound and my wound dressing looks heavy”).
The third feature is alerting/notification. This features could
give timely alert or notification to improve patient lifestyle
and/or engage the patient in the prescribed care management plan (eg, “Ms. Jones, today the weather outside is
beautiful, you may want to walk outside but make sure to
wear your new prescribed shoes”). It could also provide
time-effective alerting for the purpose of preventive care
(eg, “Ms. Jones, your big toe is hotter than your other big
toe, you may want to check your feet for any potential signs
of lesion/callus/redness and if you see anything concerning,
notify your caregiver or consult with your podiatrist”). This
features could also guide patients about optimum dosage of
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Basatneh et al
Table 1. Some Examples or Scenarios for Voice-Enabled Services for People With or at Risk of Diabetic Foot Ulcers.
Features
Patient-doctor interface
Patient-caregiver interface
Alerting/notification
Self-care
Gamification
Examples
Please call my primary care doctor’s office.
Please ask my doctor about the frequency of changing my wound dressing.
Please send the picture that I took from my wound to my doctor.
Please ask my podiatrist when my next appointment is.
Please tell my daughter that last night I had too much pain in my feet.
Please tell my nurse that my wound feels too moist and my dressing is too heavy.
Remind my mom at 8 am that I got her new prescribed shoes, please ensure to use them today and
tell me if you feel that any insole adjustments are needed.
Remind my mom at noon that it is time to take her medication.
Ms. Jones, your big toe is hotter than your other big toe, you may want to check your feet for any
potential signs of lesion/callus/redness.
Ms. Jones, you’ve done a great deal more activity between 10:30 and noon, more than you usually do
in an entire day. This could put your feet at risk.
Ms. Jones, today the weather outside is beautiful, you may want to walk outside but make sure to
wear your new prescribed shoes.
Ms. Jones, it seems you wore your prescribed shoes significantly less than usual yesterday! Please
make sure to wear your shoes when you are standing or walking.
Are apples good for people with diabetes?
How do I change my dressing?
I saw a callus under my big toe, what should I do?
I have a fever, does it mean my wound has gotten worse? What should I do?
Congratulations! You have 100 ulcer-free days in remission.
Congratulations! You have reached your activity goals today.
Congratulations! We received confirmation from your doctor that your wound is healing fast. Keep
using your prescribed boot when you walk or stand.
Congratulations! You wore your new prescribed shoes more than 8 hours today.
daily activities without risk. According to the statement of
the American Diabetes Association,36 maintenance of physical activity is a critical focus for blood glucose management
and overall health in individuals with diabetes and prediabetes. This statement recommended that “people with diabetes
(particularly those with type 2 diabetes) should decrease the
amount of time spent in daily sedentary behavior. In addition, prolonged sitting should be interrupted with bouts of
light activity every 30 min for blood glucose benefits, at
least in adults with type 2 diabetes. These two recommendations are additional to, and not a replacement for, increased
structured exercise and incidental movement.” However,
dosage of weight bearing activities (standing and walking)
in people with a DFU or at risk of a DFU needs to be done
carefully as to not delay wound healing or increasing risk of
foot ulcers. For example, Najafi et al12 demonstrated that
increasing number of daily steps beyond 6000 steps per day
could significantly delay wound healing irrespective of type
of offloading. The same study has concluded that prolonged
standing per day (eg, longer than 5 minutes) is a significant
negative predictor of wound healing success at 12 weeks
and thus should be avoided in particular when patient is
using removable offloading. Using a voice-enabled device
and IoMT platform, the patient could be advised when he or
she is exceeding acceptable threshold of activity. Similarly,
it could notify the patient (or caregivers) if he or she missed
the daily target of physical activities. The fourth feature is
self-care—this feature could empower the patient to improve
his or her self-care via asking questions anytime and anywhere (eg, “I saw a callus under my big toe, what should I
do?”). The fifth and final feature is gamification, used to
engage the patient in regular self-care to improve his or her
lifestyle (“Congratulations! You have 100 ulcer free days in
remission”).
This large quantity of instructions can be overwhelming
for a patient, but with the assistance of a voice-enabled
smart speaker, the entire DFU patient home care experience
could change drastically. Imagine if the home assistant gave
the patient step-by-step instructions on changing wound
dressings and issued reminders to check blood sugar levels,
take medications, or perform daily foot checks. In addition,
consider the ease of having a voice-enabled dietary assistant
that helped with DFU patient-specific meal planning and
weight loss.
Such a reality will require care providers to relay detailed
instructions to a patient’s home health device. This may seem
time-consuming, but with recent promising collaborations
between big industries (eg, Google) and physicians/researchers have expedited the development of voice recognition
models that better understand medical lingo and extract clinically significant information, it may be as easy as talking
directly to the patient.37,38 Some of these ideas were the basis
of Merck’s challenge-winning IoMT project, Wellpepper’s
“Sugarpod,” which took home the $125 000 grand prize for
582
its multimodal care plan for diabetes management as
described in the previous section.34 With the introduction of
the new value-based reimbursement model by health care
leaders,39,40 the use of health sensors for prevention and monitoring will likely grow in popularity.
As it pertains to the DFU patient, there are several predictive markers that make it possible to detect when the prognosis of diabetes is spiraling out of control, and with recent
advancements in technology, it is even possible to predict
foot ulcerations using IoMT platforms. For example, in
2017, Frykberg et al41 proposed a smart mat based on the
IoMT concept using daily plantar temperature monitoring
utilizing a technology with a similar form factor to a bathmat. Specifically, they studied a novel in-home connected
foot mat (Podimetrics Mat™, Somerville, MA, USA) to predict risk of a DFU and better stratify those who need an
urgent foot care. This simple-to-use system was designed to
require no configuration or setup by the users who simply
had to step on the mat with both feet for ∼20 s. The system
then compared the temperature profile of the two feet. Using
a threshold of ≥2.22°C difference between corresponding
sites on opposite feet, the mat correctly predicted 97% of
DFUs with an average lead time of 37 days. Adherence to the
mat was high, with 86% of participants using the mat at least
3 times per week, and an average usage of 5 times per week.
This accuracy and 37-day lead time could be sufficient to
better target those who need urgent care. Perhaps combining
this technology with a voice-enabled technology encompassing the features described above could facilitate timely intervention (eg, scheduling a timely appointment with the
patient’s podiatrist, advising the patient and/or the caregiver
for an effective preventive strategy, etc), which could ultimately assist with reducing the risk of a DFU and its devastating consequences and costs.
An IoMT model for the DFU patient should incorporate
health sensors (eg, foot mat to monitor risk of foot ulcers or
activity monitor to dose optimum daily activities, shoe sensors to monitor adherence to prescribed footwear, etc) that
can transmit valuable information to the patients, their caregivers, and/or their health care providers wirelessly through
a cloud network, as illustrated in Figure 3. Voice-enabled
smart devices such as Google Home or the Amazon Echo
may be used as a central hub to collect data from these health
sensors and relay that information to the cloud network.
The following is a sample list of several currently available network-connected medical devices that may serve this
purpose. But indeed further developments are needed to personalize the IoMT platform to assist with management of
DFUs or feet at risk of a DFU:
•• Wearable technologies to monitor the wound healing process and personalized wound care: Recent
studies have showed the benefit of wearable technologies including smart dressings to monitor risks associated with delays in wound healing and/or potential
Journal of Diabetes Science and Technology 12(3)
Figure 3. Future direction for IoMT in the care of the diabetic
foot.
adverse events such as infection. These dressings
enable monitoring bacteria in the wound dressing;42
wound-site temperature, sub-bandage pressure and
moisture level from within the wound dressing;43
wound pH,44 and even physiological stress as a potential indicator of delay in wound healing.45 Recently,
some efforts have taken place to personalize wound
care. These efforts were mainly based on measuring
parameters such as moisture, pressure, temperature
and pH inside the dressings, which have been shown
to be indicative of the healing rate, infection, and
wound healing phase.46 For example, in 2015,
Mehmood et al43 proposed a low-power portable telemetric system for wound condition sensing and monitoring, which enables measuring and transmitting
real-time information of wound-site temperature, subbandage pressure and moisture level from within the
wound dressing. Milne et al47 proposed a wearable
sensor to measure wound moisture status without disturbing or removing the dressing. The technology was
designed to determine when a dressing change is
needed. The authors concluded that a large number of
unnecessary dressing changes are being made. Thus,
their technology may assist to reduce the likelihood of
unnecessary dressing changes and thus less disturbance of the healing wound bed. If these technologies
are clinically validated in larger studies, they could
open new avenues for design-effective IoMT platforms that assist with personalizing wound care and
reducing adverse outcomes.
Basatneh et al
•• Wearable and smart platforms to monitor biomarkers for chronic health conditions: Several
wearable technologies, mobile health, or smartwatch
devices have been designed to enable noninvasive
continuous monitoring of health conditions and are
suitable for the IoMT platform. For example, a wearable diagnostic biosensor watch, invented by
UT-Dallas researchers, enables detecting three interconnected compounds: cortisol, glucose, and interleukin-6, in perspired sweat for up to a week without loss
of signal integrity.48 The discovery of this wearable
biosensor will drastically improve the way patients
with diabetes measure their blood glucose at home,
eliminating the need for pricking. This watch can be
one of the many tools that would connect to the smart
device. It would serve the purpose of monitoring routine blood-sugar recordings and relaying them to the
smart device for integration into a full medical report
along with other biometrics.
•• Smart technology to identify early signs of a DFU:
Recently, several wearable and smart home objects
have been designed to predict early signs of a DFU
and assist with management plan to prevent ulcers in
high risk patients. For example, as described above
the “smart bathmat” (Podimetrics Mat)41 can mitigate
complications by early detection of foot ulcers at
home. The mat uses foot temperatures to track risk of
foot ulceration. Another interesting platform is a realtime alerting system based on smart insoles and a
smartwatch (the SurroSense Rx, Orpyx Medical
Technologies Inc, Calgary, Canada), which allow
improved adherence to prescribed footwear and provides step-by-step simple instructions in case of high
risk conditions (eg, sustained plantar pressure).9
•• Cardiovascular health monitoring systems: Several
platforms have been designed that enable monitoring
of cardiovascular health in a networked environment
where the data is sent to a central server upon where it
is processed for the purpose of notifying the patients,
caregivers, or care providers of the overall health of
the patient. For example, the Body Cardio Scale
(Nokia, Helsinki, Finland) can assess cardiovascular
health via heart rate and pulse wave velocity. In particular, it has been showed that measuring pulse wave
velocity, which seems to be measurable by the Body
Cardio Scale, could assist in early identification of
peripheral arterial disease (PAD).49 PAD is highly
prevalent among people with diabetes and is a significant risk factor for DFUs.50 However, the effectiveness of these home-based technologies to determine
PAD or provide clinically meaningful information
about cardiovascular health needs to be clinically validated in future studies.
•• Vital sign monitoring systems: Several technologies
have been recently designed, which allow continuous
583
monitoring of vital health using mobile health or
wearable platforms (eg, VitalSync™ from MedtronicCovidien, Boulder, CO, USA; BioStampRc from
MC10, Lexington, MA, USA; Kito+, Azoi Inc, San
Francisco, CA, USA). These technologies enable
monitoring heart rate, heart rate variability, respiration rate, skin temperature, blood oxygen, and so on.
These measurements could be helpful to improve
management of the diabetic foot. For example, recent
studies have suggested that physiological stress, measurable by heart rate variability, is highly prevalent
among people with a DFU51 and is contributing in
delaying wound healing.45 Blood oxygen levels are
also vital indicators of healing.52 In addition, skin
temperature and respiratory rate can yield information
about progress of infection.53 While the manufacturers of these products claim that the vital sign readings
of their devices are accurate and reliable, their effectiveness for the purpose of clinical application
described above still needs to be validated in clinical
studies.
•• Skin condition monitoring systems: Cell phones and
other consumer digital technologies have emerged as
potentially powerful tools to empower patients to monitor the risk of a DFU and/or determine any complication associated with wound healing. For example, to
improve classification of wounds in community health
clinics, Ge et al54 developed a wound information management system that was built up by utilizing an acquisition terminal, wound descriptions, data banks, and
related software. In this system, a mobile phone was
applied as an acquisition terminal, which could be used
to access the data bank and determine wound classification. However, no clinical study was conducted to
demonstrate its clinical value. In 2015, Parmanto et al55
proposed a mobile app to support self-skincare tasks,
skin condition monitoring, adherence to self-care regimens, skincare consultation, and secure two-way communications between patients and clinicians. The
system may help in supporting self-care and adherence
to care management, while facilitating communication
between patients and clinicians. Wang et al56 developed
an app for analyzing wound images. The developed app
enables capturing wound image with the assistance of
an image capture box. The software allows detecting
wound boundary and determine healing status.
Mammas et al57 proposed a smart phone as a mobiletelemedicine platform. They evaluated the feasibility
and reliability of the platform based on simulating
experimentation by 10 specialists, who remotely examined a diabetic foot using the proposed mobile platform. They demonstrated that this platform allows
remote classification of wound as well as risk of amputation with an accuracy of 89% on average. In addition,
the acceptability of the platform was in the range of
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Journal of Diabetes Science and Technology 12(3)
89-100% among specialists. A similar concept was proposed by Foltynski et al,58 in which an app was designed
to measure wound area and then sends the data to a
clinical database for the production of a graph of the
wound area change over time. The team has also suggested an elliptical method59 to improve wound size
estimation from 16 different wound shapes. Sanger
et al60 proposed a mobile app to engage patients in
wound tracking, which in turn could assist in identifying wound infection. However, their study was limited
to design concept with no clinical study. An interesting
application of mHealth was proposed by Quinn et al61
to improve patient referral strategy from tertiary centers. Specifically, they proposed utilizing mobile phone
technology to decentralize care from tertiary centers to
the community, improving efficiency and patient satisfaction, while maintaining patient safety. Their designed
app enables remote collection of patient wound images
prospectively and their transmission with clinical queries, from the primary health care team to the tertiary
center. They tested this platform in five public health
nurses in geographically remote areas of the region.
They demonstrated that images could be transmitted
securely, and that the platform is safe and reliable to use
for remote wound bed assessment and determining skin
integrity/color. These technologies could add significant features to the IoMT platform to assist with smart
and remote management of wound healing in patients
with diabetes and reduce the need of frequent visits
from clinics.
Privacy and Security Concerns
As new opportunities for leveraging consumer-grade electronics and artificial intelligence (AI) grow, concerns for
patient privacy and the security of life-critical connected
devices (eg, wirelessly connected insulin pumps and pens)
grows in tandem. Several groups have called for increased
transparency of security and privacy capabilities for IoMT
devices,62-64 a kind of security “nutrition” label that will
allow manufacturers to document the security capabilities of
their devices to raise the confidence of patients, regulators,
and other stakeholders. In 2016, the Diabetes Technology
Society established such a program, called DTSec,65 which
provides a cyber security standard whose goal is to raise confidence in the security of network-connected medical devices
through independent expert security evaluation. This consulting service enables electronic developers to put their connected health care devices through an expert security
evaluation that would then be listed in the public record. This
program focuses on assuring safe clinical use against malicious attacks. This program is also currently being adopted
as a joint IEEE/UL standard and program, with hopes to
expand it beyond its current scope of diabetes devices to
other forms of connected health care systems.
Beyond safe operation, patient privacy is exposed to a
new set of challenges in the IoMT. While patient privacy is
arguably well understood and certainly regulated within traditional medical systems, the advent of personal consumer
electronics (such as home assistants) used in health care contexts creates novel challenges. In general, consumer electronics purchased by patients for personal use (rather than
being prescribed and delivered as a health care solution) fall
outside the bounds of HIPAA and other regulatory umbrellas.
Therefore, it is incumbent upon solutions providers and the
rest of the health care stakeholder community to adopt a program that is conceptually similar to the DTSec approach but
adds privacy-specific requirements—such as the right to be
asked for consent prior to using recording devices and the
right to be forgotten. The security and privacy nutrition label
would inform patients which rights are protected by the solution and what level of independent evaluation has been
applied to these claims. Because the IoMT is made up of
devices that are not manufactured by traditional health care
manufacturers, this assurance program must be broad and
general enough to allow the specification of security and privacy requirements on any form of IoMT system, including
home assistants, wearables, network access points, and more.
Conclusion
The IoMT has opened new avenues and opportunities in
health care from remote monitoring to smart sensors and
medical device integration. It has the potential to empower
patients to take care of their own health and thus promoting
patients’ central role and responsibility in enabling an optimized health care ecosystem. This rapidly developing infrastructure has the potential to not only keep patients safe and
healthy but also improve how physicians deliver personalized
and timely care. Recent market research indicates the “sensor
market in consumer healthcare” will be worth $47.40 billion
by 2020.66 With DFU care nearly doubling the costs of diabetes in the United States,4 there is hope that a new era in development of medical sensors and their integration with IoMT
can help alleviate the economic burden of this disease.
The benefits of IoMT will likely extend beyond the realm of
consumer health care, benefitting researchers with its ability to
continuously and remotely monitor patients. While IoMT is
being celebrated as the future of medicine, there are still some
concerns that need to be addressed on patient compliance, battery life issues, and security and privacy. Nonetheless, we find
ourselves in the early stages of a dramatic change in health
care: where the merger of consumer electronics and medical
devices has made the home the clinic of the future.
Abbreviations
AI, artificial intelligence; DFU, diabetic foot ulcer; ICT, information and communication technology; IoMT, Internet of Medical
Things; IOT, Internet of things; PAD, peripheral arterial disease.
585
Basatneh et al
Declaration of Conflicting Interests
The author(s) declared no potential conflicts of interest with respect
to the research, authorship, and/or publication of this article.
15.
Funding
The author(s) received no financial support for the research, authorship, and/or publication of this article.
16.
ORCID iD
17.
Bijan Najafi
https://orcid.org/0000-0002-0320-8101
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