As people pay more attention to public and mental health, we value information about the human body and health more than ever before. With the development of artificial intelligence/machine learning (AI/ML), the research methods, diagnostic tools, and treatment options available to medical professionals are improving every day. By harnessing the power of the Internet of Things (IoT) and connected health devices (also known as the Internet of Medical Things, or IoMT), we can gain more accurate and timely insights into an individual's physical health status. This article will introduce the technological developments in the Internet of Medical Things, as well as solutions launched by Silicon Labs.
Connected health devices can monitor physical and mental health conditions
Connected health devices refer to small, wireless, often wearable electronic gadgets equipped with sensors that allow users to monitor their physical and mental health based on physiological indicators. Some of these devices simply measure basic vital signs like heart rate or body temperature, while others can collect data from users' sweat, saliva, or blood to analyze the chemical composition and gain a deeper understanding of their health.
The data collected by these devices is typically transmitted to an accompanying app, where it is automatically analyzed using artificial intelligence and machine learning. The insights generated from this analysis can help users track progress toward specific health or fitness goals, monitor chronic conditions, or even automate medication delivery.
Although such devices may sound futuristic and high-tech, many of them already exist and are in use today. For example, people with diabetes often use wearable devices for continuous glucose monitoring (CGM) to manage blood sugar levels without relying on finger pricks or last-minute bodily alerts. Another type of device, the “smart insulin pen,” can use CGM data to calculate the exact dosage of insulin needed and when to administer it.
Diabetes is not the only medical field utilizing connected health devices. Devices that monitor sleep and track circadian rhythms are also common. Dental sensors are expected to provide continuous health monitoring based on information collected from saliva, while those with digestive issues can swallow vibrating capsules that simulate stomach contractions to speed up digestion. Various types of smart patches embedded with the Internet of Things (IoT) can be adhered to a patient's skin to monitor physiological signs or even deliver medication. The development of connected health device applications is limitless.
The widespread use of IoT and connected health devices can give patients more autonomy in making health-related decisions. Easily accessible data and information (automatically interpreted to produce actionable insights immediately) can help patients manage health issues more easily, such as chronic diseases, recovery after catastrophic health events, and the increasing need for health maintenance as they age.
The challenges of developing connected health devices
Connected health devices and the Internet of Things can also become extremely valuable tools for care providers. In our current healthcare system, patients typically only interact with healthcare providers when a problem arises; therefore, modern medicine is largely reactive rather than preventative.
When patients do have health complaints, most of the data used for diagnosis is either self-reported by the patient or collected in a discrete (meaning with long intervals over time) and invasive manner. Since the data collected by connected health devices is analyzed in real time, patients can also identify urgent warning signs of sudden health events and seek help in a timely manner. Finally, connected health devices can also perform automated dose calculations and drug delivery, which can give patients who must regularly self-administer medication peace of mind.
Utilizing connected health technology will enable doctors to perform proactive, non-invasive, continuous data collection, which can improve the patient’s health experience, enhance the diagnostic process, and provide more preventative care. Ultimately, connected health devices can help patients take better care of themselves, reducing health anxiety and improving overall quality of life.
Despite the many benefits that connected health devices can bring to both patients and providers, they are rarely used in formal healthcare settings today because large-scale implementation faces many significant challenges. First, there are security and privacy concerns. Due to the sensitivity of the data collected and the potentially serious consequences if connected health devices were hacked and malfunctioned, addressing this issue is especially important for connected health devices.
In addition, there are medical regulatory requirements. Any device that claims to help diagnose, treat, or manage disease or any other content related to the user’s health must also be approved by agencies such as the FDA. On the other hand, scalability issues also need to be considered. Questions around how to use connected health devices on a large scale in a practical, ethical, equitable, and safe way must be addressed. Since these issues have not been fully resolved, healthcare providers are often hesitant to recommend connected health devices to patients.
Continuous glucose monitors help control diabetes
Let’s take the example of the application of continuous glucose monitors (CGMs), which are used by patients with Type 1 or Type 2 diabetes who must monitor their blood glucose to make informed decisions about their health. CGMs allow patients to understand how different foods, medications, and even physical activities affect their blood sugar levels. This information is crucial in helping patients and their healthcare teams develop data-informed care plans to prevent potential complications, such as heart attacks, blindness, stroke, or kidney disease.
Candidates for CGMs are those who wish to have better control over their diabetes or those with complications who need to be more actively involved in their treatment plan. Type 1 or Type 2 diabetes patients who use CGMs report improved A1C levels, a reduction in hypoglycemia occurrences, higher treatment satisfaction, and an overall greater sense of well-being. Advancements in CGM technology even allow direct communication and coordination with insulin patch delivery systems, acting as an artificial pancreas to continuously monitor and stabilize blood sugar levels.
There are various types of CGMs, but all of them consist of four main components. These four components include a sensor, an analog front end (AFE), an application processor/Bluetooth receiver, and a battery. The sensor is the small wire catheter inserted under the skin of the arm or abdomen to measure glucose concentration in the fluid between blood vessels. Depending on the type of sensor used, the catheter needs to be replaced periodically, usually every few weeks.
The transmitter connects to the sensor and sends the information collected by the sensor to a handheld receiver and/or a smartphone, displaying the patient’s glucose concentration data. For example, patients can use this information to assess post-meal blood sugar changes or develop a treatment plan. Pairing with an app allows patients to view real-time data visualization of CGM results.
Wireless devices provide many possibilities for patients to receive important information and monitor their health status. Device manufacturers have recognized the importance of creating products that incorporate the key functions required for an effective CGM into portable devices for patients. Some of these necessary functions include long battery life, energy efficiency, security, and power consumption.
CGM reference design based on BG27 Bluetooth LE chip
The Internet of Things (IoT) has transformed how patients interact with monitoring their health, and electronics manufacturers like Silicon Labs are revolutionizing tools to provide patients with practical, portable, and energy-efficient devices. Silicon Labs is proud to share the latest results of its CGM reference design.
The BG27 Bluetooth LE SoC, launched by Silicon Labs, is designed to help medical device manufacturers integrate advanced Bluetooth LE connectivity into compact and complex design devices, such as providing battery support for medical applications of CGM devices, along with an MCU capable of running the application and managing power and data storage. This CGM reference design uses Analog Devices' Analog Front End (AFE) system.
Silicon Labs' new mechanism on the CGM provides a method to simulate wake up for the device using a boost enable pin when needed. This novel boost enable pin feature allows the device to operate in an ultra-low power-shelf mode until awakened by the patient. When the product is in “shelf mode,” it consumes less than 20 nanoamps of current, saving battery time until the customer uses the new device. This CGM reference design adopts a novel method of activating the pin, which is triggered by a light sensor. When the device is taken out of the packaging, the light sensor wakes up the device. For example, the patient can simply shine a phone flashlight on it to activate the product.
The current reference design’s runtime meets the 14-day market standard and uses a 1.5-volt silver oxide battery, which continues to operate even after the 14-day market standard. Silicon Labs has decided to provide a baseline implementation that can be further optimized to reduce the overall circuit board space and shrink the form factor. The CGM reference design uses a 1.8-volt analog front end (AFE), which eliminates the need for an external power boost. Since the boost is already integrated into the chip scale package, this reduces the bill of materials (BOM) count, as well as the final cost and size.
The CGM reference design includes applications that utilize Bluetooth services and power-saving applications, allowing users to choose regular updates between once per minute and once every 30 minutes, with the option to optimize the interval to extend battery life. Silicon Labs offers different power modes, allowing any Bluetooth device to switch quickly between states to minimize overall power consumption, ranging from solutions optimized for battery-powered devices to robust solutions meeting high-performance, long-range needs.
Developers are implementing the necessary security measures for connected medical devices while developing the CGM reference design. Silicon Labs has incorporated the DTSec protection profile requirements necessary for product development. Additionally, Silicon Labs’ Custom Part Manufacturing Service (CPMS) enables secure provisioning and device customization, such as bootloader, secure key programming, and locking debug during manufacturing. Silicon Labs continues to expand its solution portfolio to meet the evolving demands of technology, ensuring that the products patients receive not only exceed expectations but are also safe and efficient.
Conclusion
Although the formal use of connected health devices in healthcare environments is currently more of a desire than a reality, it is by no means a pipe dream. Many IoMT-compatible products have already sought and received approval from regulatory bodies such as the FDA, and many others are in the process of applying. In the coming years, we will continue to witness how connected health devices fundamentally transform our healthcare system for the better. Silicon Labs' BG27 Bluetooth LE SoC and CGM reference design will help connected health device developers accelerate their product development cycles and seize market opportunities as soon as possible.