Continuous glucose monitoring has revolutionized diabetes management. The devices, which are usually stuck to a person’s arm, stomach, or thigh, utilize a small sensor placed under the skin to check blood sugar levels. This has freed people living with diabetes or those who are prediabetic from having to regularly prick and test blood from their fingers. It also allows for better control of blood sugar levels.
The technology has evolved since its inception in the 2000s and has been adopted by both type-1 and type-2 diabetes patients. And the potential growth presents opportunities across the industry. The global market, which hit $6 billion in 2021, is expected to reach $31 billion by 2031, with a 17% compound annual growth rate.
Key players in the market like Abbott Laboratories, and Medtronic, have made substantial investments in research and development to enhance the accuracy, performance, and comfort of their products. Studies indicate that broader use of continuous glucose monitoring can lead to improved disease management and cut down overall healthcare expenses.
Now, the industry is on the cusp of another breakthrough — the use of non-invasive devices. Apple, Huawei, and Samsung are all reportedly developing smartwatches that can monitor a person’s blood sugar levels without needing to insert a chip under the skin. Regardless of which company gets there first — including incumbent medical device manufacturers — the industry needs to be aware not only of associated opportunities but also overcome several hurdles to push this next evolution in diabetes management.
Finding New Customer Segments
Beyond convenience, continuous glucose monitoring offers clinical advantages. The devices can be integrated with insulin pumps to form closed-loop systems, such as an artificial pancreas, which was introduced several years ago and provide efficient insulin treatment when properly adjusted. Long-term use of these devices has also been shown to prevent cardiovascular, nephrological, and nervous system damage resulting from chronically elevated glucose levels in the blood.
Nonetheless, minimally invasive methods currently on the market have certain drawbacks, such as the stigma connected to wearing the device on a patch on the skin, the perceived painful attachment process by some individuals, and the possible occurrence of skin irritation.
While there is potential for expansion within current patient segments, the pace of adoption in the coming years will depend on payers' willingness to expand coverage for patient groups that may not be as severely impacted by the disease, such as non-insulin dependent diabetes patients. Overcoming these hurdles and making glucose monitoring technology more widely applicable have been part of the drive to develop non-invasive devices.
Overcoming Technology and Regulatory Issues
Several device manufacturers and start-ups have struggled to achieve accuracy and reliability for their measurement technologies and consequently failed to bring non-invasive devices to market. The challenge is to reduce variance because of skin color, temperature, humidity, and glucose metabolism. Besides the core measurement of high glucose levels, another problem is reliably monitoring life-threatening hypoglycemia, which can arise as a result of insulin overdose. Even tech giants like Apple have encountered challenges with the practicality of their proof-of-concept device, particularly regarding its size.
Apart from technical difficulties, regulatory hurdles must be considered. In the United States, the Food and Drug Administration has been prioritizing accuracy and reliability in medical devices, including glucose monitors, and has yet to approve the first truly non-invasive device. Meanwhile, in Europe, the stricter European Union Medical Device Regulation that took effect in 2021 requires companies to comply with new regulations for the development and launch of non-invasive glucose monitoring devices, which may pose additional challenges. There is currently no precedent for the approval of non-invasive devices in Europe.
Looking Beyond Medical-grade Application
Companies looking to break into the non-invasive market also need to consider this: advances in minimal technology, as we alluded to above, have given patients more options to monitor their condition. But this doesn’t mean device manufacturers should curtail their efforts. The cost could end up being a major factor. US consumers, for instance, experience annual out-of-pocket costs somewhere between $1,000 and $3,000 for minimally invasive devices, according to GoodRx Health. And that’s if they have reasonable coverage from their insurer.
Large device manufacturers are gathering clinical evidence in hopes of demonstrating the benefits of continuous glucose monitoring across all stages of diabetes. The largest subset, the prediabetic cohort, which totaled 464 million in 2021 and is estimated to climb to 638 million by 2045, could benefit immensely from non-invasive monitoring. These relatively healthy persons with slightly elevated glucose levels could check their glucose status along with other health parameters with a device that is integrated into a wearable. With healthcare costs related to diabetes and its associated comorbidities comprising roughly a quarter of total healthcare spending in the US, implementing preventative measures to reduce the incidence of diabetes could result in significant long-term cost savings. Therefore, there is a significant consumer market for non-invasive devices in addition to prescription medical-grade glucose monitoring, which is closely watched by regulators.
Companies such as Supersapiens, Levels, and Veri already offer a taste of what glucose monitoring could look like in a non-medical setting, promising better health and fitness, nutritional advice, and better sleep. Potential integration with other sensors for heart rate variability, skin temperature, blood oxygen levels, and lactate, for example, could take the next generation of screenless trackers and smartwatches to a new level and fundamentally change the understanding of healthier living.
To successfully launch consumer-grade technology, companies must focus on factors beyond regulatory scrutiny and medical accuracy. The value proposition and marketing strategy for non-invasive devices in the consumer market differ from those in the medical device market. Companies in this space need to develop organizational capabilities that cater to the unique needs and preferences of consumers, such as design, aesthetics, and functionality, rather than solely relying on traditional medtech capabilities. They could also look to form alliances that combine the best of both worlds.
The potential advantages of non-invasive devices are enormous. Patients, commercial and government payers, clinicians, employers, and society at large could benefit from technology that reaches deeper into consumer markets and increases our ability to curb adverse problems associated with diabetes. It’s incumbent on MedTech and other device manufacturers to carefully assess market dynamics if they are going to launch breakthrough technologies.