Diabetes is a well-understood disease that affects approximately 11% of the U.S. population. Worldwide, the number is significantly greater. Unfortunately, these numbers are likely to continue to grow with rising obesity levels and dietary trends. Given how many people are impacted by this condition, it’s a wonder the device innovation used for managing it had been relatively unchanged until the last couple of decades.
Fortunately, a number of firms have since been involved with rapidly advancing the technologies now available to help ease the management of this disease. Since there is yet no cure, it’s important to ensure patients maintain a clear view of their status and avoid any potential problems from complications.
To help explain what’s driving the innovation within the sector and what advancements have been made, two representatives from Phillips-Medisize responded to questions in the following Q&A. Tony Bedford, commercial director of platform management & innovation, and Dr. Aiman Abdel-Malek, diabetes products advisor, addressed the use of continuous glucose monitors, high- and low-end delivery systems, and cost concerns.
Sean Fenske: In terms of diabetes treatment devices, why has there been so much innovation in the last year? What made this space prime for disruption?
Tony Bedford: Devices in diabetes have been available for a number of years, generally focused on either diagnostics (measurement of blood glucose levels) or the delivery of insulin. The increasing prevalence of diabetes makes this an area rich for innovation. Biosimilar insulins are becoming available, pushing the price of the treatment down and making it more affordable, and awareness of the disease continues to rise via widespread media channels (television, social media, etc.). Consequently, it’s an attractive place to create a business, with a growing need at the high end for more advanced insulin delivery systems (e.g., pumps) and diagnostic devices and at the low end for low-cost insulin/biosimilar delivery devices.
Fenske: Traditionally, most patients with diabetes need to regularly perform a finger prick to test glucose levels. This is moving toward the greater use of continuous glucose monitors. Why is that?
Bedford: Although it is reasonable to suggest there is a trend toward continuous glucose monitors (CGMs), such devices are still considerably higher cost to maintain than traditional fingerstick blood glucose monitors and therefore, the market for low-cost, strip-based devices that require manual interactions will continue to dominate. However, the development of CGMs is driven by the desire for better control of a patient’s diabetes through more accurate and real-time readings, which can be linked to (in some cases) an insulin pump for automated intervention. A diabetic patient wearing a CGM device can minimize the risk of user error (e.g., inputting incorrect insulin unit values or misreading a blood glucose level) or mitigate against the risk of a patient not realizing they are heading for a hypo- or hyperglycemic episode until it is too late. A CGM system can provide all of this support automatically for better control of a patient’s diabetes and fewer hospitalizations or clinician interventions, which is a win-win for all.
Fenske: What impact has greater connectivity solutions had on the diabetes treatment technology space?
Bedford: As already noted, diabetes technology has been largely confined to insulin delivery and glucose monitoring, although the development of applications for counting carbohydrates and other diabetes management tools can also be considered here. Improved connectivity solutions help to drive the “linking-up” of this complex “ecosystem,” without which, all patients would still have to routinely monitor, assess, and medicate manually while technological advancement would be stifled. As more technology becomes enabled, costs become depressed, better outcomes can be achieved, and treatment solutions become more widely available.
Fenske: Are technology solutions aiding with concerns over insulin availability and prices? If so, how?
Dr. Aiman Abdel-Malek: Yes, technology solutions have been instrumental in addressing concerns over insulin availability and prices. One way it’s aiding in this area is through mobile applications and digital platforms that have been developed to help patients track their insulin usage and manage their diabetes. These apps can provide reminders for insulin dosages, track blood glucose levels, and provide educational resources to help individuals manage their condition more effectively. By empowering patients to take better control of their diabetes, these solutions can potentially reduce the need for excessive insulin usage and prevent complications, leading to more affordable and accessible treatment.
Additionally, with telemedicine and remote monitoring platforms, healthcare professionals can provide virtual consultations and remotely monitor a patient’s insulin usage. These platforms improve access to care and ensure individuals have access to the insulin they need, even in remote areas or during pandemics when in-person visits may be limited.
Furthermore, as previously described, connected insulin pumps, pens, and continuous glucose monitors have significantly improved the management of diabetes. These devices provide real-time data on blood glucose levels and automatically deliver insulin as needed, reducing the risk of hypoglycemia and improving glycemic control. While these devices may initially come with a higher upfront cost, they can potentially lead to long-term savings by optimizing insulin usage and reducing healthcare complications.
In terms of addressing insulin prices, technology has enabled the sharing of information on insulin pricing and affordability. Websites and apps provide up-to-date information on various insulin products, their costs, and available discounts or assistance programs. This allows patients to make more informed decisions about their insulin purchases and explore more affordable options.
However, it is important to note technology alone cannot completely solve the concerns over insulin availability and prices. Policy changes, increased transparency, and regulatory interventions are also necessary to address the underlying issues in the insulin market.
Fenske: As more medtech is used outside the hospital and in patients’ homes, do diabetes treatment technologies serve as a template for this? Could the innovation in this space be adapted for other disease treatment protocols?
Bedford: Devices for diabetics have been around for a long time—patients have been able to take a blood glucose reading using a fingerstick and blood glucose monitor, and then deliver a calculated dose of insulin from a syringe or pen injector for many years. Arguably, this was the blueprint for drugs for chronic conditions to be self-administered by patients using pre-filled syringes (PFSs) and, more recently, autoinjector (AI) devices, which have become much more common over the past 15 years or so. Drug delivery by such means is safe, effective, and well within the capabilities of most patients. Building upon well-established, body-worn insulin pumps, coupled with pharmaceutical innovation where liquid drugs need to be administered in volumes larger than a PFS or AI can deliver, the same blueprint has been followed in order to create novel, wearable devices for short- and long-term treatment. Parkinson’s disease is a good example of one success story, where a constant basal rate treatment can improve quality of life considerably.
Fenske: What’s on the horizon in terms of diabetes treatment technology innovation? What can we expect in five to ten years?
Bedford: A number of hybrid closed-loop systems are already launched and marketed, providing automated insulin delivery to a patient in response to real-time glucose readings, although this remains an expensive technology. Expect further developments in this area as governments assess the healthcare economics.
In the UK, a report by NICE (National Institute of Health Care and Excellence) recommended this technology should be made available to Type 1 diabetic patients over the next five years under certain conditions. Decisions like this would potentially make it available to hundreds of thousands of users; should this happen elsewhere, this sector would see further innovation and development.
Over this same five-year period, we also expect to see a number of further biosimilar insulin launches. For Type 2 diabetics, we expect widespread use of GLP-1 agonists, many of which will require a suitable vehicle for self-administration to meet cost, ease of use, and sustainability targets.
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell medical device manufacturers?
Dr. Abedel-Malek: Connected treatment technology is enabling an exciting future for people with diabetes and reducing the daily burden of managing their disease. For medical device manufacturers, the key to developing innovative connected treatment solutions that will maximize the adoption by patients and providers is to ensure your solutions follow the four “S” rules.
- Simple: Designed with the user in mind
- Secure: Adhere to FDA security requirements
- Smart: Implements AI that can personalize the treatment
- Scalable: Accessible and affordable to be used by the masses
Click here to find out more about Phillips-Medisize >>>>>