Diabetes is currently one of the fastest-growing diseases facing our generation. In the U.S., diabetes’ prevalence is growing at an alarming rate, having doubled from around 11 million American cases in 2000 to around 22 million in 2014, according to the CDC. Because of the size of the market for diabetes medical devices and the high growth rate of the disease, there are a lot of eyes watching what’s happening and looking for ways to invest. Since diabetes is currently incurable, it’s a very expensive disease, particularly when it starts early in a person’s lifetime. Many medical device organizations, technology companies and entrepreneurs are looking to get their foot in the door.
Diabetes is a different beast compared to many other diseases. In diabetes, the patient population has a large amount of power in influencing treatment, which is unusual for a disease state. Because it’s incurable, healthcare providers are trying to help their patients cope with the disease, and the most important factor is a patient’s ability to follow a defined disease management regimen. In addition to being a major factor in the treatment decision-making process, diabetic patients have created a very tight-knit community and are well-connected through associations and social media. The power of this large population of patients ultimately has significant influence over the treatment process and the success of medical devices in the diabetes market.
Companies are looking long and hard at how to help make the disease more manageable. In the last few years, many different companies have come up with unique products that can help improve diabetes health, particularly around measuring blood glucose levels. The traditional way to measure one’s blood glucose level is to use a glucose meter and strips, requiring the diabetic to prick her finger. This needs to happen multiple times a day, which can be quite disruptive, and as a result, many diabetics don’t monitor their glucose levels frequently enough.
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Google’s idea is to create minimally invasive testing approaches, such as a contact lens to measure blood glucose levels, taking away the need for diabetics to stick themselves with a needle. Another company was promoting the concept of a tattoo that measures blood glucose, and another wants to provide a three-month subcutaneous device to take regular blood glucose measurements. Additionally, continuous glucose monitoring devices have already become an important part of disease control for Type I patients, and companies are hoping that these devices can be used by Type II patients, as well.
Can all of these creative ideas disrupt the market and remove finger pricking as the primary way to monitor blood glucose levels? There are four challenges that manufacturers have to figure out before disruption can occur:
- The expense: While manufacturers are creating innovations, the government and payers are trying to find ways to take costs out of one of the most expensive disease states. When compared to the free meters and low-cost strips, disruptive technologies need to demonstrate a significant impact on patient outcomes that would justify their increased cost.
- Accuracy of measurement: Finger pricking is still considered the gold standard in accuracy of blood glucose monitoring. Any new idea needs to be at least as accurate as testing with meters and strips.
- Unproven impact on health: While blood glucose monitoring is important for understanding a patient’s glucose levels multiple times a day and influences decisions on insulin usage, it doesn’t directly improve the patient’s health like other products do, such as insulin delivery devices. Will new products be better in any way at monitoring blood glucose levels than the tried-and-true method of finger pricking?
- Changing behaviors and opinions: Using meters and strips has been the default solution for many years. It will be a challenge for medical device companies to convince patients and HCPs to change their behaviors.
Unless new innovations can demonstrate a positive impact to both health and cost, it will be challenging to get by payers and the government, but there is one way that manufacturers can try to overcome these two challenges: patient influence. If the very tight-knit diabetes patient community found something that they feel is significantly better than drawing blood multiple times a day, they could band together to potentially influence the medical community and payment stakeholders to drive usage of an alternative blood glucose measurement product. In fact, there is a group of patients trying to do that right now: The diaTribe Foundation is putting together a letter to the FDA with thousands of signatures in an effort to gain approval to use continuous glucose monitoring as a replacement for blood glucose meters in making treatment decisions.
Diabetes is a challenging and unique disease, requiring patients to be diligent in the hour-by-hour management of their own actions and decisions. Given the disease’s growing prevalence, it will be interesting to see how the blood glucose monitoring options change over the next few years.