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BOLD INSIGHT

Recent research suggests that reclassifying diabetes may allow for the development of more targeted diabetes treatments. This could present opportunities to design these treatments to maximize patient safety and experience.
Currently, diabetes is diagnosed as either Type 1 or Type 2 (setting aside gestational diabetes). Research has suggested that diabetes should be reclassified into multiple separate diseases; a group of scientists in Scandinavia argues for 5 (where others argue for as many as 11). Either way, one of the key potential benefits of such a reclassification is that it could result in more personalized treatment opportunities for patients, based on the unique symptom or disease profile. If this research gains traction in the medical community, it could present an opportunity for manufacturers to tailor and design treatments to improve the patient experience and reduce medication errors.

Potential for more customized treatment

Recognizing that there are multiple proposed reclassification schemes, I will focus primarily on the proposed 5-type model. For background, in the 5-type model, the proposed types of diabetes are:

  1. severe autoimmune diabetes
  2. severe insulin-deficient diabetes
  3. severe insulin-resistant diabetes
  4. mild obesity-related diabetes
  5. mild age-related diabetes

There is literature describing the differences between these five types and the potential for targeted treatments that may result in improved health outcomes for patients. It appears that there is still a way to go from a research perspective before it is determined that those improved outcomes would be recognized by treating patients in each of these five categories differently. But for the purposes of this blog, let’s assume that there IS clinical benefit to customized treatment based on a more granular classification when treatment is administered and adhered to as intended.

Implications for product design

If diabetes were reclassified from two primary types to five or more, there would be all kinds of implications ranging from treatment efficacy to health insurance coverage and more. Let’s consider just a few use-related implications associated with increasing the variability in diabetes-related therapies, and the underlying opportunity for manufacturers of those therapies to solve for the implications through product design.

1. More delivery system options could make differentiation between delivery systems more difficult

What does this mean for differentiation between an increasing number of (e.g.) options for insulin types or delivery systems? It is not clear whether this reclassification would lead to an increase in the variety of insulin-based therapies, but it might. Assuming it could, consider the challenges that had to be addressed with increased prevalence and usage of concentrated-dose insulin (e.g., U-500) and variable syringe types (U-100, U-500, tuberculin). Introducing this concentrated dose insulin to the market provided a portion of the diabetic population with a useful treatment option, but it also made possible a dangerous error. If a diabetic patient intends to administer a 10mL dose of standard U-100 but instead administers 10mL of U-500, they would get five times the amount of insulin they intended.

One way to mitigate such a risk is by designing the two therapies (including the delivery devices, packaging, labeling, etc.) such that they can be easily differentiated. What additional therapy types or possible combinations of administration methods might result from the reclassification of diabetes? Which of these might be similar enough such that the potential for and clinical impact of confusion is high? What can be done from a design perspective to mitigate this confusion?

2. Treatments could be designed to improve patient experience

The increased granularity with which we could describe the “typical” diabetes patient in each of these more refined categories also presents an opportunity for the design of other diabetes-related therapies beyond insulin. Take oral therapies as an example – some have complex dosing procedures, and for many diabetes patients, comorbidities dictate what can be an overwhelming regimen of various pills, tablets, and capsules. This new research suggests that reclassifying those with similar disease progression and projected outcomes could help tailor treatment more effectively. For example, diabetics currently being treated with the same approach could be treated differently according to their more unique symptoms, e.g. someone more prone to blindness would be categorized (and treated) differently from those more prone to developing kidney disease.

If we are better able to predict what other health-related issues one type of diabetic patient is likely to experience compared to another, we will also be able to predict what other pills, tablets, etc. each of those two patients are likely to have in their medicine cabinet. For one type of diabetic patient, a certain color, shape, or size of pill might be easily confused with some other pill commonly prescribed to that patient population. For another patient type, a certain dosing procedure might not be advisable because it could be easily confused with others (do I take two of the red pills in the morning and one of the blue pills at night… or two of the blue pills in the morning and one of the red pills at night?). Being able to anticipate the makeup of oral treatment regimens for diabetics at a more granular level due to this proposed reclassification provides an opportunity to tailor the design of the oral treatments themselves to reduce medication errors and further improve outcomes.

3. Increased treatment customization could create space for more digital innovation

As digital innovation continues to impact healthcare, the opportunity in new, targeted treatment approaches may also lead to increased development of digital patient tools, including dosing calculators, symptom or treatment trackers, and many others. These of course already exist, but with a refined classification of diabetes and more robust information available describing each “new” type, existing concepts for digital support can be reimagined with the specific needs and constraints of each patient type.

One could argue that even if some of these use-related considerations are not addressed, the worst-case scenario is no worse than we have today –diabetics are diagnosed and treated as just Type 1 or Type 2 (oversimplification but illustrative). However, acknowledging the use-related implications of introducing new treatments or new treatment regimens for diabetics early on will help guide the design of packaging, labeling, instructions for use, training, diagnostics, or even insulin delivery systems themselves such that patients and health care providers can clearly see and understand the difference between “their” treatment regimen and those of “other” types of diabetics. And further, that their adherence to that regimen is supported by the design of its components.

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