Many small health start-ups are leveraging digital health and telemedicine services to provide patient coaching. A new study from one company demonstrates that users could see as much as a 0.8% reduction in A1c.
Thinking beyond the pill. It's a mantra repeated by many companies, and pharma is considering what its role will be in this this era of devices, apps, and more. But in all honesty, it's the small start-ups that are paving the way and demonstrating impact through small pilots and trials before larger companies jump on board.
Case in point, you have Better Therapeutics (previously FareWell), a San Francisco based health start-up that has created a company based on virtual health coaching and data analysis to help people live healthier, and manage their diabetes.1 Their platform focuses on a 'customized prescription' based on personal data entered by patients to help quantify what they need to achieve their goals, based on current medical practice and guidelines. It's a self-guided process that gives users information and uses gamification to reward behavior change through the routine use of the app/platform. Then you have certified health coaches step in using all of this data to help support patients through the process. This platform relies on patients to enter user-generated data relevant to their health, but by integrating behavioral feedback mechanics and using virtual support, it can make it stick. Better Therapeutics also has midlevel practitioners on board, so there is also a bit of escalation of therapy.
So how well does it work? They recently published the findings of their platform to help people with diabetes lower their A1c, which found on average a 0.8% drop.2 That's pretty good, about on par with the addition of 1-2 oral medications (depending on class and dosage), minus the side effects. A more in-depth look is probably worth discussing before saying its better than drugs alone. I mean, after all, fewer meds are good, but many of our drug classes also, at this point, focus on other outcomes as well (reduction of A1c aside, a decrease in cardiac issues is where many types of medications are making their impact these days).
The study was a single-arm, nonrandomized, nonblinded sample of 118 individuals enrolled through Facebook and Craigslist. Inclusion criteria were those that had a self-identified diagnosis of diabetes and an A1c >6.5%, and aged 18 years or older. Patients who could not communicate in English or could not navigate a digital device were excluded. Participants were enrolled in the platform for 12 weeks, during which they received all of the above-mentioned resources from Better Therapeutics. The primary outcomes were A1c measurement, use of medications, user engagement, and satisfaction with the platform. Most of the patients enrolled were women and in their 40-50s, and on 1-2 diabetes medications at the start of the trial.
The A1c drop of 0.8% was noted after 12 weeks, but whether this is a temporary drop or a long-lasting reduction of A1c was not determined by the study. It's hard to tell at this point if a platform like this can lead to lifelong behavioral change, or if continued use to get a clinically meaningful drop and keep it is needed. The other issue is whether a continued drop in A1c or plateau effect was observed, which could have different interpretations. Interestingly, some subjects over the course of the intervention had an increase in their medications, but when removed from the analysis pool then the average drop in A1c was 1.1%.
Coming back to medication use, 17% of the study population reported a decrease or stopping 1 or more of their diabetes medications compared to 4% who had a dose change or additional therapy added. I do not know how patients identified what quantified as diabetes medications, nor were those types of medications classified by the researchers (ex. metformin use versus sulfonylureas). This is a promising result, though, again, it's unknown what medications were changed and their overall dynamic impact on diabetes management. This study, still, relied on self-reported user data and is open to perhaps oversight regarding clinical stringency, but paves the way for potentially further studies of a longer timeframe to measure against clinical impact (e.g., micro/macrovascular impact) and not just A1c. This is pertinent, as even the FDA is asking pharmaceutical companies to demonstrate therapeutic outcomes beyond the reduction fo A1c, and its no reason to ask these digital health companies to do the same as they explore their products further.
So, what does this mean for pharmacy? Well, we're not going to see a cessation of medication therapy anytime soon. But I do expect an increasing amount of attention being directed to companies like Better Therapeutics and other chronic disease management companies, and I would be interested to see if pharmacy companies will start trying to integrate their services into their platforms.