In 2002, a revolutionary paper was published in the NEJM reporting the results of the Diabetes Prevention Program (DPP), a NIDDK-sponsored, multi-centered study asking how patients in danger of developing type two diabetes could reduce this risk.
In addition to a control arm – patients receiving standard education and counseling — there were two medication arms of the study: a group of patients who received metformin (a medication that’s been used to treat diabetes for decades – even as scientists still are working out the details of exactly how it works), and a second group of patients who received a medication from a newer class of drug called thiazolidinediones – though this arm of the study was discontinued early on due to concerns about liver toxicity. Finally, there was a fourth arm of the study, called “lifestyle” intervention, which involved trying to motivate patients to diet and significantly increase their exercise, to achieve and maintain a 7% reduction of body weight.
In clinical medicine, diet and exercise is always the initial recommendation, but often fairly pro forma, and typically done with an air of resignation – physicians typically don’t expect patients to really improve, but nevertheless want to give the approach a chance before moving on towards medical therapy.
Indeed, in the DPP, it turned out that metformin reduced the risk of progressing to diabetes by 31%, a significant benefit. Yet, the incredible shocker of the study was that the lifestyle intervention resulted in a whopping 58% reduction in progression to diabetes, an outcome so profound that the study had to be cut short as a result – given the clear benefit of this intervention, it would no longer be considered ethical to maintain patients in the other arms of the study.
“In 10 years, participants in the lifestyle changes group delayed type 2 diabetes by about four years compared with placebo, and those in the metformin group delayed it by two years. The benefits of intensive lifestyle changes were especially pronounced in the elderly. People age 60 and older lowered their rate of developing type 2 diabetes in the next 10 years by about half.”
The first question raised by the DPP was “how’d they do it?” – more specifically, how did they get achieve such profound results with lifestyle modification where so many others failed.
The answer, it turns out, is essentially that all lifestyle recommendations are not created equal; while most doctors might half-heartedly encourage patients to eat less and exercise more, the care coordinators in the DPP were intense, engaging, and persistent, their level of involvement remarkable, some might say heroic; a huge amount of effort was required.
The next question was whether the lifestyle intervention used in the DPP could be done at scale; some pilot experiments suggest the answer may be yes – for example, a study run by researchers at Indiana University and delivered by the YMCA (Y-DPP) using group counseling demonstrated weight loss results similar to the DPP.
The question now is whether DPP-style approaches can be delivered in an even more cost-effective fashion; bay area startup Omada Health, who announced their official platform launch today, hopes to convince payors the answer is yes.
Omada, a member of the first Rock Health class, seeks to replace in-person group counseling with virtual group counseling, using a deliberately-designed interface (not surprising since Omada has roots in IDEO) and leveraging what it claims to be a proprietary approach to sort users into groups. The product also ships plug-and-play wireless scales to facilitate participation.
Omada reports promising initial results; the key questions they face now include (1) whether the success of their pilot will replicate; (2) how they will achieve adequate distribution; and (3) proving the program is either so unique or so far ahead of the game that others can’t quickly employ similar approaches.
The best thing Omada has going for it is that it’s looking in the right place, both scientifically (it’s seeking to emulate one of the most effective behavioral inventions described in the medical literature) and economically (there are significant cost-savings associated with delaying or preventing type 2 diabetes, unless of course offset by the cost of administrating a disease prevention program).
The key question for Omada is also a critical challenge – or opportunity – facing digital health more broadly: can an online support group be as durably effective as individualized, face-to-face attention? Is there even a chance that over time it could evolve to be even more effective? After all, while participants in the life-style intervention group of the DPP lost an average of 15lbs the first year, they regained 10lbs over the next decade; perhaps an ideal engagement platform could help better sustain the original weight loss.
Success here would effectively democratize the DPP approach, providing a relatively economical route to DPP –level results.
I’m excited by the possibilities here, but confess I remain somewhat skeptical: having developed a feel for the DPP approach (my diabetes training was in Nathan’s MGH clinic), I appreciate just how intense and personalized it was. The approach and mindset is perhaps most evocative of Dr. Warren Warwick, the off-the-curve cystic fibrosis physician Atul Gawande so memorably described.
On the other hand, it’s also important to recognize that the real-world choice for most pre-diabetics probably isn’t between the original DPP and a digital DPP, but rather between a digital DPP and the current, fairly discouraging, standard of care; hence there’s clearly a huge opportunity for a digital DPP, even if imperfect, to offer significant value.