Memorandum

Omada Health publishes two-year results for online prediabetes program; Interview with CEO Sean Duffy and Dr. Cameron Sepah – April 16, 2015

Executive Highlights

  • Last Friday, Omada Health announced the publication of two-year results for its digital diabetes prevention program, Prevent. Participants lost an average of 4.7% of baseline body weight at one year and maintained weight loss of 4.2% at two years. The one-year A1c reduction of 0.4% was maintained into the second year as well.
  • We had the chance to interview Omada Health’s CEO Mr. Sean Duffy and Medical Director Dr. Cameron Sepah regarding the new findings, the program’s next steps, engagement in the second year, and responses to a 2014 Diabetes Care paper’s critical outlook on diabetes prevention.

Last Friday, Omada Health announced the publication of two-year results (Sepah et al., Journal of Medical Internet Research 2015) on its year-long digital diabetes prevention program, Prevent. Results found that program starters (n=187; completing 4+ core lessons) lost a mean of 4.7% of baseline body weight at one year and maintained weight loss of 4.2% at two years. Regarding A1c, participants achieved a 0.38% reduction (baseline: 6.0%) at one year and maintained the reduction (0.43%) at two years. Weight loss and A1c data was very similar for program completers (n=155; completing 9+ core lessons). Of course, there are some super responders: close to a quarter of Omada’s participants achieve 10% weight loss or more.

The findings are notable for a digital health intervention, where peer-reviewed, two-year data is pretty much unheard of. In addition, it’s rare to see weight maintenance after the end of an active intervention, especially an online translation of the DPP curriculum where the barrier to disengaging is low (i.e., no in-person accountability). A1c continued to show a reduction from within the prediabetes range (5.7%-6.4%) to the normal range (<5.7%) rather than the expected progression to type 2 diabetes. Though JMIR is not a well-known journal, we would note that highly regarded endocrinologist Dr. Anne Peters is an author on the paper.

We also had the chance to speak with Omada Health’s CEO Mr. Sean Duffy and Medical Director Dr. Cameron Sepah (Omada Health, San Francisco, CA) about these new findings, the program’s next steps, engagement in the second year, and responses to Drs. Richard Kahn and Mayer Davidson’s critical 2014 Diabetes Care paper, “The Reality of Type 2 Diabetes Prevention.” Mr. Duffy and Dr. Sepah filled us in on new initiatives, including plans to improve engagement, extend the delivery of the curriculum past the first year, to research clinical effectiveness in low-income populations, and more. Please see the transcript of the interview below, with notable highlights in yellow.

In addition to gathering data, what is remarkable about Omada Health is its confidence in the product and business model – Omada only gets paid by insurers/payers after the core program if people maintain weight loss of 5% or more from baseline. To us, that’s a brilliant example of aligned incentives. We expect to see much more outcomes-based payment in the years to come, especially as digital interventions proliferate, many without peer-reviewed data (in part because the publication cycle is so slow).

We learned loads about digital health this year at both CES and SXSW, and feel that this field is still in its infancy. Certainly, the hype is there – the field pulled in $4.3 billion in funding in 2014, on par with $4.4 billion for 2011, 2012, and 2013 combined. While some argue that “prediabetes” is an arbitrary or perhaps unnecessary term, we believe that anyone who is overweight can benefit from what Omada is doing – education on healthy eating, exercise, and weight loss. Omada Health is not a silver bullet for the challenges that await us, just as a soda tax, fruit/vegetable subsidies, calorie counts, and more bike paths aren’t. But we are optimistic that it could be a useful tool in the toolbox, particularly a non-political approach that can hopefully scale cost-effectively.

  • No significant differences in weight loss or A1c reductions were observed between one and two years, highlighting that the improvements can be maintained even one year after the active intervention has ended. The study collected data from participants who were previously diagnosed with prediabetes via Craigslist (baseline BMI of 36.6 kg/m2; baseline weight of 222 lb; and baseline A1c of ~6%; n=220), as they participated in the Prevent program and reported weight on an ongoing basis (via a scale with a cellular chip) and A1c data at baseline, six months, one-year, and two-year time points.
    • Specifically, program starters (who completed four core lessons; n=187) lost a mean of 4.7% of baseline body weight at one year and 4.2% at two years; regarding A1c, participants achieved a 0.38% reduction at one year and a 0.43% reduction at two years. Program completers (who attended at least nine lessons; n=155) lost a mean 4.9% of baseline body weight at one year and 4.3% of at two years; this group’s mean A1c reduction was 0.40% at one year and 0.46% at two years.
  • Results showed no significant difference in the frequency of weigh-ins (via the cellular-enabled weight scale) among program starters between the first and second years; but the frequency of log-ins was significantly reduced in the second year. Specifically, program starters weighed in an average of 4.6 of the last eight months of the first year and weighed in an average of 4.5 of the first eight months of the second year. Regarding the frequency of log-ins, program starters logged in an average of 3.5 of the first year’s last eight months vs. an average of 2.7 of the second year’s first eight months. However, as Dr. Sepah pointed out in the interview, there were likely fewer log-ins due to the inherent fact that there was no longer any curriculum in the second year.
    • Overall, we believe the weight maintenance data is very encouraging and suggests that this program’s accessibility and convenience can sustain participants’ motivation and engagement. As a reminder, previous research demonstrated that Prevent’s 12-month exceeded CDC benchmarks for engagement and program completion.
    • We learned from our interview with Omada Health that the company is working on product improvement plans to continue a high level of engagement into later years. As Mr. Duffy pointed out, engagement is critical, as it is directly correlated with weight loss outcomes. Thus, Omada is working toward improving engagement past one-year by introducing a host of product changes, including a new curriculum. The company has already submitted grants to the NIH on this front.
    • While the study acknowledges that its participants come from a self-selected sample (they were recruited via the online classified ads website, Craigslist), the authors point out that this reflects how commercial programs would enroll real-world populations. The study’s remotely conducted recruitment, intervention, and assessment also can be generalized to real-world implementations. Certainly, we believe the cellular-enabled scale brings the advantage of a heard-to-cheat measurement tool with ultra convenience. As Dr. Sepah highlighted in the interview, while these results are not pulled from a large randomized controlled trial, the studied population is very similar to that of a community-based diabetes prevention program.
  • As a reminder, Prevent utilizes a unique approach in its Internet-based translation of the Diabetes Prevention Program (DPP) lifestyle intervention, focusing on small group support, personalized health coaching, a weekly DPP-based curriculum, and digital tracking tools. After the 12 months of active intervention, participants still have access to Prevent with the opportunity to proactively use the intervention on their own to continue health tracking and social support.
  • Please see our recent coverage of Omada Health for more details on the company and online diabetes prevention:

Q&A with CEO Mr. Sean Duffy and Medical Director Dr. Cameron Sepah

Q: We hear a lot about averages; have you seen any “super responders” so far in your results?

Mr. Duffy: We have a normal distribution of weight loss. Close to half of our participants have achieved 5% weight loss or more. Close to a quarter of them achieve 10% weight loss or more. Those can be considered super responders, since 10% is a clinically significant benchmark. We even have some participants who reach 25% weight loss – definitely on the right hand side of the distribution.

Q: What are the markers of someone who does really well and who does poorly in the program?

Mr. Duffy: Engagement seems to be the big marker. There’s a direct correlation with all the different engagement benchmarks and weight loss outcomes. For example, participants who do all 16 of 16 lessons lose twice as much weight as participants who do any other number of lessons.

Q: It seems like engagement was lower during the second year; while not surprising, can you discuss that in more depth? What does Omada do to encourage engagement in year two?

Dr. Sepah: There are no benchmarks for engagement past the first year because it started off as a one-year program. There were fewer log-ins in the second year, but we expected that because there’s no curriculum after the first year. The weigh-ins were the same from the first year to the second year. That’s a robust finding – if people continue to weigh in two years out, that’s important for weight management. In addition to that, we have product improvement plans in the works to encourage engagement in year two and beyond, including some grants we submitted to NIH.

Mr. Duffy: It’s an area we’re really excited to integrate into this year. A lot of people view these programs as year-long programs; but if we have someone and we have the opportunity to stay with them longer, then there’s no reason why we shouldn't continue. Our curriculum currently stops after the first year, but that won’t be the case moving forward. We’re going to keep it running and keep delivering new curriculum and see what impact that can have.

Q: Does the business model change as you go to that longer model?

Mr. Duffy: It doesn’t change much. Our current pricing model in the Sustain program is outcome-based. We completely stop charging if people regain weight beyond 5% of baseline. If someone loses 5% and we keep them there or below, we try to engage with them. If they surface back up, we still try to engage with them to get them back down, we just don’t charge for it. To some extent, the minimization of weight regain has to be considered as a core component of any of these interventions. The goal is always to minimize it. As long as there is a pricing model that’s associated with our ability to do that clinically, it’ll keep our eye on doing our very best here.

Q: And the pricing model is on a per person basis? So you charge the payer or the employer X dollars per year, is that right?

Mr. Duffy: Exactly. After you graduate from the course, it’s based on the ability to keep you at or below 5% on a monthly basis.

Q: How many individuals does Omada expect to reach in 2015?

Mr. Duffy: There are some things we can highlight. Through the first quarter of this year, we exceeded the number of people that we enrolled in the program in all of 2014. The numbers this year, even when they’re conservative, will be in the multiple tens of thousands. We’re starting to look and plan for what 2016 might look like and that should be exciting as well.

Q: How quickly do you foresee being able to scale the program in the coming years? What are your largest concerns for expanding Prevent or for Omada in the future?

Mr. Duffy: You always want to make sure you’re delivering an amazing participant experience. The person, two years out, will ideally be one of hundreds of thousands of people we’ll be helping that year and that person should feel like he or she is the only one in the program and this program was designed specifically for them. There are ways to create that feel. A lot of last year was spent really thinking through what operational processes and assistance we had to have to make sure that this is the case. This will always be a growing concern though. At each inflection point, we have to think about how to operationalize to make sure our program gives the same or better experience.

Q: What is the question you most often hear from payers?

Mr. Duffy: They’re always curious about the data. Having one-year data is very helpful, and having two-year data is even more helpful. There isn’t a specific question we most often hear. Usually the folks from the payer side really want to uncover what it takes to actually implement and they want to hear our best practices on how to get people in the door in the first place. On the whole, we have very positive meetings with payers that almost immediately go to, “okay, so tell me how this tactically works.” The questions we get are generally about tactics.

Q: What do you think is most misunderstood about Omada Health’s Prevent Program?

Mr. Duffy: Sometimes we get, “Oh so it’s an app?” which makes me cringe a little bit, because the reason Prevent works is because it includes a lot of individual elements and instruments. Each one is used to improve the experience that works for people. Yes, there’s an app that you can download but the experience also involves being matched into a group, with a health coach, kicked off on a timeline, with a digital scale, a curriculum that enfolds, packages – it is all pretty complex once you’ve gone through it. I think in the market it’s easy to think, “Oh it’s just an app,” but then you forget about the people behind it, the clinical framework, and all the different ingredients. We often use the analogy of a symphony: our product works best when multiple elements are all integrated, producing a comprehensive experience.. That’s probably the most misunderstood.

Close behind that is that people tend to forget that we group participants on a timeline. We’re the only digital health company that operationalizes clustering small groups together and kicking them all off on the exact same timeline towards a shared goal, which is such an important part of the behavior change literature.

Q: Have you seen any participants in Prevent also using weight management medications? Do you plan on integrating that into your programs, as drugs also become part of the obesity treatment paradigm?

Dr. Sepah: If you look at all the major clinical organizations such as ADA and AACE, they all recommend lifestyle intervention as the first line for treating prediabetes. Prevent represents that. If people want to use weight management medications outside of that or following that, then they can. But I think we’re always going to represent the first line approach. We’re trying to focus on addressing the root causes of obesity – the behavior that causes individuals to contract serious chronic disease.

Q: In re-reading the Richard Kahn and Mayer Davidson paper on diabetes prevention, how do you feel about their takeaways? Do you find they are valid points, or simply an interpretation of data that is not clear-cut?

Dr. Sepah: That’s exactly why we mention it up front in our paper as a response to authors like Kahn and Davison. They say that on average, these programs achieve 2.4% of weight loss. We achieved close to double that. The paper discusses how significant weight regain occurs after intervention ends. We showed no significant weight regain after the intervention ends. They also conceded that if you’re able to achieve real world two-year weight loss that can be sustained and replicated, that’s promising. We have directly addressed these three big concerns.

Q: Any thoughts on the paper’s following statement? “Two other studies provide evidence that a considerable degree of weight loss is necessary to see clinical value. In the Action for Health in Diabetes (Look AHEAD) trial, a study to determine if weight loss in people with diabetes will reduce cardiovascular events, weight loss after the first year was substantial (7.9% relative to control subjects) and at year 4 the intervention group had lost 3.6% of their initial body weight relative to control subjects. Nevertheless, after many years of follow-up, the study was halted because there was no benefit of weight reduction on cardiovascular events.”

Dr. Sepah: Look AHEAD is a different beast. We’re really focusing on people with prediabetes. DPP and other versions of DPP done internationally unequivocally show the impacts of lifestyle intervention on reducing progression of prediabetes to diabetes. The Look AHEAD trial is focused on individuals who already have type 2 diabetes and whether they go on to develop heart attacks and strokes. The outcomes for that were very high. Anne Peters, one of the PIs of the study, still considers Look AHEAD an impactful study that helped people with type 2 diabetes improve their general metabolic profile. These are just different populations and our population has a bigger chance of having clinical diabetes because they are earlier in the disease spectrum.

Q: Any thoughts on this second statement in the Kahn and Davidson paper? “As the weight loss achieved in community-based programs is usually much less than was achieved in DPP, DPS, or Look AHEAD, many-fold less than in the surgical study, and very likely not maintained for many years, the odds of a community diabetes prevention program having a favorable impact on cardiovascular disease or other diabetes-related complications seem slim.”

Dr. Sepah: This is a totally unsurprising result. Clinical trials very carefully screen the most eligible, the most ready participants who are willing to go through the rigorousness of clinical assessment. This would be tough in the real world. That’s why we publish what we do. We referenced in the conclusion of our section that this is not the same as a big, randomized, control trial. But the population looks a lot more like the population that you see in a real world intervention because you did not carefully prescreen them and make sure they have no psychological issues or anything else a clinical study screens for. This shows that a community-based diabetes prevention program can show significant results. I think our publications do that.

Q: Lastly, any thoughts on this paper’s statement? “Also, cost-effectiveness is achieved when the time horizon is about 30 years or more, but not in the first 10 to 15 years of the program. As a result, these studies do not actually represent an outcome that health plans or a national program would actually experience in a time frame more familiar to planning and budgeting or to the clinical outcomes people are likely to experience.”

Dr. Sepah: The average of programs across the board and our program shows unique clinical effectiveness and cost effectiveness. We’re going to be publishing specifically on the cost effectiveness soon.

Mr. Duffy: The good thing about the Kahn and Davidson paper is that they’re encouraging academic dialogue and the folks with the exact opposite viewpoint far outnumber Kahn and Davidson. If you look at the CDC’s response to it, you find a very different viewpoint. This one was particularly interesting to me because if you read through it, especially in the end, they highlight that we shouldn’t give up. They say that we should experiment with novel approaches to behavior modification. There are challenges with a community-based program, especially if you look at the aggregate level. But you can’t just look at the average. In that average, there are programs that did well and ones that didn’t work. The argument is that these programs need to work because if they don’t, they’re not going to be cost effective. We want to make sure our programs work, but the best way to ensure that is to not charge as if they’re working if they’re not. Really looking at data and charging for performance, we think, adds a lot to this space.

Mr. Duffy: There’s a lot of data and if you could look at all of them, it ranges from a modeling standpoint to super cost-effective or cost saving. The economic case is strong but that also has to be weighed with the clinical imperative. If it’s impossible to prevent type 2 diabetes that’s one thing; but it is possible. So in addition to the cost imperative, that’s a clinical imperative. The health of our nation requires that we take action here.

Q: How do you think about prediabetes cutoffs, since there is a tradeoff between bringing prevention to more people vs. having more economically efficient prevention efforts? What are your thoughts on the lower-bound A1c cutoff for prediabetes? Does Prevent try to focus on those with higher A1cs who are largely at greater risk of actually developing type 2 diabetes in the future?

Dr. Sepah: Anytime you change a cutoff for a clinical diagnosis, you’re going to have an inevitable trade off. But in this case, the first line intervention is lifestyle intervention, and there are no significant side effects to eating better, increasing your physical activity, and losing weight. There’s very little downside to increasing the eligible patient population. Even if some of those individuals may take longer to develop diabetes or may not have as quick of an ROI, they’re still going to benefit from the health changes. If you’re talking about a cut off or medication with significant side effects, then that’s a different issue. We leave it to the clinical experts to determine the definition of prediabetes, including CDC and ADA, and we follow those definitions.

Q: Are there any updates on Omada's pilots in low-income clinics? If any, what unique challenges other than individuals' financial limitations have you encountered in working with this population?

Mr. Duffy: We’re very excited about this work, but Rome is not going to be built in a day. We are going through two phases – the first is mostly data generation. We need to run a study. We’ve hired an extraordinary full time employee to focus on this market: Eliza Gibson. She has an amazing background working with underserved communities. She ran an underserved provider service in the Bay area called Clinic by the Bay. She, more than anyone, knows the challenges and she was easy to convince that technology is spreading everywhere, including to folks who are underserved.

I think from a timeline standpoint, step one is data generation to show to the market that it can work. This is always a challenge because there can be a skepticism that these sorts of interventions can work in the underserved. In large part, what we try to highlight is that there are definitely people that this isn’t going to be fit for. If you don’t have broadband access and you don’t have a smartphone, then this is not the right program for you. If your world around you hasn’t allowed you to gain access to those things, then there may be other more important, basic needs in your life that impact your health. But, there’s a subset of people where this is the perfect intervention, despite the fact that they’re underserved. We always try to take the glass half full approach. There are two options: we could do nothing to help the folks who would really benefit from this intervention just because they’re underserved or we try to help them. To do that, we need to show that it works clinically. We’re preparing for a trial that will be run by a PI down in southern California to show efficacy and that trial will really help a lot in the talk to Medicaid plans. Then, we can try to operationalize the program with healthcare providers.

Dr. Sepah: This is one of the reasons I joined Omada. I helped set up a behavioral diabetes management program at a VA and it was mostly working with low-income veterans and helping them manage their diabetes. The challenges I find in this population, in addition to their socioeconomic limitations, is the number of challenging social, environmental, and psychological factors. The biggest one is just access to care. It seems incredibly difficult even when care is provided for free at the VA to get low-income populations to come in on a weekly basis and get care. That was my frustration running groups at the VA and why I felt the potential at Omada. A lot of the work that we’re doing is research to figure out how to best serve these unique challenges and needs, but I think we’ll have an incredible opportunity to be able to do that because we’re going to address the accessibility issue first and foremost, which is the biggest barrier of all.

Q: How is Omada thinking about the challenge stated in the paper? “Although Prevent exceeded CDC DPRP benchmarks for program completion during the 16-week core phase, 30% of participants who initially enrolled still did not complete the program. We hypothesize that one of the key advantages of digital therapeutics—accessibility—may also be a disadvantage when it comes to program completion. The lower barrier to Internet-based program entry inevitably increases the number of participants with lower motivation, who may have never made the effort to show up to an in-person program.”

Dr. Sepah: If you look at in-person programs, 50% of people who are referred to an in-person DPP program don’t show up to the first session. There is a huge barrier to showing up and starting treatment. The CDC acknowledges that. The way that they measure completion is how many people who actually start the program and do the program for a month go on to complete the program. Because they know that there are going to be people who never show up or they might show up just to one session to see what the program is about, but are not committed to doing it. It’s not a good way of evaluating the efficacy of a program if it’s the equivalent to prescribing a medication, they take one pill and they don't like the idea of taking pills. That has nothing to do with the efficacy of the treatment.

If we measure by the CDC metrics, then actually 85% of people complete the program, which is a pretty good benchmark. This is an interesting issue. The accessibility of digital programs is so easy and so open and a lot of people aren’t committed. In the medical model, the provider is the agent of change. You go to a doctor, tell the doctor your problem, and you get a pill or procedure to fix the problem. In psychology, we say that we don’t change anyone; we just give the knowledge, skills, and tools for people to change themselves. The participant has to be willing and ready to change and then we’re going to give people the best resources to help them do that. How we’re working on this is a really exciting opportunity and I think a cutting-edge opportunity to do this is to really identify people who are ready to engage in behavioral change and figure out ways of motivating and enhancing that as much as possible so when they do go through our program, they can get excellent results.

Q: Do you do any personality screenings to try and identify what ways may be more effective for different people?

Dr. Sepah: We assess for people’s traits in terms of personality and also in terms of their state, if this is the right time for them to go through the program. We ask a lot of standardized questionnaires about how can we best personalize the program, in terms of what time they like to use it, what kind of coaching they prefer, and what makes them successful at changing other behavioral habits. We ask to better match their groups and better match their coach. The coach, the individualizing agent of the program, makes it a personal experience that caters to them. We are working on improving that assessment, those algorithms, and that coaching all the time.

Mr. Duffy: This area gets me the most excited. It’s so hard to run experiments to try and personalize more and to do interesting things because there’s no way to collect data easily. You can’t easily cluster people via in-person DPP. You can’t say, “what if we had people from different places?” It becomes harder to measure questions at a micro level. But with digital, it becomes incredibly easy. We are thinking of a lot of interesting things this year and that will continue to personalize things even further.

Q: Have you seen any impact from the two new USPSTF recommendations regarding expanding the diabetes screening criteria and intensive lifestyle intervention on your programs?

Mr. Duffy: There have been pockets of customers where that’s the key reason they’ve been interested in us. This is a very interesting time because the ACA guidance is to implement the recommendations according to reasonable medical management. You have the medical director community looking out in the world and trying to figure out what that means. The good thing is that the CDC’s efforts fit nicely into the USPSTF guidance so this will be something that will be sitting on your medical director’s desk no matter what. We think we’re an innovative, neat, and cost effective way to implement these recommendations. It has been commercially useful and we think that will continue for the next six months.

 

-- by Melissa An, Adam Brown, Sally Kim, and Kelly Close