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type2diabetestreatments-blog · 8 years ago

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A Look at Tethys: Predicting Diabetes is the Easy Part

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A Look at Tethys: Predicting Diabetes is the Easy Part

A few months ago, we got a tip from a researcher about a new product from a company called Tethys Bioscience that can quite accurately predict a person's likelihood of developing type 2 diabetes. This sounded pretty revolutionary, in large part because it has the potential to save the country billions of dollars in diabetes prevention. But does knowing your risk actually motivate people?! They've teamed up with a popular smartphone health app to find out.

Curious about this endeavor and how the pilot project turned out, we asked our columnist and correspondent Wil Dubois to take a closer look:

We've known for more than a decade that we can prevent, or at least seriously delay, type 2 diabetes. But we don't. The growth of type 2 remains explosive. Prevention is failing. Why?

It may be that we haven't had a good way to really know how to direct our prevention efforts. There are many variables, but when looking at everyone with pre-diabetes, most experts agree that approximately a quarter of them will "convert" to full-blown diabetes within five years, half will stay in a pre-diabetes state, and the final quarter will "revert back" to normal blood sugar.

What if we could know, for sure, who will get the big D and who won't? Would that make a difference to our prevention efforts? If you knew, for certain, that you would get diabetes if you didn't make changes, would it motivate you to make those changes?

Well, there's now a way to test people with pre-diabetes and determine which are likely to get full-blown diabetes, and which aren't. It's medical triage in a test tube called PreDx.

Simply put, it's a blood test that predicts the risk of getting full-blown type 2 diabetes in five years once someone has pre-diabetes. Unlike traditional screening measures that identify only who's at risk, PreDx quantifies how great that risk really is.

If you administer PreDx to a group of people with pre-diabetes, the test "identifies who's moving faster towards type 2 diabetes," according to Pamela Parkes, Senior Marketing and Communications Manager for Tethys, the Emeryville, CA-based company that developed the test.

The test analyzes seven different serum biomarkers. Three are known to most people with diabetes: fasting glucose, insulin levels, and A1C. The other four require a quick explanation. They are: ferritin, a measure of the iron in the blood which has a clear association with diabetes and diabetes control; C-reactive Protein, or CRP, an inflammatory marker commonly elevated in people with type 2 diabetes; and a pair of uncommon tests called interleukin-2 receptor-É‘ (another inflammatory marker); and adiponectin, a fat cell hormone that serves as a measure of the degree of insulin resistance.

A Poker Hand?

In trying to understand how this text works, I think of it like the diabetes predictive equivalent of having a poker hand.

Who knows why we have seven cards in a poker hand, really? But when it comes to this test, there are seven items in the PreDx panel because the company's research showed that more markers didn't make the test any more accurate, according to Caitlyn Waller Kress, the company's Director of Business Development. She says the firm, which was created to develop and market the test, originally studied over 200 different markers, winnowing the list down to 58 based on the availability of commonly available reagents and equipment for testing, and then used sophisticated computer modeling of those compounds on blood samples from the patients who developed diabetes during the ongoing Inter99 study in Denmark (the largest scientific prevention study on lifestyle in Denmark ever) to narrow in on the "smoking guns" that would predict who would convert to diabetes, and how fast it would happen.

The seven lab tests are combined with the patient's gender and age, and plugged into a patented proprietary algorithm to create a risk score on a scale of 1 to 10. A score of 5 means you have a 3.4% risk of converting to full-blown type 2 diabetes in five years. The scale angles sharply upwards from there. A score of 7 means your risk is 7.5%. A score of 8 means your risk is 12.5%. At a score of 9 your risk is 25%. At a maximum score of 9.9, your risk of moving from pre-diabetes to full-blown diabetes is a whopping 78%.

A score of 10 would mean you already have full-blown diabetes, and so in poker terms... this might be something like you losing to someone with a royal flush.

About Accuracy & Cost

Juan P. Frias, Chief Medical Officer for Tethys, tells us that PreDx is "clearly better than fasting glucose or A1C," and "fairly similar to OGGT (oral glucose tolerance test) in terms of accuracy."

But he points out that the real value of PreDx is not as a screening tool. In fact, Frias is emphatic that PreDx is not a screening tool at all, but rather a way to "stratify risk" among patients who have already been diagnosed as having pre-diabetes with the less expensive fasting, fingersticks or A1C tests.

PreDx "adds a tremendous amount of specificity," according to Frias. The real value of the PreDx score, he says, is in allowing providers to "tailor intervention." It tells them which patients need the most aggressive treatment to prevent conversion.

FYI, he's the same Dr. Frias who's active in TCOYD Latino initiatives, and he led the recent Team Type 1 athlete athlete study, which aimed to "fill a major void in diabetes sports research."

The list price for the test is a whopping $585. You can't buy it yourself; it has to be ordered by your doc. If you're uninsured, there's a cash price of $300. If your uninsured and poor, you're out of luck, as the company has no patient assistance program.

Like all companies, Tethys is in the business of making money. That said, most of the 150,000 people who've had the test run over the last four years didn't pay a penny. Right now the company's test, which is CLIA Certified, is out-of-network on most insurance plans. The company is of course working hard to get on the formulary of health plans, and/or have employers subsidize the test, without billing the balance to patients.

Teaming Up with Lose It!

The folks at Tethys now have a validated working test. They're negotiating with Medicare for coverage; and in a major feather in their cap, were granted a New York state lab permit, opening them up to serving all 50 states in the U.S. In a poster presentation at the 2011 ADA Scientific sessions, a Finnish researcher was even able to show that a PreDx score could be lowered 10% following a year of intensive lifestyle intervention -- proof-positive that it's possible to change your diabetes destiny in the pre-diabetes space.

The science tied up, the marketing underway, the legal approvals behind them, the team at Tethys began to ponder broader questions. Like: Does knowing you are at severe risk of diabetes have a motivational impact on the patient? Is knowledge really power?

So they teamed up with FitNow, the folks that make the wildly popular 10-million-download weight loss app Lose It! to try to answer that question. Lose It! is a calorie and exercise tracking app that helps you spend a daily budget of calories customized to your weight loss goals. It's the Poster Child for interconnectivity, playing nice in the sand box with other fitness apps, wireless scales, pedometers, and more. It even has a social side to give you support or competition.

The App "Study"

Frias is quick to point out that the Tethys/Lose it! project was "not a clinical trial. There was no control group," or other sophisticated design. He terms it a "first look-see" at the relationship between the length of app "engagement" and knowledge of a diabetes conversation risk score.

Eighty-nine people with PreDx scores were followed, and compared to the average Lose It! user. What the researchers found was that people who had been given scientific evidence that they were at risk for developing diabetes used Lose It! 10% more than the typical user. And that result paid off. On average, over the three months, the study participants lost ten pounds each.

But did they change their health destiny? The project was designed only to look at "engagement," but five of the physicians re-tested their guinea pigs on their own at the end of the study and found that even in this very short period of time, their patients were able to lower their PreDx scores. So they lowered their risk of conversion. The star performer was a 60-year old man who lost 15 pounds over 113 days using the Lose It! app, and dropped his PreDx score from 9.7 to 5.7 — roughly cutting his five-year risk of developing diabetes from something around 70% to less than 5%.

Dropouts & Promises

Surprisingly, of the 89 people enrolled in the pilot project, 62 dropped out within two weeks, a statistic that stunned me. There was no data tracking comparing drop-outs to stay-ins, so we don't know whether higher or lower PreDx scores increased the likelihood someone would stay in the study.

Frias says he'd love to do a more sophisticated study in the future and that's absolutely being considered, but there's nothing in the works just yet. That said, according to Kress, a way to input PreDx scores and track them, by both users and their providers, will be included in the next-gen premium version of the Lose It! app — which is expected out in the near future.

As exciting as it all sounds, I know from my own clinical experience that for a few months, or even half a year, people who are diagnosed with full-blown type 2 diabetes often stay focused, only to slip back into their old habits. If that happens with a full-blown diagnosis, aren't we likely to see the same pattern with an early warning sign? I wish the Lose It! study had been longer, but at least it does show promise...

Promise that a scientific early warning, and access to easy-to-use tools, may be the first steps towards reversing the tide of the type 2 epidemic.

Disclaimer: Content created by the Diabetes Mine team. For more details click here.

Disclaimer

This content is created for Diabetes Mine, a consumer health blog focused on the diabetes community. The content is not medically reviewed and doesn't adhere to Healthline's editorial guidelines. For more information about Healthline's partnership with Diabetes Mine, please click here.

Type 2 Diabetes Treatment Type 2 Diabetes Diet Diabetes Destroyer Reviews Original Article

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organisemybiz · 8 years ago

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David Glickman Crunch Network Contributor David Glickman is an entrepreneur-in-residence and digital health advisor for Nokia Growth Partners (NGP) and founder of Lively (now part of GreatCall Inc.). How to join the network The current market for older adult care is massive — and growing at an unprecedented rate. According to an AARP report, the 106 million Americans over 50 represent a transformative force that will generate more than $13.5 trillion in annual economic activity by 2032, accounting for more than half of the U.S. GDP. In addition, Deloitte forecasts they will amass $26 trillion in financial assets by 2029. The older adult care challenge will continue to expand as nearly 10,000 baby boomers reach retirement age each day; in fact, research has shown that baby boomers will account for a 73 percent increase in the 65+ population. And, more than 30 million boomers will be managing more than one chronic health condition by 2030, according to the American Hospital Association. So how will current and future generations take care of the massive surge of parents, grandparents and great-grandparents who live longer and want to stay in their own homes? While the need for ongoing older adult care advances is clear, we’re still not sure what to call it (e.g. elder care, senior care, older adult care — what’s the right phrase to use?). In addition, many entrepreneurs aren’t sure how to make the most of it. Thankfully, older adults are embracing a variety of health-centric technology initiatives — from telemedicine and remote diagnostics to remote/automated monitoring and home-installed sensors, and I’m seeing the pace of this adoption increasing at a nice clip. We’ve got a ways to go, but the trajectory is in the right direction. Yet, Accenture predicts that half of digital health startups will fail within the first two years. So how can entrepreneurs not only survive, but also thrive? As an entrepreneur who experienced these challenges firsthand, I’m often asked what we learned or what we could have done better with the gift of hindsight. Thus, here are my six top things for an entrepreneur to consider to create a successful business when building an older adult care product, service or experience. Choose your words wisely Labels and word choice matter more for this growing market than other endeavors — people want and deserve labels that preserve their dignity and let them age with grace. As an entrepreneur and investor, I struggled with this daily — and still do. How do you describe and address your elders properly while still being respectful? Do they prefer “elder,” “older adult,” “senior,” “senior citizen”? Our team at Lively decided “older adult” was the best descriptor for our target audience, but you need to pick which one will resonate with your audience, then commit to it. Solve specific problems If you try to be all things to all older adults, you will fail. The older adult community consists of so many micro groups — from youthful 60-year-olds to frail 90-year-olds, sedentary to active, employed to retired, and so on (and frankly, “youthful” and “frail” are not usually age specific, so I caution against segmenting strictly by age — you need multiple filters). Successful companies focus on one, maybe two, archetypes and provide effective solutions for those individuals. They often serve an extremely specific older adult demographic. Pick an archetype and use your chosen audience as the filter for all other initiatives. As difficult as it is for me to admit (given their fear-based selling and circa 1970 creative and product design), traditional personal emergency pendant companies like Life Alert understand this maniacal focus on targeting, and they do it well. Dig into distribution Investors and industry leaders offer startups so many tools for success — funding, product feedback, pilots to get in the door, etc. — but none compare to distribution. Entrepreneurs trying to build an older adult care business need to understand that it is a fragmented market with a complicated sales process, where the buyer is usually more than one person. You not only have to sell to the older adult, but also to the caregiver (often an adult child). Successful older adult care businesses will be built on a foundation that addresses an incredibly specific audience. In addition, successful older adult care solutions must fit into the existing workflow or you risk stalling adoption. Distribution is what it is all about in the older adult care business. Without it, you will never reach the scale you need to thrive. The teams at ClearCare and Caremerge are good examples of companies that focused successfully on distribution. Both worked to understand what it would take to win in their market (home care agencies and senior living communities, respectively) by understanding how to make their product a “must have” rather than a “nice to have.” Once the solution became a “must” to decision makers, they had the will to mandate the solution through their organization. Prioritize design It doesn’t matter if you are 10 or 90, everyone appreciates great design. Ignoring design simply because you are targeting an older audience is an enormous, and costly, mistake. Design for older adult care solutions goes well beyond simple look and feel; great design encompasses the entire customer experience. Design can bring your brand to life by making your product/solution so easy to use (and sell) that it becomes a “must have” for your target audience. However, it is something that is extremely difficult (some may even argue currently impossible) to achieve at scale. The evolution of Personal Emergency Response (PER) buttons that don’t go around the person’s neck are a prime example: People crave it, yet no vendor has become the solution. I blame design. Our inspiration at Lively was the story of OXO and its focus on older adults leading to ultimate success. Make the user the ultimate guide Yes, the older adult should still be your primary focus. I have talked to so many startup founders in the space that lead with the benefits their solution or product provides for the caregiver, family, senior living center, hospital, insurer, etc. … basically every stakeholder other than the older adult themselves. We made that mistake when we launched Lively, but quickly realized that the older adult should take priority. Design with your defined older adult archetype in mind, first and foremost, from the start, so they “want” it. You need to offer a direct benefit to make a personal, emotional, visceral connection that moves your audience to embrace the technology and make it stick. The 2016 Survey Report from Aging 2.0 is a helpful primer for any entrepreneur trying to break into the older adult care space. Prototype everything It may seem like an obvious point, but when many entrepreneurs (me included) think about prototyping, they focus solely on design and user experience. This is indeed crucial but, looking back, prototyping must also include the distribution strategy to succeed in the older adult care market. While in-home research, testing and listening is valuable as you design the experience, you must also spend time thinking about potential distribution strategies and partners. Bring in potential partners early in the process and get answers to important questions like: Will this fit into the current workflow? How does it fit into the current payment model? What does the partner’s sales cycle look like? What is the real benefit to the user and caregiver? What is the trigger point? How can you reach the user at the exact trigger point? and more. The IoT opportunity As the Internet of Things (IoT) evolution takes hold in mainstream consumer culture and smart devices and smart homes become the norm, the opportunity for entrepreneurs to solve older adult care challenges with technology advances will continue to grow. The established tech giants will be moving into the space soon, so now is the time for entrepreneurs to stake their own claim. Timing is everything. Industry pundits predict that 50 billion devices and one trillion sensors will come online in the years ahead — from cars and computing devices to appliances and biometric sensors. The opportunities at the intersection of IoT and care are real and achievable. What would have seemed like something out of a Sci-Fi movie 10 years ago now seems like a viable next step as smart home advances and sensors continue to permeate the market. Yet, it is still quite early, and I know firsthand there are many challenges when applying IoT to older adult care solutions. Michael Rogers may have said it best in a previous AARP report: “Boomer ideals were forged in an era when human rights and individual freedoms were central concerns … Boomers want technology to fit the lives they have made and the values they hold dear.” Successful older adult care businesses will be built on a foundation that addresses an incredibly specific audience, understands the importance of distribution, makes design and user experience a priority and solves the prototyping puzzle. Entrepreneurs who can create that foundation will be able to reap the rewards of this exploding, yet challenging, market opportunity. Featured Image: Michael H/Getty Images

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