Welldoc Touts What Clinical Outcomes, Engagement Mean to Employers

The idea of using digital technology to manage diabetes is well past the “new” phase. But getting health plans and employers to incorporate these solutions to deliver positive clinical outcomes and cost savings for members who have diabetes or chronic diseases has come more slowly. For starters, employers are flooded with pitches, and many struggle to figure out which products are worthy. Second, employers want more than just clinical outcomes. They want to know how solutions, such as digital therapeutics, will cut healthcare costs.

It’s familiar territory for Laurel Pickering, MPH, who spent 24 years as head of the Northeast Business Group on Health, an employer-led coalition of healthcare leaders and stakeholders.¹ “These companies are knocking on employers’ doors every day with programs that have very little evidence of their efficacy,” Pickering told Evidence-Based Diabetes Management™ (EBDM™) in an interview. Employers, she said, want to know, “How’s your engagement?”

For Pickering, Welldoc stood apart from the crowd. And today, she is the executive vice president for enterprise solutions at Welldoc, developer of the BlueStar digital therapeutic for type 2 diabetes (T2D). Over the past decade, the company has conducted randomized clinical trials,^2,3 and other studies,⁴ with results showing BlueStar’s efficacy. “No one has that,” she said.

It’s Pickering’s task to bring BlueStar’s story to a wider network of employers and health plans, by showing them what empowering employees with T2D to manage their disease means to the bottom line.

Study findings show that the FDA-cleared BlueStar mobile medical app produces reductions in glycated hemoglobin (A1C) of 1.7% to 2%.^2,4,5 In June

2018, the company announced data that show how these results translate into savings: At the 78th Scientific Sessions of the American Diabetes Association held in Orlando, Florida, researchers from Truven Health presented an analysis that found health plans offering BlueStar to those with T2D would save $254 to $271 per member per month, depending on the user’s A1C level.⁶

BlueStar combines automated in-app coaching and real-time support with educational tools, embedded with curricula from the American Association of Diabetes Educators (AADE), under an agreement reached last year.⁷ A digital therapeutic is not a “diary,” but rather a tool that uses technology to provide people with real-time support at the decision point, based on their personal data: what they are eating, what medications they are taking, and their blood glucose results over time. Sharing information with the care team offers a more complete picture and leads to better decision making, both during office visits and in the time between visits that evidence shows matters most when managing the disease. Although today BlueStar’s main product is available without a prescription, there is also within-app access to a prescription-only insulin bolus calculator. Another version of BlueStar, the Diabetes Wellness Program, is a consumer “lifestyle” and wellness solution available through Samsung Health.⁸

Welldoc is gaining more understanding of how BlueStar users interact with the technology and how it could be scaled across different patient populations. In the EBDM™ interview, Welldoc’s Malinda Peeples, RN, MS, CDE, vice president for clinical services, programs, and research, and Pickering said this is key information for employers because they want to be assured that employees will use the technology before they make the investment. Pickering said too many employers have been burned by paying for solutions that didn’t keep employees engaged. Peeples said Welldoc understands this, and the company is taking time to study engagement because it’s crucial to the transition to value-based care. “What has really been interesting is that not only did we demonstrate outcomes in the clinical trial, we have actually seen similar ones in demonstration projects in commercialization,” she said. Welldoc has consistently seen the same findings, across different settings and patient populations, Peeples added.

So far, Welldoc reports that its study results show users engage with the app 13 to 24 times per week, and findings from a research study with Vanguard Medical Group and Horizon Blue Cross Blue Shield of New Jersey showed that 86% of active users shared the 1-page report of their data with their healthcare team.^4,9 Peeples described 3 categories of engagement with a digital therapeutic by patients, informed by a recent study completed in collaboration by Welldoc, Samsung, and Ontario Telemedicine¹⁰:

• Early adopters who are very savvy with technology and very motivated to engage in diabetes self-management.

• A second group has smartphones and has started using apps, but these users must learn to fold in the diabetes self-management element. Once this group is assisted with a digital tool, Peeples said, they learn to incorporate support into the context of their daily lives. “In-app coaching delivered by BlueStar becomes very effective,” she said.

• A third group finds diabetes self-management challenging. “This group is slower to get involved, but with BlueStar, they can actually engage.”

What’s important to Welldoc, Peeples said, is to understand how to help the patient engage with BlueStar, whether it’s through an employer or through a provider, “to use it in either setting and connect with their healthcare team.”

BlueStar can now be used for hypertension and/or weight management in people with T2D.¹¹ It’s well known that overweight and hypertension are common among people with prediabetes, a condition that affects up to 84 million Americans. In recent years, CDC has been working with the American Medical Association, the AADE, and other partners to encourage more people with prediabetes to become aware of their condition and to enroll in a yearlong National Diabetes Prevention Program (DPP), or Medicare DPP if eligible, to

make lifestyle changes to prevent or delay progressing to T2D.¹² Research now shows that after 15 years, 55% of those in the lifestyle arm of the study that formed the basis of the National DPP, progressed to T2D.¹³

And Welldoc continues to gain evidence from its work with health systems, such as Providence Health and Services in the Oregon region,¹⁴ as well as largescale efforts with employers, which Pickering said includes CBS Television and the New York City Department of Transportation. The latter includes a mix of very active and very sedentary employees.

“As a rule, employers don’t like to be first, but they like to be second. They need someone to be the early adopter,” she said. Word is spreading, and more conversations are happening. “We have good results and a great story to tell.”References

1. NEBGH president and CEO Laurel Pickering to join leading digital health company Welldoc as chief revenue officer [press release]. Columbia, MD: GlobeNewswire; October 3, 2017. globenewswire.com/news-release/2017/10/03/1140146/0/en/NEBGH-President-CEO-Laurel-Pickering-to-Join-Leading-Digital-Health-Company-Welldoc-as-Chief-Revenue-Officer.html. Accessed August 13, 2018.

2. Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. Welldoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008;10(3):160-168. doi: 10.1089/dia.2008.0283.

3. Quinn CC, Sareh PL, Shardell ML, Terrin ML, Barr EA, Gruber-Baldini AL. Mobile diabetes intervention for glycemic control: impact on physician prescribing. J Diabetes Sci Technol. 2014;8(2):362-370. doi: 10.1177/1932296813514503.

4. Tang PY, Peeples M, Duni J, Peskin S, MacLeod J, Kowiit S, Fisher ES. E-health assisted lay health coaching for self-management support. Presented at: the 76th Scientific Sessions of the American Diabetes Association; June 10-14, 2016; New Orleans, LA. Abstract 725-P. ada.scientificposters.com/index.cfm?k=56tfw2286n.

5. Welldoc receives FDA 510K clearance to offer a non-prescription version of BlueStar digital therapeutic for type 2 diabetes [press release]. Columbia, MD: GlobeNewswire; January 17, 2017. globenewswire.com/news-release/2017/01/19/909283/0/en/Welldoc-Receives-FDA-510-k-Clearance-to-Offer-a-Non-Prescription-Version-of-BlueStar-Digital-

Therapeutic-for-Type-2-Diabetes.html. Accessed August 16, 2018.

6. Shomali M, Iyer AK, Griffin BT, Peeples M. A novel economic analysis applied to innovative diabetes digital health intervention demonstrates significant financial benefits. Diabetes. 2018;67(suppl 1; abstr 1317-P). doi: 10.2337/db18-1317-P.

7. Caffrey M. Welldoc, AADE launch digital diabetes health learning network. The American Journal of Managed Care® website. ajmc.com/newsroom/Welldoc-aade-launch-diabetes-digital-health-learning-network. Published August 4, 2018. Accessed August 13, 2018.

8. Welldoc’s digital platforom for type 2 diabetes powers “Diabetes Wellness Program” within Samsung Health [press release]. Columbia, MD, and Mountainview, CA: Samsung newsroom US; March 6, 2018. news.samsung.com/us/Welldocs-digital-platform-type-2-diabetes-powers-diabetes-wellness-program-within-samsung-health/. Accessed August 13, 2018.

9. Welldoc outcomes. Welldoc website. Welldoc.com/outcomes/. Accessed August 13, 2018.

10. Desveaux L, Shaw J, Saragosa M, et al. A mobile app to improve self-management of individuals with type 2 diabetes: a qualitative realist evaluation. J Med Internet Res. 2018;20(3):e81. doi:10.2196/jmir.8712.

11. Welldoc’s BlueStar now available for hypertension and weight management [press release]. Columbia, MD: Welldoc; July 9, 2018. Welldoc.com/news/Welldocs-bluestar-now-available-for-hypertension-and-weight-management/. Accessed August 13, 2018.

12. Berg S. Diabetes prevention entered the spotlight in 2017. American Medical Association Wire website. wire.ama-assn.org/delivering-care/diabetes-prevention-entered-spotlight-2017. Published December 26, 2017. Accessed August 13, 2018.

13. Diabetes Prevention Program Research Group. Long-term effects of lifestyle intervention or metformin on diabetes development and microvascular complications over 15-year follow-up: the Diabetes Prevention Program Outcomes Study. Lancet Diabetes Endocrinol. 2015;3(11):866-875. doi: 10.1016/S2213-8587(15)00291-0.

14. Welldoc announces Providence Health & Services’ implementation of BlueStar digital therapeutic in a pilot program for individuals with type 2 diabetes [press release]. Columbia, MD: GlobeNewswire; April 3, 2018. globenewswire.com/news-release/2018/04/03/1459243/0/en/Welldoc-Announces-Providence-Health-Services-Implementation-

of-BlueStar-Digital-Therapeutic-in-a-Pilot-Program-for-Individuals-with-Type-2-Diabetes.html. Accessed August 13, 2018.

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