Rx for Technology: BlueStar for Diabetes

Diabetes affects 25.8 million people or 8.3% of the American population, with an additional 79 million patients classified as having prediabetes.¹ Of those 25.8 million people, approximately 90% to 95% have type 2 diabetes. In 2012, the total cost-burden of diabetes, including both direct medical costs and reduced productivity, was $245 billion.²

Fortunately, recent medical innovations have resulted in several new classes of diabetes treatments, including glucagon-like peptide-1 (GLP-1) agonists, dipeptidyl peptidase-4 (DPP-4) inhibitors, and sodium-glucose co-transporter-2 (SGLT2) inhibitors. Some patients may also be turning to a new class of diabetes treatment known as mobile prescription therapy. This class contains digital health solutions indicated for the self-management of diabetes. The first product of this kind is BlueStar (WellDoc, Baltimore, Maryland), a US Food and Drug Administration (FDA)-cleared prescription-only therapy for adults with type 2 diabetes.³ Approved by the FDA in 2010, BlueStar is now being commercialized, so pharmacists should have a basic understanding of the product and be ready to discuss it with their patients as an option for diabetes management support.^3,4 It provides coaching and support for patients using both computers and mobile devices.3 Unlike other health-related applications and software packages, BlueStar is only available by prescription because its software is powered by evidence-based algorithms based on an individual’s treatment plan.³

This mobile prescription therapy has been evaluated through controlled trials. In the first trial, the investigators assessed how hemoglobin A_1c levels were affected by a cell phone– and web-based diabetes management and therapy optimization product.⁵ Thirty patients were recruited and randomized to receive either the intervention tool or standard care. After 3 months, the intervention group achieved statistically significant improvements in A_1c levels, with an average decrease of 2.03% compared with 0.68% in the control group. Healthcare professionals reported that the system reduced logbook review time, facilitated treatment decisions, and provided organized data.

The second study tested whether adding real-time coaching and clinical decision support would further reduce the mean reduction in A_1c levels compared with standard diabetes management.6 This trial included 163 patients with type 2 diabetes and progressed over a 12-month treatment period. After 12 months, patients in the intervention group had a mean reduction in A_1c levels of 1.9% compared with 0.7% in the control group.

BlueStar is similar to a drug in that the physician can prescribe the product for 1 month with additional refills to supplement medication therapy as needed. The pharmacy will adjudicate the claim, and the manufacturer is then notified so that they can dispatch a certified diabetes educator to get the patient started, help them download BlueStar to their smart phone and/or computer, reconcile medications, and teach the patient how to use the software.

When using this tool, patients can enter their diabetes medication regimen, glucose readings, and lifestyle information, such as diet and exercise, to receive automated, real-time, and longitudinal coaching. The automated coaching is based on the American Diabetes Association and American Association of Diabetes Educators educational guidelines.⁷ The providers who are involved with the patient’s care receive an analyzed summary of the patient’s data that can then be used to modify treatments and aid in conversation with the patient.⁷ BlueStar is Health Insurance Portability and Accountability Act compliant as well.⁸ It is similar to the free app, MyFitnessPal, which tracks diet and exercise, in that real-time tracking by the patient is necessary to reap the best results. Unlike MyFitnessPal, however, BlueStar allows the integration of medication information and glucose readings in addition to diet and exercise data, which can provide a more holistic approach to patients’ health.⁸ It also provides information on diabetes, coaching support, medication reminders, testing reminders, and appointment dates.

That being said, BlueStar may work best for highly motivated patients, since patient input and participation is necessary for best results. As dispensing pharmacists, your role in encouraging patients to actively use these disease-management tools is essential. Patients should be encouraged to routinely monitor their glucose readings, diet, and exercise information to better manage their disease.

Although the exact cost of BlueStar is still unknown, it is expected to be about one-third to one-half the price of a branded diabetes medication.⁹ It is listed in Medi-Span with an average wholesale price of $222 and a wholesale acquisition cost of $185.10 Net pricing will vary based on each health plan and rebates with pharmacy benefit managers, according to the manufacturer.⁸ A few Fortune 500 companies such as Ford Motor Company, Rite Aid, and DexCom have already said that they were going to offer pharmacy coverage of BlueStar for their employees.¹¹ WellDoc is currently hiring a direct sales force to market directly to prescribers, so pharmacists may be seeing more prescriptions for the product in the coming months.¹²

Similar to other therapies, there are some barriers to using BlueStar, primarily because patients still need to log their blood glucose readings. BlueStar does not link with a glucometer to automatically upload the readings, but this could change with the advent of more meters with wireless capabilities. In addition, it is not currently available nationwide, but is being piloted around the United States and will undergo a regional rollout later this year.13 However, in the meantime, if providers are interested in BlueStar, they can register via an e-mail list that will notify them when the product is available in their area.³

References

1. Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates in general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: US Department of Health & Human Services, Centers for Disease Control and Prevention; 2011.
2. American Diabetes Association. Economic costs of diabetes in the United States in 2012. Diabetes Care. 2013;36:1033-1046.
3. BlueStar. What is BlueStar? www.bluestardiabetes.com/?page_id=357. Accessed March 4, 2014.
4. Fiore K. Will docs write Rx for apps? MedPage Today. January 16, 2014. www.medpagetoday.com/Endocrinology/GeneralEndocrinology/43841. Accessed April 21, 2014.
5. Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini AL. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008; 10:160-168.
6. Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011;34(9):1934-1942.
7. Diatribe. Welldoc announces the launch of BlueStar, a software-based product for type 2 diabetes. July 22, 2013. http://diatribe.org/issues/56/new-now-next/5. Accessed April 21, 2014.
8. Maas A. Mobile prescription therapy offers novel approach to diabetes treatment. Atlantic Information Services Health. July 26, 2013. http://aishealth.com/archive/ndbn072613-01. Accessed April 21, 2014.
9. Moukheiber Z. Trailblazer WellDoc to sell first mobile prescription therapy. Forbes. June 14, 2013. http://www.forbes.com/sites/zinamoukheiber/2013/06/14/trailblazer-welldoc-to-sell-first-mobile-prescription-therapy/. Accessed April 21, 2014.
10. Medi-Span. PriceRx Drug Price Analysis. Indianapolis, IN: Wolters Kluwer Health; 2013. Accessed March 4, 2014.
11. Dolan B. WellDoc’s BlueStar secures first mobile health reimbursement. MobiHealthNews. June 13, 2013. http://mobihealthnews.com/23026/welldocs-bluestar-secures-first-mobile-health-reimbursement/. Accessed April 21, 2014.
12. Moukheiber Z. WellDoc raises $20 million to market first mobile prescription for diabetes management. Forbes. January 10, 2014. www.forbes.com/sites/zinamoukheiber/2014/01/10/welldoc-raises-20-million-to-market-first-mobile-
    prescription-for-diabetes-management/. Accessed April 21, 2014.
13. Newman HL. You need a prescription to use this app. Slate. January 7, 2014. www.slate.com/blogs/future_tense/2014/01/07/you_need_a_prescription_to_use_this_diabetes_mobile_health_tracking_monitoring.html. Accessed April 21, 2014.