BlueStar Rx healthcare provider user guide

FDA-Cleared
Digital Health

Use Welldoc’s digital health solutions to deliver a virtual channel of care delivery to your patients.

The information on this page is intended for clinicians only. If you are a patient and have any questions about managing your diabetes, or would like additional information about whether the BlueStar app may be right for you, please contact your doctor.

Welldoc's digital solutions can help

Studies in type 2 diabetes

12-month randomized-controlled clinical trial

In a prospective, randomized, controlled study, Quinn et al. (Diabetes Care, 2011) found that, individuals with type 2 diabetes whose A1C levels were poorly controlled (>9.0%) or abnormal (7.5-8.9%) at the time of enrollment, and who were randomized to use a mobile phone app to help them manage their diabetes in addition to usual care, improved A1C by an average 1.9%, compared with 0.7% improvement in persons randomized to usual care alone, a difference of 1.2% (P < 0.001) over 12 months.

Methodology

  • Primary endpoint: change in A1C over one year
  • Randomization to one of four groups: (1) usual care (n=56), (2) usual care plus patient mobile app/access to web portal for diabetes management (n=23), (3) usual care, mobile app/portal for patient, plus provider access to raw patient data (n=22), and (4) usual care, mobile app/portal for patient, plus patient data tied to decision support for their physician (n=62)
  • 213 patients enrolled; 163 included in the analysis

 

Study Limitations

  • Private insurance only
  • Study dropout rates required use of mixed-effects statistical modeling to impute missing observations

Study Results

The results from the study (Figure 1) indicate am A1C reduction of 1.9%, compared with 0.7% improvement in persons randomized to usual care alone, a difference of 1.2% (P < 0.001) over 12 months. The results stratified on baseline A1C show that the results in Figure 1 do not indicate regression to the mean. Figure 2 shows the results within strata of baseline A1C less than 9%, and Figure 3 shows the results within strata of baseline A1C greater than or equal to 9%.

3-month randomized-controlled clinical trial

In a prospective, randomized, controlled study, Quinn et al. (Diabetes Technology and Therapeutics, 2008) found that individuals whose A1C levels were greater than or equal to 7.5% within most recent three months and recieved Welldoc’s software experienced an average decrease in A1c of 2.03%. Patients in the control group obtained an average A1C reduction of  0.68% (P < 0.02, one-tailed). Of the intervention patients, 84% had medications titrated or changed by their HCP compared to controls (23%, P = 0.002).

Methodology

  • Primary Endpoint: change in A1C over three months and change in prescribing behavior
  • Randomization to one of two groups: usual care (n=15) and usual care plus BlueStar (n=15)
  • 30 patients enrolled; 26 included in the analysis

Study Limitations

  • Small sample size

Over 45 Clinical Publications

We rigorously examine our products and their impact, evidenced in over 45 peer-reviewed publications, posters, and presentations.

Clinical Studies

Clinical Studies Diabetes Technology Therapeutics

Older Adult Self-Efficacy Study of Mobile Phone Diabetes Management.

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Clinical Studies Journal of Diabetes Science and Technology

Mobile Diabetes Intervention for Glycemic Control: Impact on Physician Prescribing.

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Demonstration Project

Frameworks

Frameworks Encore Presentation at AADE 2018

Technology-Enabled Diabetes Self-Management Education & Support

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Frameworks American Association of Diabetes Educators

Expanding reach: AADE7 moves into the digital space

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EMR Integration

EMR Integration Journal of Diabetes Science and Technology

Integration of a mobile-integrated therapy with electronic health records: lessons learned.

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Post-Marketing Outcomes

Post-Marketing Outcomes Diabetes Technology Society, Bethesda, MD

Determinants of Engagement in Digital Health: What Makes it Stick?

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Post-Marketing Outcomes Diabetes Technology Society, Washington D.C.

A Data Science Framework for Mobile Health–Engagement and Outcomes

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Whitepapers & Articles

Whitepapers & Articles mHealth

Technology to overcome therapeutic inertia

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Clinical Models

Clinical Models AADE, New Orleans

Educators: Go Mobile & Join the Digital Revolution!

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Clinical Models AADE In Practice

Are You Ready to Be an eEducator?

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Book Chapters

Book Chapters mHealth Innovation: Best Practices from the Mobile Frontiers

A. Case Study: Mobile prescription therapy

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Book Chapters Connected Health: Improving Care, Health, and Efficiency with Wearables

Case Study: The IoT and Big Data in Healthcare Unleashing the Next Generation of Value Creation

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Mansur Shomali

Chief Medical Officer

Welldoc, Inc

Whoever is seeing that patient also needs to adjust the therapy. Because if the patient is doing all the right things, but they're on the wrong meds, it's not going to be a good solution. Tools like BlueStar, they bring that data to providers so that we can get decision support from it.

Fully HIPAA compliant

Fully HIPAA
Compliant

ISO 13485 certified

ISO 13485
Certified

FDA cleared

FDA Cleared with seven 510 (k)s, Rx, and OTC

SOC 2 certified

SOC 2
Certified

Choose a tool your patients will love

“I have really been able to transform my life in a short amount of time with this BlueStar App”

Candy Barnes, BlueStar User

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Out Team is Ready to Assist Implementation

  • Implementation

    Our implementation leads help you choose a plan we are confident will succeed.

  • Marketing

    Our marketing team develops a plan to engage your unique patients and providers.

  • Strategy

    Our data scientists build models to forecast your ROI and engagement.

  • Clinical Team

    Our clinical experts ensure you have science to back up your decision.

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