DTx Product Case Study: BlueStar®

Patients using BlueStar typically achieve a 1.7 to 2 points average decrease in HbA1c in the first 3 to 6 months of usage.

Digital therapeutics deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Product Overview

Medical condition:

Targets type 1 and type 2 diabetes

Note: In November 2019, the FDA cleared BlueStar to now cover type 1 diabetes under 510(k) K190013. However, the clinical data discussed here is related to type 2 diabetes.

Target patient population:

Patients with type 1 and type 2 diabetes and possible co-morbidities of hypertension/obesity who are experiencing consistently elevated A1c values despite traditional interventions, and who struggle with managing the other aspects of their diabetes, including managing medication, food, activity, sleep, diet and psycho-social factors.

What to expect:

Helps lower blood glucose levels for adults living with type 1 and type 2 diabetes

Clinical
Overview

Indications for use:

BlueStar® and BlueStar Rx® Systems are indicated for use by healthcare providers and their patients – aged 18 years and older – to aid in their diabetes self-management. Contact Welldoc® for complete IFU.

Outcomes:

Demonstrated through 45 different peer-reviewed, clinical publications, studies, and posters (including 3 multi-site, randomized controlled trials), patients experienced a drop in HbA1c of 1.7 to 2 points on average, improved medication adherence, and better glucose control.

Directions:

Patients can either use the mobile app or the web version of BlueStar. The mobile app uniquely works on- or off-line, to address the requirement for “always-on” support for FDA-mandated patient safety requirements.

Patients will be encouraged by 30,000+ automated, tailored, and unique coaching messages which empower users to make the most of every minute. Users will take in real-time actions – including daily medication administration, physical activity, smart food choices, and psycho-social well-being – based on recommendations provided by the program that are driven by clinical guidelines.

Risks & warnings:

BlueStar is not currently indicated for patients who are under the age of 18, or who are currently pregnant, or who use a continuous glucose monitor. BlueStar is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment.

Place in therapy:
Complementary to current therapies including pharmacologic-related, diet-related, exercise-related, or knowledge-related therapy pathways.

Product
Access

Product description:

BlueStar includes an always-on, fully-automated software coach; a SmartVisit™ report that goes to the patient’s healthcare provider team via fax, email, or EMR; and a population management portal that allows an administrator to manage, review, report, survey, and dialog with patients or cohorts of patients.

Prescription status:

BlueStar does not require a prescription unless patients intend to use BlueStar with an insulin titration system.

Patient access:

Patients download the BlueStar Program through an app on the Apple or Google App Store. An enrollment code is generated for patients after their healthcare provider completes a prescription or enterprise makes it available (OTC).

Use of this product requires access to:

  • Internet or wifi – only for initial download and periodic syncing
  • A mobile phone, tablet, or computer

Provider access:

Healthcare providers may access the BlueStar SmartVisit report or Care Management Portal to monitor for weekly and monthly health trends, potential medication-related issues, and view patient-generated health data. BlueStar is also integrated with many major EMRs to ensure that data is securely shared with the patient record.

Coverage options:

BlueStar is typically paid for by insurance plans and employers.

Product availability:

BlueStar is available in:

  • USA: FDA-cleared Class II Medical Device
  • Canada: Health Canada-cleared Class II Medical Device
  • UK & Australia (coming soon): NICE and TGA-cleared Class II Medical Device

Engaging users. Driving outcomes.

BlueStar uniquely offers highly tailored and clinically validated real-time coaching and longitudinal insights that are driven by an artificial intelligence expert system. BlueStar is also unique because it focuses on self management for the patient but also a strong connection to the patient’s own care team – both critical to A1c reduction. It was the first digital therapeutic to undergo randomized controlled trials and obtain clearance from the FDA.

Clinical
Trials

Study Title: WellDoc™ Mobile Diabetes Management Randomized Controlled Trial: Change in Clinical and Behavioral Outcomes and Patient and Physician Satisfaction

Features: Randomized controlled study; IRB-certified study

Outcomes: The clinical evidence shows a 2.0 point mean A1C reduction for individuals living with type 2 diabetes who used BlueStar.

Study Title: Glycemic Control: Impact on Physician Prescribing Behavior

Features: Randomized controlled study; IRB-certified study

Outcomes: The clinical evidence shows a 1.9-point mean A1C reduction for individuals living with type 2 diabetes who used BlueStar.