DTx Product Profile

BlueStar®

Product Highlight

Condition targeted:

Type 1 and 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.

How it works:

BlueStar® and BlueStar Rx® Systems include:

  • A mobile app (also available via web) for individuals living with Type 1 (T1) and Type 2 (T2) diabetes, which connects to multiple health devices and data sources and provides tailored digital coaching and insights.
  • Data and insights shared with care team members via a SmartVisit™ report which provides health trends and summaries, as well as through multiple integration options offered by Welldoc.
  • BlueStar Care Management Portal for population health management, provides the ability to monitor weekly and monthly health trends

Impact:

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

Product Overview

Medical condition:

BlueStar® and BlueStar Rx® Systems are intended to help individuals with diabetes and their care teams manage diabetes and support better health with AI-driven digital coaching and insights. This supports connected experiences, self-management, and care team interventions.

 *Welldoc Diabetes Rx/OTC is an FDA-cleared medical device (“BlueStar”), intended for use by health care providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com.

Target patient population:

BlueStar is intended for individuals 18 years and older, living with T1 and T2 diabetes.

What to expect:

BlueStar is a total health approach to diabetes, by helping individuals manage health measures, like blood glucose monitoring and blood pressure, medication, activity, weight, psycho-social factors, and other health data. 

BlueStar utilizes this vital health data to provide an AI-driven solution, informing evidence based, real-time digital coaching and education. The digital coaching and insights provide real-time feedback based on blood glucose values and trends to help support lower blood glucose levels and better overall health for adults living with T1 and T2 diabetes. 

In addition, BlueStar Rx will analyze your blood glucose entries and determine if you need insulin dose adjustments based on your healthcare provider’s instructions to help support A1C reduction. 

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. Please go here for complete Indication information.

Outcomes:

Welldoc’s research consists of 50+ peer-reviewed, clinical publications, studies and posters—including 3 multi-site, randomized controlled studies. Within this extensive research, Welldoc has studied the impact of BlueStar on health measures such as HbA1c, medication adherence, and better blood 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.

BlueStar includes an extensive library of over 40,000 digital coaching messages, which are based on clinical guidelines. With over 20 patents, Welldoc’s advanced AI leverages the power of an individual’s data to provide unique, personalized, real-time coaching messages. This allows BlueStar users to receive the right guidance at the right time and take 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 individuals 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® and BlueStar Rx® Systems include:

Prescription status:

BlueStar is available over-the-counter (OTC) and does not require a prescription. However, BlueStar Rx requires a prescription for additional insulin management support.

Patient access:

Users download the BlueStar Program through an app on the Apple or Google App Store. An enrollment code is required, typically provided through their health plan, employer, or provider system.

Use of this product requires access to:

Provider access:

Welldoc provides multiple options, such as the SmartVisit report and EMR integration, to enable secure access to individual data and insights, while also supporting care team/management workflows and clinical decisions.

Coverage options:

BlueStar can be paid for by health plans or employers.

Product availability:

BlueStar is available in:

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

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