Case Study Template 2018-09-19T13:30:47+00:00

Digital therapeutics deliver technology-based clinical interventions to manage health, prevent, manage, or treat medical conditions. They are used independently or with medications to optimize patient care and health outcomes.

Medical Condition Diabetes, Type 2
Target patient population Patients with type 2 diabetes:
• experiencing consistently elevated A1c values despite traditional interventions, and
• would benefit from more regular coaching to provoke lifestyle changes
What to expect Lowers blood glucose levels for adults living with type 2 diabetes.
Indication of use BlueStar is approved to provide patients with Diabetes, Type 2 a daily coaching for the use of med blood glucose levels for adults living with type 2 diabetes.
Outcomes Based on studies, patients experienced a reduced A1C, with 80% of patients reporting a reduction in monthly insulin use as well as weight loss, increased energy, and greater blood glucose stability.
What to expect Lowers blood glucose levels for adults living with type 2 diabetes.
Directions Patients use the BlueStar mobile app 2 to 3 times a day, for periods of 5-20 minutes. Typical use is up to 20 check-ins a week for the first two weeks to build up the platform’s awareness of patient medications and routines, reducing to 10 check-ins a week for the remainder of use.

Patients will be encouraged by 25,000+ automated, tailored coaching messages empower users to make the most of every minute. Users will adjust their daily insulin doses and physical activity based on recommendations provided by the program.

Risks & warnings BlueStar may not be suitable for a non-tech adoptive individual or patient population.
Place in therapy Complementary to current therapies
Product description BlueStar is accessed through an app on a mobile device or tablet. Depending on patient needs, individuals may also be given access to a human health coach.
Prescription status Yes, a prescription is required.
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.

Use of this product requires access to:

• internet or wifi

• a mobile phone, tablet, or computer

Healthcare provider access Healthcare providers may access the BlueStar dashboard to monitor for weekly and monthly health trends, potential medication-related issues, and view patient-generated health data. These dashboards are accessible through the BlueStar clinician web portal.

BlueStar is also integrated with most major EHRs to ensure that data is securely shared with the patient record.

Coverage options BlueStar is typically paid for by insurance plans. Some patient out-of-pocket expenses are required.
Product Availability BlueStar is available in:

• USA: FDA-cleared Class II Medical Device

• Germany

• UK

• India

A Day in the Life with the BlueStar® app

BlueStar enables patients to communicate with fellow BlueStar users via surveys, notifications, and email. Healthcare providers can also leverage BlueStar population-level data to support attainment of quality ratings.

Quality Systems Standard Achieved?
Applicable sections of IEC 62304
Applicable sections of ISO 14971
Human Factors Standard Achieved?
  FDA Human Factors Testing and Guidelines
  Usability guidelines (CMMI Level 4/5, IEEE 12206, 2304)
  Applicable sections of IEC 62366
Security and Vulnerability Certifications Standard Achieved?
  SOC2
  HiTrust (if highly sensitive data and/or high volume of data)
  GDPR
  HIPAA (if capturing ePHI)
Publication Source Article Title Trial Design Outcomes
Journal of Diabetes Science and Technology Mobile Diabetes Intervention for Glycemic Control: Impact on Physician Prescribing Case-control pilot study; IRB certified study The clinical evidence shows a 1.7 to 2.0-point mean A1C reduction for individuals living with type 2 diabetes who used BlueStar

Technical Information

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United Kingdom

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United States

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