Closed Loop Medicine (CLM) is a new breed of therapeutics company focused on care pathways, outcomes and the provision of dynamic personalised regimens. The company combines proven drugs with proprietary digital therapeutics enabling the digitisation and data capture of an entire care continuum. CLM has a pipeline of regimes in development that integrate Digital + Drug + Device for the treatment of some of the biggest challenges facing 21st century health systems - sleep disorders, hypertension, chronic pain and diabetes.

Closed Loop Medicine (CLM) is a new breed of therapeutics company focused on care pathways, outcomes and the provision of dynamic personalised regimens. The company combines proven drugs with proprietary digital therapeutics enabling the digitisation and data capture of an entire care continuum. CLM has a pipeline of regimes in development that integrate Digital + Drug + Device for the treatment of some of the biggest challenges facing 21st century health systems - sleep disorders, hypertension, chronic pain and diabetes.

Welldoc’s comprehensive chronic care platform provides multi-condition support across diabetes, hypertension, and heart failure with integrated behavioral health support. Wellness, nutrition counseling, and lifestyle management are all core to our solution. Welldoc’s flagship product, BlueStar®*, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team.

Our platform includes:

• An artificial intelligence (AI) driven digital coaching app providing personalized, actionable guidance throughout an individual's chronic care journey
• Integrated behavioral health support that educates individuals through their behavioral patterns to design a personalized strategy and action plan
• Reporting and workflow integration enables care teams to easily access data insights to inform clinical interventions and decisions
• A Management Portal providing care management with enhanced population-level health data and analysis

Our approach addresses combinations of cardiometabolic conditions and comorbidities, all intended to bring more timely, personalized, meaningful digital engagement and health support.

The ways in which the Welldoc platform supports:

Diabetes

• For use by individuals with Type 1 or Type 2 Diabetes
• Delivers Real-time coaching and medication management
• Includes educational content from Association of Diabetes Care and Education Specialists (ADCES)
• Supports insulin management for individuals and their care teams
• Encourages healthy eating within the individual’s target carb range through coaching, meal planning, and other features
• Integrates hypertension and weight management

Hypertension

• Provides in-app content based on American Heart Association (AHA) guidelines
• Assists with medication adherence by setting reminders
• Connects with Bluetooth blood pressure cuffs
• Delivers coaching messages with each blood pressure and weight entry
• Incorporates and tracks food that supports the Dietary Approaches to Support Hypertension (DASH) Diet

Diabetes & Hypertension

• Individuals receive coaching and feedback primarily to manage their diabetes, with key messages that also support hypertension

Heart failure

• Supports healthy eating habits related to fluid intake, lower sodium, and managing weight gain and loss
• Provides in-app content based on AHA guidelines
• Tracks and analyzes symptoms related to heart failure
• Tracks changes in weight to identify potential fluid retention
• Provides 24/7 automated coaching for BP, symptoms, and weight

Diabetes & Heart Failure

• Individuals receive coaching and feedback, prioritized for heart failure, with key messages that also support diabetes and hypertension

Pre-Diabetes

• Based on Center for Disease Control and Prevention (CDC) standards to reduce risk of type 2 diabetes
• Calorie counter and food tracking
• Personalized automated insights based on weight, activity, and blood pressure entries
• Integrated coaching provided per CDC program guidelines
• Education and support for weight loss
• Configurable for your needs extending beyond CDC standards

Healthy Lifestyle

• Calorie counter and food tracking
• Personalized automated insights based on weight and activity
• Education and Support for weight loss
• Encourage meals within target calorie range through coaching, meal planning, and other features
• Personalized nutrition guidance coaching with real-time feedback to support progress and better health
• Large, multi-cultural food database providing a diverse selection of option

Welldoc is not intended to replace the care provided by a licensed healthcare professional. Welldoc does not support severe mental health diagnosis. Please see welldoc.com for full indications of use.

*Welldoc Diabetes Rx/OTC is an FDA-cleared medical device (“BlueStar”), intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.

Welldoc’s comprehensive chronic care platform provides multi-condition support across diabetes, pre-diabetes, hypertension, and heart failure with integrated behavioral health support. Wellness, nutrition counseling and lifestyle management are all core to our solution. Welldoc’s flagship product, BlueStar®*, an FDA-cleared digital health solution, guides individuals through the complicated journey of living with diabetes by enabling them to self-manage their care while enhancing connections to their healthcare team.

The Welldoc Platform is integrated in a way that builds upon current chronic care programs rather than duplicating or replacing existing services. Welldoc will provide an overview of their differentiated approach to digital health in chronic care and share their clinical data, demonstrating the opportunity to engage members beyond traditional care, with AI-driven, personalized digital coaching and ultimately drive overall chronic care program quality, efficiencies and value.

Our platform includes:

• An AI-driven digital coaching app providing personalized, actionable guidance throughout an individual's chronic care journey
• Reporting and workflow integration enables care teams to easily access data insights to inform clinical interventions and decisions
• A Management Portal providing care management with enhanced population-level health data and analysis

Welldoc believes that partnership is the pathway to better management of chronic conditions. Digital health solutions do not work in a silo and data and insights should be integrated into care models to support optimized interventions and clinical decisions. The Welldoc platform includes a digital ecosystem that allows for user coaching and support along with remote monitoring and tracking of patients. In addition, the platform includes integrated patient population management tools, dashboards and analytics.

Backed by Evidence and Clinical Rigor

Welldoc’s platform holds 510(k) FDA-Clearances for BlueStar®* to enable more complex diabetes management. In addition, Welldoc has over 60 clinical publications and posters and holds 31 patents for our technology and platform features. Welldoc boasts strong economic and clinical outcomes in randomized, controlled clinical trials and in real-world experience.

Extensive research has shown:

• Average cost savings of $3,048-$3,252/person with Type 2 diabetes, annually [1]
• A 1.2-2.0 point mean A1C reduction in individuals living with type 2 diabetes [2,3]
• 7.4 - 12 mmHg Drop in blood pressure in the first 3 months of use [4]
• Welldoc currently has a Net Promoter Score (NPS), a standard gauge of digital health customer satisfaction of ~70.1. Individuals engage with the app an average of ~30 times per week [5]

Digital Coaching

Welldoc offers 1:1 asynchronous chat capabilities, two-way messaging, and live video meeting capabilities directly through our application. We enable this functionality for use by our clients’ Care Management teams, allowing them to function most efficiently in data-driven interventions that prioritize the members most in need.

Welldoc is a device-agnostic solution. The Welldoc platform connects to over 400 devices and data sources, including CGM, blood glucose meters, scales, blood pressure devices, fitness trackers, pharmacy and clinical laboratory data. Given Welldoc's device-agnostic approach, preferred supplies/consumable products are dictated and provided by the client. Welldoc can configure the app to support device/supply ordering functionality from within the application if so desired. This also prevents any interference with existing formulary strategies.

Integration into care models

Our Welldoc platform can push notifications, alerts, and reports to care team members and providers within their existing workflows with integration into their EMR or care management platform. Welldoc is capable of sending and receiving data to health systems. Integration details are handled at implementation. Welldoc has existing partnerships with Xealth and Redox to support technical integrations in line with your requirements. We will partner with you to develop and execute an integration approach that can seamlessly fit into your care model and support remote patient monitoring and tracking.

Client Success and Engagement Program

Welldoc also offers full client success and engagement support as part of our offerings to support outreach, awareness building, user activation, and overall engagement with our solution. We can work directly with you to build and execute a comprehensive, multi-channel campaign and communications approach in line with your program objectives and criteria. We have created an approach to support every part of the member journey:

• Awareness: Building knowledge of total chronic care programs and the advantage of Welldoc's digital health solution.
• Registration/Activation: Supporting member enrollment activities, onboarding, and application configuration.
• Engagement: Ensuring members know how to make the best use of Welldoc's digital health solution in line with the total chronic care program; Understanding the data and insights that are critical to longer-term lifestyle changes and optimizing their treatment plan with their care teams; driving deeper engagement by recommending additional features within the application.
• Graduation/Disenrollment: We will work with you to determine the triggers for graduation or disenrollment. Given the personalization driven by AI, we typically see members utilize our solution throughout their chronic care journey to support a healthy lifestyle.
• Surveys: Understanding the member experience and receiving feedback at critical points of their journey. We deliver surveys within the app to assess social determinants of health and psychosocial issues, provide resources, and identify pertinent concerns to share with the care team.
• Data Analytics/Program Success: Welldoc is committed to helping clients and partners optimize their programs, and therefore tracks and reports on program success through actionable data and user intelligence.
• Customer Service: Welldoc offers telephone and email customer support to help get users activated and get their devices synced. Users can easily access a live agent via phone M-F; 8 am - 6 pm ET.

*Welldoc Diabetes Rx/OTC is an FDA-cleared medical device (“BlueStar”), intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.

References

[1] IBM Watson Health. Estimating the economic value of a digital therapeutic in type 2 diabetes. Welldoc-sponsored report 2018. Published August 2018.

[2] Tang PY, Duni J, Peeples MM, et al. Complementarity of digital health and peer support: “This Is What’s Coming.” Front Clin Diabetes Health. 2021;2. doi:10.3389/fcdhc.2021.646963

[3] Quinn CC, Sareh PL, Shardell ML, Terrin ML, Barr EA, Gruber-Baldini AL. Mobile Diabetes Intervention for Glycemic Control. Journal of Diabetes Science and Technology. 2014;8(2):362-370. doi:10.1177/1932296813514503

[4] Kumbara A, Iyer A, Shomali M. Blood pressure improvement in people using a digital health solution for comprehensive diabetes self-management. Poster presented at: 16th Annual Cardiometabolic Health Congress; October 14-17, 2021; National Harbor, MD.

[5] Snow K, Iyer Phd A, Shearer D, Peeples M. Interactive Digital Health: Engaging Healthy Behaviors & Clinical Outcomes.; 2020. Poster

Chronic conditions do not happen in silos. The Welldoc platform is built to provide personalized digital health support across cardiometabolic co-morbidities — through one connected chronic care hub — that seamlessly integrates into patients’ lives, existing clinical systems, and workflows based on your business needs. The Welldoc approach has the flexibility to deploy co-branded and white-labeled solutions for a seamless branded experience. If you have existing digital health assets, we offer Single Sign-On (SSO) integration to authenticate from your digital solution into our mobile application. We have also developed Software Development Kit (SDK) and API (Application Programming Interface) capabilities that enable you to build the Welldoc platform features and functionality directly into your digital assets.

Backed by Evidence and Clinical Rigor

Welldoc’s platform holds 510(k) FDA-Clearances for BlueStar®* to enable more complex diabetes management. In addition, Welldoc has over 60 clinical publications and posters and holds 31 patents for our technology and platform features. Welldoc boasts strong economic and clinical outcomes in randomized, controlled clinical trials and in real-world experience.

There are multiple benefits to Welldoc 510 K clearance and regulatory capabilities:

• Efficacy: A class II medical device is often cleared along with clinical data and comes with indications for use, which helps target the use of the SaMD product in the right intended audience and discourages off-label use.
• Device and Ecosystem Interoperability: FDA-clearance is a necessary factor in determining whether products can collect data directly from connected diabetes devices, such as BGM, CGM, and pumps. Real-time access to CGM can only be done between an iCGM (class II) and equivalent class II medical device, like Welldoc’s diabetes product BlueStar. BlueStar can collect data directly.

Welldoc is a device-agnostic solution. The Welldoc platform connects to over 400 devices and data sources, including CGM, blood glucose meters, scales, blood pressure devices, fitness trackers, pharmacy and clinical laboratory data. Given Welldoc's device-agnostic approach, preferred supplies/consumable products are dictated and provided by the client. Welldoc can configure the app to support device/supply ordering functionality from within the application if so desired. This also prevents any interference with existing formulary strategies.

As we determine new functionality to support the management of complex chronic conditions, we continue to work with the FDA to determine the pathway for new clearance requirements across our platform.

*Welldoc Diabetes Rx/OTC is an FDA-cleared medical device (“BlueStar”), intended for use by healthcare providers and their adult patients with type 1 or type 2 diabetes. For full labeling information, visit www.welldoc.com. The other Welldoc products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.