Type 1 and 2 Diabetes*, Pre-Diabetes, Hypertension, Heart Failure, Weight & Obesity Management, with integrated mental wellbeing and sleep support
How it works:
The Welldoc Platform includes:
*Welldoc® Diabetes and Welldoc Diabetes Rx is an FDA-cleared medical device, 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 App products are non-FDA-cleared and intended to promote general wellness and education/self-management of various chronic disease states.
Welldoc’s comprehensive digital health platform provides cardiometabolic condition digital coaching across pre-diabetes, diabetes, hypertension, heart failure, weight and obesity management, with integrated mental wellbeing and sleep support.
Target patient population:
The Welldoc App is intended for individuals 18 years and older:
• T1 and T2 Diabetes
• Heart failure
• Weight and obesity management
And support for:
Welldoc has achieved 11 510(k) clearances for diabetes functionality within its digital health platform, and an IP portfolio of 42 patents for its advanced AI and first-in-class tech. With over 75 clinical publications, Welldoc has built an extensive library of clinical research focused on the value of AI-powered digital health solutions.
The Welldoc® App includes Welldoc Diabetes and Welldoc Diabetes Rx, which is Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Welldoc Diabetes and Welldoc Diabetes Rx are intended to assist patients in managing their diabetes with guidance from their providers. Welldoc Diabetes Rx requires a prescription.
Indications for use:
The Welldoc® App combines the FDA cleared medical device functionality of Welldoc Diabetes and Welldoc Diabetes Rx with other non-FDA cleared wellness and educational/self-management products. Welldoc Diabetes is indicated for use by healthcare providers (HCPs) and their patients – aged 18 years and older – who have type 1 or type 2 diabetes. Welldoc Diabetes is intended to provide secure capture, storage, and transmission of blood glucose data as well as information to aid in diabetes self-management. Welldoc Diabetes analyzes and reports blood glucose test results and supports medication adherence. In addition, Welldoc Diabetes provides coaching messages (motivational, behavioral, and educational) based on real-time blood glucose values and trends. It includes software intended for use on mobile phones or personal computers in the home or in professional healthcare settings. The software also allows for entry of other diabetes-related healthcare information and provides educational information.
Welldoc Diabetes Rx adds the following prescription use only insulin management features:
*Insulin Dose Calculator may also be referred to as Insulin Calculator
Other Welldoc® App Non-Diabetes Functions:
Hypertension, Heart Failure, Behavioral Health, Prediabetes
The other disease state-focused products in the Welldoc App are non-FDA-cleared wellness and educational/self-management products and DO NOT interact with Welldoc Diabetes or Welldoc Diabetes Rx functions. They are intended to help people with hypertension, heart failure, or mild mental health conditions better manage and live well. Visit www.welldoc.com for full labeling information.
The Welldoc App is not indicated for people with gestational diabetes or who use an insulin pump. For more information, call Customer Care at 1-888-327-5345.
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.
Place in therapy:
Complementary to current therapies including pharmacologic-related, diet-related, exercise-related, or knowledge-related therapy pathways.
The Welldoc Platform includes:
Welldoc Diabetes is available over the counter (OTC) and does not require a prescription. However, Welldoc Diabetes Rx requires a prescription for additional insulin management support.
Individuals can download the Welldoc App via the App Store or Google Play Store. A program ID is provided by their health plan, health system, or employer to register for the app.
Use of this product requires access to:
The Welldoc App creates Health Reports that can be shared by the patient and/or the Welldoc Care Management Portal, enabling secure access to an individual’s data and insights to support care team workflows and population health management.
The Welldoc Platform can be paid for by health plans, health systems, or employers.
The Welldoc App is available in:
Welldoc’s digital first approach uses AI-driven algorithms to provide immediate, tailored and relevant coaching to individuals when they’re making decisions about their health. The Welldoc App empowers individuals with personalized, evidenced-based feedback to help them successfully self-manage their health condition while enhancing connections to their healthcare team.
The provided set of evidence represents a sample of conducted studies. For more research, please visit https://www.welldoc.com/clinical-research/
1 Quinn, C.C. Shardell, M.D. Terrin, M.L. Barr, E.A. Ballew, S.H. Gruber-Baldini, A.L. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control. Diabetes Care. 2011 Sep;34(9):1934-42. Erratum in: Diabetes Care. 2013 Nov;36(11):3850.
2 Kumbara A, Iyer A, Leone K, Shomali M. Evaluating the Impact of a Combined Real-Time CGM/Digital Health Solution on Glucose Control for People with Type 2 Diabetes. Poster presented at: ATTD Conference Advanced Technologies & Treatments for Diabetes, Barcelona & Online, 2022.
3 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.
4 Welldoc Data on File. Subset of multiple Welldoc programs (n = 106 who paired with weight scales/data). 68% of 106 experienced an average of 6% weight loss over a duration of 6 months. Results may vary based on Welldoc App adherence.
5 IBM Watson Health. Estimating the economic value of a digital therapeutic in type 2 diabetes. Welldoc-sponsored report 2018. Published August 2018.
6 Welldoc Data on File. Results may vary based on Welldoc App adherence.