Hyunji Sang, Sunyoung Kim, Jiyoung Hwang, Selin Woo, Yerin Hwang, Jaewon Kim, Seohei Lee, Dong Keon Yon, Sang Youl Rhee
Abstract
Diabetes, obesity, and dyslipidemia are significant contributors to cardiovascular diseases, necessitating effective strategies to manage blood glucose, blood pressure, and lipid levels through lifestyle interventions and pharmacotherapy. This study aims to assess the glycemic control and metabolic health outcomes achieved over 24 weeks with the use of the “WellCheck” digital healthcare application in patients diagnosed with type 2 diabetes mellitus (T2D) within real-world primary care settings.
Introduction
Diabetes, obesity, and dyslipidemia are significant metabolic disorders and key risk factors associated with cardiovascular diseases such as heart attack, stroke, and hypertension. According to the International Diabetes Federation (IDF), the global diabetic population has increased from 425 million in 2017 to 463 million in 2019 [1,2], with projections suggesting an explosive increase of over 783 million by 2045 [3].
Materials and methods
Study design
We designed this clinical trial as a primary care-based, prospective, multicenter, cluster-randomized, pragmatic trial to evaluate the effectiveness of the “WellCheck” application in improving glycemic control, blood pressure, and weight over 24 weeks among patients with T2D in the real-world setting of primary care practices.
Discussion
This study leverages a primary care-based, prospective, multicenter, cluster-randomized, pragmatic trial design to offer a comprehensive and real-world evaluation of the effectiveness of the “WellCheck” digital healthcare application in managing T2D. Cutting-edge treatment options, specifically Envlo and Envlomet tablets allow for a targeted investigation of their glycemic lowering and metabolic efficacy.
Conclusion
In conclusion, this primary care-based, prospective, multicenter, cluster-randomized pragmatic trial evaluating the “WellCheck” digital healthcare application holds significant clinical utility and value in the management of type 2 diabetes. When validated, the findings of this study will contribute to the evidence base on the use of digital healthcare applications, potentially validating WellCheck as a valuable tool for improving glycemic control, reducing cardiovascular risk factors, and enhancing overall metabolic health in patients with type 2 diabetes.
Acknowledgments
We would like to express our sincere gratitude to the representatives of Daewoong Pharmaceutical Co., Ltd., Seoul, Korea, for their invaluable assistance in developing the study protocol.
Citation: Sang H, Kim S, Hwang J, Woo S, Hwang Y, Kim J, et al. (2025) Impact of the WellCheck smartphone app linked to electronic health records on clinical outcomes in patients with type 2 diabetes: Study protocol for primary care-based, prospective, multicenter, cluster-randomized, pragmatic clinical trials. PLoS One 20(8): e0329003. https://doi.org/10.1371/journal.pone.0329003
Editor: Hidetaka Hamasaki, Japanese Academy of Health and Practice, JAPAN
Received: December 17, 2024; Accepted: July 8, 2025; Published: August 7, 2025
Copyright: © 2025 Sang et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: This article does not report data, and the data availability policy is not applicable to it. Deidentified research data will be made publicly available when the study is completed and published.
Funding: This work was supported by grants from Daewoong Pharmaceutical Co., Ltd. and Mcircle Corp. (KHU-20222720) awarded to S.Y.R., and by the Starting Growth Technological R&D Program (TIPS Program, No. RS-2023-00303873) awarded to S.Y.R., funded by the Ministry of SMEs and Startups (MSS, Korea) in 2023. The funders had no role in the study design, data collection and analysis, decision to publish, or manuscript preparation.
Competing interests: The authors have declared that no competing interests exist. There are no employment, consultancy, patents, products in development, or marketed products associated with this research to declare. This does not alter our adherence to PLOS ONE policies on sharing data and materials.
