Supporting self-management of kidney health in diabetic patients via a novel digital health intervention: A single-arm, pre-post trial

 

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Supporting self-management of kidney health in diabetic patients via a novel digital health intervention: A single-arm, pre-post trial

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Jingyi
Wu
Jingyi Wu joywu@pku.edu.cn Peking University School of Nursing Beijing China * Peking University Advanced Institute of Information Technology Hangzhou China
Chenghua Guo 1610122718@pku.edu.cn Peking University Advanced Institute of Information Technology Hangzhou China -
Hong’an Pan hongan6668@dingtalk.com Peking University Advanced Institute of Information Technology Hangzhou China -
Jinwei Wang gslzwjw@163.com Peking University First Hospital; Peking University Institute of Nephrology Renal Division, Department of Medicine Beijing China -
Pengfei Li pfli@bjmu.edu.cn Peking University School of Nursing Beijing China - Peking University Advanced Institute of Information Technology Hangzhou China Peking University National Institute of Health Data Science Beijing China
Luxia Zhang zhanglx@bjmu.edu.cn Peking University Advanced Institute of Information Technology Hangzhou China - Peking University First Hospital; Peking University Institute of Nephrology Renal Division, Department of Medicine Beijing China Peking University National Institute of Health Data Science Beijing China
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Diabetes has become the leading cause of chronic kidney disease in China, with 20-50% of diabetics developing diabetic kidney disease (DKD). Preventing and managing kidney disease is crucial for diabetic patients, but it often goes undetected due to a lack of early symptoms and low awareness (~10% in China). Urine albumin-to-creatinine ratio (UACR) is an effective early indicator of kidney damage. We developed a digital health intervention (DHI) based on computer-vision algorithms, the UACR point-of-care testing kit (UPT), for self-monitoring of kidney health. UPT has been validated to be highly accurate and sensitive in albuminuria screening with a C-statistic of 0.962, and can be a promising cost-effective strategy for kidney health management in the large-scale Chinese diabetic populationsWe aimed to evaluate the efficacy of the UPT-based digital intervention in kidney health management for diabetic patients.

We conducted a prospective, multicenter clinical trial with a pre-post design for a single-arm of patients. Between August 2023 and June 2024, we have recruited over 4,233 diabetic patientsregistered in the local electronic health records (EHR) system and without kidney failurefrom 66 hospitals across Yinzhou district, Ningbo city in China. Of these, 2,714 completed one-year intervention. Participants underwent one year of UACR home-monitoring and online health education via UPT at a frequency recommended by KDIGO. The healthcare seeking rates during the one-year intervention period were compared to those during the one-year pre-enrollment control period. The primary outcome was UACR testing rate in hospitals, and the secondary outcome was outpatient visiting rate. Both outcomes were extracted from the Yinzhou EHR system. The sample size is calculated based on an assumed odds ratio of 1.1 for the primary outcome. A Poisson mixed-effect regression model was utilized to estimate the intervention effect on healthcare seeking behaviors of diabetic patients.Trial registration: Chinese Clinical Trial Registry, ChiCTR2300075019.

Figure 1. Diagram of the single-arm, pre-post trial design.

The participants had a mean age of 67.9±8.2 years, and 42.6% were males. Compared with the control period, the intervention period saw higher mean annual hospital UACR tests (0.227±0.761 vs 0.197±0.683) and outpatient visits (16.2±20.5 vs 15.6±19.2). The mixed effect model suggested that the UPT-based digital intervention significantly increased healthcare seeking rates of diabetic patients, with odds ratios of 1.15 (95% confidence interval [CI] 1.03, 1.29) for UACR testing and 1.04 (95% CI 1.02, 1.05) for outpatient visits.

The UPT-based DHI significantly improved healthcare-seeking behaviors among diabetic patients, supporting its potential for enhancing kidney health self-management. Randomized controlled trials are warranted to confirm these benefits.

Kewords