Abstract
Objective
To derive the health utility scores of type 2 diabetes (T2D) patients using basal insulin (BI) with diverse characteristics in China.
Methods
The study used the data of insulin-using T2D patients on BI treatment enrolled in the BEYOND II study, which is a multi-center, observational study from 78 hospitals nationwide. The 3-level EQ-5D (EQ-5D-3L) questionnaire was administered to each patient to derive their health utility scores using the EQ-5D-3L value set for China. Patients’ clinical and sociodemographic information were retrieved from their electronic case report form (eCRF). Ordinary least-square models with different specifications were explored to identify the best-fitting model to predict the utility scores.
Results
The sample (n = 12,583) achieved a mean (standard deviation) EQ-5D-3L utility score of 0.936 (0.120). According to the model, a Chinese male who was younger than 59 years, not underweight, diagnosed with T2D shorter than 10 years, with controlled plasma glucose and free of diabetes complications/comorbidities, would have a mean utility of 0.993. Being female, older age, underweight, and higher plasma glucose, longer diabetes duration was negatively related to EQ-5D-3L scores. Comorbidities and seven of eleven complications were associated with utility decrement. Interactions between some complications were also discovered.
Conclusions
The derived health utility scores for diabetes complications could facilitate the assessment of the cost-effectiveness of health interventions for Chinese insulin-using T2D patients.
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Acknowledgments
The authors would like to thank Prof. Chen Wen from School of Public Health, Fudan University for facilitating the study
Funding
This study is supported by Sanofi China.
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Chaoyun Li and Pei Wang designed the study and analyzed the data. Pei Wang drafted the manuscript. All authors reviewed and approved to publish the final version.
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Chaoyun Li is an employee of Sanofi China; Pei Wang has received the research grant from Sanofi China.
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All procedures performed in studies involving human participants were in accordance with the ethical standards of the the Clinical Trial Ethics Committee of the Third Ailiated Hospital, Sun Yat-sen University (Reference Number [2015] 2–152 on 21 July 2015) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards.
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Informed consent was obtained from all participants at the time of data collection.
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Qualified researchers may request access to patient-level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient-level data will be anonymized, and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi’s data-sharing criteria, eligible studies, and process for requesting access can be found at: ‘https://www.clinicalstudydatarequest.com.’
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Li, C., Zhou, H. & Wang, P. Health utility of type 2 diabetes patients using basal insulin in China: results from the BEYOND II study. Acta Diabetol 58, 329–339 (2021). https://doi.org/10.1007/s00592-020-01618-1
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DOI: https://doi.org/10.1007/s00592-020-01618-1