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Abstract
Objectives Highly efficient diabetes management programs are needed for tackling diabetes in China. This study aimed to assess the effectiveness of a clinic-based intensified diabetes management model (C-IDM) in Mainland China.
Research design and methods A 2-year clinic-based randomized controlled trial was conducted among patients with type 2 diabetes in Nanjing, China. The C-IDM intervention components comprised four domains (disease targeting management, express referral channel, expert visit, patients’ self-management) and an integrated running system (disease control centers, general hospitals and local clinics). Control group participants received their usual care, while intervention participants received both the C-IDM package and the usual services. The primary outcome variable was change of hemoglobin A1c (HbA1c). Mixed-effects models were used to compute effect estimates and 95% CI with consideration of both individual and cluster-level confounders.
Results Overall, 1095 of 1143 participants were assessed at study completion. The mean change in HbA1c was significantly greater in the intervention group than in the control group (mean difference (MD)=−0.57, 95% CI −0.79 to –0.36). Similar results were observed for change in body mass index (MD=−0.29, 95% CI −0.49 to –0.10). Participants in the intervention group were more likely to achieve normal HbA1c and body weight compared with their counterparts in control group after adjusting for potentially confounding variables (adjusted OR=1.94, 95% CI 1.35 to 2.81 and 1.79, 95% CI 1.13 to 2.85, respectively).
Conclusions The C-IDM model is feasible and effective in large-scale management of patients with type 2 diabetes in China. It has public health implications for tackling the burden of diabetes in China.
Trial registration number ChiCTR-IOR-15006019.
- clinic-based
- diabetes care
- intervention
- management model
- China
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Footnotes
YX and FX are joint senior authors.
QL, QY and HW contributed equally.
Contributors Conceived, designed and directed the study: YX and FX. Performed the experiments: QL, QY, HW, ZW, YX and FX. Analyzed the data: QY, ZW and FX. Wrote the article: QL, QY, HW, ZW, YX and FX. Critical revision of the manuscript: QL, QY, HW, ZW, RSW, YX and FX.
Funding This work was jointly supported by Jiangsu Provincial Science and Technology Foundation (BR2015073), Jiangsu Province Association of Science and Technology Foundation (JSKXKT2018), Nanjing Municipal Science and Technique Foundation (201503054), and Nanjing Medical Science and Technique Development Foundation (QRX17199).
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The C-IDM trial was reviewed and approved by the academic and ethics committee of Geriatric Hospital of Nanjing Medical University and was registered with the Chinese Clinical Trial Registry. The data were analyzed without any personal identification.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request to FX.