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Minyuan Chen,1,&ast; Puhong Zhang,1,2,&ast; Yang Zhao,1,3 Nadila Duolikun,1 Linong Ji4 1The George Institute for Global Health, China, Beijing, 100600, People’s Republic of China; 2The George Institute for Global Health, Faculty of Medicine, University of New South Wales, Sydney, NSW, 2050, Australia; 3WHO Collaborating Centre on Implementation Research for Prevention and Control of Noncommunicable Diseases, Melbourne, VIC, Australia; 4Department of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Puhong Zhang, Diabetes Research Program, The George Institute for Global Health, China, Room 052A, Unit 1, Tayuan Diplomatic Office Building No. 14 Liangmahe Nan Lu, Chaoyang District, Beijing, 100600, People’s Republic of China, Tel/Fax +86 10 8280 0177, Email zpuhong@georgeinstitute.org.cn Linong Ji, Department of Endocrinology and Metabolism, Peking University People’s Hospital, No. 11, Xizhimen Nan Da Jie, Xicheng District, Beijing, 100044, People’s Republic of China, Tel +86 10 88325578, Fax +86 10 68358517, Email jiln@bjmu.edu.cnBackground: This study aims to compare the effectiveness of initiating insulin therapy in inpatient and outpatient settings during a 6-month follow-up period among patients with type 2 diabetes mellitus (T2DM) in real-world settings.Materials and Methods: The study was based on the ORBIT study, a real-world observational study which recruited patients with inadequate glycemic control by oral antidiabetic drugs (OAD) and initiated basal insulin (BI). We compare difference in initiation and evolution of insulin therapy and glycemic control after six months were compared between patients initiating basal insulin in the inpatient department (inpatient initiators) and those starting in outpatient (outpatient initiators) among participants without rehospitalization during the six months follow-up.Results: Among all 18,995 participants in the ORBIT study, 56.0% were inpatient initiators and 44.0% outpatient. We conducted in-depth analysis among 14,860 patients without rehospitalization, 8129 inpatient initiators and 6731 outpatient initiators. (1) Inpatient initiators had lower insulin therapy persistence during six months (64.2%) than outpatient ones (78.6%) (p< 0.001), which was mainly explained by more therapy switches from basal-bolus regimen to other therapies among inpatient initiators (50.1%) than that among outpatient initiators (37.5%) (p< 0.001). (2) Inpatient initiation had a higher proportion of people achieving glucose targets (HbA1c < 7%) than outpatient initiation. However, the benefit of inpatient initiation versus outpatient initiation was mainly observed among patients persisting with the initial insulin therapies (46.3% vs 39.5% p< 0.001), rather than those nonpersistent (37.3% vs 36.2%, p=0.723). (3) Among patients with HbA1c < 9%, taking only one OAD and without complications at baseline, inpatient insulin initiation did not show a higher proportion of people achieving glucose target than outpatient initiation (adjusted odds ratio=0.96, 95% CI: 0.76– 1.21).Conclusion: For patients with HbA1c ≥ 9%, who were taking more than one OAD and had complications at baseline, initiating insulin treatment during hospitalization has a higher proportion of people achieving glucose target than that in the outpatient department, but the premise is that the initial therapy is acceptable and can be maintained after discharge. Patient-centered approach with co-agreed decision-making to select a suitable insulin regimen should be strengthened.Keywords: type 2 diabetes mellitus, T2DM, basal insulin, BI, hospitalization, outpatient, glycemic control

BackgroundAs the management of type 2 diabetes remains suboptimal in primary care, the Road to Hierarchical Diabetes Management at Primary Care (ROADMAP) study was designed and conducted in diverse primary care settings to test the effectiveness of a three-tiered diabetes management model of care in China. ObjectiveThis paper aims to predetermine the detailed analytical methods for the ROADMAP study before the database lock to reduce potential bias and facilitate transparent analyses. MethodsThe ROADMAP study adopts a community-based, cluster randomized controlled trial design that compares the effectiveness of a tiered diabetes management model on diabetes control with usual care among patients with diabetes over a 1-year study period. The primary outcome is the control rate of glycated hemoglobin (HbA1c)