A Guideline-Based Decision Tree Achieves Better Glucose Control with Less Hypoglycemia at 3 Months in Chinese Diabetic Patients

Yingying Luo, Hong Wu, Xiyang Liao, Tingting Zhao, Nan Cui, Aihua Li, Xingzhi Sun, Puhong Zhang, Yahua Huang, Xia Zhang, Huiqiu Yin, Linong Ji, Yingying Luo, Hong Wu, Xiyang Liao, Tingting Zhao, Nan Cui, Aihua Li, Xingzhi Sun, Puhong Zhang, Yahua Huang, Xia Zhang, Huiqiu Yin, Linong Ji

Abstract

Introduction: China has the world's largest diabetes epidemic and has been facing a serious shortage of primary care providers for chronic diseases including diabetes. To help primary care physicians follow guidelines and mitigate the workload in primary care communities in China, we developed a guideline-based decision tree. This study aimed to validate it at 3 months with real-world data.

Methods: The decision tree was developed based on the 2017 Chinese Type 2 Diabetes (T2DM) guideline and 2018 guideline for primary care. It was validated with the data from two registry studies: the NEW2D and ORBIT studies. Patients' data were divided into two groups: the compliance and non-compliance group, depending on whether the physician's prescription was consistent with the decision tree or not. The primary outcome was the difference of change in HbA1c from baseline to 3 months between the two groups. The secondary outcomes included the difference in the proportion of patients achieving HbA1c < 7% at 3 months between the two groups, the incidence of self-reported hypoglycemia at 3 months, and the proportion of patients (baseline HbA1c ≥ 7%) with a HbA1c reduction ≥ 0.3%. The statistical analysis was performed using linear or logistic regression with inverse probability of treatment weighting with adjustments of confounding factors.

Results: There was a 0.9% reduction of HbA1c in the compliance group and a 0.8% reduction in the non-compliance group (P < 0.001); 61.1% of the participants in the compliance group and 44.3% of the participants in the non-compliance group achieved a HbA1c level < 7% at 3 months (P < 0.001). The hypoglycemic events occurred in 7.1% of patients in the compliance group vs. 9.4% in the non-compliance group (P < 0.001).

Conclusion: The decision tree can help physicians to treat their patients so that they achieve their glycemic targets with fewer hypoglycemic risks. ( http://www.clinicaltrials.gov NCT01525693 & NCT01859598).

Keywords: Decision tree; Diabetes; Glucose control; Guideline; Hypoglycemia.

Figures

Fig. 1
Fig. 1
Patient dispositions in the cohort 1 and cohort 2 datasets. ORBIT Observational Registry of Basal Insulin Treatment study, NEW2D Newly Diagnosed Type 2 Diabetes study, Pts patients, HbA1c glycosylated hemoglobin A1c, Hypo hypoglycemia
Fig. 2
Fig. 2
Patient disposition of the holistic cohort dataset. ORBIT Observational Registry of the Basal Insulin Treatment study, NEW2D Newly Diagnosed Type 2 Diabetes study, Pts patients, HbA1c glycosylated hemoglobin A1c, Hypo hypoglycemia

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