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Development and validation of a risk prediction model for severe hypoglycemia in adult patients with type 2 diabetes: a nationwide population-based cohort study

Authors Han K, Yun JS, Park YM, Ahn YB, Cho JH, Cha SA, Ko SH

Received 31 March 2018

Accepted for publication 26 July 2018

Published 23 October 2018 Volume 2018:10 Pages 1545—1559

DOI https://doi.org/10.2147/CLEP.S169835

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Cristina Weinberg

Peer reviewer comments 5

Editor who approved publication: Professor Irene Petersen


Kyungdo Han,1,* Jae-Seung Yun,2,* Yong-Moon Park,3 Yu-Bae Ahn,2 Jae-Hyoung Cho,2 Seon-Ah Cha,2 Seung-Hyun Ko2

1Department of Biostatistics, The Catholic University of Korea, Seoul, Republic of Korea; 2Division of Endocrinology and Metabolism, Department of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea; 3Epidemiology Branch, National Institute of Environmental Health Sciences, National Institutes of Health, Research Triangle Park, NC, USA

*These authors contributed equally to this work

Purpose: There is a scarcity of long-term prediction models for severe hypoglycemia (SH) in subjects with type 2 diabetes mellitus (T2DM). In this study, a model was developed and validated to predict the risk of SH in adult patients with T2DM.
Patients and methods: Baseline and follow-up data from patients with T2DM who received health evaluations from January 1, 2009, to December 31, 2010 (n=1,676,885) were analyzed as development (n=1,173,820) and validation (n=503,065) cohorts using the National Health Insurance Database (DB) in Korea. New SH episodes were identified using ICD-10 codes. A Cox proportional hazards regression model and Cox model coefficients were used to derive a risk scoring system, and 14 predictive variables were selected. A risk score nomogram based on the risk prediction model was created to estimate the 1-year risk of SH.
Results: In the development cohort, a total of 5,325 (0.45%) patients experienced SH episodes during the follow-up period. After multivariable adjustment, older age, female sex, current smoker, drinking, low body mass index, lack of exercise, previous SH events, insulin or multiple oral hypoglycemic agent use, presence of hypertension or chronic kidney disease, longer duration of diabetes, low or high glucose level, and high Charlson Comorbidity Index score were found to be significant risk factors for the development of SH and were incorporated into the risk model. The concordance indices were 0.871 (95% confidence interval, 0.863–0.881) in development cohort and 0.866 (95% CI, 0.856–0.879) in the validation cohort. The calibration plot showed a nearly 45° line, which indicates that this model predicts well an absolute SH event.
Conclusion:
This 14-variable prediction model for SH events may be a useful tool to identify high-risk patients and guide prevention of SH in adult patients with T2DM.

Keywords: type 2 diabetes, severe hypoglycemia, risk model, risk prediction

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