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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.

ABSTRACT: 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.

SUBMITTER: Han K

PROVIDER: S-EPMC6203120 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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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.

Han Kyungdo K Yun Jae-Seung JS Park Yong-Moon YM Ahn Yu-Bae YB Cho Jae-Hyoung JH Cha Seon-Ah SA Ko Seung-Hyun SH

Clinical epidemiology 20181023

<h4>Purpose</h4>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.<h4>Patients and methods</h4>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 u ...[more]

PMID: 30425585

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Project description:BackgroundWe investigated the association regarding severe hypoglycemia episodes with cardiovascular disease risk and all-cause mortality in patients with type 2 diabetes.MethodsBaseline and follow-up data (n = 1,568,097) from patients with type 2 diabetes were retrieved from the National Health Insurance System database (covering the entire Korean population). Type 2 diabetes, severe hypoglycemia, and major comorbidities were identified using International Classification of Diseases 10 codes and medication information. Individuals who were classified as type 2 diabetes in the year of 2009 were screened, and we counted severe hypoglycemia episodes from 2007 to 2009. The primary outcome was newly developed myocardial infarction (MI), stroke, heart failure, or all-cause mortality. Participants were followed from the baseline index date to the date of death or until December 31, 2015.ResultsIn total, 19,660 (1.2%) patients developed at least one severe hypoglycemia event during the period from 2007 to 2009. Mean follow-up was 5.7 years. After adjustment for confounding factors, the hazard ratio (HR) of MI significantly and sequentially increased: 0 vs. 1 episode, HR 1.56, 95% CI 1.46-1.64; 0 vs. 2 episodes, HR 1.86, 95% CI 1.61-2.15; 0 vs. 3 or more episodes, HR 1.86, 95% CI 1.48-2.35, P for trend < 0.001. Similar findings were noted regarding the relationship of severe hypoglycemia episodes with stroke, heart failure, and all-cause mortality. Risks for all outcomes were highest within 1 year from the index date and showed decreasing trends with follow-up. Sensitivity analyses of the data from the subgroup population and 797,544 subjects who received a national health examination did not change the significance of the main findings.ConclusionAmong adult Korean patients with type 2 diabetes, a severe hypoglycemia episode is associated with increased risk for cardiovascular outcomes and all-cause mortality. Significant results from dose-response, temporal, and sensitivity analyses may suggest the possibility of direct causality between severe hypoglycemia and cardiovascular outcomes and mortality.

Project description:This study investigated trends in the prescription of antidiabetic medications for patients with type 2 diabetes, focusing on changing patterns of prescriptions and the cost of drugs during the last 10 years. Retrospective data on patients with type 2 diabetes aged 30 years or older were analyzed using information from the National Health Information Database collected by the National Health Insurance Service in Korea from January 2002 to December 2013. We identified patients with type 2 diabetes who had at least one service claim in each year during the study period. The prescribing information was collected and fixed-dose combination tablets were counted as each of their constituent classes. The total number of adults with type 2 diabetes who were treated using antidiabetic agents increased from 0.87 million in 2002 to 2.72 million in 2013 in Korea. Among antidiabetic medications in 2002, sulfonylurea (SU) was the most commonly used agent (87.2%), and metformin was the second (52.9%). However, in 2013, the use of metformin increased to 80.4% of the total antidiabetic prescriptions. The use of dipeptidyl peptidase-4 (DPP-4) inhibitor increased remarkably after release in late 2008 and composed one-third of the market share with 1 million prescriptions (38.4%) in 2013. Among the prescriptions for monotherapy, only 13.0% were metformin in 2002, but the amount increased to 53.2% by 2013. In contrast, the use of SU declined dramatically from 75.2% in 2002 to 30.6% in 2013. Dual and triple combinations steadily increased from 35.0% and 6.6% in 2002 to 44.9% and 15.5% in 2013, respectively. In 2013, SU with metformin (41.7%) and metformin with DPP-4 inhibitor (32.5%) combination were most frequently prescribed. The total antidiabetic medication cost increased explosively from U.S. $70 million (82.5 billion won) in 2002 to U.S. $4 billion (480 billion won) in 2013.The use of antidiabetic agents and their costs have been increasing steadily. Metformin is the most commonly used drug recently. The use of DPP-4 inhibitor increased significantly over the past decade, whereas the use of SU decreased. However, SUs still remain the most commonly prescribed second-line agents with metformin in 2013.

Project description:ImportanceIntensive glucose-lowering treatment among patients with non-insulin-requiring type 2 diabetes may increase the risk of hypoglycemia.ObjectivesTo estimate the prevalence of intensive treatment and the association between intensive treatment, clinical complexity, and incidence of severe hypoglycemia among adults with type 2 diabetes who are not using insulin.Design, setting, and participantsRetrospective analysis of administrative, pharmacy, and laboratory data from the OptumLabs Data Warehouse from January 1, 2001, through December 31, 2013. The study included nonpregnant adults 18 years or older with type 2 diabetes who achieved and maintained a hemoglobin A1c (HbA1c) level less than 7.0% without use of insulin and had no episodes of severe hypoglycemia or hyperglycemia in the prior 12 months.Main outcomes and measuresRisk-adjusted probability of intensive treatment and incident severe hypoglycemia, stratified by patient clinical complexity. Intensive treatment was defined as use of more glucose-lowering medications than recommended by practice guidelines at specific index HbA1c levels. Severe hypoglycemia was ascertained by ambulatory, emergency department, and hospital claims for hypoglycemia during the 2 years after the index HbA1c test. Patients were categorized as having high vs low clinical complexity if they were 75 years or older, had dementia or end-stage renal disease, or had 3 or more serious chronic conditions.ResultsOf 31 542 eligible patients (median age, 58 years; interquartile range, 51-65 years; 15 483 women [49.1%]; 18 188 white [57.7%]), 3910 (12.4%) had clinical complexity. The risk-adjusted probability of intensive treatment was 25.7% (95% CI, 25.1%-26.2%) in patients with low clinical complexity and 20.8% (95% CI, 19.4%-22.2%) in patients with high clinical complexity. In patients with low clinical complexity, the risk-adjusted probability of severe hypoglycemia during the subsequent 2 years was 1.02% (95% CI, 0.87%-1.17%) with standard treatment and 1.30% (95% CI, 0.98%-1.62%) with intensive treatment (absolute difference, 0.28%; 95% CI, -0.10% to 0.66%). In patients with high clinical complexity, intensive treatment significantly increased the risk-adjusted probability of severe hypoglycemia from 1.74% (95% CI, 1.28%-2.20%) with standard treatment to 3.04% (95% CI, 1.91%-4.18%) with intensive treatment (absolute difference, 1.30%; 95% CI, 0.10%-2.50%).Conclusions and relevanceMore than 20% of patients with type 2 diabetes received intensive treatment that may be unnecessary. Among patients with high clinical complexity, intensive treatment nearly doubles the risk of severe hypoglycemia.

Dataset Information

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

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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.

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