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Validated tool screens 12-month risk for severe hypoglycemia
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Researchers have developed a validated hypoglycemia risk stratification tool based on a review of electronic medical records that can assist in characterizing the 12-month risk for hypoglycemia-related ED or hospital utilization, according to findings published in JAMA Internal Medicine.
Andrew J. Karter, PhD, of the division of research at Kaiser Permanente Northern California, and colleagues noted that hypoglycemia is now one of the most frequent adverse events in patients with type 2 diabetes, occurring more frequently than acute hyperglycemic events, particularly in older adults and those with a longer disease duration.
“One in four emergency hospitalizations for adverse drug events is related to hypoglycemia, and these rates are higher in older patients,” Karter and colleagues wrote. “Whereas interventions to prevent hypoglycemia exist, there are no validated methods to target these interventions efficiently. Accordingly, we developed and validated a hypoglycemia risk stratification tool to categorize 12-month risk of hypoglycemia-related ED or hospital use among patients with [type 2 diabetes].”
The researchers analyzed EMRs of 206,435 patients with type 2 diabetes in the Kaiser Permanente Northern California system, randomly splitting the cohort into an 80% derivation sample (n = 165,148) for tool development and a 20% internal validation sample (n = 41,287). The researchers applied similar criteria in the creation of two external validation samples of patients with type 2 diabetes from the VA Diabetes Epidemiology Cohort (n = 1,335,966) and the Group Health Cooperative (n = 14,972). Researchers used recursive partitioning in the derivation samples to create a risk classification tree, and selected 156 clinical, demographic and behavioral predictor variables for model development based on a literature review. Primary outcome was the occurrence of any hypoglycemia-related ED or hospital use in the 12 months after baseline.
The final risk tool was based on six patient-specific variables: total number of prior episodes of hypoglycemia-related ED or hospital utilization (0, 1-2 or 3 times); number of ED encounters for any reason in the prior 12 months (< 2 or 2 times); insulin use (yes or no); sulfonylurea use (yes or no); presence of severe or end-stage renal disease (yes or no) and age younger than 77 years (yes or no). The classification tree resulted in 10 mutually exclusive “leaf nodes,” each yielding an estimated annual risk of hypoglycemia-related utilization characterized as high ( 5%), intermediate (1% to 5%) or low (< 1%). In the internal validation sample, 2% of patients were characterized as high risk; 10.7% as intermediate risk and 87.3% as low risk.
Researchers noted that the tool also performed well in terms of discrimination in the external validation samples (C statistic for VA sample = 0.81; C statistic for group health sample = 0.79), and visual inspection of the calibration plots showed a reasonable match between the predicted and observed risk of hypoglycemia-related utilization within the 10 leaf nodes.
“Implementation of this tool could conceivably increase clinician awareness of patients’ hypoglycemia risk,” the researchers wrote. “Clinical researchers may also find this tool helpful in identifying patients at high risk for hypoglycemic episodes for either purposeful inclusion or exclusion in clinical trials of novel therapies and diagnostic tests.” – by Regina Schaffer
Disclosures: The FDA funded this study. The authors report no relevant financial disclosures.
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