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Risk Factors Associated with Nocturnal Hypoglycemia Events in Insulin-Treated Type 2 Diabetes Mellitus Patients: An Integrated Clinical Trial Database Analysis

*Ran Duan, Eli Lilly and Company 

Keywords: nocturnal hypoglycemia, gamma frailty model, gradient boosting, recurrent events

Nocturnal hypoglycemia event (NHE) is associated with adverse clinical outcomes and reduced quality of life. We intended to identify and quantify NHE risk factors in T2DM patients. Gradient boosting algorithm was used to identify the risk factors highly associated with NHE. A gamma frailty model was used to quantify the risk factors by estimating hazard ratios (HRs). A total of 18 clinical trials included 7,341 patients (mean age (57.1 years); mean diabetes duration(10.9 years)). In the median six-month treatment period, 43% of patients experienced NHE with a median of 0.5 episodes/month. Risk factors of NHE included older age (HR = 1.015 for one-year increase ), female (1.139), African-American (1.303 vs. Caucasian), lower body mass index (1.026 for 1-unit decrease in kg/m2), longer diabetes duration (1.008 for 1-year increase), conditions that are likely associated with hypoglycemia (i.e., diabetic nephropathy and history of hypoglycemia) (1.284), conditions possibly associated with hypoglycemia (e.g., neuropathy, proteinuria, albuminuria, major depression, and alcoholic liver disease) (1.171), concomitant sulfonylurea use (1.096), and other anti-hyperglycemic agent use (1.088).