A multistep approach for the stratification of the risk of severe hypoglycemia in patients with type 2 diabetes.

INTRODUCTION: Hypoglycemia is the major limiting factor in the glycemic management of diabetes. Aim of this study was to produce a risk stratification tool to support the medical decision making, by facilitating the identification of patients at higher risk of hypoglycemia.

EVIDENCE ACQUISITION: A multistep approach was adopted, including a systematic review of observational studies investigating risk factors for severe hypoglycemia in type 2 diabetes (T2DM), followed by an expert input forum to identify factors perceived as relevant and at the same time reliably detectable, to be used for the development of a risk score.

EVIDENCE SYNTHESIS: The systematic review led to the identification of 41 studies. Many factors have been seldom investigated, and their association with the risk of hypoglycemia is still unclear. Factors more frequently associated with a high risk of hypoglycemia were: low level of education, ethnicity, irregular meals/malnutrition, insulin and sulfonylurea therapy, polypharmacy, previous hypoglycemia, impaired renal function, cognitive impairment, depression and frailty. The expert input forum involved 35 diabetologists. Following the ranking of the relevance of the factors identified, a parsimonious yet comprehensive set of risk factors was identified.

CONCLUSIONS: The process led to the identification of relevant factors, to be used for the development of a hypoglycemia risk score. An ad-hoc study will be performed to assess the contribution of these risk factors and their relative weight. If the risk score will confirm its ability to correctly stratify patients according to their risk of hypoglycemia, it will represent a useful support to optimize the care of people with T2DM.