Incidence and Correlates of Hypoglycemia in Type 2 Diabetes. The Hypos-1 Study

Abstract

Background: To evaluate the incidence of severe and symptomatic hypoglycemia in type 2 diabetes and identify their correlates. Materials and methods: HYPOS-1 is an observational retrospective study. Socio-demographic and clinical characteristics, experience of severe hypoglycemia in the past 12 months and experience of symptomatic hypoglycemia in the past 4 weeks were recorded through a patient questionnaire and a clinical record form. Poisson multivariate models were applied. Results: Overall, 2023 patients were involved by 18 diabetes clinics. Incidence rate (IR) of severe hypoglycemia was of 0.09 events/person-years; IR of symptomatic hypoglycemia was of 9.30 events/person-years. A minority of patients accounted for the vast majority of severe episodes. The risk of severe hypoglycemia was three times higher in patients with previous severe (Incidence Rate Ratio: 3.38; 95%confidence interval: 2.47-4.62) and symptomatic hypoglycemia (IRR 3.05; 95%CI 2.18-4.26); a twofold risk of severe episodes was associated with basal-bolus insulin regimen (IRR 2.04; 95%CI 1.24-3.35) as compared with oral therapies not including secretagogues. Glucoselowering therapy (i.e. secretagogues and insulin) and previous severe hypoglycemia represented the strongest predictors of symptomatic hypoglycemia. Female gender was associated with a twofold risk of severe and a 44% higher risk of symptomatic episodes as compared to male gender. Age, diabetes duration, HbA1c, neuropathy, retinopathy, overall number of drugs, neoplasms, living status and employment status also increased the risk of severe and/or symptomatic episodes. Discussion: Hypoglycemia still represents a common acute complication for individuals with type 2 diabetes. Identifying patients at higher risk is a key strategy to reduce the burden of hypoglycemia. J ou rna l o f D ia be tes & M e ta bolism

Insulin-Induced Skin Lipohypertrophy in Type 2 Diabetes: a Multicenter Regional Survey in Southern Italy

“…The questionnaire we used addressed sociodemographic and clinical characteristics including age, gender, school education, employment, living and marital status, possible caregiver role, pen needle features and re-utilization rate, injection site rotation habits, icecold insulin injection, post-injection leaking, local discomfort/pain/redness/itching or other skin abnormalities, and hypoglycemia during the past 12 months or symptomatic hypoglycemic episodes (HE) during the past 4 weeks, as described elsewhere [16]. All patients also entered a web-based clinical record form (eCRF), including clinical characteristics, habits, and demographics, as well as insulin injection habits.…”

“…We defined (1) severe hypoglycemia (SeH) according to the 2019 ADA guideline as an episode leading to unconsciousness or requiring assistance by a third person or associated with blood glucose levels \ 54 mg/dl (3.0 mmol/l) or in the 56-70 mg/dl range [14]; (2) symptomatic hypoglycemia (SyH) as an episode characterized by at least one of the following symptoms resolving with food or sugary drink ingestion: palpitations, tremors, sweating, shakiness, irritability, concentration troubles, dizziness, hunger, blurred vision, confusion, tachycardia, or difficulty moving [13,14,16]; (3) frequent unexplained hypoglycemia (UH) as the occurrence of hypoglycemic episodes at weekly intervals or more, in the absence of any identified precipitating events, such as changes in insulin dosage, diet, or amount of physical activity [13,14,16].…”

Incidence and risk factors for severe and symptomatic hypoglycemia in type 1 diabetes. Results of the HYPOS-1 study

“…Details on sample size estimation are published elsewhere [10]. Patient characteristics according to the presence of severe and symptomatic hypoglycemia are expressed as means and their standard deviations or frequencies.…”

Role of Structured Education in Reducing Lypodistrophy and its Metabolic Complications in Insulin-Treated People with Type 2 Diabetes: A Randomized Multicenter Case–Control Study

“…Moreover, therapeutic efforts to keep glycated hemoglobin (HbA1c) within target levels quite often lead to an increased risk for hypoglycemia, especially in insulin-treated patients [18]. Hypos, especially severe ones, have significant clinical, social, and economic impacts [18].…”