title: Severe hypoglycemia and ketoacidosis over one year in Italian pediatric population with type 1 diabetes mellitus: a multicenter retrospective observational study.
abstract: OBJECTIVE
  Evaluation of incidence and correlates of severe hypoglycemia (SH) and diabetes ketoacidosis (DKA) in children and adolescents with T1DM.
  
  
  RESULTS
  Retrospective study conducted in 29 diabetes centers from November 2011 to April 2012. The incidence of SH and DKA episodes and their correlates were assessed through a questionnaire administered to parents of patients aged 0-18 years. Incidence rates and incident rate ratios (IRRs) were estimated through multivariate Poisson regression analysis and multilevel analysis. Overall, 2025 patients were included (age 12.4 ± 3.8 years; 53% males; diabetes duration 5.6 ± 3.5 years; HbA1c 7.9 ± 1.1%). The incidence of SH and DKA were of 7.7 and 2.4 events/100 py, respectively. The risk of SH was higher in females (IRR = 1.44; 95%CI 1.04-1.99), in patients using rapid acting analogues as compared to regular insulin (IRR = 1.48; 95%CI 0.97-2.26) and lower for patients using long acting analogues as compared to NPH insulin (IRR = 0.40; 95%CI 0.19-0.85). No correlations were found between SH and HbA1c levels. The risk of DKA was higher in patients using rapid acting analogues (IRR = 4.25; 95%CI 1.01-17.86) and increased with insulin units needed (IRR = 7.66; 95%CI 2.83-20.74) and HbA1c levels (IRR = 1.63; 95%CI 1.36-1.95). Mother's age was inversely associated with the risk of both SH (IRR = 0.95; 95%CI 0.92-0.98) and DKA (IRR = 0.94; 95%CI 0.88-0.99). When accounting for center effect, the risk of SH associated with the use of rapid acting insulin analogues was attenuated (IRR = 1.48; 95%CI 0.97-2.26); 33% and 16% of the residual variance in SH and DKA risk was explained by center effect.
  
  
  CONCLUSIONS
  The risk of SH and DKA is mainly associated with treatment modalities and strongly depends on the practice of specialist centers.
authors.affiliation: Division of Paediatric Diabetes in Children and Adolescents, Maternal-Infantile Department, Salesi Hospital, Ancona, Italy.
authors.forename: V
authors.initials: V
authors.lastname: Cherubini
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Via Nazionale, S. Maria Imbaro 66030, CH, Italy.
authors.forename: B
authors.initials: B
authors.lastname: Pintaudi
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Via Nazionale, S. Maria Imbaro 66030, CH, Italy.
authors.forename: M C
authors.initials: MC
authors.lastname: Rossi
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Via Nazionale, S. Maria Imbaro 66030, CH, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Lucisano
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Via Nazionale, S. Maria Imbaro 66030, CH, Italy.
authors.forename: F
authors.initials: F
authors.lastname: Pellegrini
authors.affiliation: Endocrine Unit, Department of Pediatrics, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Chiumello
authors.affiliation: Pediatric Division, Brotzu Hospital, Cagliari, Italy.
authors.forename: A P
authors.initials: AP
authors.lastname: Frongia
authors.affiliation: Women & Children's Health Department, University of Padova, Padova, Italy.
authors.forename: C
authors.initials: C
authors.lastname: Monciotti
authors.affiliation: Department of Pediatrics, Bambino Gesù Hospital, Passoscuro (RM), Roma, Italy.
authors.forename: I P
authors.initials: IP
authors.lastname: Patera
authors.affiliation: Diabetes Unit, Meyer Children Hospital, Firenze, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Toni
authors.affiliation: Department of Pediatrics, S.Orsola-Malpighi Hospital, Bologna, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Zucchini
authors.affiliation: Department of Clinical Pharmacology and Epidemiology, Fondazione Mario Negri Sud, Via Nazionale, S. Maria Imbaro 66030, CH, Italy. Electronic address: nicolucci@negrisud.it.
authors.forename: A
authors.initials: A
authors.lastname: Nicolucci
mesh_terms: D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003922:Diabetes Mellitus, Type 1 / Q000150:complications / Q000188:drug therapy / Q000453:epidemiology*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D007003:Hypoglycemia / Q000453:epidemiology* / Q000209:etiology; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D015994:Incidence; D007223:Infant; D007328:Insulin / Q000627:therapeutic use; D007336:Insulin, Isophane / Q000627:therapeutic use; D007558:Italy / Q000453:epidemiology; D007662:Ketosis / Q000453:epidemiology* / Q000209:etiology; D008297:Male; D012189:Retrospective Studies
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D007336:Insulin, Isophane
keywords: Children and adolescents; Diabetes ketoacidosis; Severe hypoglycemia; Type 1 diabetes