title: Reduction of hypoglycaemic events with a behavioural intervention: a randomized clinical trial for paediatric patients with Type 1 diabetes mellitus.
abstract: To determine if a low-intensity, clinic-integrated behavioural intervention reduced the incidence of hypoglycaemic events in children with Type 1 diabetes.
  
  
  
  A total of 390 families with children with Type 1 diabetes were enrolled in a 2-year, randomized clinical trial of a behavioural intervention. The intervention was designed to improve diabetes management practices by targeting the family's diabetes problem-solving skills. Hypoglycaemic events were categorized in two groups: those treated by oral ingestion and those treated by parenteral therapy. Events were self-reported by participants at each clinic visit, which occurred approximately every 3-4 months. Analyses included two-sample t-tests, the mean cumulative function test, and the Cox proportional hazards model for recurrent events to compare the incidence between groups.
  
  
  
  Across the entire 2-year study period, the incidence of hypoglycaemic events treated by oral ingestion of glucose-rich foods and events requiring parenteral therapy did not significantly differ between study conditions; however, during the second year of participant enrolment, the incidence of events treated by oral ingestion in the intervention group was 13.6 per 100 person-years compared with 27.3 per 100 patient-years in the control group (P = 0.02). The hazard ratio of these events during the second year was 0.49 (95% CI 0.27-0.90; P = 0.02).
  
  
  
  Our findings suggest the need for a long-term (> 1 year) focus on the implementation of interventions targeting diabetes management in young people. Behavioural interventions targeting problem-solving skills could be considered as practical, non-pharmacological strategies to reduce hypoglycaemia in adolescents with Type 1 diabetes.
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
authors.forename: B T
authors.initials: BT
authors.lastname: Gee
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
authors.forename: T R
authors.initials: TR
authors.lastname: Nansel
authors.affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.
authors.forename: A
authors.initials: A
authors.lastname: Liu
mesh_terms: D000293:Adolescent; D000294:Adolescent Behavior; D032763:Behavior Control; D002648:Child; D002652:Child Behavior; D003131:Combined Modality Therapy; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000628:therapy*; D005190:Family; D005260:Female; D005500:Follow-Up Studies; D005502:Food; D006801:Humans; D007003:Hypoglycemia / Q000178:diet therapy / Q000453:epidemiology / Q000517:prevention & control* / Q000628:therapy; D015994:Incidence; D008297:Male; D010288:Parenteral Nutrition; D010290:Parents; D011340:Problem Solving; D016016:Proportional Hazards Models; D057566:Self Report; D000073278:Self-Management; D014481:United States / Q000453:epidemiology