title: The Health Economic Value of Changes in Glycaemic Control, Weight and Rates of Hypoglycaemia in Type 1 Diabetes Mellitus.
abstract: OBJECTIVE
  Therapy-related consequences of treatment for type 1 diabetes mellitus (T1DM), such as weight gain and hypoglycaemia, act as a barrier to attaining optimal glycaemic control, indirectly influencing the incidence of vascular complications and associated morbidity and mortality. This study quantifies the individual and combined contribution of changes in hypoglycaemia frequency, weight and HbA1c to predicted quality-adjusted life-years (QALYs) within a T1DM population.
  
  
  METHODS
  We describe the Cardiff Type 1 Diabetes (CT1DM) Model, originally informed by the Diabetes Control and Complications Trial (DCCT) and updated with the Epidemiology of Diabetes Interventions and Complications (EDIC) study and Swedish National Diabetes Registry for microvascular and cardiovascular complications respectively. We report model validation results and the QALY impact of HbA1c, weight and hypoglycaemia changes.
  
  
  RESULTS
  Validation results demonstrated coefficients of determination for clinical endpoints of R2 = 0.863 (internal R2 = 0.999; external R2 = 0.823), costs R2 = 0.980 and QALYs R2 = 0.951. Achieving and maintaining a 1% HbA1c reduction was estimated to provide 0.61 additional discounted QALYs. Weight changes of ±1kg, ±2kg or ±3kg led to discounted QALY changes of ±0.03, ±0.07 and ±0.10 respectively, while modifying hypoglycaemia frequency by -10%, -20% or -30% resulted in changes of -0.05, -0.11 and -0.17. The differences in discounted costs, life-years and QALYs associated with HbA1c 6% versus 10% were -£19,037, 2.49 and 2.35 respectively.
  
  
  CONCLUSIONS
  Using a model updated with contemporary epidemiological data, this study presents an outcome-focused perspective to assessing the health economic consequences of differing levels of glycaemic control in T1DM with and without weight and hypoglycaemia effects.
authors.affiliation: Health Economics and Outcomes Research Ltd., Mulberry Drive, Cardiff, United Kingdom.
authors.forename: Phil
authors.initials: P
authors.lastname: McEwan
authors.affiliation: Health Economics and Outcomes Research Ltd., Mulberry Drive, Cardiff, United Kingdom.
authors.forename: Hayley
authors.initials: H
authors.lastname: Bennett
authors.affiliation: Health Economics and Outcomes Research Ltd., Mulberry Drive, Cardiff, United Kingdom.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Fellows
authors.affiliation: Global Health Economics and Outcomes Research, AstraZeneca, London, United Kingdom.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Priaulx
authors.affiliation: Global Health Economics and Outcomes Research, AstraZeneca, Molndal, Sweden.
authors.forename: Klas
authors.initials: K
authors.lastname: Bergenheim
mesh_terms: D000328:Adult; D001786:Blood Glucose / Q000032:analysis*; D001835:Body Weight; D017281:Cost of Illness; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000191:economics* / Q000503:physiopathology; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018803:Models, Economic; D019057:Quality-Adjusted Life Years; D035501:Uncertainty; D055815:Young Adult
chemical_list: D001786:Blood Glucose