title: Development and validation of a cost-utility model for Type 1 diabetes mellitus.
abstract: OBJECTIVE
  To develop a health economic model to evaluate the cost-effectiveness of new interventions for Type 1 diabetes mellitus by their effects on long-term complications (measured through mean HbA1c ) while capturing the impact of treatment on hypoglycaemic events.
  
  
  METHODS
  Through a systematic review, we identified complications associated with Type 1 diabetes mellitus and data describing the long-term incidence of these complications. An individual patient simulation model was developed and included the following complications: cardiovascular disease, peripheral neuropathy, microalbuminuria, end-stage renal disease, proliferative retinopathy, ketoacidosis, cataract, hypoglycemia and adverse birth outcomes. Risk equations were developed from published cumulative incidence data and hazard ratios for the effect of HbA1c , age and duration of diabetes. We validated the model by comparing model predictions with observed outcomes from studies used to build the model (internal validation) and from other published data (external validation). We performed illustrative analyses for typical patient cohorts and a hypothetical intervention.
  
  
  RESULTS
  Model predictions were within 2% of expected values in the internal validation and within 8% of observed values in the external validation (percentages represent absolute differences in the cumulative incidence).
  
  
  CONCLUSIONS
  The model utilized high-quality, recent data specific to people with Type 1 diabetes mellitus. In the model validation, results deviated less than 8% from expected values.
authors.affiliation: Health Economics, RTI Health Solutions, Manchester.
authors.forename: S
authors.initials: S
authors.lastname: Wolowacz
authors.affiliation: Health Economics, RTI Health Solutions, Manchester.
authors.forename: I
authors.initials: I
authors.lastname: Pearson
authors.affiliation: Patient-Reported Outcomes, RTI Health Solutions, Manchester.
authors.forename: P
authors.initials: P
authors.lastname: Shannon
authors.affiliation: European Health Economics & Outcomes Research, Novo Nordisk Ltd, Gatwick, UK.
authors.forename: B
authors.initials: B
authors.lastname: Chubb
authors.affiliation: Health Economics and HTA, Novo Nordisk A/S, Bagsvaerd, Denmark.
authors.forename: J
authors.initials: J
authors.lastname: Gundgaard
authors.affiliation: Diabetes Research Centre, University of Leicester, Leicester.
authors.forename: M
authors.initials: M
authors.lastname: Davies
authors.affiliation: Institute for Health and Wellbeing, University of Glasgow, Glasgow, UK.
authors.forename: A
authors.initials: A
authors.lastname: Briggs
mesh_terms: D000328:Adult; D000419:Albuminuria / Q000191:economics / Q000517:prevention & control; D002318:Cardiovascular Diseases / Q000191:economics / Q000517:prevention & control; D002386:Cataract / Q000191:economics / Q000517:prevention & control; D003362:Cost-Benefit Analysis; D048909:Diabetes Complications / Q000191:economics / Q000517:prevention & control*; D003922:Diabetes Mellitus, Type 1 / Q000191:economics / Q000378:metabolism / Q000628:therapy*; D016883:Diabetic Ketoacidosis / Q000191:economics / Q000517:prevention & control; D003929:Diabetic Neuropathies / Q000191:economics / Q000517:prevention & control; D003930:Diabetic Retinopathy / Q000191:economics / Q000517:prevention & control; D006442:Glycated Hemoglobin; D006801:Humans; D007003:Hypoglycemia / Q000139:chemically induced / Q000191:economics; D007004:Hypoglycemic Agents / Q000191:economics / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000191:economics / Q000517:prevention & control; D018803:Models, Economic; D019057:Quality-Adjusted Life Years
chemical_list: D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C517652:hemoglobin A1c protein, human