title: The impact of clinical trial design on cost-effectiveness analyses: illustration from a published study of the one-touch ultrasmart blood glucose meter for insulin-using diabetes patients.
abstract: One source of variation in cost-effectiveness analyses stems from the characteristics of the study upon which each is based. This report provides cost-effectiveness analyses using data from a recently published randomized clinical trial (RCT) comparing an integrated glucose meter/electronic logbook to a conventional glucose meter/paper logbook in helping to control hemoglobin A1c in type 1 or type 2 diabetes. RCT participants and health care professionals (HCPs) were "blinded" to results of meter downloads until week 16, when participants chose systems. They returned to "usual care" and could obtain meter results and share them with their HCPs. Those eligible returned 26-65 weeks later for an observational visit. The CORE Diabetes Model was used to estimate the 60-year cost-effectiveness of the electronic (vs. conventional) meter. With no price premium, the newer technology represented a dominant strategy (greater effectiveness/lower costs) based on the RCT alone or on the RCT + observational visit. With a $100.00/year premium, the incremental cost-effectiveness ratio was $28,053 based on the RCT, but the electronic monitor was dominant when simulations included observational visit results. One plausible reason for the greater benefits of the electronic monitor with the observational period included was the ability of patients and HCPs to make better clinical and lifestyle modifications based on fully available, formatted data. Because the advantages of the electronic meter are based on timely access to accurate feedback, the importance of naturalistic, unblinded studies for technology assessments can be appreciated. Addressing the methodological issues discussed here can help integrate clinical and economic outcomes for diabetes care innovations.
authors.affiliation: Health Economics and Outcomes Research, IMS-Health, Noblesville, IN 46060, USA. stunis@us.imshealth.com
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Tunis
authors.forename: Michael E
authors.initials: ME
authors.lastname: Minshall
mesh_terms: D015190:Blood Glucose Self-Monitoring / Q000191:economics*; D003362:Cost-Benefit Analysis; D003920:Diabetes Mellitus / Q000097:blood* / Q000188:drug therapy* / Q000191:economics; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D016032:Randomized Controlled Trials as Topic / Q000592:standards; D012107:Research Design; D014481:United States
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin