J.L. Palmer

Validation of the IMS CORE Diabetes Model.

BACKGROUND The IMS CORE Diabetes Model (CDM) is a widely published and validated simulation model applied in both type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) analyses. Validation to external studies is an important part of demonstrating model credibility. OBJECTIVE Because the CDM is widely used to estimate long-term clinical outcomes in diabetes patients, the objective of this analysis was to validate the CDM to contemporary outcomes studies, including those with long-term follow-up periods. METHODS A total of 112 validation simulations were performed, stratified by study follow-up duration. For long-term results (≥15-year follow-up), simulation cohorts representing baseline Diabetes Control and Complications Trial (DCCT) and United Kingdom Prospective Diabetes Study (UKPDS) cohorts were generated and intensive and conventional treatment arms were defined in the CDM. Predicted versus observed macrovascular and microvascular complications and all-cause mortality were assessed using the coefficient of determination (R(2)) goodness-of-fit measure. RESULTS Across all validation studies, the CDM simulations produced an R(2) statistic of 0.90. For validation studies with a follow-up duration of less than 15 years, R(2) values of 0.90 and 0.88 were achieved for T1DM and T2DM respectively. In T1DM, validating against 30-year outcomes data (DCCT) resulted in an R(2) of 0.72. In T2DM, validating against 20-year outcomes data (UKPDS) resulted in an R(2) of 0.92. CONCLUSIONS This analysis supports the CDM as a credible tool for predicting the absolute number of clinical events in DCCT- and UKPDS-like populations. With increasing incidence of diabetes worldwide, the CDM is particularly important for health care decision makers, for whom the robust evaluation of health care policies is essential.

Economic impact of severe and non-severe hypoglycemia in patients with Type 1 and Type 2 diabetes in the United States

Abstract Objective: To identify the direct and indirect costs of hypoglycemia in patients with Type 1 or Type 2 diabetes mellitus (DM) in the US setting. Methods: A literature review was conducted to identify and review studies that reported data on the economic burden of hypoglycemia and the related medical resource consumption or productivity loss related to hypoglycemia in patients with Type 1 or Type 2 DM. Relevant information was collated in an economic model to assess the direct and indirect costs following severe and non-severe hypoglycemic events in Type 1 and Type 2 DM. Results: Detailed evidence of the medical cost burden of hypoglycemic events was identified from 14 studies. For both Type 1 and Type 2 DM, episodes requiring assistance from a healthcare practitioner were identified as particularly costly and amounted to

Cost-utility of exenatide once weekly compared with insulin glargine in patients with type 2 diabetes in the UK

1161 per episode (direct costs) compared with episode costs of

Cost-effectiveness of switching to biphasic insulin aspart in poorly-controlled type 2 diabetes patients in China

66 and

Cost-Effectiveness of Aliskiren in Type 2 Diabetes, Hypertension, and Albuminuria

11 for events requiring third-party (non-medical) assistance and events managed by self-treatment, respectively. Indirect costs associated with severe hypoglycemia requiring non-medical assistance, severe hypoglycemia requiring medical assistance, and non-severe hypoglycemia were predicted to be

Long-term clinical and economic outcomes associated with liraglutide versus sitagliptin therapy when added to metformin in the treatment of type 2 diabetes: a CORE Diabetes Model analysis

242,

Cost-effectiveness of insulin aspart versus human soluble insulin in type 2 diabetes in four European countries: subgroup analyses from the PREDICTIVE study

160, and

Cost-effectiveness of switching to biphasic insulin aspart from human premix insulin in a US setting

11 for patients with Type 1 diabetes and

Therapy conversion to biphasic insulin aspart 30 improves long-term outcomes and reduces the costs of type 2 diabetes in Saudi Arabia

579,

Cost-Effectiveness of Biphasic Insulin Aspart versus Insulin Glargine in Patients with Type 2 Diabetes in China

176, and