D. Grant

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

Impact of Single Risk Factor Changes on Long Term Outcomes and Cost in a Type 2 Diabetes Modeling Study Contrasting Projections With UKPDS 68 Versus UKPDS 82 Risk Equations

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

Assessing the relationship between improved life expectancy due to better cardiovascular risk factor management and the likelihood of microvascular complications in type 2 diabetes mellitus

66 and

PRM58 Long-Term Validation of the IMS CORE Diabetes Model in Type 1 and Type 2 Diabetes

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

Assessing the Significance of HbA1c Durability in Cost Effectiveness Analysis of 2nd Line Oral Therapies in the Management of Type 2 Diabetes

242,

Quantifying the Direct and Indirect Costs Associated with Severe and Non-Severe Hypoglycaemia in Subjects with Type-2 Diabetes Who Are Treated with Insulin

160, and

Predicting the Frequency of Severe and Non-Severe Hypoglycaemia in Insulin Treated Type-2 Diabetes Subjects

11 for patients with Type 1 diabetes and

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

579,

Illustrating the relationship between the number of hypoglycaemia events, event rate reduction and the impact on estimates of quality of life improvement in health economic studies

176, and