Based on the results of our mock trial, the time required for nontreatment trial activities is considerable, and the associated costs are substantial.

The cost of diabetes, driven primarily by the cost of preventable diabetes complications, will continue to increase with the epidemic rise in its prevalence in the U.S. The Diabetes Working Group (DWG), a consortium of professional organizations and individuals, was created to examine the barriers to better diabetes care and to recommend mitigating solutions. We consolidated three sets of guidelines promulgated by national professional organizations into 29 standards of optimal care and empanelled independent groups of diabetes care professionals to estimate the minimum and maximum time needed to achieve those standards of care for each of six clinical vignettes representing typical patients seen by diabetes care providers. We used a standards-of-care economic model to compare provider costs with reimbursement and calculated “reimbursement gaps.” The reimbursement gap was calculated using the maximum and minimum provider cost estimate (reflecting the baseline- and best-case provider time estimates from the panels). The cost of guideline-driven care greatly exceeded reimbursement in almost all vignettes, resulting in estimated provider “losses” of 470,000–750,000 USD/year depending on the case mix. Such “losses” dissuade providers of diabetes care from using best practices as recommended by national diabetes organizations. The DWG recommendations include enhancements in care management, workforce supply, and payment reform.