Integrated Personalized Diabetes Management (PDM): Design of the ProValue Studies: Prospective, Cluster-Randomized, Controlled, Intervention Trials for Evaluation of the Effectiveness and Benefit of PDM in Patients With Insulin-Treated Type 2 Diabetes.

Background: Collaborative use of structured self-monitoring of blood glucose (SMBG) data and data management software, utilized within a 6-step cycle enables integrated Personalized Diabetes Management (PDM). The 2 PDM-ProValue studies shall assess the effectiveness of this approach in improving patient outcomes and practice efficiencies in outpatient settings.

Methods: The PDM-ProValue studies are 12-month, prospective, cluster-randomized, multicenter, trials to determine if use of integrated PDM in daily life improves glycemic control in insulin-treated type 2 diabetes patients. Fifty-four general medical practices (GPs) and 36 diabetes-specialized practices (DSPs) across Germany will be recruited. The practices will be randomly assigned to the control groups (CNL) or the intervention groups (INT) via cluster-randomization. CNL practices will continue with their usual care; INT practices will utilize integrated PDM. The sample size is 1,014 patients (n = 540 DSP patients, n = 474 GP patients). Each study is designed to detect a between-group difference in HbA1c change of at least 0.4% at 12 months with a power of 90% and 2-sided significance level of .05. Differences in timing and degree of treatment adaptions, treatment decisions, blood glucose target ranges, hypoglycemia, self-management behaviors, quality of life, patients attitudes, clinician satisfaction, practice processes, and resource consumption will be assessed. Study endpoints will be analyzed for the modified intent-to-treat and per protocol populations. Trial results are expected to be available in late 2016.

Discussion: Effective and efficient strategies to optimize diabetes management are needed. These randomized studies will help determine if PDM is beneficial.