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.

Endoscopic Doppler ultrasound after injection therapy for peptic ulcer hemorrhage.

BACKGROUND/AIMS: A positive Doppler signal in endoscopic Doppler ultrasound at index endoscopy predicts a high risk for rebleeding from peptic ulcer. The aim of this study was to evaluate if a negative Doppler status immediately after injection therapy may exclude a rebleeding from peptic ulcer in a high-risk cohort. METHODOLOGY: Twenty consecutive patients (pts) (age: 68 (33-91) yrs; 11 female) with peptic ulcer bleeding were enrolled. All patients with an actively bleeding ulcer and those with a non-actively bleeding, but Doppler-positive ulcer were treated by injection of adrenaline (1:10,000 dilution). Treatment was performed during index endoscopy until the Doppler status was negative. Patients were followed-up clinically and endoscopically (including Doppler ultrasound) for bleeding recurrence. RESULTS: Patients were treated by injection of 12 (6 to 20) mL of adrenaline solution until Doppler scan was negative. During follow-up four pts (20%) had a clinically overt rebleeding episode. At control endoscopy three ulcers were actively bleeding and another two were Doppler positive without rebleeding (total: five of eighteen (27.7%) Doppler-positive ulcers). Two of the twenty pts required surgical therapy due to rebleeding (10%). CONCLUSIONS: A negative endoscopic Doppler status immediately after injection therapy is not helpful to identify patients with no risk for rebleeding from peptic ulcer.

[Optimized diabetes therapy in type 2 diabetics]. / Optimierte Diabetestherapie beim Typ-2-Diabetiker.

BACKGROUND: With the prevalence of type 2 diabetes mellitus having increased to approximately 8% during recent years and a further rise likely, type 2 diabetes will develop into a major health care problem in Europe. There are roughly 8 million diabetics in Germany, with another 4 million estimated unknown case. CLINICAL FEATURES: Diabetes is an accepted risk factor in the development of micro- and macrovascular complications. These complications generate enormous costs in our health care system. The optimal treatment of diabetic complications will minimize the cost to the health care system in the long run. Therefore, it is necessary to relay current therapeutic guidelines to medical personnel on a widespread basis. AIMS AND CONCLUSION: This publication summarizes current therapeutic options in glycemic control of type 2 diabetics which correspond to 95% of all diabetics. Recently, a national guideline has been developed by the "Arzneimittelkommission der deutschen Arzteschaft", the "Deutsche Diabetes- Gesellschaft", the "Fachkommission Diabetes Sachsen", the "Deutsche Gesellschaft für Innere Medizin e. V.", and the "Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften". In this guideline, treatment recommendations are made according to the criteria of evidence-based medicine. It is the basis of this review. In addition, the significance of the modern option of functional insulin therapy (FIT) in the treatment of type 2 diabetes will be explained. In closing, innovative alternatives of applying insulin will be discussed. Unquestionably, all other risk factors such as hypertension and/or hyperlipidemia also have to be treated optimally. These risk factors will not be discussed in this publication.