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.

Improving the Quality of Outpatient Diabetes Care Using an Information Management System: Results From the Observational VISION Study.

BACKGROUND: This study aimed to evaluate the effects of information management system (IMS) use with individuals with type 1 and type 2 diabetes who were treated in outpatient settings. METHODS: In this 7-month, prospective, observational study, 965 adults with diabetes, mean (SD) baseline HbA1c 8.61(1.2)% (70.6[13.1] mmol/mol), were recruited from 132 outpatient care centers in Germany and Denmark. HbA1c was measured at baseline, month 4, and month 7. IMS reports were generated from uploaded self-monitored blood glucose data and therapy adjustments were documented at months 1 and 4. Hypoglycemic events were documented. RESULTS: Mean (SD) HbA1c decreased from baseline in type 1 and type 2 diabetes patients at month 4 (-0.61[1.03]% (-6.7[11.3] mmol/mol), n = 213; -0.88[1.22]% (-9.6[13.3] mmol/mol), n = 589, respectively) and month 7 (-0.64[1.02]% (-7.0[11.1] mmol/mol), n = 219; -0.93[1.27]% (-10.2[13.9] mmol/mol), n = 594, respectively), all P < .0001, with no increase in hypoglycemic events. Therapy was adjusted in 106(42.7)% type 1 and 349(52.4)% type 2 diabetes patients at months 1 and 105(42.3)% type 1 and 282(42.3)% type 2 diabetes patients at month 4. Physicians used IMS reports to make therapy adjustments in 90% of patients at month 1 and 86% of patients at month 4. CONCLUSIONS: Integration of the IMS into outpatient care facilitates significant improvements in glycemic control.

The multidrug resistance-associated protein 3 (MRP3) is associated with a poor outcome in childhood ALL and may account for the worse prognosis in male patients and T-cell immunophenotype.

The family of multidrug resistance-associated proteins (MRPs) belongs to the superfamily of adenosine triphosphate-binding-cassette (ABC) transporters, which have the ability to function as outward pumps for chemotherapeutic drugs and therefore might be involved in drug resistance. In this study the expression of the MRP2, MRP3, MRP4, MRP5, and SMRP genes was measured using TaqMan real-time polymerase chain reaction (PCR) in 103 children with previously untreated acute lymphoblastic leukemia (ALL) (precursor B-cell ALL [B-ALL], n = 71; T-cell ALL [T-ALL], n = 32). All 5 genes were expressed with a great variability. Only MRP3 expression was associated with a significantly worse prognosis (P =.008). The median expression of MRP3 was 10-fold higher in T-ALL than in precursor B-ALL (P <.001) and 4-fold higher in male patients than in female patients (P <.001). The prognostic impact of MRP3 was independent of immunophenotype or sex. Higher levels of MRP3 were found in patients with a poor in vivo response to prednisone, but this could not be confirmed in an independent case-control study (40 patients) for prednisone response. In healthy donors, the median expression of MRP4 was 4-fold higher in bone marrow and 8-fold higher in CD34+ stem cells compared with peripheral blood (P =.002). Our results suggest that MRP3 is involved in drug resistance in childhood ALL. It therefore represents an interesting target to overcome multidrug resistance. High levels of MRP3 could possibly be the reason for the poorer prognosis of male patients or patients who have T-ALL. Similar to other members of the family of ABC transporters, MRP4 seems to be a marker for immature stem cells.