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.

Autor:	Kulzer B; Forschungsinstitut Diabetes Akademie Bad Mergentheim, Bad Mergentheim, Germany., Daenschel W; Ärztlicher Leiter Medizinisches Versorgungszentrums am Küchwald GmbH, Chemnitz, Germany., Daenschel I; Hausarztpraxis, Lunzenau, Germany., Siegel EG; St. Josefskrankenhaus Heidelberg, Heidelberg, Germany., Schramm W; GECKO Institute for Medicine, Informatics and Economics, Heilbronn University, Heilbronn, Germany., Parkin CG; CGParkin Communications, Inc, Boulder City, NV, USA chris@cgparkin.org., Messinger D; Biometrics Department, IST GmbH, Mannheim, Germany., Weissmann J; Roche Diabetes Care GmbH, Mannheim, Germany., Djuric Z; Roche Diabetes Care GmbH, Mannheim, Germany., Mueller A; Roche Diabetes Care GmbH, Mannheim, Germany., Vesper I; Roche Diabetes Care GmbH, Mannheim, Germany., Heinemann L; Science & Co, Düsseldorf, Germany.
Jazyk:	angličtina
Zdroj:	Journal of diabetes science and technology [J Diabetes Sci Technol] 2016 May 03; Vol. 10 (3), pp. 772-81. Date of Electronic Publication: 2016 May 03 (Print Publication: 2016).
DOI:	10.1177/1932296815617487
Abstrakt:	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. Competing Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: BK, WD, ID, EGS, WS, CGP, and LH serve as paid consultants to Roche Diabetes Care GmbH for their involvement in the study design, study implementation, and preparation of the manuscript. JW, ZD, AM, and IV are employees of Roche Diabetes Care GmbH. (© 2015 Diabetes Technology Society.)
Databáze:	MEDLINE
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