Diabetes treatment patterns and goal achievement in primary diabetes care (DiaRegis) - study protocol and patient characteristics at baseline

Cardiovascular Diabetology

Study Protocol

Diethelm Tschöpe¹  Evelin Deeg²  Anselm K Gitt²  Peter Bramlage³  Tanja Plate⁴  Christiane Binz⁵  Michael Krekler⁵ 

[1] Herz- und Diabeteszentrum Nordrhein-Westfalen in Bad Oeynhausen, Universitätsklinik der Ruhr Universität, Bochum, Germany;Institut für Herzinfarktforschung Ludwigshafen an der Universität Heidelberg, Ludwigshafen, Germany;Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow, Germany;Medical Department, AstraZeneca, Wedel, Germany;Medical Department, Bristol Myers Squibb, Munich, Germany;

关键词: Metformin;    Hypoglycemia;    Severe Hypoglycemia;    Postprandial Glucose;    Antidiabetic Therapy;   

DOI  :  10.1186/1475-2840-9-53

 received in 2010-07-24, accepted in 2010-09-16,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundPatients with type 2 diabetes are at an increased risk for disease and treatment related complications after the initial approach of oral mono/dual antidiabetic therapy has failed. Data from clinical practice with respect to this patient group are however scarce. Therefore we set up a registry in primary care documenting the course and outcomes of this patient group.MethodsDiabetes Treatment Patterns and Goal Achievement in Primary Diabetes Care (DiaRegis) is a prospective, observational, German, multicenter registry including patients with type-2 diabetes in which oral mono/dual antidiabetic therapy has failed. Data were recorded at baseline and will be prospectively documented during visits at 6 ± 1, 12 ± 2 and 24 ± 2 months. The primary objective is to estimate the proportion of patients with at least 1 episode of severe hypoglycemia within one year.Results313 primary care offices included 4,048 patients between June 2009 and March 2010 of which 3,810 patients fulfilled the in- and exclusion criteria. 46.7% of patients were female; patients had a median diabetes duration of 5.5 years and most were obese with respect to BMI or waist circumference. HbA1c at baseline was 7.4%, fasting plasma glucose 142 mg/dl and postprandial glucose 185 mg/dl. Co-morbidity in this patient population was substantial with 17.9% having coronary artery disease, 14.4% peripheral neuropathy, 9.9% heart failure and 6.0% peripheral arterial disease. 68.6% of patients received oral monotherapy, 31.4% dual oral combination therapy. The most frequent antidiabetic agent used as monotherapy was metformin (79.0%) followed by sulfonylureas (14.8%).ConclusionsDiaRegis is a large, prospective registry in primary diabetes care to document the course and outcomes of patients with type-2 diabetes in which the initial approach of oral mono/dual antidiabetic therapy has failed. The two year follow-up will allow for a prospective evaluation of these patients during multiple adjustments of therapy.

【 授权许可】

Unknown   
© Bramlage et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.