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

• Published in: Cardiovascular diabetology Vol. 9; no. 1; p. 53
• Main Authors: Bramlage, Peter, Binz, Christiane, Gitt, Anselm K, Krekler, Michael, Plate, Tanja, Deeg, Evelin, Tschöpe, Diethelm
• Format: Journal Article
• Language: English
• Published: England BioMed Central 16.09.2010; BioMed Central Ltd; BMC
• Subjects: Adult; Comorbidity; Costs; Data collection; Diabetes; Diabetes Complications - epidemiology; Diabetes Complications - therapy; Diabetes Mellitus, Type 2 - drug therapy; Diabetes Mellitus, Type 2 - epidemiology; Epidemiology; Female; Follow-Up Studies; Geographic Information Systems; Germany; Humans; Hypoglycemia; Hypoglycemia - chemically induced; Hypoglycemia - epidemiology; Hypoglycemic Agents - administration & dosage; Hypoglycemic Agents - adverse effects; Insulin; Male; Metformin - administration & dosage; Metformin - adverse effects; Pharmaceutical industry; Primary Health Care - statistics & numerical data; Registries - statistics & numerical data; Risk Factors; Studies; Study Protocol; Sulfonylurea Compounds - administration & dosage; Sulfonylurea Compounds - adverse effects; Germany
• ISSN: 1475-2840; 1475-2840
• DOI: 10.1186/1475-2840-9-53

Patients 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. Diabetes 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. 313 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%). DiaRegis 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.