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

Multicenter Study

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

Peter Bramlage et al. Cardiovasc Diabetol. 2010.

Abstract

Background: 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.

Methods: 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.

Results: 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%).

Conclusions: 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.

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Figures

Figure 1

Intensified treatment has been associated with an increase in the rate of hypoglycemia [4-6].

Figure 2

Graphical study design. M, month(s); FU, follow-up; D, Day; FPG, fasting plasma glucose; PPG, post-prandial glucose; EQ-5D, EuroQol-5D; DTSQ, Diabetes Treatment Satisfaction Questionnaire

Figure 3

Regional distribution of participating practices throughout Germany (as of 30.04.2010).

Figure 4

Patient flow chart. OAD, oral antidiabetic drugs

Figure 5

Drug utilization in DiaRegis of patients on oral monotherapy (68.6% of all patients) (panel A) and on dual oral combination therapy (31.4%of all patients) (panel B).

Figure 6

Reason for a change of pharmacotherapy at baseline (panel A) and choice of drugs thereafter (panel B).

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