Institute for Cardiovascular Pharmacology and Epidemiology, Mahlow, Germany.
Cardiovasc Diabetol. 2010 Sep 16;9:53. 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.
初始口服单药/二联降糖治疗失败后，2 型糖尿病患者发生疾病和治疗相关并发症的风险增加。然而，临床实践中针对此类患者群体的数据较为匮乏。因此，我们在初级保健中设立了一项登记处，记录该患者群体的病程和结局。
糖尿病治疗模式和初级保健中的血糖达标登记研究（DiaRegis）是一项前瞻性、观察性、德国多中心登记研究，纳入了初始口服单药/二联降糖治疗失败的 2 型糖尿病患者。数据在基线时记录，并将在 6 ± 1、12 ± 2 和 24 ± 2 个月时进行前瞻性记录。主要目的是评估一年内至少发生 1 次严重低血糖的患者比例。
2009 年 6 月至 2010 年 3 月期间，313 个初级保健办公室纳入了 4048 例患者，其中 3810 例患者符合纳入和排除标准。46.7%的患者为女性；中位糖尿病病程为 5.5 年，大多数患者根据 BMI 或腰围判定为肥胖。基线时的糖化血红蛋白（HbA1c）为 7.4%，空腹血糖为 142mg/dl，餐后血糖为 185mg/dl。该患者群体合并症较多，有 17.9%的患者患有冠状动脉疾病，14.4%的患者患有周围神经病变，9.9%的患者患有心力衰竭，6.0%的患者患有外周动脉疾病。68.6%的患者接受了口服单药治疗，31.4%的患者接受了口服双联药物联合治疗。作为单药治疗最常用的降糖药物是二甲双胍（79.0%），其次是磺脲类药物（14.8%）。
DiaRegis 是一项在初级保健中开展的大型、前瞻性登记研究，旨在记录初始口服单药/二联降糖治疗失败的 2 型糖尿病患者的病程和结局。为期 2 年的随访将允许对这些患者进行前瞻性评估，观察其在多次治疗调整期间的情况。
