Diabetes and endocrine and metabolic diseases Unit and the Centre for Applied Clinical Research (Ce.R.C.A.) Clinical Institute "Beato Matteo" (Hospital Group San Donato), Vigevano, Italy.
Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy.
Endocrine. 2018 Apr;60(1):46-49. doi: 10.1007/s12020-017-1427-x. Epub 2017 Sep 21.
Recent studies showed that a structured patient therapeutic education (PTE) may decrease both mortality and the development of diabetes complications. Nevertheless, no data are available in the literature on the impact of individual PTE on the complications in newly diagnosed type 2 diabetic patients. Aim of the present randomized controlled trial is to evaluate the impact of individual PTE on the occurrence of macrovascular complications in newly diagnosed type 2 diabetic patients when compared to usual care (UC) and group PTE.
Six hundred newly diagnosed type 2 diabetic patients will be enrolled. The patients will be randomly assigned to one of these three groups: individual PTE, group PTE and UC. A comprehensive and complete PTE will be delivered to all the patients: PTE will include eleven themes. Primary composite endpoint of the study is occurrence of vascular complications, including cardiovascular death, non fatal coronary disease, non fatal stroke, peripheral artery disease. Secondary endpoints are: foot ulcers, amputations, sexual dysfunction, quality of life, microvascular complications, bone health, intensification of diabetes and hypertension therapy.
The present trial can give precious information on the features for the most effective PTE.
最近的研究表明，结构化的患者治疗教育（PTE）可能会降低死亡率和糖尿病并发症的发展。然而，文献中尚无关于个体 PTE 对新诊断 2 型糖尿病患者并发症影响的数据。本随机对照试验的目的是评估与常规护理（UC）和团体 PTE 相比，个体 PTE 对新诊断 2 型糖尿病患者大血管并发症发生的影响。
将纳入 600 名新诊断的 2 型糖尿病患者。患者将被随机分配到这三组中的一组：个体 PTE、团体 PTE 和 UC。将向所有患者提供全面完整的 PTE：PTE 将包括十一个主题。研究的主要复合终点是血管并发症的发生，包括心血管死亡、非致命性冠心病、非致命性中风、外周动脉疾病。次要终点是：足部溃疡、截肢、性功能障碍、生活质量、微血管并发症、骨骼健康、糖尿病和高血压治疗的强化。
本试验可以为最有效的 PTE 提供宝贵信息。
