Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of Non-Intensive Insulin Therapy in Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 182
- 试验地点
- 2
- 主要终点
- A1c values
研究概览
简要总结
A new diabetes education program for the initiation of non-intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 CT) was developed.
In the evaluation, this new developed program is compared with an education programs which is currently used for diabetes education. It is expected that the new developed program (MEDIAS 2 CT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this program will be tested.
详细描述
The MEDIAS 2 CT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 6 lessons of 90 minutes each. MEDIAS 2 CT was designed to help patients perform conventional insulin therapy. In addition, MEDIAS 2 CT focused on controlling metabolic risk factors (elevated lipids and blood pressure), coping with the risk of late complications, and reducing the emotional burden of diabetes and its treatment.
The active comparator condition (ACC-CT) consisted of an established patient education program for type 2 diabetic patients with conventional insulin treatment. This education program was developed in the 1980s and 1990s and is more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes. Both treatment arms (MEDIAS 2 CT and ACC) consisted of 6 lessons, which were conducted as group sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •type 2 diabetes
- •two years diabetes duration with oral treatment
- •BMI > 20 and < 40 kg/m²
- •written informed consent
排除标准
- •current psychiatric disease
- •dementia or other severe cognitive impairment
- •severe complications
- •severe conditions (e.g., cancer)
- •gestational diabetes.
结局指标
主要结局
A1c values
时间窗: six months follow up after termination of the programs
次要结局
- Quality of life(six months follow up)
- Self-care behavior(six months follow up)
- Depression(six months follow up)
- Diabetes knowledge(six months follow up)
- Diabetes related emotional burden(six months follow up)
- Diabetes related distress(six months follow up)
研究者
Norbert Hermanns
Prof. Dr.
Forschungsinstitut der Diabetes Akademie Mergentheim