Evaluation of a Self-management Oriented Diabetes Education Program for the Initiation of 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
- 186
- 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 intensive insulin therapy in type 2 diabetic patients (MEDIAS 2 ICT) 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 ICT) can demonstrate non-inferiority with regard to the main outcome variable glycemic control. If non-inferiority can be demonstrated superiority of this programs will be tested.
The results regarding the intervention arms "MEDIAS ICT" vs. " ACC" (control condition) will be separately analyzed and published.
详细描述
The MEDIAS 2 ICT program is based on a self-management/empowerment approach. It is conducted as a group program comprising 10 lessons of 90 minutes each. MEDIAS 2 ICT is designed to help patients perform multiple-injection insulin therapy and adjust their insulin doses depending on carbohydrate consumption, physical exercise, and pre-prandial glucose levels. In addition, MEDIAS 2 ICT focuses 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) consist of a combination of two previously established and evaluated education programs - a diabetes education program to initiate mealtime insulin and a hypertension education program for the treatment of hypertension. These education programs were developed in the 1980s and 1990s and were more didactic-oriented, focusing primarily on the acquisition of knowledge, skills, and information about the correct treatment of diabetes and hypertension.
Both treatment arms (MEDIAS 2 ICT and ACC) consisted of 10 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
- •age < 75 and age > 17 years
- •two years diabetes duration with oral treatment
- •BMI > 20 nad BMI < 40 kg/m²
- •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 month follow up after termination of the programs
次要结局
- diabetes related distress (Problem areas in Diabetes Questionnaire -PAID) and satisfaction with insulin therapy (Insulin Treatment Experience Questionnaire ITEQ)(6 month follow up)
- Self care behavior (Summary of Self-Care Activities Scale)(6 month follow up)
- Quality of life using the SF 12 mental and physical composite scales(six month follow up)
- diabetes knowledge (Diabetes knowledge test for insulin treatment in type 2 diabetes)(6 month follow up)
- weight (Body mass index)(6 month follow up)
- lipids (total cholesterol, triglycerides, HDL and LDL)(6 month follow up)
研究者
Norbert Hermanns
Prof. Dr.
Forschungsinstitut der Diabetes Akademie Mergentheim