Evaluation of a Newly Developed Treatment and Education Program (INPUT) for Diabetic Patients Performing an Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Changes in Glycemic Control Measured by A1c
研究概览
简要总结
This study is a randomized, controlled, prospective trial with a 6-month follow-up. A newly developed treatment and education programme for diabetic patients with an insulin pump therapy (INPUT) will be tested compared to a waiting group. Primary outcome variable is the difference in glycemic control between baseline and the 6-month follow-up. Secondary outcome variables are: severe hypoglycaemia, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes empowerment, self-care behavior, hypoglycemia awareness, and attitudes towards insulin pump therapy.
详细描述
INPUT is a self-management-based treatment and education program for diabetic patients with an insulin pump (CSII). It is designed to empower patients to adequately perform their therapy in daily life and to integrate their diabetes and their insulin pump into their lifes in order to enhance quality of life.
INPUT ist tested in an randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for CSII exists.
This study is a multi-center study. Study centers are specialized diabetes practices throughout Germany. Patients will be approached by their respective practice and informed about the study. Study measurements as well as the conduct of INPUT will take place at the respective practice.
Baseline measurement will take place 2 weeks prior to the beginning of INPUT. After completion of baseline measurement, all patients from one study center will be randomized centrally by the Research Institute of the Diabetes Academy Mergentheim (FIDAM). 2 weeks and 6 months after the completion of INPUT, follow-up measurements will be conducted at the respective study center.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Secondary outcome measures will be assessed via psychometrically tested questionnaires, Case Reports Forms, or patient files.
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
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing insulin pump therapy
- •Prior participation in a structured diabetes education program
- •HbA1c ≥ 7,5% but ≤ 13%
- •Ability to understand, speak and write German language
- •informed consent (if necessary, informed consent of the parents)
排除标准
- •Diabetes duration < 1 year
- •severe organic disease preventing a regular participation in the training course
- •pregnancy
- •severe cognitive impairment
- •current treatment of psychiatric disorder
- •renal disease requiring dialysis
研究组 & 干预措施
INPUT
INPUT consists of 12 lessons comprising all relevant information in order to treat diabetes with an insulin pump. Patients learn to effectively use the different features of their pump in order to improve not only glycemic control but also to improve the implementation of pump therapy in daily life. Psychological and motivational aspects of living with diabetes and living with an insulin pump are addressed as well.
干预措施: INPUT (Behavioral)
Waiting list
Patients are randomly assigned to the waiting list. After completion of the 6-month follow-up, these patients will also receive training with INPUT.
结局指标
主要结局
Changes in Glycemic Control Measured by A1c
时间窗: 6 months
Difference between baseline A1c and A1c at the 6-month follow-up
次要结局
- Diabetes Empowerment(6 months)
- Satisfaction with current treatment(6 months)
- Attitudes towards insulin pump therapy(6 months)
- Hypoglycaemia Awareness(6 months)
- Health-related Quality of Life(6 months)
- Severe hypoglycaemia(6 months)
- Depressive symptoms(6 months)
- Diabetes Self-Management(6 months)
- Diabetes Distress(6 months)
- Problem Areas in Diabetes(6 months)
研究者
Norbert Hermanns
CEO
Forschungsinstitut der Diabetes Akademie Mergentheim