Evaluation of a Newly Developed Psychoeducational Treatment and Education Program for People With Type 1 and Type 2 Diabetes on an Intensified Insulin Therapy Who Use Flash Glucose Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 216
- 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 psychoeducational treatment and education programme for diabetic patients on an insulin therapy who use flash glucose monitoring (FGM) 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: time-in-range, frequency and duration of hypo- and hyperglycemic episodes, diabetes-related distress, depressive symptoms, health-related quality of life, diabetes self-efficacy, self-care behavior, and hypoglycemia awareness.
详细描述
The investigators developed a new psychoeducational treatment and education program - called FLASH - for diabetic patients on an intensive insulin therapy who use flash glucose monitoring (FGM).
FLASH is a self-management-based treatment and education program. It is designed to empower patients to adequately use FGM in daily life and to train patients how to analyze their glucose data. FLASH consists of four lessons (90 minutes each).
FLASH is tested in a randomized controlled trial (RCT) with a waiting-list control group since no certified and effective treatment and education program for FGM 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 FLASH will take place at the respective practice.
Baseline measurement will take place prior to the beginning of FLASH. 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 FLASH, follow-up measurements will be conducted at the respective study center.
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
- •Intensified insulin therapy / insulin pump therapy
- •previous participation in a structured diabetes education program
- •HbA1c ≥ 7,5% but ≤ 14%
- •Reduction of HbA1c as therapeutic goal
- •Indication for using FGM
- •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
- •Type 2 diabetes without insulin or non-intensified insulin therapy
- •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
FLASH
Intervention: Conduct of the newly developed treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH).
FLASH consists of 4 lessons focusing on empowering patients to autonomously use flash glucose monitoring (FGM) in their daily routine. Patients learn to effectively interpret the different information provided by FGM in order to improve not only glycemic control but also to improve the implementation of insulin therapy in daily life. Psychological and motivational aspects of living with diabetes and handling of the FGM are addressed as well.
干预措施: Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) (Behavioral)
Waiting List
Diabetic patients using FGM receive treatment as usual until the last measurement point. After completion of the study, they are offered participation in the FLASH program.
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
- Changes in hypoglycemic episodes(6 months)
- Changes in the duration of hypoglycemic episodes(6 months)
- Diabetes Distress(6 months)
- Changes in hyperglycemic episodes(6 months)
- Changes in the duration of hyperglycemic episodes(6 months)
- Diabetes Empowerment(6 months)
- Depressive symptoms(6 months)
- Changes in "time-in-range"(6 months)
- Hypoglycaemia Awareness(6 months)
- Problem Areas in Diabetes(6 months)
研究者
Norbert Hermanns
CEO
Forschungsinstitut der Diabetes Akademie Mergentheim