Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring
- Conditions
- Diabetes Mellitus
- Interventions
- Behavioral: Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)
- Registration Number
- NCT03175315
- Lead Sponsor
- Norbert Hermanns
- Brief Summary
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.
- Detailed Description
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.
HbA1c as a marker of glycemic control will be analyzed in a central laboratory. Time-in-range and the frequency and duration of hypo- and hyperglycemic episodes will be assessed via stored glucose data on patients FGM devices. The other secondary outcome measures will be assessed via psychometrically tested questionnaires or via patient files.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 216
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description FLASH Treatment and education program for patients with diabetes who use flash glucose monitoring (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.
- Primary Outcome Measures
Name Time Method Changes in Glycemic Control Measured by A1c 6 months Difference between baseline A1c and A1c at the 6-month follow-up
- Secondary Outcome Measures
Name Time Method Changes in hypoglycemic episodes 6 months Differences between the frequency of hypoglycemic glucose values (\<70 mg/dl) (baseline vs. follow-up)
Changes in the duration of hypoglycemic episodes 6 months Differences between the duration of hypoglycemic glucose values (\<70 mg/dl) (baseline vs. follow-up)
Diabetes Distress 6 months The Diabetes Distress Scale (DDS-28) assesses diabetes-related stressors due to living and treating diabetes. Different aspects of distress are covered such as hypoglycemia-related distress, physician-related distress
Changes in hyperglycemic episodes 6 months Differences between the frequency of hyperglycemic glucose values (\>180 mg/dl) (baseline vs. follow-up)
Changes in the duration of hyperglycemic episodes 6 months Differences between the duration of hyperglycemic glucose values (\>180 mg/dl) (baseline vs. follow-up)
Diabetes Empowerment 6 months Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
Depressive symptoms 6 months The presence and extent of typical depressive symptoms are assessed via self-report.
Changes in "time-in-range" 6 months Difference in the duration of glycemic values spent between 70 mg/dl and 180 mg/dl between baseline and the 6-month follow-up
Hypoglycaemia Awareness 6 months The hypoglycemia awareness questionnaire provides a score indicating the severity of hypoglycaemia unawareness. This scale ranges from 0 (maximum hypoglycaemia awareness) to 7 (minimum hypoglycaemia awareness), where a score of 4 suggests reduced hypoglycaemia awareness.
Problem Areas in Diabetes 6 months The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
Trial Locations
- Locations (1)
Diabetes und Stoffwechselpraxis Wetter
🇩🇪Wetter, Germany