Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FLASH<br>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. | Behavioral: Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)<br>* Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.<br>|
| No Intervention: Waiting List<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Glycemic Control Measured by A1c | Difference between baseline A1c and A1c at the 6-month follow-up | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in time-in-range | Difference in the duration of glycemic values spent between 70 mg/dl and 180 mg/dl between baseline and the 6-month follow-up | 6 months | 
| Changes in hypoglycemic episodes | Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up) | 6 months | 
| Changes in the duration of hypoglycemic episodes | Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up) | 6 months | 
| Changes in hyperglycemic episodes | Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up) | 6 months | 
| Changes in the duration of hyperglycemic episodes | Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up) | 6 months | 
| Hypoglycaemia Awareness | 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. | 6 months | 
| Diabetes Empowerment | Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy. | 6 months | 
| Diabetes Distress | 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 | 6 months | 
| Problem Areas in Diabetes | The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes. | 6 months | 
| Depressive symptoms | The presence and extent of typical depressive symptoms are assessed via self-report. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychoeducation, treatment and education programme, self-management, diabetes education, flash glucose monitoring