Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

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.
    

Intervention name(s): Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)
Intervention type(s): Behavioral
Intervention description(s): Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychoeducation; treatment and education programme; self-management; diabetes education; flash glucose monitoring