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

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.

• Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) (Behavioral): Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.

Primary outcomes

• Changes in Glycemic Control Measured by A1c [6 months]: Difference between baseline A1c and A1c at the 6-month follow-up

Secondary outcomes

• 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
• 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)
• 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)
• 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.
• Diabetes Empowerment [6 months]: Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
• 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
• 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.
• Depressive symptoms [6 months]: The presence and extent of typical depressive symptoms are assessed via self-report.

Sex: All, ages: 16 Years to 75 Years

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

• Results publication: Hermanns N, Ehrmann D, Schipfer M, Kroger J, Haak T, Kulzer B. The impact of a structured education and treatment programme (FLASH) for people with diabetes using a flash sensor-based glucose monitoring system: Results of a randomized controlled trial. Diabetes Res Clin Pract. 2019 Apr;150:111-121. doi: 10.1016/j.diabres.2019.03.003. Epub 2019 Mar 4. PMID 30844467
• Results publication: Schipfer M, Albrecht C, Ehrmann D, Haak T, Kulzer B, Hermanns N. Makes FLASH the difference between the intervention group and the treatment-as-usual group in an evaluation study of a structured education and treatment programme for flash glucose monitoring devices in people with diabetes on intensive insulin therapy: study protocol for a randomised controlled trial. Trials. 2018 Feb 5;19(1):91. doi: 10.1186/s13063-018-2479-9. PMID 29402319

• Norbert Hermanns, PhD, Principal investigator, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)