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

Norbert Hermanns

Status: Completed

Conditions: Diabetes Mellitus

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03175315

NH052017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 patients

Sex: All

Ages: 16 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

216 participants in 2 patient groups

FLASH

Experimental group

Description:

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.

Treatment:

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

Waiting List

No Intervention group

Description:

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.