Clinical trial NCT03175315: Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: psychoeducation
treatment and education programme
self-management
diabetes education
flash glucose monitoring
Lead sponsor: Forschungsinstitut der Diabetes Akademie Mergentheim
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2017-06-05
Enrollment: 216
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Glycemic Control Measured by A1c
timeFrame: 6 months
Secondary outcomes:
measure: Changes in "time-in-range"
timeFrame: 6 months
measure: Changes in hypoglycemic episodes
timeFrame: 6 months
measure: Changes in the duration of hypoglycemic episodes
timeFrame: 6 months
measure: Changes in hyperglycemic episodes
timeFrame: 6 months
measure: Changes in the duration of hyperglycemic episodes
timeFrame: 6 months
measure: Hypoglycaemia Awareness
timeFrame: 6 months
measure: Diabetes Empowerment
timeFrame: 6 months
measure: Diabetes Distress
timeFrame: 6 months
measure: Problem Areas in Diabetes
timeFrame: 6 months
measure: Depressive symptoms
timeFrame: 6 months
Other outcomes:
Locations:
city: Wetter
country: Germany
facility: Diabetes und Stoffwechselpraxis Wetter
Study officials:
affiliation: Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
name: Norbert Hermanns, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.