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

Diabetes Mellitus Clinical Trial

— FLASH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03175315
• Other study ID #: NH052017
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: March 9, 2018

Study information

• Verified date: August 2018
• Source: Forschungsinstitut der Diabetes Akademie Mergentheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: March 9, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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

Locations

Country	Name	City	State
Germany	Diabetes und Stoffwechselpraxis Wetter	Wetter

Sponsors (2)

Lead Sponsor	Collaborator
Norbert Hermanns	Abbott Diabetes Care Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Glycemic Control Measured by A1c	Difference between baseline A1c and A1c at the 6-month follow-up	6 months
Secondary	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
Secondary	Changes in hypoglycemic episodes	Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)	6 months
Secondary	Changes in the duration of hypoglycemic episodes	Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)	6 months
Secondary	Changes in hyperglycemic episodes	Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)	6 months
Secondary	Changes in the duration of hyperglycemic episodes	Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)	6 months
Secondary	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
Secondary	Diabetes Empowerment	Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.	6 months
Secondary	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
Secondary	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
Secondary	Depressive symptoms	The presence and extent of typical depressive symptoms are assessed via self-report.	6 months