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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus
- Sponsor
- Norbert Hermanns
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Changes in Glycemic Control Measured by A1c
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Norbert Hermanns
CEO
Forschungsinstitut der Diabetes Akademie Mergentheim
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
Outcomes
Primary Outcomes
Changes in Glycemic Control Measured by A1c
Time Frame: 6 months
Difference between baseline A1c and A1c at the 6-month follow-up
Secondary Outcomes
- Changes in hypoglycemic episodes(6 months)
- Changes in the duration of hypoglycemic episodes(6 months)
- Diabetes Distress(6 months)
- Changes in hyperglycemic episodes(6 months)
- Changes in the duration of hyperglycemic episodes(6 months)
- Diabetes Empowerment(6 months)
- Depressive symptoms(6 months)
- Changes in "time-in-range"(6 months)
- Hypoglycaemia Awareness(6 months)
- Problem Areas in Diabetes(6 months)