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NCT Number: NCT03175315

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diabetes und Stoffwechselpraxis Wetter

Wetter, 58300, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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

  1. Changes in "time-in-range"

    Time frame: 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

  2. Changes in hypoglycemic episodes

    Time frame: 6 months

    Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)

  3. Changes in the duration of hypoglycemic episodes

    Time frame: 6 months

    Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)

  4. Changes in hyperglycemic episodes

    Time frame: 6 months

    Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)

  5. Changes in the duration of hyperglycemic episodes

    Time frame: 6 months

    Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)

  6. Hypoglycaemia Awareness

    Time frame: 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.

  7. Diabetes Empowerment

    Time frame: 6 months

    Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.

  8. Diabetes Distress

    Time frame: 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

  9. Problem Areas in Diabetes

    Time frame: 6 months

    The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.

  10. Depressive symptoms

    Time frame: 6 months

    The presence and extent of typical depressive symptoms are assessed via self-report.

Sponsors and collaborators

Lead sponsor

Norbert Hermanns

Other

Collaborators

  • Abbott Diabetes Care

Registry information

Official study 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

Acronym: FLASH

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 5, 2017
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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