Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 6 for:    flash | diabetes | Germany
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03175315
Recruitment Status : Completed
First Posted : June 5, 2017
Last Update Posted : August 3, 2018
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by (Responsible Party):
Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2017
Actual Primary Completion Date : March 9, 2018
Actual Study Completion Date : March 9, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: FLASH

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.

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.

No Intervention: Waiting List
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03175315


Locations
Layout table for location information
Germany
Diabetes und Stoffwechselpraxis Wetter
Wetter, Germany, 58300
Sponsors and Collaborators
Norbert Hermanns
Abbott Diabetes Care
Investigators
Layout table for investigator information
Principal Investigator: Norbert Hermanns, PhD Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Norbert Hermanns, CEO, Forschungsinstitut der Diabetes Akademie Mergentheim
ClinicalTrials.gov Identifier: NCT03175315     History of Changes
Other Study ID Numbers: NH052017
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norbert Hermanns, Forschungsinstitut der Diabetes Akademie Mergentheim:
psychoeducation
treatment and education programme
self-management
diabetes education
flash glucose monitoring

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases