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Diabetes MellitusFLASHNCT03175315

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

A study testing Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) in people with Diabetes Mellitus, run by Norbert Hermanns at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 16 to 75 years
Conditions the study is for
Diabetes Mellitus
What is being tested?
Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
1 siteGermany
Study dates
2 May 2017to 9 Mar 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Diabetes und Stoffwechselpraxis Wetter

    Wetter, 58300

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)
Keywords
psychoeducation, treatment and education programme, self-management, diabetes education, flash glucose monitoring
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)Behavioural

    Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.

Study groups in NCT03175315
Study groupRoleWhat they receive
FLASHExperimentalIntervention: 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.
Receives: Behavioral: Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)
Waiting ListNo interventionDiabetic 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Glycemic Control Measured by A1c

    Difference between baseline A1c and A1c at the 6-month follow-up

    Measured: 6 months

Secondary outcomes (10)

  1. 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

    Measured: 6 months

  2. Changes in hypoglycemic episodes

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

    Measured: 6 months

  3. Changes in the duration of hypoglycemic episodes

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

    Measured: 6 months

  4. Changes in hyperglycemic episodes

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

    Measured: 6 months

  5. Changes in the duration of hyperglycemic episodes

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

    Measured: 6 months

  6. 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.

    Measured: 6 months

  7. Diabetes Empowerment

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

    Measured: 6 months

  8. 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

    Measured: 6 months

  9. Problem Areas in Diabetes

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

    Measured: 6 months

  10. Depressive symptoms

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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2017
  2. Study start2 May 2017
  3. Primary completion9 Mar 2018
  4. Study completion9 Mar 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03175315
Sponsor's protocol ID
NH052017
Acronym
FLASH
Status last verified
Aug 2018
First submitted
2 May 2017
Last updated
3 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30844467

  • 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.

    PubMed 29402319

Questions about this trial

What is this clinical trial studying?

A study testing Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH) in people with Diabetes Mellitus, run by Norbert Hermanns at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Glycemic Control Measured by A1c (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03175315, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2018.

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