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

2. august 2018 opdateret af: Norbert Hermanns

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

216

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
      • Wetter, Tyskland, 58300
        • Diabetes und Stoffwechselpraxis Wetter

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

16 år til 75 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Adfærdsmæssigt: 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.
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in Glycemic Control Measured by A1c
Tidsramme: 6 months
Difference between baseline A1c and A1c at the 6-month follow-up
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Changes in "time-in-range"
Tidsramme: 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
6 months
Changes in hypoglycemic episodes
Tidsramme: 6 months
Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
6 months
Changes in the duration of hypoglycemic episodes
Tidsramme: 6 months
Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
6 months
Changes in hyperglycemic episodes
Tidsramme: 6 months
Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
6 months
Changes in the duration of hyperglycemic episodes
Tidsramme: 6 months
Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
6 months
Hypoglycaemia Awareness
Tidsramme: 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.
6 months
Diabetes Empowerment
Tidsramme: 6 months
Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
6 months
Diabetes Distress
Tidsramme: 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
6 months
Problem Areas in Diabetes
Tidsramme: 6 months
The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
6 months
Depressive symptoms
Tidsramme: 6 months
The presence and extent of typical depressive symptoms are assessed via self-report.
6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Norbert Hermanns

Samarbejdspartnere

Abbott Diabetes Care

Efterforskere

  • Ledende efterforsker: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

2. maj 2017

Primær færdiggørelse (Faktiske)

9. marts 2018

Studieafslutning (Faktiske)

9. marts 2018

Datoer for studieregistrering

Først indsendt

2. maj 2017

Først indsendt, der opfyldte QC-kriterier

31. maj 2017

Først opslået (Faktiske)

5. juni 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

3. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NH052017

Plan for individuelle deltagerdata (IPD)

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