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

2 augusti 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

216

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

16 år till 75 år (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Beteende: 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.
Inget ingripande: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in Glycemic Control Measured by A1c
Tidsram: 6 months
Difference between baseline A1c and A1c at the 6-month follow-up
6 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in "time-in-range"
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
6 months
Changes in hyperglycemic episodes
Tidsram: 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
Tidsram: 6 months
Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
6 months
Hypoglycaemia Awareness
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 6 months
The presence and extent of typical depressive symptoms are assessed via self-report.
6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Norbert Hermanns

Samarbetspartners

Abbott Diabetes Care

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

2 maj 2017

Primärt slutförande (Faktisk)

9 mars 2018

Avslutad studie (Faktisk)

9 mars 2018

Studieregistreringsdatum

Först inskickad

2 maj 2017

Först inskickad som uppfyllde QC-kriterierna

31 maj 2017

Första postat (Faktisk)

5 juni 2017

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

3 augusti 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 augusti 2018

Senast verifierad

1 augusti 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • NH052017

Plan för individuella deltagardata (IPD)

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NEJ

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