Evaluation of a Treatment and Education Program for Diabetic Patients Who Use Flash Glucose Monitoring (FLASH)
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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Wetter, Allemagne, 58300
- Diabetes und Stoffwechselpraxis Wetter
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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. |
Treatment and education program based on the self-management theory of behavioral medicine.
The program is delivered by certified and specially trained diabetes educators.
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Aucune 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Changes in Glycemic Control Measured by A1c
Délai: 6 months
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Difference between baseline A1c and A1c at the 6-month follow-up
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Changes in "time-in-range"
Délai: 6 months
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Difference in the duration of glycemic values spent between 70 mg/dl and 180 mg/dl between baseline and the 6-month follow-up
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6 months
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Changes in hypoglycemic episodes
Délai: 6 months
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Differences between the frequency of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
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6 months
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Changes in the duration of hypoglycemic episodes
Délai: 6 months
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Differences between the duration of hypoglycemic glucose values (<70 mg/dl) (baseline vs. follow-up)
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6 months
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Changes in hyperglycemic episodes
Délai: 6 months
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Differences between the frequency of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
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6 months
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Changes in the duration of hyperglycemic episodes
Délai: 6 months
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Differences between the duration of hyperglycemic glucose values (>180 mg/dl) (baseline vs. follow-up)
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6 months
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Hypoglycaemia Awareness
Délai: 6 months
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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.
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6 months
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Diabetes Empowerment
Délai: 6 months
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Empowerment is measured by a German version of the Diabetes Empowerment Scale, a measure of diabetes-related psychosocial self-efficacy.
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6 months
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Diabetes Distress
Délai: 6 months
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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
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6 months
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Problem Areas in Diabetes
Délai: 6 months
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The Problem Areas in Diabetes Scale (PAID) assesses the psychosocial adaptation to the burden of living with and treating diabetes.
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6 months
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Depressive symptoms
Délai: 6 months
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The presence and extent of typical depressive symptoms are assessed via self-report.
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6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Norbert Hermanns, PhD, Forschungsinstitut der Diabetes Akademie Mergentheim (FIDAM GmbH)
Publications et liens utiles
Publications générales
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NH052017
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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