Individualized Exercise Consultation in Type 1 Diabetes (ACTIVE-T1D)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Background Physical activity is a recommended and integral component of T1D treatment, as it confers a range of health benefits, including improved insulin sensitivity, better glycaemic regulation, enhanced cardiovascular fitness, healthier lipid profiles, weight management, reduced blood pressure, and a lower risk of diabetes-related complications (1). Additionally, regular exercise supports psychological well-being and overall quality of life for people living with type 1 diabetes (2). However, despite written guidelines on the topic (3), individuals with type 1 diabetes often experience challenges with blood glucose excursions before, during, and after exercise (4, 5), limiting participation in regular exercise.
In recognition of limited guidance for individuals with type 1 diabetes regarding exercise (6), the Clinic for Athletes with Type One Diabetes (CATOD) was established in 2019 at the Steno Diabetes Center Aarhus (SDCA). CATOD is the first clinic of its kind and has transformed care for individuals with type 1 diabetes who exercise. Initially, the clinic primarily supported highly active athletes with type 1 diabetes through sports camps followed by a 6-12 month consultation programme focused on exercise and diabetes management strategies(7).
Since 2023 the clinic has expanded to provide 1-3 videoconsultations to a broad range of individuals with type 1 diabetes across the nation in order to help them with exercise obstacles. The problems presented span from going for a walk or bicycling to work without getting a low blood glucose to how to manage glucose during marathon training and competition. During the consultations, the individual with type 1 diabetes receives individualized guidance on exercise, glucose management, insulin adjustment, and nutrition.
Evidence from a prior questionnaire administered to participants who received the intervention suggests that many benefited from the advice and were able to modify their exercise habits, facilitating more effective and less burdensome physical activity.
Aim This study aims to expand current knowledge on the effectiveness of individualized exercise consultations in people with type 1 diabetes. Specifically, we will evaluate whether individualized, video-based exercise consultations can improve physical activity levels, glycemic control and patient empowerment.
Objectives
To determine whether individualized, exercise-specific consultations:
- Increase physical activity levels
- Improve glycemic control during and around exercise, as well as overall glycemic control
- Enhance confidence and self-management related to exercise
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Rakel F Johansen, MD, PhD
- Numéro de téléphone: +4540530612
- E-mail: rfjohansen@clin.au.dk
Sauvegarde des contacts de l'étude
- Nom: Jesper F Mortensen, MSc
- Numéro de téléphone: +45 23234145
- E-mail: jfm@au.dk
Lieux d'étude
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Aarhus, Danemark, 8200
- steno diabetes center Aarhus
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Contact:
- Rakel F Johansen, MD Phd
- Numéro de téléphone: +4540530612
- E-mail: rfjohansen@clin.au.dk
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Diagnosis of type 1 diabetes
- Age ≥18 years
- Willingness to participate
Exclusion Criteria:
- None
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Exercise Consultations
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Participants will receive individualized 30-minute video consultations concerning exercise and type 1 diabetes obstacles. During the consultations, individuals with type 1 diabetes are guided by a physician and, when relevant, an exercise physiologist from Steno Diabetes Center Aarhus (SDCA). The intervention will in most cases consist of two consultations, although an additional consultation may be offered if considered relevant. The first consultation is planned based on information about the individual's exercise habits and specific challenges. All consultations are conducted via video, allowing participants to receive tailored, practical advice adapted to their daily life and preferred physical activities. Consultations will address the topics that the patient presents, which may include, but is not limited to:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diabetes and Exercise Self-Management Ability Score, assessed using eight Likert-scale questions regarding the participant's perceived ability to manage type 1 diabetes and exercise-related challenges.
Délai: Eight months
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Each item is scored on a 5-point Likert scale: 1 = strongly disagree, 2 = disagree, 3 = neither agree nor disagree, 4 = agree, and 5 = strongly agree.
The total score ranges from 8 to 40, with higher scores indicating greater perceived ability to manage type 1 diabetes during exercise.
The score is assessed before the first consultation, immediately after the final consultation, and 6 months after the final consultation.
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Eight months
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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
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
- 1-20-72-8-26
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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