Assessing the Clinical Feasibility of the DiaFocus System for Integrated Personalized Management of Type 2 Diabetes: 6-Month Pilot Cohort Study
Notice bibliographique
Résumé
Background: Type 2 diabetes (T2D) is a complex, chronic condition that requires ongoing management. An important aspect of effective diabetes management is shared decision-making between the person with diabetes and the health care professionals (HCPs) to tailor individual treatment plans. Personal health technologies can play a crucial role in this collaborative effort by providing tools for monitoring, communication, and education. Objective: This study aims to test the clinical feasibility of DiaFocus, a mobile health system developed for adults with T2D. Methods: This was a single-arm, prospective, 6-month pilot study in a clinical outpatient setting at Steno Diabetes Center Copenhagen, Denmark. The DiaFocus system includes an app for the participants and a web portal for the HCPs. The system collects diabetes-related data, including participant-reported lifestyle surveys, sensor-based measures on physical activity, and participant-selected focus areas, aiming to support communication and shared decision-making at clinical visits. Participants were eligible if they were ≥18 years old, diagnosed with T2D≥12 months, spoke Danish, and had a smartphone (iOS 13+ or Android 8.0+). For each participant, 3 visits and 1 telephone call were scheduled during the 6-month study period. The DiaFocus system's acceptability and feasibility were assessed through retention rates, app usage, participant feedback, and by the CACHET Unified Method for Assessment of Clinical Feasibility (CUMACF) questionnaire. The clinical outcomes were assessed by the following questionnaires: Diabetes Distress Scale (DDS), Perceived Competence for Diabetes (PCDS), Diabetes Treatment Satisfaction Questionnaire (DTSQs+c), hemoglobin A1c levels, and body weight. Results: A total of 17 participants with T2D were included in the study, 15 completed the study, and data were analyzed on an intention-to-treat basis. The median age was 68 (IQR 56-72) years, 12 (71%) were males, the median diabetes duration was 18 (IQR 11-21) years, and the median hemoglobin A1c was 59 (IQR 49-68) mmol/mol. Participants found the DiaFocus system feasible to support diabetes management despite technical problems, and they valued the ability to set focus areas. The most common focus areas were "blood glucose" (n=10, 59%) and "exercise" (n=9, 53%), but areas such as "sleep" and "mood" were also used. The CUMACF questionnaire showed that 90% (9/10) of the participants had very favorable views of how easy the system is to understand, learn, and use, and 80% (8/10) of the participants agreed or strongly agreed that the system was useful. Feedback was generally positive, indicating participants would use a refined version. Despite these findings, no statistically significant changes in clinical outcomes were observed throughout the study period using the DiaFocus system. Conclusions: This pilot study demonstrated that the DiaFocus system is clinically feasible and acceptable for users with T2D, although there is a need for optimization of app functionality and stability.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,006 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,001 |
| Études des sciences et des technologies | 0,001 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,001 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».