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Eine Studie entspricht den Filterkriterien
Kartenansicht

Continuous Glucose Monitoring for Self-Management of Type 2 Diabetes in Young Adults (CAPAZ-2D)

Offene Rekrutierung
Die Details der klinischen Studie sind hauptsächlich auf Englisch verfügbar. Trial Radar KI kann jedoch helfen! Klicken Sie einfach auf 'Studie erklären', um die Informationen zur Studie in der ausgewählten Sprache anzuzeigen und zu besprechen.
Die klinische Studie NCT07065721 (CAPAZ-2D) ist eine interventionsstudie zur Untersuchung von Typ-2-Diabetes mellitus (T2DM) und hat den Status offene rekrutierung. Die Studie startete am 2. Oktober 2025 und soll 40 Teilnehmer aufnehmen. Durchgeführt von San Diego State University ist der Abschluss für 31. Dezember 2025 geplant. Die Daten von ClinicalTrials.gov wurden zuletzt am 9. Oktober 2025 aktualisiert.
Kurzbeschreibung
Type 2 diabetes in increasing common in young adults. Utilizing a mixed-methods, community-based approach, this study offers continuous glucose monitors (CGMs) to young adults with type 2 diabetes for 30 days, and collects both quantitative and qualitative data to understand barriers and facilitators of CGM use, participants' changes in awareness of glucose patterns while using the CGM, and preferences for a CGM-based self-management intervention.
Ausführliche Beschreibung
The prevalence of type 2 diabetes (T2D) is rising in young adults and is associated with increased complications and reduced life expectancy. Poor adherence to diabetes self-management behaviors is common in young adulthood, often leading to poor glycemic control, and existing self-management interventions have had limited effectiveness in this age group. Continuous glucose monitors (CGMs) provide real-time glucose data that can support behavior change and reduce common self-management barriers such as glycemic unawareness, but their use in younger adults is limited. As "digital natives," young adults are well-poised to benefit from CGM interventions, particularly if they reduce barriers of standard self-management education (e.g., time burden). Qualitative data has shown that young adults are interested in CGM use but lack both access to CGMs and understanding of how to best utilize CGM data. The purpose of this proposal is to utilize a mixed-methods, community-engaged approach to generate pilot data for the development of a self-management intervention that pairs CGM glucose data with behavioral data (e.g., FitBit step count, dietary intake) to improve self-management and glycemic awareness and control. Young adults with T2D will be recruited to participate in a 30-day trial wear of CGMs, during which self-management behaviors will also be assessed. Afterward, qualitative interviews with participants will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns, and preferences for a CGM-based intervention.
Offizieller Titel

CAPAZ-2D: Continuous Glucose Monitoring to Augment and Personalize Self-Management of Type 2 Diabetes in Hispanic/Latinx Young Adults

Erkrankungen
Typ-2-Diabetes mellitus (T2DM)
Weitere Studien-IDs
  • CAPAZ-2D
  • IRB-24-8450
NCT-Nummer
Studienbeginn (tatsächlich)
2025-10-02
Zuletzt aktualisiert
2025-10-09
Studienende (vorauss.)
2025-12-31
Geplante Rekrutierung
40
Studientyp
Interventionsstudie
PHASE
Nicht zutreffend
Status
Offene Rekrutierung
Stichwörter
continuous glucose monitor
type 2 diabetes
young adult
Primäres Ziel
Behandlung
Zuteilungsmethode
Nicht zutreffend
Interventionsmodell
Einarmige Studie
Verblindung
Keine (offene Studie)
Studienarme/Interventionen
Teilnehmergruppe/StudienarmIntervention/Behandlung
ExperimentellCGM Wear
Participants will wear a continuous glucose monitor for 30 days. They will also wear a FitBit activity tracker watch and complete weekly surveys to report diabetes self-management behaviors.
Kontinuierlicher Glukosemonitor
Participants will wear a continuous glucose monitoring sensor for 30 days. They will also wear a FitBit wrist watch to be able to track their physical activity and they will complete weekly surveys to report diabetes self-management behaviors. After the 30 days, they will participate in a qualitative interview to respond to questions about their experiences.
Hauptergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Qualitative data regarding CGM use
Semi-structured qualitative interviews will be conducted to understand barriers and facilitators of CGM use, changes in awareness of glucose patterns or relationships between glucose and health behaviors, and preferences for a future CGM-based intervention.
Immediately after the intervention
Nebenergebnismessungen
ErgebnismessungBeschreibung der MessungZeitrahmen
Acceptability and feasibility of CGM wear
Mean rating of CGM feasibility, acceptability, utility, satisfaction ≥ 3/5 on a 0-5 scale
Immediately after the intervention
Eignungskriterien

Zugelassene Altersgruppen
Erwachsene
Mindestalter
18 Years
Zugelassene Geschlechter
Alle
  • adult 18-45 years of age
  • diagnosis of type 2 diabetes in the last 5 years, as evidenced in the electronic medical record
  • no prior use or experience with wearable CGMs
  • possession of a smart phone that is compatible with Dexcom CGM sensors (nearly all smartphones are compatible) and willing to download and utilize the Dexcom CGM app
  • fluency in English or Spanish

  • severe mental illness (e.g., psychosis, suicidal ideation);
  • pregnancy or <6 months postpartum
Scripps Health logoScripps Health
Zentrale Studienkontakte
Kontakt: Jessica L McCurley, PhD, MPH, 619-594-2132, [email protected]
1 Studienstandorte in 1 Ländern

California

Scripps Health, San Diego, California, 92121, United States
Samantha Bagsic, PhD, Kontakt, 858-554-5708, [email protected]
Offene Rekrutierung