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NCT06264258 · ClinicalTrials.gov registry record · NA
Game-based Pediatric Diabetes Education
A NA study of Diabetes Mellitus, Type 1 and Behavior, Health, sponsored by Carnegie Mellon University.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 1
- Study location
NCT06264258 is a NA study of Diabetes Mellitus, Type 1 and Behavior, Health that is actively recruiting participants, run by Carnegie Mellon University. The registered enrollment target is 80 participants, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06264258, a NA study of Diabetes Mellitus, Type 1 and Behavior, Health, is actively recruiting participants, sponsored by Carnegie Mellon University.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D). The investigators hypothesize that adoption of DVx-T1D™ by T1D patients will positively influence healthy dietary and physical activity behaviors by providing nutrition and lifestyle education through a playful, Artificial Intelligence (AI)-based, cartoon-style medium of mobile gaming, and result in improvements in their T1D control. The investigators propose to conduct a longitudinal randomized controlled trial (RCT) over a 3-month period with a study population of 80 T1D participants (40 each in two arms of the trial) of 6-12 years old. The investigators will quantify the impact of the mobile game app plus standard care vs. standard care (with no exposure to the app) on T1D control (assessed by glycosylated hemoglobin or HbA1c measured during clinic visits and continuous glucose monitoring (CGM) parameters measured at home), physical activity levels and food choices of children (measured using food logs and surveys). Game telemetry, food logs, clinical, anthropometric, demographic, and survey data will be collected to obtain adequately powered, theory-driven evidence of the value of game-based approaches delivered via mobile apps.
Conditions Studied
Interventions
- BEHAVIORAL DVx-T1D™ app
Study Locations (1)
Pennsylvania
- UPMC Children's Hospital of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2024-05-22 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06264258
The ClinicalTrials.gov registry entry for NCT06264258 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,265-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (94% lower). The listed sponsor is Carnegie Mellon University, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 1 intervention - of which DVx-T1D™ app is the first listed.
NCT06264258 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06264258 about?
NCT06264258 is a clinical study titled "Game-based Pediatric Diabetes Education". The goal of this study is to evaluate the impact of a mobile app video game called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™, proposed as a low-risk, non-invasive, digital therapeutic candidate for behavior change in children 6 to 12 years of age with Type 1 Diabetes (T1D). The investigators h...
What is the current status of trial NCT06264258?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2024-05-22. Estimated completion is 2026-06-30.
What conditions does trial NCT06264258 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1, Behavior, Health.
What interventions are being tested in trial NCT06264258?
The interventions under investigation include: DVx-T1D™ app (BEHAVIORAL).
Who is sponsoring clinical trial NCT06264258?
This trial is sponsored by Carnegie Mellon University, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06264258 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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