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NCT06264258: DVx-T1D
Game-based Pediatric Diabetes Education
NA trial testing DVx-T1D™ app in Diabetes Mellitus, Type 1 in 80 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Carnegie Mellon University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 80 |
| Start date | 22 May 2024 |
| Primary completion | 31 December 2025 |
| Estimated completion | 30 June 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- DVx-T1D™ app
Conditions studied
- Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
- Behavior, Health — all drugs for Behavior, Health →
Sponsor
Carnegie Mellon University
Who can join
Adults 6 to 12, any sex, with Diabetes Mellitus, Type 1 or Behavior, Health. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06264258
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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- NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
- NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting
Other Carnegie Mellon University trials
Trials by the same sponsor.
- NCT07350733 — Cognitive Training for Student Sleep and Wellness · NA · recruiting
- NCT06320808 — Evaluating FDA's Proposed Patient Medication Information Handout · NA · completed
- NCT05925556 — Pilot Brief Communal Coping Intervention for Adults With Type 1 Diabetes · NA · completed
- NCT05821608 — Heads up Messages to Increase Call Pick-up Rates · NA · unknown
- NCT06459596 — Pilot Brief Communal Coping Intervention for Adults With Type 2 Diabetes · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06264258 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Carnegie Mellon University
- Last refreshed: 12 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06264258.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing