Ignite Creation Date:
2024-05-06 @ 8:07 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06264258
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-02-12
Brief Title:
Game-based Pediatric Diabetes Education
Sponsor:
Carnegie Mellon University
Organization:
Carnegie Mellon University
Study Overview
Official Title:
Evaluating Game-based Pediatric Diabetes Education
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DVx-T1D
Brief 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
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
Detailed Description:
Youth with T1D who comply with inclusion criteria and provide consent will be randomized to either the treatment arm will be given a tablet with the game or the control arm no tablet will be given no exposure to the game Participants in both arms will continue receiving standard of care treatment Participants will be asked to maintain food and activity logs and answer questionnaires about lifestyle
Participants will be evaluated at baseline and at 3 months with interim contact in between Devices will be downloaded to collect app usage data game telemetry Exposure time will be tracked by the application Survey to elicit barriers and challenges encountered during the study will also be conducted
Participants will be evaluated at baseline and at 3 months with interim contact in between Devices will be downloaded to collect app usage data game telemetry Exposure time will be tracked by the application Survey to elicit barriers and challenges encountered during the study will also be conducted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None