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Behavioural Intervention

Game-based App for Type 1 Diabetes (DVx-T1D Trial)

N/A
Recruiting
Research Sponsored by Carnegie Mellon University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have been diagnosed with type 1 diabetes for at least 1 year.
Be currently taking insulin through multiple daily injections or an insulin pump.
Must not have
Children with type 2 diabetes, cystic fibrosis related diabetes, or secondary diabetes.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up three months
Awards & highlights

Summary

This trial aims to see if a mobile video game app called Digital Vaccine for Type 1 Diabetes (DVx-T1D)™ can help kids aged 6 to 12 with Type 1

Who is the study for?
This trial is for children aged 6 to 12 with Type 1 Diabetes. They should be willing to use the DVx-T1D™ app alongside their standard diabetes care and participate in activities like food logging and surveys. The study excludes details on who can't join, but typically those with other health issues or unable to follow the trial procedures would be excluded.
What is being tested?
The study tests if a mobile game called DVx-T1D™ improves Type 1 Diabetes management in kids by teaching them about healthy eating and exercise through fun, AI-driven games. It's a randomized controlled trial comparing the game plus usual care against just usual care over three months.
What are the potential side effects?
Since this intervention involves using an educational video game app, there are no direct medical side effects expected from participation. However, increased screen time could potentially impact sleep or behavior.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had type 1 diabetes for over a year.
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I am currently managing my diabetes with insulin injections or a pump.
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I am over 18 years old.
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I am between 6 and 12 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My child has type 2, cystic fibrosis related, or secondary diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and three months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention
Change in glucose average and variability
Secondary study objectives
Change in game play patterns over time
Changes in the quality of food consumption

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DVx-T1D+Standard CareExperimental Treatment1 Intervention
Participants will continue receiving the clinic's standard of care. Anthropometrics, clinical and laboratory data will be collected at three time points, baseline, 6 weeks and 3 months. Participants will be asked to maintain food, glucose, and activity logs. In addition, participants in this arm will be provided a tablet that has the gaming applications already loaded and receive training on the application. Exposure time will be tracked by the application.
Group II: Standard CareActive Control1 Intervention
Participants will receive the clinic's standard of care. Anthropometrics, clinical and laboratory data will be collected at three time points, baseline, 6 weeks and 3 months. Participants will be asked to maintain food, glucose, and activity logs.

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Who is running the clinical trial?

Carnegie Mellon UniversityLead Sponsor
77 Previous Clinical Trials
539,830 Total Patients Enrolled
University of PittsburghOTHER
1,762 Previous Clinical Trials
16,347,923 Total Patients Enrolled
~34 spots leftby Dec 2024
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