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Behavioural Intervention

DVx-T1D+Standard Care 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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up three months

Awards & highlights

DVx-T1D Trial 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.Check my eligibility

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.See study design

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.

DVx-T1D Trial 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.

DVx-T1D Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ three months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in HbA1c values and and insulin dose adjusted HbA1c before and after the intervention

Change in glucose average and variability

Secondary outcome measures

Change in game play patterns over time

Changes in the quality of food consumption

DVx-T1D 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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Carnegie Mellon UniversityLead Sponsor

76 Previous Clinical Trials

539,850 Total Patients Enrolled

University of PittsburghOTHER

1,723 Previous Clinical Trials

16,342,876 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to partake in this research investigation?

"Children aged between 6 and 12 years exhibiting specific health behaviors are eligible for inclusion in this medical study, which is accepting approximately 80 participants."

Answered by AI

Are potential participants currently able to apply for enrollment in this ongoing clinical trial?

"Indeed, the details found on clinicaltrials.gov indicate that this investigation is currently seeking suitable participants. The trial was first listed on March 1st, 2024 and most recently revised on February 12th, 2024. Enrollment of approximately 80 subjects will take place at a single site."

Answered by AI

What is the number of individuals currently undergoing treatment within this medical study?

"Affirmative. Information available on clinicaltrials.gov indicates that this particular medical trial is actively seeking participants. The records were first made public on March 1st, 2024 and the latest update was noted on February 12th, 2024. Approximately 80 individuals are sought after for enrollment from a single site."

Answered by AI

Is the clinical trial open to individuals above 75 years of age?

"Prospective participants in this research must be between 6 and 12 years old. Among ongoing clinical trials, there are a total of 249 focused on individuals under the age of 18 and 985 targeting those above 65 years old."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Game-based Pediatric Diabetes Education

Rema Padman 2024. "Game-based Pediatric Diabetes Education". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06264258.

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