Game-based App for Type 1 Diabetes

(DVx-T1D Trial)

Overseen By Neha Sudhir

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Carnegie Mellon University

Must be taking: Insulin

Disqualifiers: Type 2 diabetes, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile game app designed to help children with Type 1 Diabetes make healthier lifestyle choices. The DVx-T1D™ app uses a fun, cartoon-style game to teach nutrition and encourage physical activity, potentially improving diabetes control. Participants will either use the app alongside their usual diabetes care or continue with standard care alone. Children aged 6 to 12 who have managed Type 1 Diabetes for over a year and regularly check their blood sugar are well-suited for this study. As an unphased trial, this study provides a unique opportunity for children to engage with innovative technology that could enhance their diabetes management.

Will I have to stop taking my current medications?

The trial does not specify whether participants need to stop taking their current medications. However, since the study involves a mobile app and standard care, it is likely that participants will continue their current insulin regimen.

What prior data suggests that the DVx-T1D™ app is safe for children with Type 1 Diabetes?

Research shows that the DVx-T1D™ app is a low-risk, non-invasive digital tool. This app uses a fun game to help children with Type 1 Diabetes change their habits. As a digital tool, it doesn't involve drugs or physical treatments, which usually means fewer safety concerns.

The app encourages healthy habits through a cartoon-style game and is not expected to cause physical side effects. It focuses on improving eating and exercise habits in a safe and enjoyable way. Designed as a low-risk tool, the app is safe for kids to use without causing harm. Research generally considers it safe based on its purpose and design. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DVx-T1D™ app because it offers a novel approach to managing Type 1 Diabetes by integrating game-based learning into standard care. Unlike traditional treatments that focus solely on insulin management and lifestyle adjustments, this app uses gamification to engage users in tracking their food intake, glucose levels, and physical activity. By transforming daily diabetes management tasks into interactive games, it aims to improve adherence and make the process more enjoyable. This innovative approach has the potential to enhance patient engagement and ultimately improve health outcomes for individuals with Type 1 Diabetes.

What evidence suggests that the DVx-T1D™ app is effective for Type 1 Diabetes?

Research has shown that smartphone apps can help young people with Type 1 Diabetes (T1D) manage their blood sugar levels. Studies have found that these apps, when combined with regular diabetes care, can improve condition management. In this trial, participants in one arm will use the DVx-T1D app, which teaches users about healthy eating and exercise in a fun, game-like way, alongside standard care. This approach aims to improve key health indicators, such as HbA1c levels, which measure blood sugar control over time. Although limited data exists specifically on DVx-T1D, using apps for diabetes management has shown promise. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Resident of Allegheny County

I have had type 1 diabetes for over a year.

Check blood sugar with a meter at least 4 times per day or use a continuous glucose monitor.

Exclusion Criteria

My child has type 2, cystic fibrosis related, or secondary diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Evaluation

Participants are evaluated at baseline for anthropometrics, clinical, and laboratory data

1 week

1 visit (in-person)

Treatment

Participants receive either standard care or standard care plus the DVx-T1D game for 3 months

12 weeks

3 visits (in-person) at baseline, 6 weeks, and 3 months

Follow-up

Participants are monitored for changes in HbA1c, glucose levels, and lifestyle behaviors

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• DVx-T1D™ app

Trial Overview 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.

How Is the Trial Designed?

Group I: DVx-T1D+Standard Care Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

Carnegie Mellon University

Lead Sponsor

Trials

80

Recruited

540,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Digital health interventions that include game components can significantly enhance motivation for physical activity and improve dietary behaviors in patients with type 2 diabetes, as evidenced by a systematic review of 10 randomized controlled trials.

Despite these positive findings, the overall quality of the studies was low, with high risk of bias, indicating a need for more rigorous research to clarify the effectiveness and identify which game elements are most beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Digital Health Interventions Containing Game Components for the Self-management of Type 2 Diabetes: Systematic Review. Ossenbrink, L., Haase, T., Timpel, P., et al.[2023]

The acT1ve mobile health app was piloted with 10 young participants with type 1 diabetes over 6 weeks, showing high user satisfaction and functionality, with a total quality score of 4.3 out of 5.

Participants reported increased knowledge and confidence in managing their blood glucose during exercise, indicating the app's potential as a supportive tool for young people with type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Mobile Health App to Educate and Empower Young People With Type 1 Diabetes to Exercise Safely: Prospective Single-Arm Mixed Methods Pilot Study. Shetty, VB., Soon, WHK., Roberts, AG., et al.[2021]

A systematic review of 9 studies found that gamification can enhance diabetes self-management behaviors, particularly in physical activity and self-efficacy, which are crucial for individuals with type 2 diabetes.

Most studies reported a reduction in A1C levels, indicating that gaming interventions may effectively improve diabetes outcomes, although not all self-care behaviors were addressed in the research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Gaming (Gamification) on Diabetes Self-Care Behaviors and Glycemic Outcomes Among Adults With Type 2 Diabetes. Brady, VJ., Mathew Joseph, N., Ju, HH.[2023]

A new conceptual framework for designing video games aimed at children with type 1 diabetes was developed through a study involving 21 children aged 7 to 12, focusing on their needs and preferences.

The framework includes six phases that correspond to stages of behavioral change, ensuring that the game design is both engaging and effective in promoting healthy behaviors related to diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conceptual framework for designing video games for children with type 1 diabetes. Sparapani, VC., Fels, S., Kamal, N., et al.[2023]

Digital games can effectively support diabetes management for both children and adults by using gamification and social components to motivate behavior change and improve lifestyle habits.

While the paper highlights examples of mobile and desktop games designed for type 1 and type 2 diabetes, it emphasizes the need for more comprehensive research to evaluate their effectiveness across different age groups and patient needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital games for type 1 and type 2 diabetes: underpinning theory with three illustrative examples. Kamel Boulos, MN., Gammon, S., Dixon, MC., et al.[2022]

Teenagers with diabetes often feel isolated and burdened by their condition, leading to low usage of traditional monitoring tools.

The DiaApp project aims to create a smartphone app that gamifies diabetes management, encouraging teens to engage with their health through competition and education, based on insights from preliminary focus group interviews.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious disease - serious game. Hertel, NT., Vedel, K., Rohde, L., et al.[2013]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

Citations

1. cmu.edu cmu.edu/heinz/digital-vaccine-project/digital-vaccine-candidates/childrens_project.html

DVx-CLINIC - Digital Vaccine Project Desired Outcome Measures: The primary outcome measures encompass alterations in glycosylated hemoglobin (HbA1c) levels, insulin dose-adjusted HbA1c, glucose ...

2. ctv.veeva.com ctv.veeva.com/study/gamification-of-pediatric-diabetes-education

Game-based Pediatric Diabetes Education (DVx-T1D) 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)™, ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2023.1074946/full

Effect of smartphone apps on glycemic control in young ... Conclusion: The current pooled data analysis did not reveal a significant reduction in HbA1c in young patients with T1D undergoing treatment ...

4. policylab.us policylab.us/clinical-trials/l/pennsylvania/pittsburgh/type-1-diabetes

Type 1 Diabetes Clinical Trials in Pittsburgh, PA - Policy Lab This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10337628/

Effectiveness of a new smartphone application on type 1 ... Self-management smartphone apps appear to be effective on glycaemic control and should be considered an adjuvant intervention to standard diabetes care.

6. trialstoday.org trialstoday.org/search/results?status=recruiting&gender=&age=&zip=&radius=25&condition=&healthy=&type=&interventionalpurpose=&observationalmodel=&query=University%20of%20Iowa%20Neurology&page=eJyLViooSi3LzC8tVtJR8nMOMTAxNjMyNDdT0tG1hAEcTDM9U2MzQ0MdQ3MDQ2MLCwsDENBRyksuMTAxMzYzNzdVigUAY_kWJQ--

Save Selected 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- ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02619487

The Impact of Mobile Technology on Clinical Outcomes in ... The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and ...

8. policylab.us policylab.us/clinical-trials/l/pennsylvania/pittsburgh/diabetes?page=2

Diabetes Clinical Trials in Pittsburgh, PA - Policy Lab This study will evaluate the safety, efficacy and durability of SR-02 administered to the omentum of patients of Type 1 diabetes with severe recurrent ...