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

Trial Summary

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 data supports the effectiveness of the treatment DVx-T1D™ app, Digital Vaccine for Type 1 Diabetes?

Research suggests that digital games can help people with diabetes manage their condition by motivating them to change their behavior and lifestyle. While more studies are needed, gamification (using game-like elements) has shown potential benefits in diabetes management, which may support the effectiveness of the DVx-T1D™ app. ^{1 2 3 4 5}

How is the DVx-T1D™ app treatment different from other treatments for type 1 diabetes?

The DVx-T1D™ app is unique because it uses gamification (turning tasks into games) to help people with type 1 diabetes manage their condition, making it more engaging and motivating compared to traditional methods. This approach is designed to improve self-management by encouraging regular monitoring and lifestyle changes through interactive and fun activities. ^{3 4 5 6 7}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

I have had type 1 diabetes for over a year.

Exclusion Criteria

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Effectiveness of Digital Health Interventions Containing Game Components for the Self-management of Type 2 Diabetes: Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of Gaming (Gamification) on Diabetes Self-Care Behaviors and Glycemic Outcomes Among Adults With Type 2 Diabetes. [2023]

3. Brazil pubmed.ncbi.nlm.nih.gov

Conceptual framework for designing video games for children with type 1 diabetes. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

Digital games for type 1 and type 2 diabetes: underpinning theory with three illustrative examples. [2022]

5. Canada 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. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Serious disease - serious game. [2013]

7. United States 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. [2018]