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OpenTrials
Completed

NCT Number: NCT05953532

Developing a mHealth Simulation Platform for Youth

The investigators will conduct a 12-week single group feasibility pilot field study among youth who will use a diabetes technology education application in their natural home environment.

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Key information

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital, Columbus, Ohio, United States

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About this study

The investigators will purposively select N=20 youth with at least 6 youth from each of 3 age ranges (10-12, 13-15, and 16-18) from eligible participants. Youth will use the software in their home environment for 12-weeks. Youth's diabetes device data will be used to select simulation content, targeted to meet each participant's educational needs. Youth will meet with research staff via video chat at the onset of testing where a URL link to the platform will be shared. Youth will be assigned 3 scenarios/week. At the end of each scenario youth are guided to additional resources in the platform that they may choose to access. Youth will meet with a member of the research team via video chat or phone call weekly to discuss platform issues or confusion as well as any questions regarding self-management content. Platform performance will be monitored by researchers and performance data will be collected and stored within the application database.

Feasibility measures will include recruitment, weekly research sessions attendance, and global attrition data. Sustained engagement measures will be collected from the application database and will include the frequency platform was accessed, number of assigned simulations completed (3 per week), and additional, optional, content accessed. Glycemic control measures including A1C will be obtained from the youth's EHR. Youth's diabetes devices will be downloaded at baseline and at 4, 6 and 12 weeks. Glucose values from device downloads will be aggregated into derived measures of glucose control consistent with American Diabetes Association guidelines on glucose targets. Self-management patterns and responsiveness will be assessed using pre- and post- diabetes device downloads at baseline, 4, 8, and 12 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of type 1 diabetes >1 year
  • 10-18 years of age
  • Currently uses insulin pump or HCL therapy
  • Duration of 6 months of pump therapy

Exclusion criteria

  • Significant learning disability
  • Self-reported pregnancy
  • Inability to read and write English

Treatment and study plan

A1Control

Other

diabetes self-management and diabetes technology education software

Primary outcomes

  1. Measure of Engagement in Personal Healthcare

    Time frame: 12-weeks

    frequency that the platform is accessed by the participant, number of assigned simulations scenarios completed (out of 3 assigned per week), and additional, optional, content accessed by the participant

Secondary outcomes

  1. Glycemic control

    Time frame: baseline, 4, 8, and 12 weeks

    Percent time spent in target glucose range (70-180mg/dl)

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Developing a Diabetes Self-management mHealth Simulation Platform for Youth

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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