Developing a mHealth Simulation Platform for Youth

October 16, 2025 updated by: Ohio State University

Developing a Diabetes Self-management 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Columbus, Ohio, United States, 43210
        • The Ohio State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: All Participants
All participants will perform the same study activities
Other: A1Control
diabetes self-management and diabetes technology education software

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycemic control
Time Frame: baseline, 4, 8, and 12 weeks
Percent time spent in target glucose range (70-180mg/dl)
baseline, 4, 8, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

July 31, 2025

Study Completion (Actual)

July 31, 2025

Study Registration Dates

First Submitted

June 13, 2023

First Submitted That Met QC Criteria

July 12, 2023

First Posted (Actual)

July 20, 2023

Study Record Updates

Last Update Posted (Estimated)

October 20, 2025

Last Update Submitted That Met QC Criteria

October 16, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022N0018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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