Skip to content

Developing a mHealth Simulation Platform for Youth

Developing a Diabetes Self-management mHealth Simulation Platform for Youth

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05953532
Enrollment
20
Registered
2023-07-20
Start date
2023-11-01
Completion date
2025-07-31
Last updated
2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Engagement, Patient

Brief summary

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.

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.

Interventions

OTHERA1Control

diabetes self-management and diabetes technology education software

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single group pilot study to evaluate youth engagement

Eligibility

Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Measure of Engagement in Personal Healthcare12-weeksfrequency 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

MeasureTime frameDescription
Glycemic controlbaseline, 4, 8, and 12 weeksPercent time spent in target glucose range (70-180mg/dl)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026