Developing a mHealth Simulation Platform for Youth

Engagement, Patient Clinical Trial

Official title:

Developing a Diabetes Self-management mHealth Simulation Platform for Youth

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953532
• Other study ID #: 2022N0018
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Ohio State University
• Contact: Eileen Faulds, PhD
• Phone: 614-247-8366
• Email: Eileen.Faulds[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 31, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Engagement, Patient

Intervention

Other:
• A1Control
diabetes self-management and diabetes technology education software

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of Engagement in Personal Healthcare	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	Glycemic control	Percent time spent in target glucose range (70-180mg/dl)	baseline, 4, 8, and 12 weeks