NCT05953532

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

October 20, 2025

Status Verified

October 1, 2025

Enrollment Period

1.7 years

First QC Date

June 13, 2023

Last Update Submit

October 16, 2025

Conditions

Engagement, Patient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Glycemic control

    baseline, 4, 8, and 12 weeks

Study Arms (1)

All Participants

OTHER

All participants will perform the same study activities

Other: A1Control

Interventions

A1ControlOTHER

diabetes self-management and diabetes technology education software

All Participants

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single group pilot study to evaluate youth engagement
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 20, 2023

Study Start

November 1, 2023

Primary Completion

July 31, 2025

Study Completion

July 31, 2025

Last Updated

October 20, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(2)