Clinical Trials Directory

Trials / Completed

CompletedNCT03521362

MyT1DHero: an mHealth Intervention for Type 1 Diabetes

MyT1DHero: A Randomized Controlled Trial of an mHealth Intervention to Improve Parent-child Communication and Adolescent Self-management of Type 1 Diabetes

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
Michigan State University · Academic / Other
Sex
All
Age
10 Years – 15 Years
Healthy volunteers
Not accepted

Summary

The overall objective of the proposed research is to improve HbA1c, adherence to treatment plans, and family communication surrounding adolescents' self-management of T1D. The investigators will test the efficacy of the MyT1DHero app against an attention control group. This will allow investigators to better understand the health and psychosocial improvements being made through the app.

Detailed description

This research seeks to realize the potential and test the efficacy of MyT1DHero to improve adolescent users' glycemic control and adherence to blood glucose monitoring. The investigators' goal is to help families receive more social support, and to improve diabetes knowledge, self-efficacy, family communication, and quality of life. The investigators further seek to decrease family conflict among children with T1D and their parents. In a 12-month RCT, investigators will randomize 166 adolescents and their parents to one of two groups: (1) attention control, or (2) the MyT1DHero app. Adolescents enrolled in the study will be 10-15 years old, and will have been living with T1D for \<1 year or \>5 years at the start of the study. The primary outcome will be a change in the participants' HbA1C from baseline levels at the start of the study, to levels measured after 12 months.

Conditions

Interventions

TypeNameDescription
DEVICEMyT1DHeroMyT1DHero is an app with two separate interfaces, one for the parent and one for the child, that work together to help them communicate about diabetes management. The child receives system reminders to enter their blood glucose numbers, and parents receive a notification about each blood glucose test their child enters. Parents are also able to use the app to communicate with their child about their plan for care. The app has customizable blood glucose reminders and ranges, videos of support from other adolescents with T1D, snack lists, and other educational information on T1D.
DEVICEOther T1D Mobile AppA mobile app will be used in this control/comparison group that only has blood sugar testing reminders and logging capabilities. There will be no other components of the app.

Timeline

Start date
2019-01-01
Primary completion
2021-12-01
Completion
2021-12-01
First posted
2018-05-11
Last updated
2022-04-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03521362. Inclusion in this directory is not an endorsement.