MyT1DHero: an mHealth Intervention for Type 1 Diabetes

NCT ID: NCT03521362

Last Updated: 2022-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2021-12-01

Brief 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

Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

MyT1DHero App

Participants in this group will receive use of the MyT1DHero app.

Group Type: EXPERIMENTAL

MyT1DHero

Intervention Type: DEVICE

MyT1DHero 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.

"Other" T1D App

Participants in this group will receive use of a different app with less capabilities.

Group Type: ACTIVE_COMPARATOR

Other T1D Mobile App

Intervention Type: DEVICE

A 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.

Interventions

MyT1DHero

MyT1DHero 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.

Intervention Type: DEVICE

Other T1D Mobile App

A 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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• The adolescents must:

1. have a T1D diagnosis according to the ADA practice guidelines,

2. be 10 to 15 years old,

3. have had a diagnosis of T1D for at least six months,

4. have an HbA1c > 7,

5. have had at least two outpatient visits in the past two years,

6. be treated at Spectrum for diabetes,

7. be fluent in English,

8. have a parent/guardian willing to participate,

9. have and be allowed to use a mobile phone for the study, and

10. have permission from their care team to participate.

The parent/guardian must:

1. have an adolescent with T1D who is 10 to 15 years old,

2. be fluent in English, and

3. have daily access to email and the Internet (for appointment reminders and technical support).

Exclusion Criteria

• For the adolescents include:

1. significant medical conditions other than T1D,

2. being treated for thyroid disorders, celiac disease, or eating disorders, and

3. being in foster care.

(a) a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and intellectual and developmental disabilities.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spectrum Health Hospitals

OTHER

Sponsor Role: collaborator

American Diabetes Association

OTHER

Sponsor Role: collaborator

Michigan State University

OTHER

Sponsor Role: lead

Responsible Party

Bree Holtz

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Michigan State University

East Lansing, Michigan, United States

Countries

United States

Related Links

http://myt1dhope.msu.edu/

T1D Parent Website

http://myt1d.org/wordpress/

Study Website

Other Identifiers

MyT1DHeroRCT

Identifier Type: -

Identifier Source: org_study_id