MyT1DHero: an mHealth Intervention for Type 1 Diabetes

NCT03521362 | Completed

• 1 other identifier: MyT1DHeroRCT
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Keywords

mHealth; Adolescent

Outcome Measures

Primary Outcomes (2)

• Change from Baseline Diabetes Behavior Rating Scale at 12 months

  A measure of diabetes adherence for both parent and child participants. Never (1) - Always(5) with a higher score indicating better adherence.

  Baseline and 12 months

• Change from Baseline HbA1c at 6 months and 12 months

  A laboratory test that measures how high blood glucose has been on average over the last 8-12 weeks - for child participants only (Lower number is best)

  Baseline, 6 months, and 12 months

Secondary Outcomes (21)

• Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months

  Baseline and 12 months

• Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months

  Baseline and 12 months

• Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months

  Baseline and 12 months

• Change from Baseline Diabetes Empowerment Scale Short Form at 12 months

  Baseline and 12 months

• Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months

  Baseline and 12 months

Study Arms (2)

MyT1DHero App

EXPERIMENTAL

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

Device: MyT1DHero

"Other" T1D App

ACTIVE COMPARATOR

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

Device: Other T1D Mobile App

Interventions

MyT1DHero 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.

MyT1DHero App

Other T1D Mobile App 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.

"Other" T1D App

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The adolescents must:
• have a T1D diagnosis according to the ADA practice guidelines,
• be 10 to 15 years old,
• have had a diagnosis of T1D for at least six months,
• have an HbA1c \> 7,
• have had at least two outpatient visits in the past two years,
• be treated at Spectrum for diabetes,
• be fluent in English,
• have a parent/guardian willing to participate,
• have and be allowed to use a mobile phone for the study, and
• have permission from their care team to participate.
• The parent/guardian must:
• have an adolescent with T1D who is 10 to 15 years old,
• be fluent in English, and
• have daily access to email and the Internet (for appointment reminders and technical support).

You may not qualify if:

• For the adolescents include:
• significant medical conditions other than T1D,
• being treated for thyroid disorders, celiac disease, or eating disorders, and
• 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.

Sponsors & Collaborators

• Michigan State University: lead
• Corewell Health West: collaborator
• American Diabetes Association: collaborator

Study Sites (1)

Michigan State University

East Lansing, Michigan, 48823, United States

Location

Related Links

• T1D Parent Website
• Study Website

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: May 11, 2018
• Study Start: January 1, 2019
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (1)