MyT1DHero: an mHealth Intervention for Type 1 Diabetes

M

Michigan State University

Status

Completed

Conditions

Type1diabetes

Treatments

Device: Other T1D Mobile App
Device: MyT1DHero

Study type

Interventional

Funder types

Other

Identifiers

NCT03521362
MyT1DHeroRCT

Details and patient eligibility

About

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.

Full 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.

Enrollment

33 patients

Sex

All

Ages

10 to 15 years old

Volunteers

No Healthy Volunteers

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.

Exclusion criteria for both the adolescents and parents/guardians include:

(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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

33 participants in 2 patient groups

MyT1DHero App
Experimental group
Description:
Participants in this group will receive use of the MyT1DHero app.
Treatment:
Device: MyT1DHero
"Other" T1D App
Active Comparator group
Description:
Participants in this group will receive use of a different app with less capabilities.
Treatment:
Device: Other T1D Mobile App

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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