Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens

NCT ID: NCT03436628

Last Updated: 2020-10-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-12-31

Brief Summary

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Type 1 diabetes (T1D) afflicts approximately 154,000 people under the age of 20. Most people with T1D are diagnosed at a young age; their parents have to manage their child's condition. Eventually, the child must begin to take steps to transition to self-management. During the transition from parent to adolescent self-management, difficulties arise because adolescents may not be fully aware of, or want, to take responsibility for all the necessary tasks to successfully manage their T1D. Though there are other apps on the market to help with diabetes care, NONE do what the proposed app will do. The proposed self-management mobile app allows for monitoring the patients' T1D by linking their self-management information to their parents' cell phone, and thus also helps to bridge communication gaps. Prior research suggests that these are critical gaps that must be filled in order for successful transition in care to occur, the proposed app will help fill some of these gaps.

Detailed Description

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Conditions

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Type 1 Diabetes Mellitus Adolescent Behavior Parent-Child Relations Communication

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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App Use

Kids (10-15 years old) with type 1 diabetes and one of their parents will receive the MyT1DHero app to use for a 3-month period. Participants are urged to use the app four times each day.

Group Type EXPERIMENTAL

MyT1DHero

Intervention Type DEVICE

A mobile phone application

Interventions

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MyT1DHero

A mobile phone application

Intervention Type DEVICE

Eligibility Criteria

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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 A1c \> 7;97
5. have had at least two outpatient visits in the past two years;
6. be treated at Sparrow for diabetes;
7. be fluent in English;
8. have a parent/guardian willing to participate;
9. be allowed to use a mobile phone for the study;
10. have permission from their care team.

The parent/guardian must:

1. have an adolescent with T1D who is 10 to 15 years old;
2. be fluent in English;
3. have daily access to email and the Internet (for appointment reminders and technical support).

Exclusion Criteria

The exclusions for adolescents include:

1. significant medical conditions other than T1D;
2. being treated for thyroid disorders, celiac disease, or eating disorders;
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 mental retardation).
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sparrow Health System

OTHER

Sponsor Role collaborator

Michigan State University

OTHER

Sponsor Role lead

Responsible Party

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Bree Holtz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bree M Holtz, PhD

Role: PRINCIPAL_INVESTIGATOR

Michigan State University

Locations

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Michigan State University

East Lansing, Michigan, United States

Site Status

Countries

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United States

References

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Holtz B, Mitchell KM, Holmstrom AJ, Cotten SR, Dunneback JK, Jimenez-Vega J, Ellis DA, Wood MA. An mHealth-Based Intervention for Adolescents With Type 1 Diabetes and Their Parents: Pilot Feasibility and Efficacy Single-Arm Study. JMIR Mhealth Uhealth. 2021 Sep 14;9(9):e23916. doi: 10.2196/23916.

Reference Type DERIVED
PMID: 34519670 (View on PubMed)

Holtz BE, Mitchell KM, Hershey DD, Cotten SR, Holmstrom AJ, Richman J, Dunneback JK, Wood MA. Using an mHealth App to Transition Care of Type 1 Diabetes from Parents to Teens: Protocol for a Pilot Study. JMIR Res Protoc. 2018 Oct 30;7(10):e10803. doi: 10.2196/10803.

Reference Type DERIVED
PMID: 30377142 (View on PubMed)

Related Links

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http://myt1d.org

Study Information Website

Other Identifiers

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MyT1DHero

Identifier Type: -

Identifier Source: org_study_id

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