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

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.

Study Overview

• Status: Completed
• Conditions: Communication; Type 1 Diabetes Mellitus; Parent-Child Relations; Adolescent Behavior
• Intervention / Treatment: Device: MyT1DHero

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • East Lansing, Michigan, United States, 48824
      • Michigan State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 15 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

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 mental retardation).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: MyT1DHero; A mobile phone application

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Adherence to Self-management	Measured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome	Baseline and 3 months
Change in Hemoglobin A1c (HbA1c)	A laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Support	Measured with the Multidimensional Scale of Perceived Social Support (5 point likert scale, all of the time-never); A lower value represents a better outcome	Baseline and 3 months
Change in Self-Efficacy	Measured using Diabetes Empowerment Scale - Short Form (5-point likert scale, strongly disagree-strongly agree); A higher value represents a better outcome	Baseline and 3 months
Change in Quality of Life	Measured using PedsQL (5-point likert scale, never-almost always); A higher value represents a better outcome	Baseline and 3 months
Change in Conflict	Measured using Diabetes Family Conflict Scale (3-point likert scale, always-never); A lower value represents a better outcome	Baseline and 3 months
Parenting	Measured using Alabama Parenting Questionnaire (5-point likert scale, very often-never); Values of this scale vary based on which sub scale is being used. For negative parenting sub scales, a lower value represents a better outcome; and for positive parenting sub scales, a higher value represents a better outcome.	Baseline
Change in Parental Monitoring	Measured using Parental Monitoring of Diabetes Care Scale (5-point likert scale, always-never); A lower value represents a better outcome	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Michigan State University
• Collaborators: Sparrow Health System
• Investigators: Principal Investigator: Bree M Holtz, PhD, Michigan State University

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Study Information Website

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 15, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: MyT1DHero

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No