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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03436628
• Other study ID #: MyT1DHero
• Status: Completed
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2020
• Source: Michigan State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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).

Related Conditions & MeSH terms

• Adolescent Behavior
• Communication
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Parent-Child Relations
• Type 1 Diabetes Mellitus

Intervention

Device:
• MyT1DHero
A mobile phone application

Locations

Country	Name	City	State
United States	Michigan State University	East Lansing	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
Michigan State University	Sparrow Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Study Information Website