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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03436628
Enrollment
70
Registered
2018-02-19
Start date
2018-03-01
Completion date
2019-12-31
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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.

Interventions

DEVICEMyT1DHero

A mobile phone application

Sponsors

Sparrow Health System
CollaboratorOTHER
Michigan State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Adherence to Self-managementBaseline and 3 monthsMeasured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome
Change in Hemoglobin A1c (HbA1c)Baseline and 3 monthsA laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome

Secondary

MeasureTime frameDescription
Change in Quality of LifeBaseline and 3 monthsMeasured using PedsQL (5-point likert scale, never-almost always); A higher value represents a better outcome
Change in ConflictBaseline and 3 monthsMeasured using Diabetes Family Conflict Scale (3-point likert scale, always-never); A lower value represents a better outcome
Change in Social SupportBaseline and 3 monthsMeasured with the Multidimensional Scale of Perceived Social Support (5 point likert scale, all of the time-never); A lower value represents a better outcome
Change in Parental MonitoringBaseline and 3 monthsMeasured using Parental Monitoring of Diabetes Care Scale (5-point likert scale, always-never); A lower value represents a better outcome
ParentingBaselineMeasured 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.
Change in Self-EfficacyBaseline and 3 monthsMeasured using Diabetes Empowerment Scale - Short Form (5-point likert scale, strongly disagree-strongly agree); A higher value represents a better outcome

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026