An interventional study of MyT1DHero in Type 1 Diabetes Mellitus, Adolescent Behavior and Parent-Child Relations, sponsored by Michigan State University. Completed at 1 site in United States. Open to participants aged 10 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Michigan State University · Not applicable, Interventional, and Health services research
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.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's enrollment of 70 is above the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Michigan State University is the lead sponsor of 143 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The adolescents must:
The parent/guardian must:
Exclusion Criteria:
The exclusions for adolescents include:
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).
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
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
Time frame: 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
Time frame: Baseline and 3 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Baseline and 3 months
Plan to share: No
Ran from Mar 2018 to primary completion in Jul 2019, 16 months.
Of 844 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 16 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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