Type1diabetesNCT03521362

MyT1DHero: an mHealth Intervention for Type 1 Diabetes

A study testing MyT1DHero and Other T1D Mobile App in people with Type1diabetes, run by Michigan State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The overall objective of the proposed research is to improve HbA1c, adherence to treatment plans, and family communication surrounding adolescents' self-management of T1D. The investigators will test the efficacy of the MyT1DHero app against an attention control group. Read more about this study

Who is it for?: Ages 10 to 15 years
Conditions the study is for: Type1diabetes
What is being tested?: MyT1DHero and Other T1D Mobile App
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 1 siteUnited States
Study dates: 1 Jan 2019to 1 Dec 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 10 to 15 years
All sexes
No healthy volunteers
Child

Who may be able to join

The adolescents must:
have a T1D diagnosis according to the ADA practice guidelines,
be 10 to 15 years old,
have had a diagnosis of T1D for at least six months,
have an HbA1c > 7,
have had at least two outpatient visits in the past two years,

Show all 15Show fewer

be treated at Spectrum for diabetes,
be fluent in English,
have a parent/guardian willing to participate,
have and be allowed to use a mobile phone for the study, and
have permission from their care team to participate.
The parent/guardian must:
have an adolescent with T1D who is 10 to 15 years old,
be fluent in English, and
have daily access to email and the Internet (for appointment reminders and technical support).

Who cannot join

For the adolescents include:
significant medical conditions other than T1D,
being treated for thyroid disorders, celiac disease, or eating disorders, and
being in foster care.
Exclusion criteria for both the adolescents and parents/guardians include:
a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and intellectual and developmental disabilities.

Trial locations and contacts

1 site in 1 country.

United States1 site

Michigan State University
East Lansing, Michigan, 48823

Other trials in United States

About this study

Official title: MyT1DHero: A Randomized Controlled Trial of an mHealth Intervention to Improve Parent-child Communication and Adolescent Self-management of Type 1 Diabetes

Read the detailed description

This research seeks to realize the potential and test the efficacy of MyT1DHero to improve adolescent users' glycemic control and adherence to blood glucose monitoring. The investigators' goal is to help families receive more social support, and to improve diabetes knowledge, self-efficacy, family communication, and quality of life. The investigators further seek to decrease family conflict among children with T1D and their parents. In a 12-month RCT, investigators will randomize 166 adolescents and their parents to one of two groups: (1) attention control, or (2) the MyT1DHero app. Adolescents enrolled in the study will be 10-15 years old, and will have been living with T1D for <1 year or >5 years at the start of the study. The primary outcome will be a change in the participants' HbA1C from baseline levels at the start of the study, to levels measured after 12 months.

Conditions: Type1diabetes
Being tested: MyT1DHero, Other T1D Mobile App
Keywords: mHealth, Adolescent

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MyT1DHeroDevice
MyT1DHero is an app with two separate interfaces, one for the parent and one for the child, that work together to help them communicate about diabetes management. The child receives system reminders to enter their blood glucose numbers, and parents receive a notification about each blood glucose test their child enters. Parents are also able to use the app to communicate with their child about their plan for care. The app has customizable blood glucose reminders and ranges, videos of support from other adolescents with T1D, snack lists, and other educational information on T1D.
Other T1D Mobile AppDevice
A mobile app will be used in this control/comparison group that only has blood sugar testing reminders and logging capabilities. There will be no other components of the app.

Study groups in NCT03521362
Study group	Role	What they receive
MyT1DHero App	Experimental	Participants in this group will receive use of the MyT1DHero app. Receives: Device: MyT1DHero
"Other" T1D App	Active comparator	Participants in this group will receive use of a different app with less capabilities. Receives: Device: Other T1D Mobile App

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline Diabetes Behavior Rating Scale at 12 months
A measure of diabetes adherence for both parent and child participants. Never (1) - Always(5) with a higher score indicating better adherence.
Measured: Baseline and 12 months
Change from Baseline HbA1c at 6 months and 12 months
A laboratory test that measures how high blood glucose has been on average over the last 8-12 weeks - for child participants only (Lower number is best)
Measured: Baseline, 6 months, and 12 months

Secondary outcomes (21)

Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months
A measure of social support for the parent participants. Never (1) - Always (5), with a higher score indicating better support.
Measured: Baseline and 12 months
Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months
A measure of social support for the parent participants. Never (1) - Always (5), with a higher score indicating more support.
Measured: Baseline and 12 months
Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months
A measure of social support for the child participants. Never (1) - Always (5), with a higher score indicating more support.
Measured: Baseline and 12 months
Change from Baseline Diabetes Empowerment Scale Short Form at 12 months
A measure of diabetes-related self-efficacy for both parent and child participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more empowerment.
Measured: Baseline and 12 months
Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months
A measure of self-efficacy for the parent participants. I am not at all confident (1) - I am very confident (5), with a higher score indicating higher self-efficacy.
Measured: Baseline and 12 months
Change from Baseline NIH Toolbox Self-efficacy (ages 8-12) at 12 months
A measure of self-efficacy for the child participants. Never (1) - Very often (5), with a higher score indicating higher self-efficacy.
Measured: Baseline and 12 months
Change from Baseline Confidence in Diabetes Self-Care (Psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and U.S. patients with type 1 diabetes) at 12 months
A measure of diabetes-related self-efficacy for the child participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more confidence in self-care ability.
Measured: Baseline and 12 months
Change from Baseline PROMIS® Item Bank v1.0 - General Life Satisfaction - Short Form 5a at 12 months
A measure of quality of life for the parent participants. Strongly disagree (1) - Strongly agree (7), with a higher score indicating more life satisfaction.
Measured: Baseline and 12 months
Change from Baseline PedsQL (Measurement Model for the Pediatric Quality of Life Inventory) at 12 months
A measure of quality of life for the child participants. Never (0) - Almost Always (4), with a lower score indicating better quality of life.
Measured: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Stigma - Short Form at 12 months
A measure of stigma for the child participants. Never (1) - Always (5), with a higher score indicating more feelings of stigma.
Measured: Baseline and 12 months
Change from Baseline Diabetes Conflict Scale at 12 months
A measure of conflict for both the parent and child participants. Almost Always (1) - Never (3), with a higher score indicating less conflict.
Measured: Baseline and 12 months
Change from Baseline PROMIS® Parent Proxy Item Bank v1.0 - Family Relationships - Short Form 8a at 12 months
A measure of family characteristics for both the parent and child participants. Never (1) - Always (4), with a higher score indicating better family relationships.
Measured: Baseline and 12 months
Change from Baseline Diabetes Family Behavior Scale at 12 months
A measure of family characteristics for both the parent and child participants. All of the time (1) - Never (5), with a lower score indicating better family behavior.
Measured: Baseline and 12 months
Change from Baseline Family Functioning Scale at 12 months
A measure of family characteristics for both the parent and child participants. Totally disagree (1) - Totally agree (6). Responses are summed. Subscales include intimacy (items 1, 4, 6, 10, 13, 15, 18, 20, 23, 26, 27, 29), conflict (items 3, 5, 8, 9, 12, 14, 17, 19, 22, 24), and parenting style (items 2, 7, 11, 16, 21, 25, 28, 30).
Measured: Baseline and 12 months
Change from Baseline Impact on Family (Construct: Parental perceptions of the impact of a child's medical condition on the family) at 12 months
A measure of family characteristics for the parent participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more impact (burden).
Measured: Baseline and 12 months
Change from Baseline Family Satisfaction (FSS) at 12 months
A measure of family characteristics for the parent participants. Very dissatisfied (1) - Extremely satisfied (5), with a higher score indicating more satisfaction.
Measured: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Anxiety - Short Form at 12 months
A measure of anxiety for the parent participants. Never (1) - Always (5), with a higher score indicating more anxiety.
Measured: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Anxiety - Short Form at 12 months
A measure of anxiety for the child participants. Never (1) - Almost always (5), with a higher score indicating more anxiety; Not at all (1) - Very much (5); with a higher score indicating more anxiety.
Measured: Baseline and 12 months
Change from Baseline Short-Form Outcome Expectations at 12 months
A measure of diabetes outcome expectancy for both the parent and child participants. Strongly disagree (1) - Strongly agree (5), with a higher score indicating more positive outcome expectations
Measured: Baseline and 12 months
Usability and Satisfaction Questionnaire
A measure of technology usability and satisfaction for both the parent and child participants
Measured: 12 months
Unified theory of acceptance and use of technology (UTAUT) Vantakesh, Morris, et al., 2003
A measure of technology usability and satisfaction for both the parent and child participants
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20191 Dec 2021

First posted11 May 2018
Study start1 Jan 2019
Primary completion1 Dec 2021
Study completion1 Dec 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Type1diabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03521362
Sponsor's protocol ID: MyT1DHeroRCT
Status last verified: Apr 2022
First submitted: 18 Apr 2018
Last updated: 25 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MyT1DHero: A Randomized Controlled Trial of an mHealth Intervention to Improve Parent-child Communication and Adolescent Self-management of Type 1 Diabetes
ClinicalTrials.gov ID: NCT03521362
Acronym / sponsor ID: MyT1DHeroRCT
Conditions: Type1diabetes
Keywords: mHealth, Adolescent
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Michigan State UniversityUniversity, hospital or other
Collaborators: Corewell Health West, American Diabetes Association
Study start: 1 Jan 2019 (actual)
Primary completion: 1 Dec 2021 (actual)
Study completion: 1 Dec 2021 (actual)
First posted: 11 May 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MyT1DHero App	Experimental	Device: MyT1DHeroParticipants in this group will receive use of the MyT1DHero app.
"Other" T1D App	Active comparator	Device: Other T1D Mobile AppParticipants in this group will receive use of a different app with less capabilities.

Who may qualify

Ages: 10 to 15 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (15 listed)

The adolescents must:
have an adolescent with T1D who is 10 to 15 years old,
be fluent in English, and
have daily access to email and the Internet (for appointment reminders and technical support).

Key exclusion criteria (6 listed)

For the adolescents include:
a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and intellectual and developmental disabilities.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MyT1DHeroMyT1DHero is an app with two separate interfaces, one for the parent and one for the child, that work together to help them communicate about diabetes management. The child receives system reminders to enter their blood glucose numbers, and parents receive a notification about each blood glucose test their child enters. Parents are also able to use the app to communicate with their child about their plan for care. The app has customizable blood glucose reminders and ranges, videos of support from other adolescents with T1D, snack lists, and other educational information on T1D.	Device	MyT1DHero App
Other T1D Mobile AppA mobile app will be used in this control/comparison group that only has blood sugar testing reminders and logging capabilities. There will be no other components of the app.	Device	"Other" T1D App

Primary outcome

Change from Baseline Diabetes Behavior Rating Scale at 12 months
Time frame: Baseline and 12 months
A measure of diabetes adherence for both parent and child participants. Never (1) - Always(5) with a higher score indicating better adherence.
Change from Baseline HbA1c at 6 months and 12 months
Time frame: Baseline, 6 months, and 12 months
A laboratory test that measures how high blood glucose has been on average over the last 8-12 weeks - for child participants only (Lower number is best)

21 secondary outcomes

Change from Baseline PROMIS Item Bank v2.0 - Informational Support - Short Form 6a at 12 months
Time frame: Baseline and 12 months
Change from Baseline PROMIS Item Bank v2.0 - Emotional Support - Short Form 8a at 12 months
Time frame: Baseline and 12 months
Change from Baseline NIH Toolbox Emotional Support (Ages 8-17) at 12 months
Time frame: Baseline and 12 months
Change from Baseline Diabetes Empowerment Scale Short Form at 12 months
Time frame: Baseline and 12 months
Change from Baseline PROMIS® Item Bank v.1.0 - General Self-Efficacy at 12 months
Time frame: Baseline and 12 months
Change from Baseline NIH Toolbox Self-efficacy (ages 8-12) at 12 months
Time frame: Baseline and 12 months
Change from Baseline Confidence in Diabetes Self-Care (Psychometric properties of a new measure of diabetes-specific self-efficacy in Dutch and U.S. patients with type 1 diabetes) at 12 months
Time frame: Baseline and 12 months
Change from Baseline PROMIS® Item Bank v1.0 - General Life Satisfaction - Short Form 5a at 12 months
Time frame: Baseline and 12 months
Change from Baseline PedsQL (Measurement Model for the Pediatric Quality of Life Inventory) at 12 months
Time frame: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Stigma - Short Form at 12 months
Time frame: Baseline and 12 months
Change from Baseline Diabetes Conflict Scale at 12 months
Time frame: Baseline and 12 months
Change from Baseline PROMIS® Parent Proxy Item Bank v1.0 - Family Relationships - Short Form 8a at 12 months
Time frame: Baseline and 12 months
Change from Baseline Diabetes Family Behavior Scale at 12 months
Time frame: Baseline and 12 months
Change from Baseline Family Functioning Scale at 12 months
Time frame: Baseline and 12 months
Change from Baseline Impact on Family (Construct: Parental perceptions of the impact of a child's medical condition on the family) at 12 months
Time frame: Baseline and 12 months
Change from Baseline Family Satisfaction (FSS) at 12 months
Time frame: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Anxiety - Short Form at 12 months
Time frame: Baseline and 12 months
Change from Baseline Neuro-QOL Item Bank v1.0 -Pediatric Anxiety - Short Form at 12 months
Time frame: Baseline and 12 months
Change from Baseline Short-Form Outcome Expectations at 12 months
Time frame: Baseline and 12 months
Usability and Satisfaction Questionnaire
Time frame: 12 months
Unified theory of acceptance and use of technology (UTAUT) Vantakesh, Morris, et al., 2003
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
Study WebsiteLink provided by the sponsor.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MyT1DHero and Other T1D Mobile App in people with Type1diabetes, run by Michigan State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Diabetes Behavior Rating Scale at 12 months (time frame: Baseline and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03521362.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.