Type 1 Diabetes MellitusNCT03436628
Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens
A study testing MyT1DHero in people with Type 1 Diabetes Mellitus and Adolescent Behavior, run by Michigan State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 10 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Adolescent Behavior, Parent-Child Relations
- What is being tested?
- MyT1DHero
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 31 Dec 2019
- 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
- Healthy volunteers accepted
- 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 A1c > 7;97
- have had at least two outpatient visits in the past two years;
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- be treated at Sparrow for diabetes;
- be fluent in English;
- have a parent/guardian willing to participate;
- be allowed to use a mobile phone for the study;
- have permission from their care team.
- The parent/guardian must:
- have an adolescent with T1D who is 10 to 15 years old;
- be fluent in English;
- have daily access to email and the Internet (for appointment reminders and technical support).
Who cannot join
- The exclusions for adolescents include:
- significant medical conditions other than T1D;
- being treated for thyroid disorders, celiac disease, or eating disorders;
- 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 mental retardation).
Trial locations and contacts
1 site in 1 country.
United States1 site
Michigan State University
East Lansing, Michigan, 48824
About this study
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.
- Being tested
- MyT1DHero
- Medical subject headings
- Diabetes Mellitus, Type 1, Adolescent Behavior, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyT1DHeroDevice
A mobile phone application
| Study group | Role | What they receive |
|---|---|---|
| App Use | Experimental | 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. Receives: Device: MyT1DHero |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline and 3 months
Secondary outcomes (6)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Mar 2018
- Primary completion31 Jul 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Sparrow Health System
- Responsible party
- Principal investigator, Bree Holtz, Michigan State University
- Investigators
- Bree M Holtz, PhD, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03436628
- Sponsor's protocol ID
- MyT1DHero
- Status last verified
- Oct 2020
- First submitted
- 5 Feb 2018
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34519670Holtz 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.
PubMed 30377142
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using an mHealth App to Transition Care of Type-1 Diabetes From Parents to Teens
- ClinicalTrials.gov ID
- NCT03436628
- Acronym / sponsor ID
- MyT1DHero
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Sparrow Health System
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Feb 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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| App Use | Experimental | Device: MyT1DHeroKids (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. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 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 A1c > 7;97
- have had at least two outpatient visits in the past two years;
Key exclusion criteria (6 listed)
- significant medical conditions other than T1D;
- being treated for thyroid disorders, celiac disease, or eating disorders;
- being in foster care.
- a diagnosis of a major psychiatric or neurocognitive disorder (e.g., traumatic brain injury, dementia, schizophrenia, bipolar disorder, borderline personality disorder, and mental retardation).
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 |
|---|---|---|
| MyT1DHeroA mobile phone application | Device | App Use |
Primary outcome
Change in Adherence to Self-management
Time frame: Baseline and 3 months
Measured with the Diabetes Behavior Rating Scale (5 point likert scale, never-always); A higher value represents a better outcome
Change in Hemoglobin A1c (HbA1c)
Time frame: Baseline and 3 months
A laboratory test of HbA1c will be collected at the local hospital; A lower value represents a better outcome
6 secondary outcomes
Change in Social Support
Time frame: Baseline and 3 months
Change in Self-Efficacy
Time frame: Baseline and 3 months
Change in Quality of Life
Time frame: Baseline and 3 months
Change in Conflict
Time frame: Baseline and 3 months
Parenting
Time frame: Baseline
Change in Parental Monitoring
Time frame: Baseline and 3 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 19 Oct 2020.
- Derived from this study: PubMed 34519670Holtz 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.
- Derived from this study: PubMed 30377142Holtz 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.
- Study Information WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Bree M Holtz, PhD principal investigator
Michigan State University
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 in people with Type 1 Diabetes Mellitus and Adolescent Behavior, 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 19 Oct 2020. 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 in Adherence to Self-management (time frame: Baseline and 3 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 NCT03436628, which also lists 2 linked publications.
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 19 Oct 2020.