Diabetes Mellitus, Type 1Edu4UNCT02619487
The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
A study testing text message to parent only and text message to parent and adolescent in people with Diabetes Mellitus, Type 1, run by University of Louisville at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the Type 1 Diabetes (T1D). Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- text message to parent only and text message to parent and adolescent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2019to 13 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 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be willing to agree to participate(assent) in the study and have the permission of the parent to do so.
- Have a diagnosis of Type 1 diabetes for ≥ one year.
- Be aged 8 to 18 years old.
- Be on insulin therapy for ≥ one year.
- Have a parent/legal guardian with access to a working cell phone or have a parent/legal guardian with access to a working cell phone and have a working cell phone (if 13 years of age or older).
- Utilize one of the following mobile carriers: T-Mobile, Sprint, Verizon, AT\&T, or Virgin Mobile.
- The parent/legal guardian must express intent to maintain a carrier plan for the duration of the study.
- The parent/legal guardian must be able to read English OR the parent/legal guardian and the adolescent must be able to read English.
Who cannot join
- Participants, who in the opinion of the investigator, have any contraindication to tight glycemic control.
- Individuals who are unable to undertake blood glucose testing during the study period
- Individuals who are deemed unable or unlikely to comply with the protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the Type 1 Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12 years old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with T1D,no text message sent to parents of children age 8-12 years, and no text message sent to adolescents or parents of adolescents age 13-18 years old.
Read the detailed description
Managing Type 1 Diabetes requires daily checks of blood glucose and medication adjustments. Children and adolescents are known to have more difficulty with this than adults. Parents/legal guardians also face the task of helping with this self-management. A weekly text message regarding Type 1 Diabetes, sent to the parent or the parent and adolescent, may help to remind and motivate an individual to perform the daily tasks needed to manage their Type 1 Diabetes.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- text message to parent only, text message to parent and adolescent
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
text message to parent onlyOther
Also called e-health intervention
A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
text message to parent and adolescentOther
A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
| Study group | Role | What they receive |
|---|---|---|
| 8-12 years old, parent receiving text | Experimental | text message to parent only Receives: Other: text message to parent only |
| 13-18 years old, parent receiving text | Active comparator | text message to parent only Receives: Other: text message to parent only |
| 13-18 years, both receiving text | Active comparator | Text message to parent and adolescent Receives: Other: text message to parent and adolescent |
| No text | No intervention | No text will be sent |
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control assessed by HbA1C level.
review of lab value
Measured: up to one year after randomization occurs
Secondary outcomes (4)
number of episodes of Diabetic Ketoacidosis (DKA)
chart review of self reported episodes of Diabetic Ketoacidosis and chart review of hospitalizations related to DKA
Measured: up to one year after randomization occurs
number of episodes of severe hypoglycemia
chart review of reported episodes of severe hypoglycemia and chart review of hospitalizations related to hypoglycemia
Measured: up to one year after randomization occurs
number of patient contacts to the diabetes educator
chart review of educator documentation of communication with subject
Measured: up to one year after randomization occurs
number of hospitalizations related to T1D
chart review of hospitalizations related to T1D
Measured: up to one year after randomization occurs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startMar 2019 (estimated)
- Primary completion13 Dec 2019 (estimated)
- Study completion13 Dec 2019 (estimated)
Why it stopped: Due to limited staff resources, we were unable to start enrolling participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gwendolyn Pierce, University of Louisville
- Investigators
- Gwendolyn S Pierce, MSN, Principal investigator, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619487
- Sponsor's protocol ID
- 01
- Acronym
- Edu4U
- Status last verified
- Dec 2018
- First submitted
- 8 Jun 2015
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Mobile Technology on Clinical Outcomes in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02619487
- Acronym / sponsor ID
- Edu4U / 01
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to limited staff resources, we were unable to start enrolling participants.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- Mar 2019 (estimated)
- Primary completion
- 13 Dec 2019 (estimated)
- Study completion
- 13 Dec 2019 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- 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.
The purpose of this study is to determine whether a simple text message reminder sent to the parent of an child/adolescent with Type 1 Diabetes(or parent and adolescent) is effective in helping the individual(or parent) become more compliant with self-managing the Type 1 Diabetes (T1D). There will be 5 arms: text message sent to parents of children age 8-12 years old with T1D, text messages sent to parents of adolescents ,age 13-18 years old, with T1D,text messages sent to parents of adolescents with T1D as well as the adolescent with T1D,no text message sent to parents of children age 8-12 years, and no text message sent to adolescents or parents of adolescents age 13-18 years old.
Detailed description
Managing Type 1 Diabetes requires daily checks of blood glucose and medication adjustments. Children and adolescents are known to have more difficulty with this than adults. Parents/legal guardians also face the task of helping with this self-management. A weekly text message regarding Type 1 Diabetes, sent to the parent or the parent and adolescent, may help to remind and motivate an individual to perform the daily tasks needed to manage their Type 1 Diabetes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 8-12 years old, parent receiving text | Experimental | Other: text message to parent onlytext message to parent only |
| 13-18 years old, parent receiving text | Active comparator | Other: text message to parent onlytext message to parent only |
| 13-18 years, both receiving text | Active comparator | Other: text message to parent and adolescentText message to parent and adolescent |
| No text | No intervention | –No text will be sent |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Be willing to agree to participate(assent) in the study and have the permission of the parent to do so.
- Have a diagnosis of Type 1 diabetes for ≥ one year.
- Be aged 8 to 18 years old.
- Be on insulin therapy for ≥ one year.
- Have a parent/legal guardian with access to a working cell phone or have a parent/legal guardian with access to a working cell phone and have a working cell phone (if 13 years of age or older).
Key exclusion criteria (3 listed)
- Participants, who in the opinion of the investigator, have any contraindication to tight glycemic control.
- Individuals who are unable to undertake blood glucose testing during the study period
- Individuals who are deemed unable or unlikely to comply with the protocol.
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 |
|---|---|---|
| text message to parent onlyAlso: e-health interventionA weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year | Other | 13-18 years old, parent receiving text, 8-12 years old, parent receiving text |
| text message to parent and adolescentA weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year | Other | 13-18 years, both receiving text |
Primary outcome
glycemic control assessed by HbA1C level.
Time frame: up to one year after randomization occurs
review of lab value
4 secondary outcomes
number of episodes of Diabetic Ketoacidosis (DKA)
Time frame: up to one year after randomization occurs
number of episodes of severe hypoglycemia
Time frame: up to one year after randomization occurs
number of patient contacts to the diabetes educator
Time frame: up to one year after randomization occurs
number of hospitalizations related to T1D
Time frame: up to one year after randomization occurs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- 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.
Gwendolyn S Pierce, MSN principal investigator
University of Louisville
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing text message to parent only and text message to parent and adolescent in people with Diabetes Mellitus, Type 1, run by University of Louisville 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 8 inclusion and 3 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: withdrawn, as of the sponsor's last update on 17 Dec 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
glycemic control assessed by HbA1C level. (time frame: up to one year after randomization occurs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Dec 2018.