Type 1 DiabetesFL3XNCT02280564
Study of A Cell-Phone System to Improve Health of Youth With Diabetes
A study testing health coaching with technology support in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 3 sites in United States.
Trial summary
FL3X is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. Read more about this study
- Who is it for?
- Ages 12 to 16 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- health coaching with technology support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2011to Mar 2013
- 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 12 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- type 1 diabetes with duration at least 12 months
- between ages 12-16 years at registration
- poor glycemic control (A1c 8.0-13.0%)
- parent/guardian willing to also participate
- minority race/ethnicity
- low income
Who cannot join
- pregnant (if female)
- diabetes type 2 or gestational
- no health insurance
- Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Colorado Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206
WakeMed Hospital
Raleigh, North Carolina, 27610
About this study
Official title: Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes
FL3X is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. Utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.
Read the detailed description
FL3X utilizes diabetes care providers (diabetes educators) as health coaches to employ behavioral modification techniques including motivational interviewing and problem solving skills training. Coaches help adolescents and their families learn these techniques to improve diabetes self management behaviors and diabetes care.
- Conditions
- Type 1 Diabetes
- Being tested
- health coaching with technology support
- Keywords
- motivational interviewing, problem solving skills, family communication, technology support, cell phone system
- 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.
health coaching with technology supportBehavioural
Also called FL3X
Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard diabetes care |
| Health coaching with technology support | Experimental | Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support. Receives: Behavioral: health coaching with technology support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in HbA1c at 4 months
Measured: 4 months
Secondary outcomes (1)
Change from Baseline in Quality of Life measures at 4 months
Quality of Life will be assessed via self report questionnaire data.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startMar 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill
- Investigators
- Elizabeth Mayer-Davis, PhD, Principal investigator, UNC-CH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280564
- Sponsor's protocol ID
- 10-0240
- Other IDs
- R21DK085483-01
- Acronym
- FL3X
- Status last verified
- Oct 2014
- First submitted
- 29 Oct 2014
- Last updated
- 31 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes
- ClinicalTrials.gov ID
- NCT02280564
- Acronym / sponsor ID
- FL3X / 10-0240
- Conditions
- Type 1 Diabetes
- Keywords
- motivational interviewing, problem solving skills, family communication, technology support, cell phone system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Mar 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 31 Oct 2014 (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.
FL3X is an integrated diabetes self-management system that incorporates modern cell phone technology with behavioral modification approaches to improve diabetes self-management in high-risk youth. Utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.
Detailed description
FL3X utilizes diabetes care providers (diabetes educators) as health coaches to employ behavioral modification techniques including motivational interviewing and problem solving skills training. Coaches help adolescents and their families learn these techniques to improve diabetes self management behaviors and diabetes care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard diabetes care |
| Health coaching with technology support | Experimental | Behavioral: health coaching with technology supportBehavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support. |
Who may qualify
- Ages
- 12 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- type 1 diabetes with duration at least 12 months
- between ages 12-16 years at registration
- poor glycemic control (A1c 8.0-13.0%)
- parent/guardian willing to also participate
- minority race/ethnicity
Key exclusion criteria (4 listed)
- pregnant (if female)
- diabetes type 2 or gestational
- no health insurance
- Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)
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 |
|---|---|---|
| health coaching with technology supportAlso: FL3XIntensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills. | Behavioural | Health coaching with technology support |
Primary outcome
Change from Baseline in HbA1c at 4 months
Time frame: 4 months
1 secondary outcome
Change from Baseline in Quality of Life measures at 4 months
Time frame: 4 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 31 Oct 2014.
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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.
Elizabeth Mayer-Davis, PhD principal investigator
UNC-CH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing health coaching with technology support in people with Type 1 Diabetes, run by University of North Carolina, Chapel Hill at 3 sites 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 6 inclusion and 4 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 31 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 in HbA1c at 4 months (time frame: 4 months). 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 31 Oct 2014.