Study of A Cell-Phone System to Improve Health of Youth With Diabetes
FL3X
Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes
2 other identifiers
interventional
74
1 country
3
Brief 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. Utilizing such approaches will increase adherence to diabetes management behaviors and improve glucose control by providing increased autonomy over diabetes care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2011
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 29, 2014
CompletedFirst Posted
Study publicly available on registry
October 31, 2014
CompletedOctober 31, 2014
October 1, 2014
2 years
October 29, 2014
October 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline in HbA1c at 4 months
4 months
Secondary Outcomes (1)
Change from Baseline in Quality of Life measures at 4 months
4 months
Study Arms (2)
Control
NO INTERVENTIONStandard diabetes care
Health coaching with technology support
EXPERIMENTALBehavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support.
Interventions
Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- pregnant (if female)
- diabetes type 2 or gestational
- no health insurance
- Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Colorado Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, 80045, United States
WakeMed Hospital
Raleigh, North Carolina, 27610, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45206, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Mayer-Davis, PhD
UNC-CH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 29, 2014
First Posted
October 31, 2014
Study Start
March 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
October 31, 2014
Record last verified: 2014-10