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Study of A Cell-Phone System to Improve Health of Youth With Diabetes (FL3X)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01286350
First received: January 26, 2011
Last updated: February 18, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes
 Behavioral: health coaching with technology support

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Change from Baseline in HbA1c at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Baseline in Quality of Life measures at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Quality of Life will be assessed via self report questionnaire data.


Estimated Enrollment: 60
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard diabetes care
Experimental: Health Coaching
Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support
 Behavioral: health coaching with technology support
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

Ages Eligible for Study:   12 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • pregnant (if female)
  • diabetes type 2 or gestational
  • no health insurance
  • Pre-existing systemic chronic disease (drug abuse, cancer, psychiatric conditions)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01286350

Locations
United States, Colorado
University of Colorado Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
United States, North Carolina
WakeMed Hospital
Raleigh, North Carolina, United States, 27610
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45206
Sponsors and Collaborators
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Elizabeth Mayer-Davis, PhD UNC-CH
  More Information

Additional Information:
FL3X Study Official Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Elizabeth Mayer-Davis, PhD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01286350     History of Changes
Other Study ID Numbers: 10-0240, R21DK085483-01
Study First Received: January 26, 2011
Last Updated: February 18, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of North Carolina, Chapel Hill:
motivational interviewing
problem solving skills
family communication
technology support
cell phone system

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013