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

This study has been completed.
Sponsor:
Collaborator:
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: March 6, 2014
Last verified: March 2014

January 26, 2011
March 6, 2014
March 2011
March 2013   (final data collection date for primary outcome measure)
Change from Baseline in HbA1c at 4 months [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01286350 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Study of A Cell-Phone System to Improve Health of Youth With Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes
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.
  • No Intervention: Control
    Standard diabetes care
  • Experimental: Health Coaching
    Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support
    Intervention: Behavioral: health coaching with technology support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
March 2013
March 2013   (final data collection date for primary outcome measure)

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)
Both
12 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01286350
10-0240, R21DK085483-01
No
Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Elizabeth Mayer-Davis, PhD UNC-CH
University of North Carolina, Chapel Hill
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP