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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280564
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : October 31, 2014
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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Behavioral: health coaching with technology support Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of A Cell-Phone System to Improve Health of Youth With Diabetes
Study Start Date : March 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control
Standard diabetes care
Experimental: Health coaching with technology support
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.
Other Name: FL3X




Primary Outcome Measures :
  1. Change from Baseline in HbA1c at 4 months [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Change from Baseline in Quality of Life measures at 4 months [ Time Frame: 4 months ]
    Quality of Life will be assessed via self report questionnaire data.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280564


Locations
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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
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Principal Investigator: Elizabeth Mayer-Davis, PhD UNC-CH
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Responsible Party: Elizabeth Mayer-Davis, PhD, Professor, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02280564    
Other Study ID Numbers: 10-0240
R21DK085483-01 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2014    Key Record Dates
Last Update Posted: October 31, 2014
Last Verified: October 2014
Keywords provided by Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill:
motivational interviewing
problem solving skills
family communication
technology support
cell phone system
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases