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

October 29, 2014 updated by: Elizabeth Mayer-Davis, PhD, University of North Carolina, Chapel Hill

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Barbara Davis Center for Childhood Diabetes
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • FL3X

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in HbA1c at 4 months
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

October 29, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

October 31, 2014

Study Record Updates

Last Update Posted (Estimate)

October 31, 2014

Last Update Submitted That Met QC Criteria

October 29, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-0240
  • R21DK085483-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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