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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: health coaching with technology support

• Registration Number: NCT02280564
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2011-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-10
• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Last Update Submitted: 2014-10-29
• Study First Posted: 2014-10-31
• Last Update Posted: 2014-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health coaching with technology support	health coaching with technology support	Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in HbA1c at 4 months	4 months

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Quality of Life measures at 4 months	4 months	Quality of Life will be assessed via self report questionnaire data.

Trial Locations

Locations (3)

WakeMed Hospital; 🇺🇸 Raleigh, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

University of Colorado Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States