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

Type 1 Diabetes Clinical Trial

— FL3X  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280564
• Other study ID #: 10-0240
• Secondary ID: R21DK085483-01
• Status: Completed
• Phase: N/A
• First received: October 29, 2014
• Last updated: October 29, 2014
• Start date: March 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2014
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	University of Colorado Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	WakeMed Hospital	Raleigh	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in HbA1c at 4 months		4 months	No
Secondary	Change from Baseline in Quality of Life measures at 4 months	Quality of Life will be assessed via self report questionnaire data.	4 months	No