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

University of North Carolina (UNC)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: health coaching with technology support

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02280564

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

10-0240

Details and patient eligibility

About

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.

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Control

No Intervention group

Description:

Standard diabetes care

Health coaching with technology support

Experimental group

Description:

Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support.

Treatment:

Behavioral: health coaching with technology support