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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02280564

Acronym

FL3X

Enrollment

Registered

2014-10-31

Start date

2011-03-31

Completion date

2013-03-31

Last updated

2014-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

motivational interviewing, problem solving skills, family communication, technology support, cell phone system

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.

Interventions

BEHAVIORALhealth 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 16 Years

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)

Design outcomes

Primary

Measure	Time frame
Change from Baseline in HbA1c at 4 months	4 months

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026