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

Study Overview
=================
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.

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

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: health coaching with technology support


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard diabetes care | |
| Experimental: Health coaching with technology support<br>Behavioral strategies including problem solving skills building, family communication counseling, technology support, motivational interviewing support. | Behavioral: health coaching with technology support<br>* Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.<br>* Other names: FL3X;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in HbA1c at 4 months |  | 4 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
motivational interviewing, problem solving skills, family communication, technology support, cell phone system