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

NCT ID: NCT02280564

Last Updated: 2014-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control

Standard diabetes care

Group Type NO_INTERVENTION

No interventions assigned to this group

Health coaching with technology support

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

Group Type EXPERIMENTAL

health coaching with technology support

Intervention Type BEHAVIORAL

Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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FL3X

Eligibility Criteria

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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)
Minimum Eligible Age

12 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth Mayer-Davis, PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth Mayer-Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

UNC-CH

Locations

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University of Colorado Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Site Status

WakeMed Hospital

Raleigh, North Carolina, United States

Site Status

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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R21DK085483-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10-0240

Identifier Type: -

Identifier Source: org_study_id