FL3X Study: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes (FL3X)

Type 1 Diabetes Clinical Trial

— FL3X  

Official title:

FL3X: An Adaptive Intervention to Improve Outcomes for Youth With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286350
• Other study ID #: 13-2856 (UNC IRB)
• Secondary ID: 1UC4DK101132-01
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to see if a behavioral intervention for adolescents with type 1 diabetes will improve adherence to T1D self-management activities and improve diabetes outcomes. We expect the intervention to improve diabetes outcomes when compared to usual care.

Description:

The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support. All FL3X intervention participants will receive "FL3X-Basic", which is the initial 3-month intervention that includes 4 sessions (40-60 min), supplemented with short additional contacts (via text, email, or web-based communication) as needed. Thereafter, applying principles of adaptive interventions, based on a decision rule using A1c values measured at defined intervals, participants are iteratively assigned to "FL3X-Check-in" or "FL3X-Regular", both of which continue with MI and PSST for the underlying counseling strategy. In FL3X-Check-in, participants who are doing well ("responders") will receive minimal ongoing support to reinforce successful strategies through brief monthly "touch-base" contacts. In FL3X-Regular, those who are "Regular-responders" will have a minimum of 3-4 in-person full-length sessions (40-60 min) over each 6-month interval, with additional brief contacts as needed (e.g., text, voice, or internet). FL3X participants randomized to the control group will receive usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 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
• not planning on moving in the following 18 months

Exclusion Criteria:

• pregnant (if female)
• diabetes type 2 or gestational
• Pre-existing systemic chronic disease (drug abuse, cancer, certain psychiatric conditions)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• FL3X: Flexible Lifestyle Empowering Change
The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support.

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

Sponsors (7)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Children's Hospital Medical Center, Cincinnati, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Nemours Children's Clinic, University of Colorado Denver School of Medicine Barbara Davis Center, University of Pittsburgh, University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cost of intervention delivery	The study will evaluate cost to deliver intervention compared to usual care.	0-30 months
Primary	Hemoglobin A1c	HbA1c will be measured to determine impact on glucose control	0, 3, 6, 12, 18, 24, 30 months
Secondary	Motivation	Motivation related to diabetes care will be assessed	0, 3, 6, 12, 18, 24, 30 months
Secondary	Problem solving skills	Assess use of problem solving skills relative to diabetes care	0, 3, 6, 12, 18, 24, 30 months
Secondary	Hypoglycemia	Monitoring low blood sugar from continuous glucose monitoring	0, 6, 18 mo
Secondary	Diabetes self-management behaviors	Assess use of diabetes self-management behaviors	0, 3, 6, 12, 18, 24, 30 months
Secondary	Risk factors for diabetes complications	Assess variables related to diabetes complications	0, 3, 6, 12, 18, 24, 30 months
Secondary	Health-related quality of life	Assess health-related quality of life	0, 3, 6, 12, 18, 24, 30 months