Intensive Care Program for Youth With Diabetes

Joslin Diabetes Center1 site in 1 country154 target enrollmentApril 2002

ConditionsType 1 Diabetes

Overview

Phase: N/A
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: Joslin Diabetes Center
Enrollment: 154
Locations: 1
Primary Endpoint: Glycemic control, assessed by hemoglobin A1c
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.

Registry

clinicaltrials.gov

Start Date

April 2002

End Date

June 2005

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Joslin Diabetes Center

Responsible Party

Principal Investigator

Lori Laffel

Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section

Joslin Diabetes Center

Eligibility Criteria

Inclusion Criteria

•Age 8-16 years
•Type 1 diabetes diagnosed by standard American Diabetes Association criteria
•Type 1 diabetes duration of at least 6 months
•Residence in northeastern U.S.
•Established clinic patient
•Fluency in English or Spanish

Exclusion Criteria

•Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
•Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)

Outcomes

Primary Outcomes

Glycemic control, assessed by hemoglobin A1c

Time Frame: Every 3 months

Secondary Outcomes

Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)(Annually)
Weight, assessed by z-BMI (age- and gender-adjusted body mass index)(Every 3 months)
Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia(Every 3 months)