Multicentre Randomized Controlled Trial of Structured Transition on Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes

University of Western Ontario, Canada4 sites in 1 country188 target enrollmentApril 2012

ConditionsType 1 Diabetes

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Type 1 Diabetes
Sponsor: University of Western Ontario, Canada
Enrollment: 188
Locations: 4
Primary Endpoint: The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care.
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance as well as glycemic control after transition from pediatric to adult diabetes care.

Detailed Description

The purpose of this study is to determine if a structured transition program for adolescents and young adults with Type 1 Diabetes (T1D) improves diabetes clinic attendance and management as well as glycemic control after transition from pediatric to adult diabetes care.

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

June 30, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Western Ontario, Canada

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Established T1D diagnosis for a minimum of one year (chosen to allow time for adjustment to a new diagnosis and more stable disease control).
•Between the ages of 17 and 20 years. It is left to the clinical judgment of the pediatric endocrinologist to determine individually the appropriate age of the transition for each subject
•At least 1 visit during the previous year with the pediatric endocrinologist at a Diabetes Clinic (aim is to minimize the non-adherence with the intervention).
•Ability to participate in all aspects of this clinical trial.
•Written informed consent/assent must be obtained and documented.
•Resident of Ontario.

Exclusion Criteria

•Pregnant or lactating females or intent to become pregnant during the next 3 years.
•Conditions which in the opinion of the investigator may interfere with the subject's ability to participate in the study.
•Prior enrollment in the current study.
•Current participation in another clinical trial or participation in another clinical trial in the 6 months prior to enrollment.

Outcomes

Primary Outcomes

The proportion of subjects who fail to attend at least one outpatient adult endocrinology visit during the second year after transition to adult diabetes care.

Time Frame: 30 months