Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatment transition coordinator
Phase phase 4
Sponsor University of Western Ontario, Canada
Collaborator Juvenile Diabetes Research Foundation
Start date April 2012
End date October 2016
Trial size 188 participants
Trial identifier NCT01351857, CCTN1102

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Other)
A Transition Coordinator, a Certified Diabetes Educator, will provide transition support and the link between pediatric and adult diabetes care. The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
transition coordinator
The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
(No Intervention)
Subjects in the control group will transition to adult care equal to the intervention group and will differ only by exclusion of Transition Coordinator. Control group will receive the current standard of diabetes care otherwise unchanged. Three months following randomization, subjects in the control group will be referred to the adult endocrinologist in the same way as subjects in the intervention group

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
time frame: 30 months

Eligibility Criteria

Male or female participants from 17 years up to 20 years old.

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.

Additional Information

Official title 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
Principal investigator Cheril Clarson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by University of Western Ontario, Canada.