Clinical trial NCT01351857: Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
17 to 20 years of age
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2011-05-11
Enrollment: 188
Sex: ALL
Minimum age (years): 17
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.
timeFrame: 30 months
Secondary outcomes:
measure: In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
timeFrame: 30 months
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Health Care
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - Children's Hospital
state: Ontario
city: Mississauga
country: Canada
facility: Trillium Pediatric Diabetes Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
Study officials:
affiliation: London Health Sciences Centre - Children's Hospital
name: Cheril Clarson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Healthcare Centre
name: Tamara Spaic
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osgood DW, Foster EM, Courtney ME. Vulnerable populations and the transition to adulthood. Future Child. 2010 Spring;20(1):209-29. doi: 10.1353/foc.0.0047.
citation: Spaic T, Robinson T, Goldbloom E, Gallego P, Hramiak I, Lawson ML, Malcolm J, Mahon J, Morrison D, Parikh A, Simone A, Stein R, Uvarov A, Clarson C; JDRF Canadian Clinical Trial CCTN1102 Study Group. Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. Diabetes Care. 2019 Jun;42(6):1018-1026. doi: 10.2337/dc18-2187. Epub 2019 Apr 22.
citation: Spaic T, Mahon JL, Hramiak I, Byers N, Evans K, Robinson T, Lawson ML, Malcolm J, Goldbloom EB, Clarson CL; JDRF Canadian Clinical Trial CCTN1102 Study Group. 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 (Transition Trial). BMC Pediatr. 2013 Oct 9;13:163. doi: 10.1186/1471-2431-13-163.