Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
TransClin
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
1 other identifier
interventional
188
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2012
Longer than P75 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2011
CompletedFirst Posted
Study publicly available on registry
May 11, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 28, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2017
CompletedNovember 9, 2018
November 1, 2018
5.2 years
May 10, 2011
November 7, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
30 months
Secondary Outcomes (1)
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
30 months
Study Arms (2)
Transition Coordinator
OTHERA 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.
Current Standard of Care
NO INTERVENTIONSubjects 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
St. Joseph's Health Care
London, Ontario, N6A 4V2, Canada
London Health Sciences Centre - Children's Hospital
London, Ontario, N6A 5W9, Canada
Trillium Pediatric Diabetes Clinic
Mississauga, Ontario, L5B 1B8, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
Related Publications (3)
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.
PMID: 20364628BACKGROUNDSpaic 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.
PMID: 31010873DERIVEDSpaic 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.
PMID: 24106787DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheril Clarson, MD
London Health Sciences Centre - Children's Hospital
- PRINCIPAL INVESTIGATOR
Tamara Spaic
St. Joseph's Healthcare Centre
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2011
First Posted
May 11, 2011
Study Start
April 1, 2012
Primary Completion
June 28, 2017
Study Completion
June 30, 2017
Last Updated
November 9, 2018
Record last verified: 2018-11