Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes (TransClin)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Western Ontario, Canada
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
University of Western Ontario, Canada
ClinicalTrials.gov Identifier:
NCT01351857
First received: May 10, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Other: Transition Coordinator
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Western Ontario, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In the 2 years of transfer to adult care-Frequency of A1C testing and mean levels Frequency of retinal exam microalbumin to creatinine ratio fasting lipid profile and foot exam testing Rate of hospitalization/ER visits for acute complications of diabetes [ Time Frame: 30 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 188
Study Start Date: April 2012
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Transition Coordinator
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.
Other: 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: Current Standard of Care
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

  Eligibility

Ages Eligible for Study:   17 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351857

Contacts
Contact: Cheril Clarson, MD cheril.clarson@lhsc.on.ca
Contact: Tamara Spaic, MD tamaraspaic@gmail.com

Locations
Canada, Ontario
London Health Sciences Centre - Children's Hospital Recruiting
London, Ontario, Canada, N6A 5W9
Principal Investigator: Cheril Clarson, MD         
St. Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Tamara Spaic         
Trillium Pediatric Diabetes Clinic Not yet recruiting
Mississauga, Ontario, Canada, L5B 1B8
Principal Investigator: Angelo Simone, MD         
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Principal Investigator: Margaret Lawson, MD         
Sponsors and Collaborators
University of Western Ontario, Canada
Juvenile Diabetes Research Foundation
Investigators
Principal Investigator: Cheril Clarson, MD London Health Sciences Centre - Children's Hospital
Principal Investigator: Tamara Spaic St. Joseph's Healthcare Centre
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Western Ontario, Canada
ClinicalTrials.gov Identifier: NCT01351857     History of Changes
Other Study ID Numbers: CCTN1102
Study First Received: May 10, 2011
Last Updated: March 19, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of Western Ontario, Canada:
Type 1 Diabetes
17 to 20 years of age

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 20, 2014