Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes (TransClin)
This study is currently recruiting participants.
Verified September 2012 by University of Western Ontario, Canada
Sponsor:
University of Western Ontario, Canada
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: September 28, 2012
Last verified: September 2012
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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: | December 2016 |
| Estimated Primary Completion Date: | June 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
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:
| 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: | September 28, 2012 |
| 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 June 13, 2013