Type 1 Diabetes Clinical Trial
— TransClinOfficial 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
NCT number | NCT01351857 |
Other study ID # | CCTN1102 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2012 |
Est. completion date | June 30, 2017 |
Verified date | November 2018 |
Source | Western University, Canada |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 188 |
Est. completion date | June 30, 2017 |
Est. primary completion date | June 28, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 20 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre - Children's Hospital | London | Ontario |
Canada | St. Joseph's Health Care | London | Ontario |
Canada | Trillium Pediatric Diabetes Clinic | Mississauga | Ontario |
Canada | Children's Hospital of Eastern Ontario | Ottawa | Ontario |
Lead Sponsor | Collaborator |
---|---|
University of Western Ontario, Canada | Juvenile Diabetes Research Foundation |
Canada,
Osgood DW, Foster EM, Courtney ME. Vulnerable populations and the transition to adulthood. Future Child. 2010 Spring;20(1):209-29. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test) | In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test) & 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 | 30 months |
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