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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01351857
First Posted: May 11, 2011
Last Update Posted: March 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Western University, Canada ( University of Western Ontario, Canada )
May 10, 2011
May 11, 2011
March 24, 2017
April 2012
May 2017   (Final data collection date for primary outcome 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. [ Time Frame: 30 months ]
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 ]
structured transition program that will span 18 months or to receive standard diabetes care. Subjects will be seen in the pediatric care setting for 6 months and will then be transferred to the adult care setting where they will be seen for one year. There will then be a one-year follow-up period for outcome assessment.
Complete list of historical versions of study NCT01351857 on ClinicalTrials.gov Archive Site
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test) [ Time Frame: 30 months ]
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
The frequency of A1C testing in the two years of transfer to adult care. Mean A1C levels during the two years of transfer to adult care [ Time Frame: 30 months ]
Not Provided
Not Provided
 
Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
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
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.
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetes
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.
  • 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.
    Intervention: Other: Transition Coordinator
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
188
October 2017
May 2017   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
17 Years to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01351857
CCTN1102
Yes
Not Provided
Not Provided
Western University, Canada ( University of Western Ontario, Canada )
University of Western Ontario, Canada
Juvenile Diabetes Research Foundation
Principal Investigator: Cheril Clarson, MD London Health Sciences Centre - Children's Hospital
Principal Investigator: Tamara Spaic St. Joseph's Healthcare Centre
Western University, Canada
December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP