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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 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

May 10, 2011
March 19, 2014
April 2012
October 2016   (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 ] [ Designated as safety issue: No ]
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 ]
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 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 ]
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 ] [ Designated as safety issue: No ]
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.
 
Recruiting
188
April 2017
October 2016   (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.
Both
17 Years to 20 Years
No
Contact: Cheril Clarson, MD cheril.clarson@lhsc.on.ca
Contact: Tamara Spaic, MD tamaraspaic@gmail.com
Canada
 
NCT01351857
CCTN1102
Yes
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
University of Western Ontario, Canada
March 2014

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