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

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ClinicalTrials.gov Identifier: NCT01351857
Recruitment Status : Active, not recruiting
First Posted : May 11, 2011
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
Juvenile Diabetes Research Foundation
Information provided by (Responsible Party):
Western University, Canada ( University of Western Ontario, Canada )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Other: Transition Coordinator Phase 4

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2012
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   17 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351857


Locations
Canada, Ontario
St. Joseph's Health Care
London, Ontario, Canada, N6A 4V2
London Health Sciences Centre - Children's Hospital
London, Ontario, Canada, N6A 5W9
Trillium Pediatric Diabetes Clinic
Mississauga, Ontario, Canada, L5B 1B8
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
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

Additional Information:
Publications:
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
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: December 2016

Keywords provided by Western University, Canada ( 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