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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Transition Coordinator
Sponsored by
University of Western Ontario, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, 17 to 20 years of age

Eligibility Criteria

17 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Joseph's Health Care
  • London Health Sciences Centre - Children's Hospital
  • Trillium Pediatric Diabetes Clinic
  • Children's Hospital of Eastern Ontario

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Transition Coordinator

Current Standard of Care

Arm Description

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.

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

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 10, 2011
Last Updated
November 7, 2018
Sponsor
University of Western Ontario, Canada
Collaborators
Juvenile Diabetes Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01351857
Brief Title
Diabetes Care Management Compared to Standard Diabetes Care in Adolescents and Young Adults With Type 1 Diabetes
Acronym
TransClin
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 Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 28, 2017 (Actual)
Study Completion Date
June 30, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Western Ontario, Canada
Collaborators
Juvenile Diabetes Research Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 Diabetes, 17 to 20 years of age

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
188 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transition Coordinator
Arm Type
Other
Arm Description
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.
Arm Title
Current Standard of Care
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Transition Coordinator
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)
Description
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
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheril Clarson, MD
Organizational Affiliation
London Health Sciences Centre - Children's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tamara Spaic
Organizational Affiliation
St. Joseph's Healthcare Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
London Health Sciences Centre - Children's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Trillium Pediatric Diabetes Clinic
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
20364628
Citation
Osgood DW, Foster EM, Courtney ME. Vulnerable populations and the transition to adulthood. Future Child. 2010 Spring;20(1):209-29. doi: 10.1353/foc.0.0047.
Results Reference
background
PubMed Identifier
31010873
Citation
Spaic T, Robinson T, Goldbloom E, Gallego P, Hramiak I, Lawson ML, Malcolm J, Mahon J, Morrison D, Parikh A, Simone A, Stein R, Uvarov A, Clarson C; JDRF Canadian Clinical Trial CCTN1102 Study Group. Closing the Gap: Results of the Multicenter Canadian Randomized Controlled Trial of Structured Transition in Young Adults With Type 1 Diabetes. Diabetes Care. 2019 Jun;42(6):1018-1026. doi: 10.2337/dc18-2187. Epub 2019 Apr 22.
Results Reference
derived
PubMed Identifier
24106787
Citation
Spaic T, Mahon JL, Hramiak I, Byers N, Evans K, Robinson T, Lawson ML, Malcolm J, Goldbloom EB, Clarson CL; JDRF Canadian Clinical Trial CCTN1102 Study Group. 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 (Transition Trial). BMC Pediatr. 2013 Oct 9;13:163. doi: 10.1186/1471-2431-13-163.
Results Reference
derived

Learn more about this trial

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

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