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

Sponsors

Lead Sponsor: University of Western Ontario, Canada

Collaborator: Juvenile Diabetes Research Foundation

Source Western University, 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.

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.

Overall Status Completed
Start Date April 2012
Completion Date June 30, 2017
Primary Completion Date June 28, 2017
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test) 30 months
Enrollment 188
Condition
Intervention

Intervention Type: Other

Intervention Name: Transition Coordinator

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.

Arm Group Label: Transition Coordinator

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.

Gender: All

Minimum Age: 17 Years

Maximum Age: 20 Years

Healthy Volunteers: No

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

Canada

Verification Date

November 2018

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Transition Coordinator

Type: Other

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.

Label: Current Standard of Care

Type: No Intervention

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

Acronym TransClin
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov