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

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351857
• Other study ID #: CCTN1102
• Status: Completed
• Phase: Phase 4
• Start date: April 2012
• Est. completion date: June 30, 2017

Study information

• Verified date: November 2018
• Source: Western University, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: June 30, 2017
• Est. primary completion date: June 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
Canada	London Health Sciences Centre - Children's Hospital	London	Ontario
Canada	St. Joseph's Health Care	London	Ontario
Canada	Trillium Pediatric Diabetes Clinic	Mississauga	Ontario
Canada	Children's Hospital of Eastern Ontario	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Western Ontario, Canada	Juvenile Diabetes Research Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Osgood DW, Foster EM, Courtney ME. Vulnerable populations and the transition to adulthood. Future Child. 2010 Spring;20(1):209-29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	30 months

External Links

•   The Fact Sheet. Diabetes Type 1