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

University of Western Ontario, Canada

Status and phase: Completed; Phase 4

Conditions: Type 1 Diabetes

Treatments: Other: Transition Coordinator

Study type: Interventional

Funder types: Other

Identifiers

NCT01351857

CCTN1102

Details and patient eligibility

About

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.

Full 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.

Enrollment: 188 patients

Sex: All

Ages: 17 to 20 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

188 participants in 2 patient groups

Transition Coordinator

Other group

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.

Treatment:

Other: Transition Coordinator

Current Standard of Care

No Intervention group

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