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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01351857
Acronym
TransClin
Enrollment
188
Registered
2011-05-11
Start date
2012-04-30
Completion date
2017-06-30
Last updated
2018-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes, 17 to 20 years of age

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.

Interventions

OTHERTransition 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.

Sponsors

Juvenile Diabetes Research Foundation
CollaboratorOTHER
University of Western Ontario, Canada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
17 Years to 20 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime frameDescription
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)30 monthsIn 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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026