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

Phase 4

Completed

• Conditions: Type 1 Diabetes

• Registration Number: NCT01351857
• Lead Sponsor: University of Western Ontario, 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.

Study Timeline

• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Study Start: 2012-04
• Primary Completion: 2017-06-28
• Study Completion: 2017-06-30
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 188

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
In the 2 year transfer to adult care-Frequency of A1C (glycated hemoglobin test)	30 months	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

Trial Locations

Locations (4)

St. Joseph's Health Care; 🇨🇦 London, Ontario, Canada

London Health Sciences Centre - Children's Hospital; 🇨🇦 London, Ontario, Canada

Trillium Pediatric Diabetes Clinic; 🇨🇦 Mississauga, Ontario, Canada

Children's Hospital of Eastern Ontario; 🇨🇦 Ottawa, Ontario, Canada