Bridging the Gap to Adult Diabetes Care

Type1diabetes Clinical Trial

Official title:

Bridging the Gap to Optimize Care and Outcomes for Youth With Diabetes Between Pediatric and Adult Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03781973
• Other study ID #: CTO project ID: 1581
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2024
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Adolescents with type 1 diabetes face particular challenges related to having a chronic illness that requires daily intensive self-management and medical follow-up during a period when their social, developmental, educational, and family situations are in flux. When transitioning from pediatric to adult care, over a third of youth have a care gap of >6 months. During this vulnerable period youth are at risk for acute life-threatening complications such as diabetic ketoacidosis, and for poor glycemic control, which confers an increased risk of chronic diabetes complications. Gaps in care may be a result of deficiencies in transition processes causing some young people to be poorly prepared for adult care and dissatisfied with the transition process. Ineffective transition can lead to decreased frequency of diabetes visits and an increased risk of adverse events in young adulthood. Further, risk factors such as psychiatric comorbidity and behavioural problems in adolescents with type 1 diabetes are associated with poor outcomes in early adulthood. Quality improvement initiatives can be designed to optimize care processes such as referral systems to adult diabetes providers. Our overall objective is to optimize care and outcomes for youth with diabetes as they transition to adult care. Specific Aim 1: To improve glycemic control in youth around the time of transition from pediatric to adult diabetes care Specific Aim 2: To evaluate the fidelity and quality of a quality improvement intervention designed to improve transition care processes and to identify contextual factors associated with variation in outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

Inclusion Criteria:

• All youth with a clinical diagnosis of type 1 diabetes followed at participating centres at the time of their final pediatric clinic visit between Jan 1, 2018 and Dec 31, 2020.
• Participants will be transitioning to Adult Care (ages ~16-19 yrs).
• Capacity to read and understand English (we estimate that >95% of participants will fulfill this requirement).
• Capacity to consent for themselves.

Exclusion Criteria:

• Individuals with non-type 1 diabetes.
• Individuals with type 1 diabetes who move out of Ontario within 12 months after their final pediatric visit.
• Individuals with type 1 diabetes who do not have the capacity to consent for themselves.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type1diabetes

Intervention

Behavioral:
• Data platform +Quality Performance feedback reports
Teams from each of the participating sites will attend the webinars. Each site will share an example of a QI initiative that they are executing and describe the success and challenges.

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital	Hamilton	Ontario
Canada	Children's Hospital, London Health Sciences Centre	London	Ontario
Canada	Markham Stouffville Hospital, Clinic 4	Markham	Ontario
Canada	Trillium Health Partners	Mississauga	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Hemoglobin A1c	HbA1c value up to 12 months after the final pediatric visit.
Secondary	Number of Diabetes-related admissions, ED visits, death	The occurrence of at least one diabetes-related admissions or emergency department visit or death	number of occurrences up to12 months after the final pediatric visit.
Secondary	Time from the final pediatric visit to the first adult diabetes visit	identified using physician service claims and defined as the first diabetes office visit by an adult endocrinologist, internist, or family physician	Time in months up to 12 months after the final pediatric visit