Diabetes Transition Coordinator Study

NCT06300047 | Enrolling By Invitation

• 1 other identifier: REB23-0679
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to assess the effects and evaluate the implementation of a pediatric to adult care transition intervention in youth with T1D on clinical, patient-reported, and implementation outcomes, including an economic analysis. The 3 main aims are:

1. 1.To assess the effects of our transition intervention on clinical and patient-reported outcomes.
2. 2.To implement the transition intervention and evaluate the implementation outcomes.
3. 3.To evaluate the economic impacts of the transition intervention. Participants will have access to a transition coordinator before, during, and after their planned transition from pediatric to adult care as standard of care.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Lost to Followup

  % of participants who are lost to follow up as defined by not attending at least one routine clinic visit in adult diabetes care with a health care professional to be ascertained from physician billing claims or NACRS claims data

  within 1 year of transfer date from pediatric care

Secondary Outcomes (9)

• Patient Reported Outcome Survey 1

  within 2 months of transfer from pediatric care, repeated at 12 months after transfer

• Patient Reported Outcome Survey 2

  within 2 months of transfer from pediatric care, repeated at 12 months after transfer

• Patient Reported Outcome Survey 3

  within 2 months of transfer from pediatric care, repeated at 12 months after transfer

• Clinical Outcome 1

  one year prior to transfer from pediatric care up to 18 months post transfer

• Clinical Outcome 2

  one year prior to transfer from pediatric care up to 18 months post transfer

Study Arms (2)

Usual Care Group

NO INTERVENTION

No intervention group used as a control leading into the intervention for comparative analysis. Patients in this arm receive care as usual with no changes and are not aware of the intervention group.

Intervention Group

EXPERIMENTAL

Patients in this arm receive access to and support from a Transition coordinator who will meet with them prior to transition from pediatric to adult care and follow up with them every 2 months throughout the first year of their transition period utilizing phone, text, email, social media.

Other: Non-Medical Transition Coordinator

Interventions

Non-Medical Transition Coordinator OTHER

Participants in this intervention arm will have access to the non-medical transition coordinator to support their transition from pediatric to adult care.

Intervention Group

Eligibility Criteria

• Age: 17 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• a diagnosis of T1D according to Diabetes Canada's guidelines for at least 12 months
• aged 17 to 18 years
• have had an appointment with their pediatric endocrinologist in the last 12 months
• in the last year of pediatric care and transferring to adult care in Alberta within the next year
• English proficiency (for surveys)
• Personal Health Number (PHN) for data linkage.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• University of Calgary: lead
• Juvenile Diabetes Research Foundation: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Sonia Butalia, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The usual care group is defined as the group who receives usual care and serves as the control group. This group is defined prior to the implementation of the intervention. We include a two month wash out period between our two groups to avoid care providers 'holding on' to patients they feel may benefit from the intervention

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: March 8, 2024
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)