Recruiting

Observational Study

Sponsor:

Anne-Sophie Brazeau

Code:

NCT05910840

Conditions

Diabetes Mellitus

Diabetes Mellitus, Type 1

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Metabolic Disease

Endocrine System Diseases

Eligibility Criteria

Sex: All

Age: 14 - 16

Healthy Volunteers: Not accepted

Interventions

Support-t

Study Details

Brief summary:

The investigators will conduct a randomized controlled trial (RCT) to examine how an online training and peer support platform could help the preparation to transition to adult care. Among 14-16 year old youth with Type 1 Diabetes (T1D), the investigators aim to assess the effect of an online training and peer support platform (Support-t) integrated in usual care, compared with usual care on Hemoglobin A1c (HbA1c), adverse outcomes and psychosocial measures during the preparation for transition to adult care. The investigators will conduct a multi-site, parallel group, blinded (outcome assessors, data analysts), superiority RCT of adolescents with T1D (14-16 years of age) followed at one of 4 university teaching hospital-based pediatric diabetes clinics in the province of Quebec.

Conditions

Diabetes Mellitus

Diabetes Mellitus, Type 1

Glucose Metabolism Disorders (Including Diabetes Mellitus)

Metabolic Disease

Endocrine System Diseases

Study ID

NCT05910840

Start date

Oct 7, 2024

Status verified date

Sep, 2025

Completion date

Oct, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adolescents with a clinical diagnosis of T1D
  • 14-16 years of age
  • Receiving diabetes care at one of 4 university teaching hospital-based pediatric diabetes clinics in Quebec: Montreal Children's Hospital-McGill University Health Centre, Centre hospitalier universitaire de Sherbrooke, Le Copain-Hôpital de Gatineau, Centre Hospitalier Universitaire de Québec
  • Having access to internet
  • Having an active email address
  • Fluent in English or French

Exclusion Criteria:

  • Severe neurocognitive disabilities
  • Patients with conditions associated with shortened erythrocyte survival, such as hemolytic anemia or other conditions associated with inaccurate HbA1c

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Support-t plus usual diabetes care

Access to the Support-t online training and peer support platform in addition to usual diabetes care for 18 months. Support-t contains 3 components: 1) Educational material, 2) News blog and 3) Patients' discussion forum. Health care providers from the pediatric diabetes clinics will receive Support-t training and will be encouraged to recommend the Support-t platform during routine care with their patients from the active arm.

no intervention: Usual diabetes care only

Usual diabetes care for 18 months, which consists of visits with their health care provider and ad-hoc diabetes education with nurses and dietitians. Health care providers from the pediatric diabetes clinics will be instructed not to discuss or refer to the Support-t platform with patients from the control arm. Control arm participants will have the option to use the Support-t platform after the 18-month study.

Interventions

Support-t

Support-t plus usual diabetes care for 18 months

Primary outcome measure

  • Change from Baseline Hemaglobin A1c (HbA1c) at 18 months [ Time Frame: 18 months ]

Central Contacts and Locations

Central contacts

Anne-Sophie Brazeau, PhD

(514) 398-7848anne-sophie.brazeau@mcgill.ca

Amelie Roy-Fleming, MSc

amelie.roy-fleming@mcgill.ca

Locations

Montreal Children's Hospital - McGill University Health Centre

Recruiting

Montreal, Canada

Contacts

Meranda Nakhla, MD

meranda.nakhla@mcgill.ca

Elise Mok, PhD

elise.mok@affiliate.mcgill.ca

More Information

Sponsor

Anne-Sophie Brazeau

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

  • Transition Care
  • Pediatric
  • Adolescent
  • Education
  • Hemaglobin A1c
  • Self-management
  • Randomized Controlled Trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Anne-Sophie Brazeau on 2025-09-25.