{
  "abstract": "Introduction Type 1 diabetes (T1D) demands self-management skills, knowledge and confidence to prevent medical complications. Adolescents living with T1D have distinct developmental challenges resulting in a worsening in glycaemic stability, irregular care and an increased risk for complications all while transitioning to adult healthcare. Age-specific online platforms could facilitate transition by fostering self-management education and support. The Support online self-guided training platform has been shown to increase the confidence of adults with T1D in managing their glycaemia. We aim to test the effectiveness of Support-t (ie, adapted for youth), compared with usual care, in improving haemoglobin A1c (HbA1c) and to understand the context of its implementation.Methods We will conduct a multisite, assessor-blinded, randomised controlled, parallel group, two-arm, superiority trial, evaluating effectiveness and implementation of Support-t versus usual care in 200 adolescents (14–16 years old) living with T1D. The active arm will have an 18-month access to Support-t, and their healthcare team will be trained on the platform’s content. The control arm will receive usual care. The primary outcome is HbA1c at 18 months. Secondary outcomes include self-efficacy for diabetes self-management, transition readiness, diabetes-specific quality of life, diabetes distress, continuous glucose monitoring metrics, number of severe hypoglycaemic events, diabetic ketoacidosis, T1D-related emergency department visits and hospitalisations as well as engagement and satisfaction. A subgroup of participants in the active arm and of healthcare providers will be interviewed assessing barriers, facilitators, engagement and fidelity of the intervention. Primary analysis will be by intention-to-treat. The difference in mean HbA1c at 18 months (with a 95% CI) will be calculated between both arms. A cost-effectiveness analysis is also planned.Ethics and dissemination December 8, 2024 version of the protocol was approved by the McGill University Health Centre Research Ethics Board (MP-37-2024-9734). Results will be disseminated through peer-reviewed publications and patient-partners’ network.Trial registration number ClinicalTrials.gov ( NCT05910840).",
  "authors": [
    {
      "affiliations": [
        "McGill University School of Human Nutrition, Sainte-Anne-de-Bellevue, Québec, Canada"
      ],
      "name": "Amélie Roy-Fleming"
    },
    {
      "affiliations": [
        "Department of Pediatrics, McGill University Health Centre, Montreal, Quebec, Canada",
        "Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada"
      ],
      "name": "Meranda Nakhla"
    },
    {
      "affiliations": [
        "Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada"
      ],
      "name": "Elise Mok"
    },
    {
      "affiliations": [
        "Unité de Pédiatrie, Hôpital de Gatineau, Gatineau, Quebec, Canada"
      ],
      "name": "Andréanne Vanasse"
    },
    {
      "affiliations": [
        "McGill University School of Human Nutrition, Sainte-Anne-de-Bellevue, Québec, Canada"
      ],
      "name": "Liana Cianci"
    },
    {
      "affiliations": [
        "Department of Psychology, University of Windsor, Windsor, Ontario, Canada"
      ],
      "name": "Jessica Kichler"
    },
    {
      "affiliations": [
        "Unité de Pédiatrie, Université de Sherbrooke, Sherbrooke, Quebec, Canada"
      ],
      "name": "Judith Simoneau-Roy"
    },
    {
      "affiliations": [
        "Unité de Pédiatrie, Hôpital de Gatineau, Gatineau, Quebec, Canada"
      ],
      "name": "Yohann Couture"
    },
    {
      "affiliations": [
        "Unité de Pédiatrie, Centre Hospitalier Universitaire de Québec-Université Laval, Québec City, Quebec, Canada"
      ],
      "name": "Julie Gagné"
    },
    {
      "affiliations": [
        "Ministère de la Santé et des Services sociaux du Québec, Québec City, Québec, Canada"
      ],
      "name": "Mariève Dupont"
    },
    {
      "affiliations": [
        "McGill University School of Human Nutrition, Sainte-Anne-de-Bellevue, Québec, Canada"
      ],
      "name": "Anne-Sophie Brazeau"
    }
  ],
  "title": "Support-t, an online training and peer support platform to accompany youth living with type 1 diabetes transitioning to adult healthcare: protocol of an effectiveness-implementation trial",
  "uid": "8c402779-81ac-54b6-b5ec-ac16c264d1bf"
}
