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NCT Number: NCT05910840

Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care

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.

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Key information

Conditions

Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Glucose Metabolism Disorders (Including Diabetes Mellitus) Immune System Diseases Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

14 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinique de pédiatrie Le Copain-Hôpital de Gatineau, Gatineau, Canada

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About this study

The transition from pediatric to adult diabetes care is a challenging period for adolescents and young adults living with chronic conditions, such as Type 1 Diabetes (T1D). For youth with T1D, transition from pediatric to adult care is characterized by deterioration in glycemic control (Hemoglobin A1c [HbA1c]), reduced adherence to diabetes management tasks and increased risk of diabetes complications. The investigators propose to examine an online training and peer support platform as a potential alternative for delivering transition care. In adolescents with T1D, the investigators hypothesize that an online training and peer support platform (Support-t), when integrated into usual pediatric care, as compared with usual care alone, will result in better HbA1c, less adverse outcomes and better psychosocial outcomes during the preparation for transfer to adult care.

Primary Aim: To determine the impact of adding access to Support-t to usual care compared with usual care alone, on HbA1c during the preparation for transfer to adult care.

Secondary Aims: To determine the impact of adding access to Support-t to usual care compared with usual care alone, on self-efficacy, diabetes distress, quality of life (QOL; diabetes specific), readiness to transfer to adult care, glucose management, severe hypoglycemic episodes, diabetic ketoacidosis (DKA), T1D-related ED-visits and hospitalizations during the preparation for transfer to adult care. 2. To determine the cost-effectiveness of Support-t. 3. To understand the context for implementation in regards to level of engagement on Support-t, satisfaction and experience (barriers, facilitators) with Support-t.

Methods: 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 Quebec. Patients will be recruited over 20 months. Interventions will occur over 18 months. Follow-up will be to 18 months from enrollment. Allocation will be concealed with a 1:1 intervention to control ratio. Participants in the active arm will have access to a mobile-based online training and peer support platform (Support-t) added to usual care. Participants in the control group will have in parallel with the intervention group, their usual diabetes care. The primary outcome is the change in HbA1c measured at 18 months (HbA1c measured at 18 months - HbA1c measured at baseline). Secondary outcomes are self-efficacy, diabetes distress, QOL, readiness to transfer, glucose management, severe hypoglycemic episodes, DKA, T1D-related ED-visits and hospitalizations. Assessments are at baseline, 6, 12 and 18 months. Analysis will be by intention-to-treat. Outcomes will be calculated and compared between the 2 trial arms using differences with 95% Confidence Intervals, along with a cost-effectiveness analysis. Interviews will be conducted to analyze the context for implementation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Support-t

Other

Support-t plus usual diabetes care for 18 months

Primary outcomes

  1. Change from Baseline Hemaglobin A1c (HbA1c) at 18 months

    Time frame: 18 months

    HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test

Secondary outcomes

  1. Change from Baseline Hemaglobin A1c (HbA1c) at 6 and 12 months

    Time frame: 6, 12 months

    HbA1c measured with a venous or capillary blood sample as part of the standard of diabetes care will be derived from the medical record chart or measured using an A1c Test Kit, which is a non-fasting, finger prick, whole blood test

  2. Continuous Glucose Monitoring (CGM) - % Time in range

    Time frame: 0, 6, 12, 18 months

    % Time in range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart

  3. Continuous Glucose Monitoring (CGM) - % Time above range

    Time frame: 0, 6, 12, 18 months

    % Time above range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart

  4. Continuous Glucose Monitoring (CGM) - % Time below range

    Time frame: 0, 6, 12, 18 months

    % Time below range (3.9-10.0mmol/L) over the past 4 weeks will be derived from the medical record chart

  5. Continuous Glucose Monitoring (CGM) - Standard deviation

    Time frame: 0, 6, 12, 18 months

    Standard deviation of the past 4 weeks will be derived from the medical record chart

  6. Continuous Glucose Monitoring (CGM) - % Coefficient of variation

    Time frame: 0, 6, 12, 18 months

    % Coefficient of variation of the past 4 weeks will be derived from the medical record chart

  7. Severe hypoglycemic events

    Time frame: 0, 6, 12, 18 months

    Any severe hypoglycemic events in the past 6 months will be derived from self-report and from the medical record chart

  8. Diabetic Ketoacidosis (DKA) events

    Time frame: 0, 6, 12, 18 months

    Any Diabetic Ketoacidosis (DKA) events in the past 6 months will be derived from self-report and from the medical record chart

  9. Diabetes-related hospitalizations

    Time frame: 0, 6, 12, 18 months

    Any diabetes-related hospitalizations in the past 6 months, expressed as number of hospitalizations per person-years (P-Y) at risk will be derived from self-report and from the medical record chart

  10. Diabetes-related emergency department visits

    Time frame: 0, 6, 12, 18 months

    Any diabetes-related emergency-department visits in the past 6 months, expressed as number of emergency department visits per person-years (P-Y) at risk will be derived from self-report and from the medical record chart

  11. Self-efficacy

    Time frame: 0, 6, 12, 18 months

    Self-efficacy for Diabetes Self-Management Measure (SEDM) assesses self-efficacy. The score ranges from 1 to 10. All item scores are averaged to compute the score. A higher score represents a better outcome.

  12. Diabetes distress

    Time frame: 0, 6, 12, 18 months

    Problem Areas in Diabetes Scale-Teen (PAID-T) assesses adolescent diabetes distress. The scores range from 14 to 84. A total distress score is computed by summing responses. Higher scores indicate youth perception of feeling more burdened related to T1D.

  13. Diabetes specific Quality of Life (QOL)

    Time frame: 0, 6, 12, 18 months

    Type 1 Diabetes and Life (T1DAL) questionnaire assesses diabetes specific QOL for 12-17 year old adolescents living with T1D. Scores are transformed on a scale from 0 to 100. The total score ranges from 0 to 100. To calculate the total score, the mean is computed as the sum of all item scores divided by the number of items answered on all the scales. A higher total score represents a better outcome. The subscale scores (Daily Emotional Experiences & Daily Activities, Handling Diabetes Well, Peer Relationships, and Family Relationships) range from 0 to 100. To calculate the subscale scores, the mean is computed as the sum of the items in the subscale divided by the number of items answered on the subscale. Higher subscale scores represent a better outcome.

  14. Transition readiness

    Time frame: 0, 6, 12, 18 months

    Readiness Assessment of Emerging Adults with Type 1 Diabetes Diagnosed in Youth (READDY) assesses diabetes-related knowledge or skill items by querying respondents on 42 total items split into 5 domains: knowledge, navigation, health behaviors, and insulin pump skills. Respondents answer on a Likert scale from "yes, I can do this" scored 5 to "Haven't thought about it" scored 1. Confidence level is evaluated in each domain with a higher score indicating more confidence.

  15. Cost effectiveness (HbA1c)

    Time frame: 12 and 18 months

    Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for HbA1c

  16. Cost effectiveness (self-efficacy)

    Time frame: 12 and 18 months

    Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for self-efficacy

  17. Cost effectiveness (diabetes distress)

    Time frame: 12 and 18 months

    Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for diabetes distress

  18. Cost effectiveness (QOL)

    Time frame: 12 and 18 months

    Cost effectiveness of access to Support-t in addition to usual care compared with usual care in terms of incremental cost effectiveness ratio (ICER) for QOL

Other outcomes

  1. Engagement with Support-t platform (T1D patient) - time in minutes on platform

    Time frame: 6, 12, 18 months

    Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform

  2. Engagement with Support-t platform (T1D patient) - discussion forum participation

    Time frame: 6, 12, 18 months

    Engagement metrics will be extracted using Google analytics - participation on the platform discussion forum

  3. Engagement with Support-t platform (T1D patient) - content accessed

    Time frame: 6, 12, 18 months

    Engagement metrics will be extracted using Google analytics - specific content accessed from the platform

  4. Engagement with Support-t platform (T1D patient) - total pages viewed

    Time frame: 6, 12, 18 months

    Engagement metrics will be extracted using Google analytics - total pages viewed from the platform

  5. Engagement with Support-t platform (T1D patient) - downloaded documents

    Time frame: 6, 12, 18 months

    Engagement metrics will be extracted using Google analytics - downloaded documents from the platform

  6. Engagement with Support-t platform (T1D patient) - use of calculators

    Time frame: 6, 12, 18 months

    Engagement metrics will be extracted using Google analytics - use of calculators on the platform

  7. Engagement with Support-t platform (Health Care Provider) - time in minutes on platform

    Time frame: 6, 12 months

    Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform

  8. Engagement with Support-t platform (Health Care Provider) - content accessed

    Time frame: 6, 12 months

    Engagement metrics will be extracted using Google analytics - specific content accessed from the platform

  9. Engagement with Support-t platform (Health Care Provider) - total pages viewed

    Time frame: 6, 12 months

    Engagement metrics will be extracted using Google analytics - total pages viewed from the platform

  10. Engagement with Support-t platform (Health Care Provider) - downloaded documents

    Time frame: 6, 12 months

    Engagement metrics will be extracted using Google analytics - downloaded documents from the platform

  11. Engagement with Support-t platform (Health Care Provider) - use of calculators

    Time frame: 6, 12 months

    Engagement metrics will be extracted using Google analytics - use of calculators on the platform

  12. Satisfaction with Support-t platform - T1D patient

    Time frame: 6, 12, 18 months

    Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.

  13. Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient

    Time frame: 18 months

    Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology

  14. Experience with Support-t platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider

    Time frame: 12 months

    Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Roy-Fleming, MSc

CONTACT

[email protected]

Anne-Sophie Brazeau, PhD

CONTACT

[email protected]

(514) 398-7848

Sponsors and collaborators

Lead sponsor

Anne-Sophie Brazeau

Other

Collaborators

  • CHU de Quebec-Universite Laval
  • CSSS de Gatineau
  • Centre de recherche du CHU de Sherbrooke
  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Registry information

Official study title

Support-t, an Online Training and Peer Support Platform to Accompany Youth Living With Type 1 Diabetes Transitioning to Adult Healthcare

Acronym: Support-t

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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