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NCT Number: NCT06069583

Implementation of Support in the Care of Adults Living With Type 1 Diabetes

The investigators will conduct a trial to evaluate if an online training and support platform can help adults living with type 1 diabetes (T1D) in their diabetes self-management. Investigators will compare a group that has access to the "Support" platform through their usual medical care to a group that accesses the platform independently. The first group will be recruited through four participating clinics in the province of Quebec (Canada). The second group will be composed of adults living with T1D across Canada. Participants will have access to the platform for 12 months and will be asked to complete online questionnaires at the beginning and after 6 and 12 months, and share their glucose reader data with the research team. A subgroup of participants as well as healthcare professionals from the four clinics will be invited to participate in an individual interview aiming to understand the barriers and facilitators of integration "Support" in clinical care.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de l'université de Montreal, Montreal, Quebec, Canada

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About this study

Type 1 diabetes (T1D) is a chronic condition which requires life-sustaining insulin therapy as well as knowledge, skills and confidence to self-manage. Tailored diabetes self-management education (DSME) should be offered to all people living with diabetes (PWT1D) at diagnosis, but also in a timely manner according to needs. DSME has the potential to improve quality of life and decrease diabetes complications. Despite the positive outcomes of other DSME programs, participation rates of DSME vary greatly perhaps because access remains sub-optimal. Also, healthcare professionals (HCPs) face a challenge to remain aware of the particularities of T1D and stay up-to-date on the rapidly evolving evidence-based knowledge, technologies and therapies available. The investigators propose to examine an online training and peer support platform, called "Support" as a potential alternative for DSME.

The overall purpose of this hybrid effectiveness-implementation study is to investigate if integrating the "Support" platform to routine medical care of adults living with T1D (i.e., diabetes team referring to the "Support" platform during appointments) can improve diabetes self- management, in comparison with navigating the "Support" platform independently of usual care (i.e., the platform not being discussed during appointment) (Effectiveness), and to study the factors affecting its implementation in real-life settings (Implementation).

This study is a mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial.

ARM 1: PWT1D participants will have access to Support as part of their regular care (their HCPs will use "Support" in their care). PWT1D participants in ARM 1 are followed in one of the 4 participating clinics either in-person or remotely or hybrid.

ARM 2: PWT1D participants will have access to "Support", independently from their regular care (they may initiate discussion about the platform with their diabetes care team who might register themselves on the platform, but will not prompt to any specific section on the platform and will not receive any training about the platform). PWT1D participants in ARM 2 can be followed in any other clinics in Canada.

Implementation data will be gathered through HCP participants in the participating clinics.

Participants will have to answer online surveys at baseline, 6 months and 12 months. After completing the baseline questionnaire, they will receive an access to the platform. A subgroup of participants as well as participating HCPs will be invited for individual interviews to discuss their experience in using the platform.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of T1D (including LADA - latent autoimmune diabetes in adults)
  • Have access to Internet
  • Use of an active email address
  • Comprehension of English or French
  • Live in Canada

Exclusion criteria

  • Unable to use the Support platform

Treatment and study plan

Support platform

Behavioral

The study will be conducted over a 12-month period. This should allow participants to see their medical team 2 to 3 times during this timeframe. Participants of arms 1 and 2 will have access to the Support platform and will receive a monthly newsletter, informing them of news on the platform and acting as a reminder to log in. Several features are included in this responsive-designed platform to enhance participation, such as a visual of personal progress, ability to bookmark content, change their avatar.

Support contains 3 main components: Educational material, News blog written by HCPs weekly in collaboration with patient-partners on up-to-date topics related to T1D, a peer-to-peer discussion forum which is moderated daily by a HCP specializing in T1D.

Primary outcomes

  1. Self-efficacy for diabetes management

    Time frame: 0, 6 and 12 months

    Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)

Secondary outcomes

  1. Well-being

    Time frame: 0, 6 and 12 months

    WHO-5 well-being index

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

    Time frame: 0, 6 and 12 months

    % Time in range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.

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

    Time frame: 0, 6 and 12 months

    % Time above range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.

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

    Time frame: 0, 6 and 12 months

    % Time below range (3.9-10.0mmol/L) over the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.

  5. Continuous Glucose Monitoring (CGM) - Standard deviation

    Time frame: 0, 6 and 12 months

    Standard deviation of the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.

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

    Time frame: 0, 6 and 12 months

    % Coefficient of variation of the past 4 weeks. Participants may share their account access so the research team will be able to export data or may upload a PDF of their data through REDCap.

  7. Hemoglobin A1c

    Time frame: 0, 6 and 12 months

    self-reported last Hemoglobin A1c (date and value) through online questionnaire

  8. Severe hypoglycemic events

    Time frame: 0, 6 and 12 months

    Self-reported severe hypoglycemic events in the past 6 months

  9. Diabetic Ketoacidosis (DKA) events

    Time frame: 0, 6 and 12 months

    Self-reported DKA events in the past 6 months

  10. calls to 911

    Time frame: 0, 6 and 12 months

    Self-reported number of calls to 911 in the past 6 months

  11. calls to 811

    Time frame: 0, 6 and 12 months

    Self-reported number of calls to 811 in the past 6 months

  12. Cost effectiveness (self-efficacy)

    Time frame: 6 and 12 months

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

  13. Cost effectiveness (HbA1c)

    Time frame: 6 and 12 months

    Cost effectiveness of access to Support as part of usual care compared with independent access in terms of incremental cost effectiveness ratio (ICER) for HbA1c

Other outcomes

  1. Implementation question

    Time frame: 0 month

    Participants will be asked where they heard about the platform.

  2. communication with health care team

    Time frame: 0, 6 and 12 months

    Question about type (in-person, phone, video call or email) and frequency of communication with health care team

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

    Time frame: 6, 12 months

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

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

    Time frame: 6, 12 months

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

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

    Time frame: 6, 12 months

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

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

    Time frame: 6, 12 months

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

  7. Engagement with Support 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 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 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 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 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 months

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

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

    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

  14. Experience with Support 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.

Anne-Sophie Brazeau, PhD

CONTACT

[email protected]

5143987848

amelie Roy-Fleming, MSc

CONTACT

[email protected]

5147790749

Sponsors and collaborators

Lead sponsor

McGill University

Other

Collaborators

  • Centre de Recheche du Centre Hospitalier Université Laval
  • Centre de médecine métabolique de Lanaudière
  • Centre hospitalier de l'Université de Montréal (CHUM)
  • Institut de Recherches Cliniques de Montreal

Registry information

Official study title

Using the Support Online Platform for Self-management Education of Adults Living With Type 1 Diabetes as Part of Usual Care or Independently: an Implementation Study

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 6, 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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