An interventional study of Support platform in Type 1 Diabetes, Metabolic Disease and Endocrine System Diseases, sponsored by McGill University. Recruiting at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by McGill University · Not applicable, Interventional, and Prevention
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.
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.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 322 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
- Unable to use the Support platform
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.
Behavioral: Support platform
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.
Behavioral: Support platform
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.
Self-efficacy for diabetes management
Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)
Time frame: 0, 6 and 12 months
Well-being
WHO-5 well-being index
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time in range
% 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.
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time above range
% 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.
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Time below range
% 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.
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - Standard deviation
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.
Time frame: 0, 6 and 12 months
Continuous Glucose Monitoring (CGM) - % Coefficient of variation
% 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.
Time frame: 0, 6 and 12 months
Hemoglobin A1c
self-reported last Hemoglobin A1c (date and value) through online questionnaire
Time frame: 0, 6 and 12 months
Severe hypoglycemic events
Self-reported severe hypoglycemic events in the past 6 months
Time frame: 0, 6 and 12 months
Diabetic Ketoacidosis (DKA) events
Self-reported DKA events in the past 6 months
Time frame: 0, 6 and 12 months
calls to 911
Self-reported number of calls to 911 in the past 6 months
Time frame: 0, 6 and 12 months
calls to 811
Self-reported number of calls to 811 in the past 6 months
Time frame: 0, 6 and 12 months
Cost effectiveness (self-efficacy)
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
Time frame: 6 and 12 months
Cost effectiveness (HbA1c)
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
Time frame: 6 and 12 months
Implementation question
Participants will be asked where they heard about the platform.
Time frame: 0 month
communication with health care team
Question about type (in-person, phone, video call or email) and frequency of communication with health care team
Time frame: 0, 6 and 12 months
Engagement with Support platform (T1D patient) - time in minutes on platform
Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform
Time frame: 6, 12 months
Engagement with Support platform (T1D patient) - total pages viewed
Engagement metrics will be extracted using Google analytics - total pages viewed from the platform
Time frame: 6, 12 months
Engagement with Support platform (T1D patient) - downloaded documents
Engagement metrics will be extracted using Google analytics - downloaded documents from the platform
Time frame: 6, 12 months
Engagement with Support platform (T1D patient) - use of calculators
Engagement metrics will be extracted using Google analytics - use of calculators on the platform
Time frame: 6, 12 months
Engagement with Support platform (Health Care Provider) - time in minutes on platform
Engagement metrics will be extracted using Google analytics - time (minutes) spent on the platform
Time frame: 6, 12 months
Engagement with Support platform (Health Care Provider) - content accessed
Engagement metrics will be extracted using Google analytics - specific content accessed from the platform
Time frame: 6, 12 months
Engagement with Support platform (Health Care Provider) - total pages viewed
Engagement metrics will be extracted using Google analytics - total pages viewed from the platform
Time frame: 6, 12 months
Engagement with Support platform (Health Care Provider) - downloaded documents
Engagement metrics will be extracted using Google analytics - downloaded documents from the platform
Time frame: 6, 12 months
Engagement with Support platform (Health Care Provider) - use of calculators
Engagement metrics will be extracted using Google analytics - use of calculators on the platform
Time frame: 6, 12 months
Satisfaction with Support-t platform - T1D patient
Satisfaction will be rated on a scale from 1 to 10. Higher scores indicate greater satisfaction with the platform.
Time frame: 6, 12 months
Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - T1D patient
Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
Time frame: 12 months
Experience with Support platform (Barriers, facilitators, satisfaction, fidelity) - Health Care Provider
Individual interviews to understand the experience in the context of implementation of the Support-t platform (Barriers, facilitators, satisfaction, fidelity) using qualitative descriptive methodology
Time frame: 12 months
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