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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Type 1 Diabetes; Metabolic Disease
• Intervention / Treatment: Behavioral: Support platform

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 322
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Sophie Brazeau, PhD; Phone Number: 5143987848; Email: anne-sophie.brazeau@mcgill.ca
• Study Contact Backup: Name: amelie Roy-Fleming, MSc; Phone Number: 5147790749; Email: amelie.roy-fleming@mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Recruiting
      • Institut de recherches cliniques de Montreal
      • Contact: Marie Devaux; Phone Number: 5149875500; Email: type1support@mcgill.ca
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Université de Montréal
      • Contact: Ann Gobeil; Phone Number: 514-890-8000; Email: type1support@mcgill.ca
    • Québec, Quebec, Canada, G1V 0E8
      • Recruiting
      • Centre hospitalier de Quebec, Université Laval
      • Contact: Claudia Huard; Phone Number: 418-525-4444; Email: type1support@mcgill.ca
    • Terrebonne, Quebec, Canada, J6X 4P7
      • Recruiting
      • Centre de Medecine Metabolique de Lanaudiere
      • Contact: Tammy Cadieux; Phone Number: 514-907-5101; Email: type1support@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Support integrated in usual care; 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; 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.
Active Comparator: Support through independent access; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-efficacy for diabetes management	Diabetes Self-Management Questionnaire-Revised (DSMQ-R; 27-items, score on 10)	0, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Well-being	WHO-5 well-being index	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.	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.	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.	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.	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.	0, 6 and 12 months
Hemoglobin A1c	self-reported last Hemoglobin A1c (date and value) through online questionnaire	0, 6 and 12 months
Severe hypoglycemic events	Self-reported severe hypoglycemic events in the past 6 months	0, 6 and 12 months
Diabetic Ketoacidosis (DKA) events	Self-reported DKA events in the past 6 months	0, 6 and 12 months
calls to 911	Self-reported number of calls to 911 in the past 6 months	0, 6 and 12 months
calls to 811	Self-reported number of calls to 811 in the past 6 months	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	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	6 and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation question	Participants will be asked where they heard about the platform.	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	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	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	6, 12 months
Engagement with Support platform (T1D patient) - downloaded documents	Engagement metrics will be extracted using Google analytics - downloaded documents from the platform	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	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	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	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	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	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	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.	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	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	12 months

Collaborators and Investigators

• Sponsor: McGill University
• Collaborators: Centre hospitalier de l'Université de Montréal (CHUM); Institut de Recherches Cliniques de Montreal; Centre Hospitalier de l'Universite Laval (CHUL); Centre de médecine métabolique de Lanaudière
• Investigators: Principal Investigator: Anne-Sophie Brazeau, PhD, School of Human Nutrition - McGill University

Publications and helpful links

General Publications

• Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
• Xie LF, Roy-Fleming A, Haag S, Costa DD, Brazeau AS. Development of the Support self-guided, web application for adults living with type 1 diabetes in Canada by a multi-disciplinary team using a people-oriented approach based on the Behaviour Change Wheel. Digit Health. 2023 Jan 24;9:20552076231152760. doi: 10.1177/20552076231152760. eCollection 2023 Jan-Dec.
• Xie LF, Itzkovitz A, Roy-Fleming A, Da Costa D, Brazeau AS. Understanding Self-Guided Web-Based Educational Interventions for Patients With Chronic Health Conditions: Systematic Review of Intervention Features and Adherence. J Med Internet Res. 2020 Aug 13;22(8):e18355. doi: 10.2196/18355.
• Kruger J, Brennan A, Thokala P, Basarir H, Jacques R, Elliott J, Heller S, Speight J. The cost-effectiveness of the Dose Adjustment for Normal Eating (DAFNE) structured education programme: an update using the Sheffield Type 1 Diabetes Policy Model. Diabet Med. 2013 Oct;30(10):1236-44. doi: 10.1111/dme.12270. Epub 2013 Aug 19.
• Stanton-Fay SH, Hamilton K, Chadwick PM, Lorencatto F, Gianfrancesco C, de Zoysa N, Coates E, Cooke D, McBain H, Heller SR, Michie S; DAFNEplus study group. The DAFNEplus programme for sustained type 1 diabetes self management: Intervention development using the Behaviour Change Wheel. Diabet Med. 2021 May;38(5):e14548. doi: 10.1111/dme.14548. Epub 2021 Mar 10.
• Pereira K, Phillips B, Johnson C, Vorderstrasse A. Internet delivered diabetes self-management education: a review. Diabetes Technol Ther. 2015 Jan;17(1):55-63. doi: 10.1089/dia.2014.0155.
• Schmitt A, Kulzer B, Ehrmann D, Haak T, Hermanns N. A Self-Report Measure of Diabetes Self-Management for Type 1 and Type 2 Diabetes: The Diabetes Self-Management Questionnaire-Revised (DSMQ-R) - Clinimetric Evidence From Five Studies. Front Clin Diabetes Healthc. 2022 Jan 13;2:823046. doi: 10.3389/fcdhc.2021.823046. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2024
• Primary Completion (Estimated): May 5, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 29, 2023
• First Submitted That Met QC Criteria: September 29, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: type 1 diabetes; adults; Online education; Hemaglobin A1c; self-management education
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Autoimmune Diseases; Metabolic Diseases; Immune System Diseases; Endocrine System Diseases
• Other Study ID Numbers: MP-02-2024-11714

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No