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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMcGill University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

322 Participants
are divided into 2 treatment groups
Group A: Support integrated in usual careExperimental treatment 1 intervention
Group B: Support through independent accessActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Self-efficacy for diabetes management

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

Time frame
0, 6 and 12 months

Secondary outcomes

1

Well-being

WHO-5 well-being index

Time frame
0, 6 and 12 months
2

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
3

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
4

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

Other outcomes

1

Implementation question

Participants will be asked where they heard about the platform.

Time frame
0 month
2

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
3

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
4

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

McGill University

Lead sponsor

Institut de Recherches Cliniques de Montreal

Collaborator

Centre de Recheche du Centre Hospitalier Université Laval

Collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Centre de médecine métabolique de Lanaudière

Collaborator