NCT06069583

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started May 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
May 2024Oct 2027

First Submitted

Initial submission to the registry

September 29, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 6, 2023

Completed
7 months until next milestone

Study Start

First participant enrolled

May 5, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

3 years

First QC Date

September 29, 2023

Last Update Submit

September 22, 2025

Conditions

Type 1 DiabetesMetabolic DiseaseEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Keywords

self-management educationHemaglobin A1cOnline educationadultstype 1 diabetes

Outcome Measures

Primary Outcomes (1)

  • Self-efficacy for diabetes management

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

    0, 6 and 12 months

Secondary Outcomes (13)

  • Well-being

    0, 6 and 12 months

  • Continuous Glucose Monitoring (CGM) - % Time in range

    0, 6 and 12 months

  • Continuous Glucose Monitoring (CGM) - % Time above range

    0, 6 and 12 months

  • Continuous Glucose Monitoring (CGM) - % Time below range

    0, 6 and 12 months

  • Continuous Glucose Monitoring (CGM) - Standard deviation

    0, 6 and 12 months

  • +8 more secondary outcomes

Other Outcomes (14)

  • Implementation question

    0 month

  • communication with health care team

    0, 6 and 12 months

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

    6, 12 months

  • +11 more other outcomes

Study Arms (2)

Support integrated in usual care

EXPERIMENTAL

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

Support through independent access

ACTIVE COMPARATOR

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

Interventions

Support platformBEHAVIORAL

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.

Support integrated in usual careSupport through independent access

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- Unable to use the Support platform

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

Centre hospitalier de l'université de Montreal

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

Centre hospitalier de Quebec, Université Laval

Québec, Quebec, G1V 0E8, Canada

RECRUITING

Centre de médecine métabolique de Lanaudière

Terrebonne, Quebec, J6x 4P7, Canada

RECRUITING

Related Publications (7)

  • 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.

    PMID: 36762025BACKGROUND

  • 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.

    PMID: 32788152BACKGROUND

  • 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.

    PMID: 23815547BACKGROUND

  • 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.

    PMID: 33617669BACKGROUND

  • 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.

    PMID: 25238257BACKGROUND

  • 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.

    PMID: 22310560BACKGROUND

  • 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.

    PMID: 36994332BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersNutritional and Metabolic Diseases

Study Officials

  • Anne-Sophie Brazeau, PhD

    School of human nutrition - McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Sophie Brazeau, PhD

CONTACT

5143987848anne-sophie.brazeau@mcgill.ca

amelie Roy-Fleming, MSc

CONTACT

5147790749amelie.roy-fleming@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: mixed-method multi-site, 2 arms, non-randomized, type 1 hybrid effectiveness-implementation trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 29, 2023

First Posted

October 6, 2023

Study Start

May 5, 2024

Primary Completion (Estimated)

May 5, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

September 25, 2025

Record last verified: 2025-09

Locations

CA(4)