SUPPORT Online Training Platform for Type 1 Diabetes Self-management Education and Support (SUPPORT)

NCT04233138 | Completed DMC

• 1 other identifier: SUPPORT
• Study Type: interventional
• Target: 285
• Locations: 1 country
• Sites: 1

Brief Summary

There are evidences that some healthcare teams are not proposing new therapeutic and technology options that have the potential to reduce hypoglycemia for people with type 1 diabetes. In practice, people living with type 1 diabetes report receiving education related to insulin pumps usage mainly on key functions (how the device works) at initiation and not enough about proactive adjustments (how to optimally use the device) especially on the long-term. In brief, short-term education is technical and product-specific, rather than being based on patients' needs.There is a need to test the efficacy of different programs that may be more suited to patients' needs and desires while offering the opportunity to reduce costs (e.g. web based). Since there is a lack of expertise related to optimal use of new technologies and therapies for people living with type 1 diabetes, we propose to design and test a web-based training (e.g. courses including videos and quizzes) and support (e.g. discussion forum) platform. This will be tested through a registry-based trial. The overall purpose of this study is to evaluate, among a group of adults living with type 1 diabetes, the SUPPORT online education platform in terms of users' satisfaction, engagement and efficacy to change the fear and the frequency of hypoglycemia.

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Users' satisfaction of the SUPPORT platform

  Online questionnaire- General satisfaction of the SUPPORT platform-8 items

  after 6 months

Secondary Outcomes (4)

• Users' engagement on the SUPPORT platform

  baseline to 6 months

• Change in the frequency and the fear of hypoglycemia

  6-month, and 12-month

• Change in the glycated hemoglobin

  at 6 months and 12 months

• Knowledge about diabetes self-management

  at baseline, 6 months and 12 months

Study Arms (1)

Intervention

EXPERIMENTAL

The intervention group will have immediate access to the SUPPORT platform.

Other: SUPPORT online platform for people with type 1 diabetes

Interventions

SUPPORT online platform for people with type 1 diabetes OTHER

All participants accepting the SUPPORT study will receive the full intervention for 6 months. Their learning is individualized depending on the way they take their insulin (injection or pump) and the way they measure their blood sugar (finger prick or continuous glucose monitoring). The training program starts with mandatory module on hypoglycemia. Once completed, participants will unlock all level 1 (out of 3 levels) modules from the 6 categories (medication, blood sugar monitoring, nutrition, physical activity, hypo- and hyperglycemia, health and other situations). The platform contains functionalities such as discussion forum, quizzes, videos, downloadable forms, etc. During the first 6 months, participants will receive a bi-weekly newsletter to inform them about what's new on the platform.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years old
• Completed phase 2 of the BETTER registry
• Self-reported diagnosis of type 1 diabetes for ≥ 1 year
• Daily use of ≥ 4 injections of insulin or CSII
• Have access to Internet
• Use of an active email address
• Comprehension of English or French

You may not qualify if:

• Ongoing pregnancy
• Other illnesses limiting diabetes care or access to the platform (e.g. dementia and blindness)

Sponsors & Collaborators

• McGill University: lead
• Institut de Recherches Cliniques de Montreal: collaborator
• Juvenile Diabetes Research Foundation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W1R7, Canada

Location

Related Publications (1)

• Xie LF, Housni A, Roy-Fleming A, Bandini A, Delormier T, Costa DD, Brazeau AS. Evaluation of Support, a self-guided online type 1 diabetes self-management education and support web application-a mixed methods study. Digit Health. 2023 Sep 28;9:20552076231204435. doi: 10.1177/20552076231204435. eCollection 2023 Jan-Dec.

  PMID: 37780064 DERIVED

Study Officials

• Anne-Sophie Brazeau, PhD

  McGill University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants enrolling in the study have access to the online platform for 12 months (6 months with reminders, 6 months no reminders).

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 18, 2020
• Study Start: February 5, 2020
• Primary Completion: March 19, 2023
• Study Completion: September 19, 2023
• Last Updated: September 25, 2025

Record last verified: 2022-04

Locations

CA (1)