Type 1 Diabetes Virtual Self-management Education and Support
NCT ID: NCT05756829
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
580 participants
INTERVENTIONAL
2023-05-10
2027-03-31
Brief Summary
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STUDY DESIGN: A pragmatic multicenter, open-label, randomized trial to evaluate the short-term effectiveness of a multifaceted virtual health care intervention in improving glycemic control in individuals with T1D. Planned recruitment is 580 participants from 10 specialized T1D centres in Ontario.
INTERVENTION: Our intervention will include 1) frequent, brief virtual visits between patients with T1D and certified diabetes educators (conducted in real time using a secure telemedicine video interface accessible from any PC, tablet or smart phone) combined with automatic appointment reminders, and 2) a centralized web-based platform to provide educational classes, tools, and resources for diabetes self-management. Virtual visits will be an adjunct to routine in-clinic visits for blood pressure monitoring, foot checks, and surveillance for other complications of diabetes. This approach aims to enable patients to receive more education and support than is feasible in traditional health care models, and in a way that is more seamless (i.e. results in fewer disruptions to their daily life) and tailored to their individual needs based on their stage in life.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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High frequency, low-touch virtual health care
Participants in this arm will receive a high frequency, low-touch virtual health care intervention through the Maple application, as an adjunct to usual T1D care. High-frequency visits will occur every 2 +/- 1 weeks for a total of 6 months.
Participants will also receive access to a virtual library to support T1D self-learning and as a guided educational tool.
High frequency, low touch virtual health care
Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months
Standard Care
Participants in this arm will receive the standard of care offered for their condition and by their clinic.
No interventions assigned to this group
Interventions
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High frequency, low touch virtual health care
Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months
Eligibility Criteria
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Inclusion Criteria
2. Physician diagnosis of type 1 diabetes
3. Currently on an insulin pump or using multiple daily insulin injections.
4. HbA1c ≥ 7.5% on most recent laboratory report or estimated from CGM/FGM\* report, within the last 4 months
\*14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)
5. Has access to a mobile device or computer/tablet with a video camera
6. Seen for at least one visit in the previous 6 months by participating certified diabetes educator at the selected diabetes clinic OR If a transitioning patient: Currently enrolled in a diabetes program below AND had at least one visit or touch-point prior in the previous 6 months by participating certified diabetes educator at on of our participating diabetes clinics
7. OHIP coverage
8. Currently using an active email address or be willing to obtain an email address
9. Has consistent and reliable access to internet
10. Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period
Exclusion Criteria
2. Unable to use a computer/tablet or mobile phone
3. Pregnant
4. On dialysis
5. Unable to fluently speak or read English (self-reported)
18 Years
ALL
No
Sponsors
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Unity Health Toronto
OTHER
Responsible Party
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Gillian Booth
Nominated Principal Investigator
Principal Investigators
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Gillian Booth, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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Waterloo Regional Health Network
Kitchener, Ontario, Canada
Mackenzie Health
Richmond Hill, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre, Unity Health Toronto
Toronto, Ontario, Canada
Charles H. Best Diabetes Centre
Whitby, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Jacquelyn Coyne
Role: primary
Ada Wong
Role: primary
Saloni Choksi
Role: primary
Saloni Choksi
Role: primary
Andrej Orszag
Role: primary
Scarlett Lau
Role: primary
Saloni Choksi
Role: primary
Saloni Choksi
Role: primary
Other Identifiers
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CTO Project ID: 3644
Identifier Type: -
Identifier Source: org_study_id