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NCT05756829 | RECRUITING | type1diabetes

Type 1 Diabetes Virtual Self-management Education and Support
Sponsor:

Unity Health Toronto

Information provided by (Responsible Party):

Gillian Booth

Brief Summary:

OVERVIEW: People living with type 1 diabetes (T1D) are expected to fit self-management and regular clinical consultations into busy lives. T1D self-management programs that offer frequent contact with care teams are most effective in helping patients achieve optimal glycemic control. However, this is difficult to deliver in the context of current T1D care which involves time-consuming in-person visits during working hours. The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control, while reducing the burden on individuals and their healthcare teams. 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.

Condition or disease

type1diabetes

Intervention/treatment

High frequency, low touch virtual health care

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 580 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Type 1 Diabetes Virtual Self-management Education and Support
Actual Study Start Date : 2023-05-10
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-03-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Outpatients ≥18 years of age
  • 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, within the last 4 months
  • 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
  • 1. Diagnosed with non-Type 1 diabetes
  • 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)
Type 1 Diabetes Virtual Self-management Education and Support

Location Details

NCT05756829

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Canada, Ontario

Grand River Hospital

Kitchener, Ontario, Canada, N2G 1G3

RECRUITING

Canada, Ontario

Mackenzie Health

Richmond Hill, Ontario, Canada, L4C 4Z3

NOT YET RECRUITING

Canada, Ontario

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada, M4N 3M5

RECRUITING

Canada, Ontario

Unity Health Toronto

Toronto, Ontario, Canada, M5B 1W8

RECRUITING

Canada, Ontario

Mount Sinai Hospital

Toronto, Ontario, Canada, M5g 1x5

RECRUITING

Canada, Ontario

Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

RECRUITING

Canada, Ontario

Charles H. Best Diabetes Centre

Whitby, Ontario, Canada, L1m 1Z5