Virtual self-management education for type 1 diabetes

Type 1 Diabetes Virtual Self-management Education and Support

This study tests if a virtual support program can help people with type 1 diabetes manage their blood sugar better without needing to go to in-person appointments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 580 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Unity Health Toronto (Academic / other)
• Locations: 9 sites (Kitchener, Ontario and 8 other locations)
• Trial ID: NCT05756829 on ClinicalTrials.gov

What this trial studies

This study evaluates a virtual health care intervention designed to improve glycemic control in individuals with type 1 diabetes (T1D) by providing frequent, low-touch support. It is a pragmatic multicenter, open-label, randomized trial involving 580 participants from 10 specialized T1D centers in Ontario. The intervention aims to reduce the burden of traditional in-person visits while enhancing patient engagement and metabolic control through digital means.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a physician diagnosis of type 1 diabetes who are currently using insulin pumps or multiple daily injections.

Not a fit: Patients diagnosed with non-Type 1 diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve glycemic control for patients with type 1 diabetes while minimizing the demands of in-person healthcare visits.

How similar studies have performed: Other studies have shown promise in using virtual health care approaches for chronic disease management, indicating potential success for this intervention.

Eligibility 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 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:

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)

Where this trial is running

Kitchener, Ontario and 8 other locations

• Waterloo Regional Health Network — Kitchener, Ontario, Canada (Recruiting)
• Mackenzie Health — Richmond Hill, Ontario, Canada (Recruiting)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (Recruiting)
• St. Michael's Hospital, Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
• Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
• Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
• St. Joseph's Health Centre, Unity Health Toronto — Toronto, Ontario, Canada (Recruiting)
• Women's College Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
• Charles H. Best Diabetes Centre — Whitby, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Gillian Booth, MD — Unity Health Toronto
• Study coordinator: Stephanie de Sequeira, MPH

Conditions type1diabetes