Type 1 Diabetes Virtual Self-management Education and Support

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Outpatients ≥18 years of age

• Physician diagnosis of type 1 diabetes

• Currently on an insulin pump or using multiple daily insulin injections.

• HbA1c ≥ 7.5% on most recent laboratory report, within the last 4 months

• Has access to a mobile device or computer/tablet with a video camera

• 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

• OHIP coverage

• Currently using an active email address or be willing to obtain an email address

• Has consistent and reliable access to internet

⁃ Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period

Locations
Other Locations
Canada
Waterloo Regional Health Network
RECRUITING
Kitchener
Mackenzie Health
RECRUITING
Richmond Hill
Mount Sinai Hospital
RECRUITING
Toronto
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Toronto General Hospital
RECRUITING
Toronto
Unity Health Toronto
ACTIVE_NOT_RECRUITING
Toronto
Charles H. Best Diabetes Centre
RECRUITING
Whitby
Contact Information
Primary
Stephanie de Sequeira, MPH
stephanie.desequeira@unityhealth.to
416-864-6060
Time Frame
Start Date: 2023-05-10
Estimated Completion Date: 2027-03-31
Participants
Target number of participants: 580
Treatments
Experimental: 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.
No_intervention: Standard Care
Participants in this arm will receive the standard of care offered for their condition and by their clinic.
Related Therapeutic Areas
Sponsors
Leads: Unity Health Toronto

This content was sourced from clinicaltrials.gov