RecruitingNot ApplicableNCT05756829

Type 1 Diabetes Virtual Self-management Education and Support


Sponsor

Unity Health Toronto

Enrollment

580 participants

Start Date

May 10, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a virtual (online video) diabetes self-management education and support program for adults with type 1 diabetes who are having difficulty keeping their blood sugar in a healthy range, to see if this program helps improve control. **You may be eligible if...** - You are 18 or older with a doctor-confirmed diagnosis of type 1 diabetes - You are using an insulin pump or taking multiple daily insulin injections - Your most recent HbA1c (a 3-month blood sugar average) is 7.5% or higher - You have access to a device with a video camera (phone, tablet, or computer) - You have had at least one diabetes clinic visit at the participating center **You may NOT be eligible if...** - Your blood sugar is well-controlled (HbA1c below the threshold) - You do not use insulin (pump or injections) as your diabetes treatment - You do not have a device that supports video calls Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERHigh 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


Locations(9)

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

Women's College Hospital

Toronto, Ontario, Canada

Charles H. Best Diabetes Centre

Whitby, Ontario, Canada

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NCT05756829


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