Type 1 Diabetes Virtual Self-management Education and Support

Study Overview
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Brief Summary
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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.

Official Title
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Type 1 Diabetes Virtual Self-management Education and Support

Conditions
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type1diabetes

Intervention / Treatment
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* Other: High frequency, low touch virtual health care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients ≥18 years of age Physician diagnosis of type 1 diabetes Currently on an insulin pump or using multiple daily insulin injections. HbA1c ≥ 8.0% 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 Exclusion Criteria: Diagnosed with non-Type 1 diabetes Unable to use a computer/tablet or mobile phone Pregnant On dialysis Unable to fluently speak or read English (self-reported)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High frequency, low-touch virtual health care<br>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. | Other: High frequency, low touch virtual health care<br>* Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months<br>|
| No Intervention: Standard Care<br>Participants in this arm will receive the standard of care offered for their condition and by their clinic. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline HbA1c at 6 months |  | Baseline, pre-intervention AND Up to 4 weeks after the intervention |