Virtual Self-management Education and Support for Type 1 Diabetes
(T1ME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current diabetes treatment, as the trial focuses on virtual self-management support.
Is virtual self-management education and support for type 1 diabetes safe for humans?
How is the high frequency, low touch virtual health care treatment for type 1 diabetes different from other treatments?
This treatment is unique because it uses virtual self-management education and support, allowing patients to manage their diabetes remotely with frequent, low-intensity interactions. This approach increases accessibility and provides ongoing support, unlike traditional in-person programs that may have limited follow-up.36789
What data supports the effectiveness of the treatment High frequency, low touch virtual health care for Type 1 Diabetes?
Research shows that using internet and information technology for diabetes management can improve patient outcomes by providing timely support and education, which helps patients manage their condition better. Additionally, telemedicine has been shown to significantly improve blood sugar levels and weight management in diabetes patients, indicating that virtual health care can be an effective tool for self-management.1011121314
Who Is on the Research Team?
Gillian Booth
Principal Investigator
Unity Health Toronto
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Type 1 Diabetes who have a high HbA1c level (≥8.0%), use an insulin pump or multiple daily injections, and can handle both in-person and virtual healthcare visits for 6 months. Participants need reliable internet access, an email address, and must be fluent in English. Pregnant individuals, those on dialysis, or unable to use digital devices are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a high frequency, low-touch virtual health care intervention through the Maple application, with virtual visits every 2 +/- 1 weeks for a total of 6 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- High frequency, low touch virtual health care
High frequency, low touch virtual health care is already approved in Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Unity Health Toronto
Lead Sponsor