580 Participants Needed

Virtual Self-management Education and Support for Type 1 Diabetes

(T1ME Trial)

Recruiting at 6 trial locations
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Overseen ByStephanie de Sequeira, MPH
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Unity Health Toronto
Must be taking: Insulin
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

Research on a similar electronic information system for diabetes management showed it was safe, with a reduction in diabetes-related crises and improved blood glucose control.12345

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?

GB

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

Your most recent lab test showed that your HbA1c level is 8.0% or higher in the last 4 months.
I have been diagnosed with type 1 diabetes by a doctor.
I can attend all required visits, both in-person and online, for 6 months.
See 6 more

Exclusion Criteria

I am currently on dialysis.
Unable to use a computer/tablet or mobile phone
Unable to fluently speak or read English (self-reported)
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

6 months
12-13 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • High frequency, low touch virtual health care
Trial Overview The study tests a 'high frequency, low touch' virtual healthcare program designed to improve diabetes management without disrupting daily life. It includes regular brief online meetings with diabetes educators and a web platform offering educational resources tailored to the patient's life stage.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: High frequency, low-touch virtual health careExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

High frequency, low touch virtual health care is already approved in Canada for the following indications:

🇨🇦
Approved in Canada as Virtual Diabetes Self-Management Education and Support for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials
572
Recruited
470,000+

Published Research Related to This Trial

Information technology significantly enhances diabetes management by providing patients with tailored, just-in-time support, allowing for better self-management of their condition through online tools and resources.
The integration of technology in diabetes care enables clinicians to efficiently support a larger number of patients, facilitating continuous communication and personalized guidance without the constraints of traditional office hours.
Internet and information technology use in treatment of diabetes.Kaufman, N.[2022]
E-health educational interventions for patients with type 1 diabetes (T1D) did not show a significant difference in HbA1c levels compared to standard care, based on a meta-analysis of 6 randomized controlled trials involving 757 subjects.
The study emphasizes the need for more rigorous and well-designed trials to explore how e-health education can be effectively integrated into clinical practice for better diabetes management.
E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials.Feigerlová, E., Oussalah, A., Zuily, S., et al.[2022]
In a 3-month study involving 28 patients, telemedicine consultations led to a significant 16% reduction in hemoglobin A1c (HbA1c) levels, indicating improved diabetes control.
The telemedicine group also experienced a 4% reduction in total body weight, suggesting that remote management can enhance self-management of diabetes effectively.
Telemedicine improved diabetic management.Whitlock, WL., Brown, A., Moore, K., et al.[2022]

Citations

Internet and information technology use in treatment of diabetes. [2022]
E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials. [2022]
Telemedicine improved diabetic management. [2022]
A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. [2022]
The efficacy of telehealth delivered educational approaches for patients with chronic diseases: A systematic review. [2022]
Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. [2018]
What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. [2021]
New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]
Older adults using cellular telephones for diabetes management: a pilot study. [2017]
Diabetes intervention in the information age. [2019]
COVID: The Missing Trigger to Start a Remote FIT Course. [2023]
Design, construction, and implementation of an online platform for patients with type 1 diabetes: EncoDiab. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Development of the Support self-guided, web application for adults living with type 1 diabetes in Canada by a multi-disciplinary team using a people-oriented approach based on the Behaviour Change Wheel. [2023]
Home-based video visits for pediatric patients with poorly controlled type 1 diabetes. [2022]
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