Type 1 Diabetes Virtual Self-management Education and Support

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.

Recruiting

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Key information

Conditions

Type1diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Waterloo Regional Health Network, Kitchener, Ontario, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 ≥ 7.5% on most recent laboratory report or estimated from CGM/FGM* report, within the last 4 months

*14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)

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)

Treatment and study plan

High frequency, low touch virtual health care

Other

Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months

Primary outcomes

Change from Baseline HbA1c at 6 months

Time frame: Baseline, pre-intervention AND Up to 4 weeks after the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie de Sequeira, MPH

CONTACT

[email protected]

416-864-6060

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Acronym: T1ME

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2027
First posted: Mar 6, 2023
Registry last updated: Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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