Type 1 Diabetes Virtual Self-management Education and Support (T1ME)

April 15, 2026 updated by: Unity Health Toronto

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

580

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Kitchener, Ontario, Canada, N2G 1G3
        • Recruiting
        • Waterloo Regional Health Network
        • Principal Investigator:
          • Luciana Parlea
        • Contact:
      • Richmond Hill, Ontario, Canada, L4C 4Z3
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Health Sciences Centre
        • Principal Investigator:
          • Baiju Shah
        • Contact:
      • Toronto, Ontario, Canada, M5G 1X5
        • Recruiting
        • Mount Sinai Hospital
        • Contact:
        • Principal Investigator:
          • Bruce Perkins
      • Toronto, Ontario, Canada, M5G 2C4
        • Recruiting
        • Toronto General Hospital
        • Principal Investigator:
          • Calvin Ke
        • Contact:
      • Toronto, Ontario, Canada
        • Not yet recruiting
        • Women's College Hospital
        • Contact:
        • Principal Investigator:
          • Geetha Mukerji
      • Toronto, Ontario, Canada, M5B 1W8
        • Recruiting
        • St. Michael's Hospital, Unity Health Toronto
        • Principal Investigator:
          • Gillian Booth
        • Contact:
      • Toronto, Ontario, Canada, M6R 1B5
        • Recruiting
        • St. Joseph's Health Centre, Unity Health Toronto
        • Contact:
        • Principal Investigator:
          • Shagufta Khan
      • Whitby, Ontario, Canada, L1M 1Z5
        • Recruiting
        • Charles H. Best Diabetes Centre
        • Principal Investigator:
          • Valerie Lewis
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Outpatients ≥18 years of age
  2. Physician diagnosis of type 1 diabetes
  3. Currently on an insulin pump or using multiple daily insulin injections.

  4. 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)

  5. Has access to a mobile device or computer/tablet with a video camera
  6. 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
  7. OHIP coverage
  8. Currently using an active email address or be willing to obtain an email address
  9. Has consistent and reliable access to internet
  10. Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period

Exclusion Criteria:

  1. Diagnosed with non-Type 1 diabetes
  2. Unable to use a computer/tablet or mobile phone
  3. Pregnant
  4. On dialysis
  5. Unable to fluently speak or read English (self-reported)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High frequency, low-touch virtual health care

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
Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months
No Intervention: Standard Care
Participants in this arm will receive the standard of care offered for their condition and by their clinic.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Gillian Booth, MD, Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

February 9, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTO Project ID: 3644

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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