Recruiting

Diabetes Education

Sponsor:

Unity Health Toronto

Code:

NCT05756829

Conditions

type1diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

High frequency, low touch virtual health care

Study Details

Brief summary:

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.

Conditions

type1diabetes

Study ID

NCT05756829

Start date

May 10, 2023

Status verified date

Jan, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

580 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

no intervention: Standard Care

Participants in this arm will receive the standard of care offered for their condition and by their clinic.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Stephanie de Sequeira, MPH

416-864-6060stephanie.desequeira@unityhealth.to

Locations

Waterloo Regional Health Network

Recruiting

Kitchener, Ontario, Canada, N2G 1G3

Contacts

Jacquelyn Coyne

jacquelyn.coyne@wrhn.ca

Principal Investigator:

Luciana Parlea

Mackenzie Health

Recruiting

Richmond Hill, Ontario, Canada, L4C 4Z3

Contacts

Ada Wong

Ada.Wong@MackenzieHealth.ca

Principal Investigator:

Nathalie Leung

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Saloni Choksi

Saloni.Choksi@unityhealth.to

Principal Investigator:

Baiju Shah

St. Michael's Hospital, Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Saloni Choksi

Saloni.Choksi@unityhealth.to

Principal Investigator:

Gillian Booth

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Andrej Orszag

Andrej.Orszag@uhn.ca

Principal Investigator:

Bruce Perkins

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Contacts

Scarlett Lau

KaWing.Lau@uhn.ca

Principal Investigator:

Calvin Ke

St. Joseph's Health Centre, Unity Health Toronto

Recruiting

Toronto, Ontario, Canada, M6R 1B5

Contacts

Saloni Choksi

Saloni.Choksi@unityhealth.to

Principal Investigator:

Shagufta Khan

Charles H. Best Diabetes Centre

Recruiting

Whitby, Ontario, Canada, L1M 1Z5

Contacts

Saloni Choksi

Saloni.Choksi@unityhealth.to

Principal Investigator:

Valerie Lewis

More Information

Sponsor

Unity Health Toronto

Last update posted

Apr 21, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2026-04-21.