Type 1 Diabetes Virtual Self-management Education and Support

NCT05756829 | Recruiting

• 1 other identifier: CTO Project ID: 3644
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 9

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline HbA1c at 6 months

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

Study Arms (2)

High frequency, low-touch virtual health care

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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 OTHER

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

High frequency, low-touch virtual health care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (9)

Waterloo Regional Health Network

Kitchener, Ontario, N2G 1G3, Canada

RECRUITING

Mackenzie Health

Richmond Hill, Ontario, L4C 4Z3, Canada

RECRUITING

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

St. Michael's Hospital, Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

RECRUITING

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

St. Joseph's Health Centre, Unity Health Toronto

Toronto, Ontario, M6R 1B5, Canada

RECRUITING

Women's College Hospital

Toronto, Ontario, Canada

NOT YET RECRUITING

Charles H. Best Diabetes Centre

Whitby, Ontario, L1M 1Z5, Canada

RECRUITING

Study Officials

• Gillian Booth, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie de Sequeira, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2023
• First Posted: March 6, 2023
• Study Start: May 10, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-01

Locations

CA (9)