NCT05756829 Type 1 Diabetes Virtual Self-management Education and Support
| NCT ID | NCT05756829 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Unity Health Toronto |
| Condition | type1diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 580 participants |
| Start Date | 2023-05-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 580 participants in total. It began in 2023-05-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Gillian Booth, MD
PRINCIPAL INVESTIGATOR
Unity Health Toronto
Frequently Asked Questions
Who can join the NCT05756829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying type1diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05756829 currently recruiting?
Yes, NCT05756829 is actively recruiting participants. Contact the research team at stephanie.desequeira@unityhealth.to for enrollment information.
Where is the NCT05756829 trial being conducted?
This trial is being conducted at Kitchener, Canada, Richmond Hill, Canada, Toronto, Canada, Toronto, Canada and 5 additional locations.
Who is sponsoring the NCT05756829 clinical trial?
NCT05756829 is sponsored by Unity Health Toronto. The principal investigator is Gillian Booth, MD at Unity Health Toronto. The trial plans to enroll 580 participants.
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