Clinical trial NCT05756829: Type 1 Diabetes Virtual Self-management Education and Support
Official title: Type 1 Diabetes Virtual Self-management Education and Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: type1diabetes
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 580
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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, within the last 4 months
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)

Primary outcomes:
measure: Change from Baseline HbA1c at 6 months
timeFrame: Baseline, pre-intervention AND Up to 4 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Kitchener
country: Canada
facility: Grand River Hospital
state: Ontario
city: Richmond Hill
country: Canada
facility: Mackenzie Health
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Whitby
country: Canada
facility: Charles H. Best Diabetes Centre
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Gillian Booth, MD
role: PRINCIPAL_INVESTIGATOR
References: