Type 1 Diabetes Virtual Self-management Education and Support

type1diabetes Clinical Trial

— T1ME  

Official title:

Type 1 Diabetes Virtual Self-management Education and Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756829
• Other study ID #: CTO Project ID: 3644
• Status: Recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: June 30, 2025

Study information

• Verified date: August 2023
• Source: Unity Health Toronto
• Contact: Stephanie de Sequeira, MPH
• Phone: 416-864-6060
• Email: stephanie.desequeira[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 580
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 = 8.0% 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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• type1diabetes

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Unity Health Toronto	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline HbA1c at 6 months		Baseline, pre-intervention AND Up to 4 weeks after the intervention