T1ME: Type 1 Diabetes Virtual Self-management Education and Support

• Sponsor: Unity Health Toronto (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05756829
• Collaborator: (none)
• Enrollment: 580
• Arms: 2
• Anticipated Duration (Months): 26.9

Study Details

Study Description

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: We will conduct 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. We will aim to recruit 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.

Condition or Disease	Intervention/Treatment	Phase
type1diabetes	Other: High frequency, low touch virtual health care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 580 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Type 1 Diabetes Virtual Self-management Education and Support
• Anticipated Study Start Date: Apr 3, 2023
• Anticipated Primary Completion Date: Dec 31, 2024
• Anticipated Study Completion Date: Jun 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
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.	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
No Intervention: Standard Care Participants in this arm will receive the standard of care offered for their condition and by their clinic.

Outcome Measures

Primary Outcome Measures

1. Change from Baseline HbA1c at 6 months [Baseline, pre-intervention AND Up to 4 weeks after the intervention]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Unity Health Toronto

Investigators

• Principal Investigator: Gillian Booth, MD, Unity Health Toronto

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gillian Booth, Scientist, Unity Health Toronto
• ClinicalTrials.gov Identifier: NCT05756829
• Other Study ID Numbers: CTO Project ID: 3644
• First Posted: Mar 6, 2023
• Last Update Posted: Mar 6, 2023
• Last Verified: Mar 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Mar 6, 2023