Type 1 Diabetes Virtual Self-management Education and Support (T1ME)
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|ClinicalTrials.gov Identifier: NCT05756829
Recruitment Status : Recruiting
First Posted : March 6, 2023
Last Update Posted : August 25, 2023
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.
|Condition or disease
|Other: High frequency, low touch virtual health care
|Study Type :
|Interventional (Clinical Trial)
|Estimated Enrollment :
|None (Open Label)
|Type 1 Diabetes Virtual Self-management Education and Support
|Actual Study Start Date :
|May 10, 2023
|Estimated Primary Completion Date :
|December 31, 2024
|Estimated Study Completion Date :
|June 30, 2025
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.
- Change from Baseline HbA1c at 6 months [ Time Frame: Baseline, pre-intervention AND Up to 4 weeks after the intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05756829
|Contact: Stephanie de Sequeira, MPH
|Unity Health Toronto
|Toronto, Ontario, Canada, M5B 1W8
|Contact: Adhiyat Najam firstname.lastname@example.org
|Principal Investigator: Gillian Booth
|Mount Sinai Hospital
|Not yet recruiting
|Toronto, Ontario, Canada, M5G 1X5
|Contact: Andrej Orszag Andrej.Orszag@uhn.ca
|Principal Investigator: Bruce Perkins
|Gillian Booth, MD
|Unity Health Toronto