NCT05756829

Type 1 Diabetes Virtual Self-management Education and Support

Unity Health Toronto·ClinicalTrials.gov·otherRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
type1diabetes
Drug/Device/Intervention
High frequency, low touch virtual health care
Study type
Interventional
Intervention type
other
Sponsor & location
Primary sponsor
Unity Health Toronto
Location
Toronto, Canada
Timeline & enrollment
Phase
N/A
Start date
May 10, 2023
End date
Jun 30, 2025
Enrollment
580 participants
Primary outcome

Change from Baseline HbA1c at 6 months

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.

ICD-10 classifications
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT05756829
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT05756829 through Pure Global AI's free database. This phase not specified trial is sponsored by Unity Health Toronto and is currently Recruiting. The study focuses on type1diabetes. Target enrollment is 580 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.