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Type 1 Diabetes Virtual Self-management Education and Support - Trial NCT05756829

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.

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NCT05756829
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Trial Details
ClinicalTrials.gov โ€ข NCT05756829
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Type 1 Diabetes Virtual Self-management Education and Support

Study Focus

type1diabetes

High frequency, low touch virtual health care

Interventional

other

Sponsor & Location

Unity Health Toronto

Toronto, Canada

Timeline & Enrollment

N/A

May 10, 2023

Jun 30, 2025

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 mellitus
Type 1 diabetes mellitus with unspecified complications
Type 1 diabetes mellitus with other specified complications
Type 1 diabetes mellitus without complications
Type 1 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT05756829

Non-Device Trial