Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05756829
Status:
RECRUITING
Last Update Posted:
2023-08-25
First Post:
2023-02-09
Brief Title:
Type 1 Diabetes Virtual Self-management Education and Support
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
Type 1 Diabetes Virtual Self-management Education and Support
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
T1ME
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 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 ie results in fewer disruptions to their daily life and tailored to their individual needs based on their stage in life
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 ie results in fewer disruptions to their daily life and tailored to their individual needs based on their stage in life
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None