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Type 1 Diabetes Virtual Self-management Education and Support (T1ME)

Primary Purpose

type1diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High frequency, low touch virtual health care
Sponsored by
Unity Health Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for type1diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Outpatients ≥18 years of age Physician diagnosis of type 1 diabetes Currently on an insulin pump or using multiple daily insulin injections. HbA1c ≥ 8.0% on most recent laboratory report, within the last 4 months Has access to a mobile device or computer/tablet with a video camera 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 OHIP coverage Currently using an active email address or be willing to obtain an email address Has consistent and reliable access to internet Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period Exclusion Criteria: Diagnosed with non-Type 1 diabetes Unable to use a computer/tablet or mobile phone Pregnant On dialysis Unable to fluently speak or read English (self-reported)

Sites / Locations

  • Unity Health TorontoRecruiting
  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

High frequency, low-touch virtual health care

Standard Care

Arm Description

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.

Participants in this arm will receive the standard of care offered for their condition and by their clinic.

Outcomes

Primary Outcome Measures

Change from Baseline HbA1c at 6 months

Secondary Outcome Measures

Full Information

First Posted
February 9, 2023
Last Updated
August 23, 2023
Sponsor
Unity Health Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT05756829
Brief Title
Type 1 Diabetes Virtual Self-management Education and Support
Acronym
T1ME
Official Title
Type 1 Diabetes Virtual Self-management Education and Support
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
type1diabetes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High frequency, low-touch virtual health care
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Participants in this arm will receive the standard of care offered for their condition and by their clinic.
Intervention Type
Other
Intervention Name(s)
High frequency, low touch virtual health care
Intervention Description
Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months
Primary Outcome Measure Information:
Title
Change from Baseline HbA1c at 6 months
Time Frame
Baseline, pre-intervention AND Up to 4 weeks after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Outpatients ≥18 years of age Physician diagnosis of type 1 diabetes Currently on an insulin pump or using multiple daily insulin injections. HbA1c ≥ 8.0% on most recent laboratory report, within the last 4 months Has access to a mobile device or computer/tablet with a video camera 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 OHIP coverage Currently using an active email address or be willing to obtain an email address Has consistent and reliable access to internet Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period Exclusion Criteria: Diagnosed with non-Type 1 diabetes Unable to use a computer/tablet or mobile phone Pregnant On dialysis Unable to fluently speak or read English (self-reported)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephanie de Sequeira, MPH
Phone
416-864-6060
Email
stephanie.desequeira@unityhealth.to
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gillian Booth, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unity Health Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adhiyat Najam
Email
adhiyat.najam@unityhealth.to
First Name & Middle Initial & Last Name & Degree
Gillian Booth
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrej Orszag
Email
Andrej.Orszag@uhn.ca
First Name & Middle Initial & Last Name & Degree
Bruce Perkins

12. IPD Sharing Statement

Learn more about this trial

Type 1 Diabetes Virtual Self-management Education and Support

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