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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05756829
Recruitment Status : Recruiting
First Posted : March 6, 2023
Last Update Posted : August 25, 2023
Sponsor:
Information provided by (Responsible Party):
Gillian Booth, Unity Health Toronto

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.


Condition or disease Intervention/treatment Phase
type1diabetes Other: High frequency, low touch virtual health care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change from Baseline HbA1c at 6 months [ Time Frame: Baseline, pre-intervention AND Up to 4 weeks after the intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients ≥18 years of age
  2. Physician diagnosis of type 1 diabetes
  3. Currently on an insulin pump or using multiple daily insulin injections.
  4. HbA1c ≥ 8.0% on most recent laboratory report, within the last 4 months
  5. Has access to a mobile device or computer/tablet with a video camera
  6. 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
  7. OHIP coverage
  8. Currently using an active email address or be willing to obtain an email address
  9. Has consistent and reliable access to internet
  10. Willing and able to comply with scheduled in-person and virtual visits for 6 month intervention period

Exclusion Criteria:

  1. Diagnosed with non-Type 1 diabetes
  2. Unable to use a computer/tablet or mobile phone
  3. Pregnant
  4. On dialysis
  5. Unable to fluently speak or read English (self-reported)

Information from the National Library of Medicine

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


Contacts
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Contact: Stephanie de Sequeira, MPH 416-864-6060 stephanie.desequeira@unityhealth.to

Locations
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Canada, Ontario
Unity Health Toronto Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Adhiyat Najam       adhiyat.najam@unityhealth.to   
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         
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Gillian Booth, MD Unity Health Toronto
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Responsible Party: Gillian Booth, Nominated Principal Investigator, Unity Health Toronto
ClinicalTrials.gov Identifier: NCT05756829    
Other Study ID Numbers: CTO Project ID: 3644
First Posted: March 6, 2023    Key Record Dates
Last Update Posted: August 25, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases