type1diabetesT1MENCT05756829
Type 1 Diabetes Virtual Self-management Education and Support
A study testing High frequency, low touch virtual health care in people with type1diabetes, run by Unity Health Toronto at 9 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- type1diabetes
- What is being tested?
- High frequency, low touch virtual health care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 580 participants
- Where
- 9 sitesCanada
- Study dates
- 10 May 2023to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients ≥18 years of age
- Physician diagnosis of type 1 diabetes
- Currently on an insulin pump or using multiple daily insulin injections.
- HbA1c ≥ 7.5% on most recent laboratory report or estimated from CGM/FGM* report, within the last 4 months
- 14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)
- Has access to a mobile device or computer/tablet with a video camera
Show all 11Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Canada9 sites, 9 recruiting
- Recruiting
Waterloo Regional Health Network
Kitchener, Ontario, N2G 1G3
Jacquelyn Coyne, jacquelyn.coyne@wrhn.ca
Luciana Parlea
- Recruiting
Mackenzie Health
Richmond Hill, Ontario, L4C 4Z3
Ada Wong, Ada.Wong@MackenzieHealth.ca
Nathalie Leung
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Saloni Choksi, Saloni.Choksi@unityhealth.to
Baiju Shah
- Recruiting
St. Michael's Hospital, Unity Health Toronto
Toronto, Ontario, M5B 1W8
Saloni Choksi, Saloni.Choksi@unityhealth.to
Gillian Booth
- Recruiting
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Andrej Orszag, Andrej.Orszag@uhn.ca
Bruce Perkins
- Recruiting
Toronto General Hospital
Toronto, Ontario, M5G 2C4
Scarlett Lau, KaWing.Lau@uhn.ca
Calvin Ke
- Recruiting
St. Joseph's Health Centre, Unity Health Toronto
Toronto, Ontario, M6R 1B5
Saloni Choksi, Saloni.Choksi@unityhealth.to
Shagufta Khan
- Not yet recruiting
Women's College Hospital
Toronto, Ontario
Ishraq Rahman, Ishraq.Rahman@wchospital.ca
Geetha Mukerji
- Recruiting
Charles H. Best Diabetes Centre
Whitby, Ontario, L1M 1Z5
Saloni Choksi, Saloni.Choksi@unityhealth.to
Valerie Lewis
About this study
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.
- Conditions
- type1diabetes
- Being tested
- High frequency, low touch virtual health care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High frequency, low touch virtual health careOther
Virtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months
| Study group | Role | What they receive |
|---|---|---|
| High frequency, low-touch virtual health care | Experimental | 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. Receives: Other: High frequency, low touch virtual health care |
| Standard Care | No intervention | Participants in this arm will receive the standard of care offered for their condition and by their clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline HbA1c at 6 months
Measured: Baseline, pre-intervention AND Up to 4 weeks after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start10 May 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 580 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gillian Booth, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756829
- Sponsor's protocol ID
- CTO Project ID: 3644
- Acronym
- T1ME
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2023
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type 1 Diabetes Virtual Self-management Education and Support
- ClinicalTrials.gov ID
- NCT05756829
- Acronym / sponsor ID
- T1ME / CTO Project ID: 3644
- Conditions
- type1diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 580 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High frequency, low-touch virtual health care | Experimental | Other: High frequency, low touch virtual health careParticipants 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. |
| Standard Care | No intervention | –Participants in this arm will receive the standard of care offered for their condition and by their clinic. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Outpatients ≥18 years of age
- Physician diagnosis of type 1 diabetes
- Currently on an insulin pump or using multiple daily insulin injections.
- HbA1c ≥ 7.5% on most recent laboratory report or estimated from CGM/FGM* report, within the last 4 months
- 14 day look back window, with a wear rate of 70%, based on Estimated A1c or Glucose management Indicator (GMI)
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High frequency, low touch virtual health careVirtual visits between certified diabetes educators and patients occurring every 2 +/- 1 weeks for a total of 6 months | Other | High frequency, low-touch virtual health care |
Primary outcome
Change from Baseline HbA1c at 6 months
Time frame: Baseline, pre-intervention AND Up to 4 weeks after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gillian Booth, MD principal investigator
Unity Health Toronto
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High frequency, low touch virtual health care in people with type1diabetes, run by Unity Health Toronto at 9 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephanie de Sequeira, MPH (416-864-6060, stephanie.desequeira@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline HbA1c at 6 months (time frame: Baseline, pre-intervention AND Up to 4 weeks after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.