Virtual Self-management Education and Support for Type 1 Diabetes

(T1ME Trial)

Recruiting at 9 trial locations

Overseen By Stephanie de Sequeira, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Must be taking: Insulin

Disqualifiers: Non-Type 1 diabetes, Pregnant, Dialysis, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 6 months

580 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a virtual health care program to improve blood sugar management for people with type 1 diabetes (T1D). Known as high frequency, low touch virtual health care, the program provides frequent, short virtual visits with diabetes educators and access to online educational resources, making diabetes care more convenient and less disruptive. It targets those with T1D who use insulin pumps or multiple daily injections and have recently experienced higher blood sugar levels. Participants need reliable internet access and should feel comfortable using a computer or smartphone for virtual appointments. As an unphased trial, this study offers a unique opportunity to explore innovative diabetes management strategies that could enhance daily life.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current diabetes treatment, as the trial focuses on virtual self-management support.

What prior data suggests that this virtual health care intervention is safe for individuals with type 1 diabetes?

Research shows that virtual health care for managing type 1 diabetes is generally safe. Studies have found that patients handle these programs well. Frequent, short online visits help manage diabetes without major disruptions to daily life.

No significant reports of problems have been linked to using virtual self-management tools. These tools offer educational resources and support, which many patients find helpful for managing their condition. Since this virtual care method doesn't involve new medications or invasive procedures, it carries a low risk of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about high frequency, low-touch virtual health care for Type 1 Diabetes (T1D) because it offers a unique, tech-driven approach to disease management. Unlike traditional T1D treatments that rely heavily on in-person visits and self-monitoring, this method utilizes regular virtual check-ins through the Maple app, making healthcare more accessible and less invasive. Additionally, this approach includes access to a virtual library, empowering patients with self-learning tools to better manage their condition. This innovative strategy could significantly enhance patient engagement and adherence, potentially leading to improved health outcomes.

What evidence suggests that this virtual health care intervention is effective for type 1 diabetes?

Research has shown that online programs for managing type 1 diabetes can improve health. In this trial, participants in the "High frequency, low-touch virtual health care" arm will receive frequent but short virtual visits with diabetes educators through the Maple application, as an adjunct to usual T1D care. Studies have found that using diabetes apps and telehealth services can help lower hemoglobin A1C levels, an important measure of blood sugar control. This online care model provides regular support without the need for in-person appointments, aiming to make managing diabetes easier and more flexible for everyday life. Early findings suggest this method can enhance diabetes management without interrupting daily activities. ^{1 2 3 4 5}

Who Is on the Research Team?

Gillian Booth

Principal Investigator

Unity Health Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Type 1 Diabetes who have a high HbA1c level (≥8.0%), use an insulin pump or multiple daily injections, and can handle both in-person and virtual healthcare visits for 6 months. Participants need reliable internet access, an email address, and must be fluent in English. Pregnant individuals, those on dialysis, or unable to use digital devices are excluded.

Inclusion Criteria

Your most recent lab test showed that your HbA1c level is 8.0% or higher in the last 4 months.

I have been diagnosed with type 1 diabetes by a doctor.

I can attend all required visits, both in-person and online, for 6 months.

Exclusion Criteria

I am currently on dialysis.

Unable to use a computer/tablet or mobile phone

Unable to fluently speak or read English (self-reported)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a high frequency, low-touch virtual health care intervention through the Maple application, with virtual visits every 2 +/- 1 weeks for a total of 6 months

6 months

12-13 virtual visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High frequency, low touch virtual health care

Trial Overview The study tests a 'high frequency, low touch' virtual healthcare program designed to improve diabetes management without disrupting daily life. It includes regular brief online meetings with diabetes educators and a web platform offering educational resources tailored to the patient's life stage.

How Is the Trial Designed?

Group I: High frequency, low-touch virtual health care Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

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

High frequency, low touch virtual health care is already approved in Canada for the following indications:

Approved in Canada as Virtual Diabetes Self-Management Education and Support for:

• Type 1 Diabetes Management

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Published Research Related to This Trial

Home-based video visits for pediatric patients with poorly controlled type 1 diabetes (T1D) over six months led to a significant reduction in HbA1c levels by an average of 0.8%, indicating improved glycemic control.

Patients reported high satisfaction with the video visit experience, with 94% stating they were 'very satisfied', and the frequency of in-person clinic visits also increased during the study, suggesting enhanced overall care engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based video visits for pediatric patients with poorly controlled type 1 diabetes. Crossen, S., Glaser, N., Sauers-Ford, H., et al.[2022]

A study involving 31 diabetes educators in Australia revealed that they found the use of technology in managing type 1 diabetes to be burdensome, indicating a need for better support and training in technology use.

Despite the potential benefits of diabetes-related technologies, care delivery was often fragmented and inconsistent, suggesting that improvements in policy and service structure are necessary to enhance the effectiveness of these tools in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. James, S., Perry, L., Gallagher, R., et al.[2018]

A significant 86% of the 111 diabetes patients experienced at least one adverse event (AE) or potential adverse event (PotAE) over a 9-month period, highlighting the prevalence of safety issues in chronic disease management.

The majority of AEs (63%) were related to medication management, and 77% of events involved patient actions, indicating that enhancing patient self-management and communication with healthcare providers is crucial for preventing these events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. Sarkar, U., Handley, MA., Gupta, R., et al.[2021]

Information technology significantly enhances diabetes management by providing patients with tailored, just-in-time support, allowing for better self-management of their condition through online tools and resources.

The integration of technology in diabetes care enables clinicians to efficiently support a larger number of patients, facilitating continuous communication and personalized guidance without the constraints of traditional office hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet and information technology use in treatment of diabetes. Kaufman, N.[2022]

E-health educational interventions for patients with type 1 diabetes (T1D) did not show a significant difference in HbA1c levels compared to standard care, based on a meta-analysis of 6 randomized controlled trials involving 757 subjects.

The study emphasizes the need for more rigorous and well-designed trials to explore how e-health education can be effectively integrated into clinical practice for better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

E-health education interventions on HbA1c in patients with type 1 diabetes on intensive insulin therapy: A systematic review and meta-analysis of randomized controlled trials. Feigerlová, E., Oussalah, A., Zuily, S., et al.[2022]

In a 3-month study involving 28 patients, telemedicine consultations led to a significant 16% reduction in hemoglobin A1c (HbA1c) levels, indicating improved diabetes control.

The telemedicine group also experienced a 4% reduction in total body weight, suggesting that remote management can enhance self-management of diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telemedicine improved diabetic management. Whitlock, WL., Brown, A., Moore, K., et al.[2022]

Web-based interventions for managing type 2 diabetes, which include features like tracking blood glucose and scheduling physician visits, have been shown to improve patient engagement and health outcomes significantly.

Despite their effectiveness, comprehensive web-based diabetes management systems are not widely implemented due to high development costs and lack of reimbursement, which are barriers that need to be addressed for broader adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. Brown, LL., Lustria, ML., Rankins, J.[2022]

A systematic review of 16 high to moderate quality studies found that virtual education for patients with chronic diseases significantly improved health outcomes in 11 out of 16 studies compared to usual care.

Overall, virtual education was either more effective or comparable to traditional care methods, suggesting it is a viable alternative for managing chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of telehealth delivered educational approaches for patients with chronic diseases: A systematic review. Rush, KL., Hatt, L., Janke, R., et al.[2022]

Effective management of Type 1 diabetes requires a collaborative approach involving patients, families, and healthcare teams, emphasizing the importance of person-centered education and support.

The COVID-19 pandemic has heightened the need for remote diabetes self-management education, prompting a shift towards virtual programs like the FIT course, which is designed to enhance diabetes management skills and confidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

COVID: The Missing Trigger to Start a Remote FIT Course. Dos Santos Mamed, M., Gastaldi, G.[2023]

A web-based telecommunications system was tested in a 3-month pilot study with older patients who have Type 2 diabetes, showing promise in improving medication adherence and self-care practices.

The system enhances communication between patients and healthcare providers, allowing for better feedback and support in managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older adults using cellular telephones for diabetes management: a pilot study. Durso, SC., Wendel, I., Letzt, AM., et al.[2017]

An electronic information system for diabetes management was tested over one year with 204 patients, showing significant improvements in blood glucose control, as evidenced by a 1.0-1.3% reduction in glycated hemoglobin for active users.

The system also reduced the prevalence of diabetes-related crises (hyperglycemia or hypoglycemia) by approximately three-fold, demonstrating its efficacy in enhancing patient safety and management of diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes intervention in the information age. Albisser, AM., Harris, RI., Sakkal, S., et al.[2019]

The New-Onset Diabetes Educator (NODE) web application significantly improved diabetes knowledge among child/caregiver dyads, with post-intervention scores showing a medium effect size (Δ=0.56) compared to standard education methods.

NODE was found to be user-friendly and feasible, suggesting it could be an effective tool for enhancing diabetes self-management education at the time of diagnosis, potentially leading to better long-term health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. Bernier, A., Fedele, D., Guo, Y., et al.[2023]

A virtual platform called EncoDiab was developed based on feedback from 33 type 1 diabetes patients, providing tools and resources to aid in self-management of their condition.

The platform includes practical tools like an insulin-dose calculator and a library of information, demonstrating its feasibility for improving patient engagement and management of type 1 diabetes in a public health setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, construction, and implementation of an online platform for patients with type 1 diabetes: EncoDiab. Alvarado-Martel, D., Cañas, F., Velasco, R., et al.[2020]

The 'Support' web application is a pioneering self-guided tool designed for adults with type 1 diabetes (T1D), developed with input from both patients and healthcare professionals to address barriers in diabetes self-management education and support (DSME/S).

This bilingual app offers interactive learning paths and resources focused on hypoglycemia, aiming to enhance user engagement and motivation, and is currently being evaluated for its feasibility and clinical effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the Support self-guided, web application for adults living with type 1 diabetes in Canada by a multi-disciplinary team using a people-oriented approach based on the Behaviour Change Wheel. Xie, LF., Roy-Fleming, A., Haag, S., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782362/

Implementation Plan for a High-Frequency, Low-Touch Care ... The T1ME trial is comprised of 3 components aimed at supporting self-management changes and goal advancement: (1) virtual care software that ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10899831/

Telehealth Technologies in Diabetes Self-management ... Efficacy of diabetes app use has been evaluated in several studies by demonstrating improvement in health-related outcomes, such as lower hemoglobin A1C, ...

3. withpower.com withpower.com/trial/phase-diabetes-mellitus-3-2023-39d64

Virtual Self-management Education and Support for Type 1 ... Trial Overview The study tests a 'high frequency, low touch' virtual healthcare program designed to improve diabetes management without disrupting daily life.

4. researchgate.net researchgate.net/publication/358607021_Developing_a_Successful_Implementation_Plan_for_a_High_Frequency_Low_Touch_Care_Model_at_Specialized_Type_1_diabetes_Clinics_The_Type_1_Diabetes_Virtual_Self-Management_and_Education_support_T1ME_Tria

The Type 1 Diabetes Virtual Self-Management and ... Developing a Successful Implementation Plan for a High Frequency, Low Touch Care Model at Specialized Type 1 diabetes Clinics: The Type 1 Diabetes Virtual Self- ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05756829/type-1-diabetes-virtual-self-management-education-and-support

Type 1 Diabetes Virtual Self-management Education and ... The proposed study will test a virtual health care intervention to deliver "high frequency, low touch" care aimed at improving metabolic control ...