Virtual Self-management Education and Support for Type 1 Diabetes

(T1ME Trial)

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Gillian Booth

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Unity Health Toronto

Must be taking: Insulin

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

Stay on Your Current Meds

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment High frequency, low touch virtual health care for Type 1 Diabetes?

Research shows that using internet and information technology for diabetes management can improve patient outcomes by providing timely support and education, which helps patients manage their condition better. Additionally, telemedicine has been shown to significantly improve blood sugar levels and weight management in diabetes patients, indicating that virtual health care can be an effective tool for self-management. ^{1 2 3 4 5}

Is virtual self-management education and support for type 1 diabetes safe for humans?

Research on a similar electronic information system for diabetes management showed it was safe, with a reduction in diabetes-related crises and improved blood glucose control. ^{6 7 8 9 10}

How is the high frequency, low touch virtual health care treatment for type 1 diabetes different from other treatments?

This treatment is unique because it uses virtual self-management education and support, allowing patients to manage their diabetes remotely with frequent, low-intensity interactions. This approach increases accessibility and provides ongoing support, unlike traditional in-person programs that may have limited follow-up. ^{8 11 12 13 14}

Research Team

Gillian Booth

Principal Investigator

Unity Health Toronto

Eligibility Criteria

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 am 18 years old or older and not hospitalized.

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

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)

Trial Timeline

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

Treatment Details

Interventions

• High frequency, low touch virtual health care (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Sharon Straus

Unity Health Toronto

Chief Medical Officer

MD and MSc in Clinical Epidemiology, University of Toronto

Altaf Stationwala

Unity Health Toronto

Chief Executive Officer

Bachelor's degree in Health Administration, University of Ottawa

Findings from Research

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]

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]

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 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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Telemedicine improved diabetic management. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A review of web-assisted interventions for diabetes management: maximizing the potential for improving health outcomes. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

The efficacy of telehealth delivered educational approaches for patients with chronic diseases: A systematic review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. [2018]

7. England pubmed.ncbi.nlm.nih.gov

What happens between visits? Adverse and potential adverse events among a low-income, urban, ambulatory population with diabetes. [2021]

8. Canada pubmed.ncbi.nlm.nih.gov

New-Onset Diabetes Educator to Educate Children and Their Caregivers About Diabetes at the Time of Diagnosis: Usability Study. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Older adults using cellular telephones for diabetes management: a pilot study. [2017]

10. England pubmed.ncbi.nlm.nih.gov

Diabetes intervention in the information age. [2019]

11. Switzerland pubmed.ncbi.nlm.nih.gov

COVID: The Missing Trigger to Start a Remote FIT Course. [2023]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Design, construction, and implementation of an online platform for patients with type 1 diabetes: EncoDiab. [2020]

13. United States 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. [2023]

14. England pubmed.ncbi.nlm.nih.gov

Home-based video visits for pediatric patients with poorly controlled type 1 diabetes. [2022]