Digital Health Management Tool for Type 1 Diabetes

(KiT Trial)

Not currently recruiting at 7 trial locations

Overseen By Mikayla Sonnenberg

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: The Hospital for Sick Children

Disqualifiers: Intellectual disability, Non-resident, Others

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

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital health management tool designed to assist young adults with type 1 diabetes as they transition from pediatric to adult care. The tool functions like a chatbot, sending personalized messages to enhance confidence in diabetes management. Suitable participants include those with type 1 diabetes who are transitioning to adult care and have a mobile phone for receiving text messages. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions that could ease the transition to adult care for others with type 1 diabetes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a digital tool to help manage diabetes, so it's unlikely that medication changes are required.

What prior data suggests that this eHealth tool is safe for managing type 1 diabetes?

Research shows that digital health tools can be safe and helpful for managing diabetes. Studies have found that tools like apps or text messaging systems boost health knowledge and improve condition management. For instance, a review found that digital health tools benefit teens with type 1 diabetes by enhancing their understanding and skills.

Digital tools are generally easy to use, involving simple actions like sending text messages or using apps. Unlike medicines, they don't cause physical side effects, making them low-risk. Instead, they provide useful information and reminders to help manage diabetes effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the eHealth Tool for Type 1 Diabetes because it offers a personalized approach to managing the condition, unlike standard treatments that mainly focus on insulin therapy and routine check-ups. This tool acts like a chatbot and engages adolescents with diabetes through tailored text messaging, helping them build confidence in managing their care as they transition to adult healthcare. It stands out by providing personalized educational content, a structured educational curriculum, and interactive Q&A features, all aimed at empowering patients to take charge of their health in a more dynamic and supportive way.

What evidence suggests that this eHealth tool is effective for managing type 1 diabetes?

Studies have shown that digital health tools can effectively help people manage diabetes. For example, mobile health apps have been linked to lower HbA1c levels, indicating better blood sugar control. Research also shows that digital devices can improve overall diabetes outcomes and are cost-effective. Additionally, digital health tools may enhance the quality of life for people with diabetes. This trial tests an eHealth tool to see if it can help young adults with type 1 diabetes manage their condition more effectively as they transition to adult care. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for young adults with Type 1 Diabetes who are transitioning to adult care. They must be within 6 months of turning 18 or transferring care, willing to complete questionnaires, and proficient in English or French. Participants need a mobile device capable of SMS and an email address. Those with intellectual disabilities affecting diabetes care or enrolled in other SMS-based trials can't join.

Inclusion Criteria

I have a working mobile phone.

I am proficient in English or French.

I own a mobile device capable of sending and receiving texts.

Exclusion Criteria

Currently enrolled in any other clinical research trial with an SMS-based intervention

Currently enrolled in another diabetes intervention trial that will continue beyond the final pediatric diabetes visit

Unable to carry out their diabetes care independently due to an intellectual or neurocognitive disability; discerned from medical chart during pre-screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including self-reported questionnaires and outcome measures

1 week

1 visit (virtual)

Intervention

Participants receive text message-based intervention for T1D self-management support and education

12 months

Ongoing virtual engagement

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• eHealth Tool

Trial Overview The study tests an eHealth tool designed to help improve self-care in managing Type 1 Diabetes during the transition from pediatric to adult healthcare services. The effectiveness will be measured through questionnaires at baseline, six months, and twelve months after starting the use of the digital tool.

How Is the Trial Designed?

Group I: eHealth Tool Experimental Treatment 1 Intervention

The Intervention is a text messaging algorithm that will operate like a chatbot, querying adolescents with T1D about their confidence with different aspects of T1D self-management as they are preparing to transition to adult diabetes care. The intervention has 4 components of messaging: personalized Educational Content, Standard Educational Curriculum, Provide participant compensation for filling out the questionnaires, Question \& Answer feature.

Group II: Control Active Control 1 Intervention

Participants randomized to the control arm will also be offered the same incentives to complete questionnaires (outcome measures) but will not receive any other components of the intervention - no personalized/customized support or diabetes resource messages and no reminders. Control arm participants will continue with their usual T1D transition care.

Who Is Running the Clinical Trial?

The Hospital for Sick Children

Lead Sponsor

Trials

724

Recruited

6,969,000+

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Trillium Health Partners

Collaborator

Trials

8

Recruited

3,100+

Published Research Related to This Trial

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]

In a study of 81 youths with type 1 diabetes, using a glucometer-connected mobile app increased the frequency of self-monitoring blood glucose (SMBG) by 2.3 times with each additional data sync, indicating improved engagement in diabetes self-management.

However, the frequency of syncing glucometer data did not show a significant impact on hemoglobin A1c (HbA1c) levels or mean blood glucose, suggesting that while the app may enhance monitoring habits, its effect on overall glycemic control is still uncertain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile App for Synchronizing Glucometer Data: Impact on Adherence and Glycemic Control Among Youths With Type 1 Diabetes in Routine Care. Clements, MA., Staggs, VS.[2018]

In a 6-month study involving 100 adults with type 1 diabetes, the use of the iBGStar® glucose meter combined with an iPhone led to a significant reduction in A1c levels compared to traditional self-monitoring methods (-0.51 vs. -0.16, p = 0.04).

Both groups showed improvements in hypoglycemia fear scores, but the iBGStar® group did not experience an increased risk of hypoglycemia, indicating that this mobile technology can enhance glycemic control without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar&#174; in Type 1 Diabetes Management. Garg, SK., Shah, VN., Akturk, HK., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10012107/

The effectiveness of digital health technologies for patients ... DM-specific mHealth apps may reduce HbA1c levels in patients with T1DM, T2DM and Prediabetes. The review highlights a need for further research.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0149291825001663

The Role, Potential Benefits and Cost-effectiveness of ... Digital devices may improve outcomes for people with diabetes. Digital devices have been shown to be cost-effective in diabetes care.

3. withpower.com withpower.com/trial/phase-diabetes-mellitus-8-2022-38720

Digital Health Management Tool for Type 1 Diabetes · Info ... This trial tests a digital tool that sends personalized text messages to help young adults manage their type 1 diabetes as they move to adult care.

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Health Outcomes Following Engagement With a Digital Health ... This study provides evidence of a significant positive effect on self-reported quality of life among people living with type 2 diabetes engaging with a digital ...

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Impact of digital health interventions for adolescents with ... This systematic review provides an overview on the impact of digital health interventions for adolescents with type 1 diabetes on health literacy

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Evaluating Digital Health Solutions in Diabetes and the Role ... We aimed to summarize current literature on the use of patient-reported outcome measures (PROMs) in diabetes as well as in selected guidelines for Health ...

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Diabetes Digital App Technology: Benefits, Challenges, and ... Digital health technology, especially digital and health applications (“apps”), have been developing rapidly to help people manage their diabetes.