Digital Health Management Tool for Type 1 Diabetes

(KiT Trial)

Recruiting at 5 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

234 Participants Needed

Trial Summary

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 data supports the effectiveness of the eHealth Tool for managing Type 1 Diabetes?

Research suggests that digital tools, like smartphone apps and wearable devices, can help people with Type 1 Diabetes manage their condition by providing real-time data and connecting them with healthcare teams. These tools can make it easier to track blood sugar levels and other health information, potentially improving self-management and care coordination. ^{1 2 3 4 5}

How does the eHealth Tool treatment for Type 1 Diabetes differ from other treatments?

The eHealth Tool for Type 1 Diabetes is unique because it uses connected technologies like smartphone apps and wearable devices to provide real-time, personalized data-driven management. This digital ecosystem allows for better coordination between patients and healthcare providers, making it easier to manage the complex factors affecting blood glucose levels. ^{2 4 6 7 8}

What is the purpose of this trial?

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. The tool provides support, education, and resources through SMS. It also collects feedback to measure its effectiveness.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States 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. [2020]

2. United States 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. [2018]

3. Canada pubmed.ncbi.nlm.nih.gov

Adapting a Patient-Reported Outcome Measure to Digital Outpatient Specialist Health Care Services for Type 1 Diabetes: User Involvement Study. [2022]

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

A Digital Ecosystem of Diabetes Data and Technology: Services, Systems, and Tools Enabled by Wearables, Sensors, and Apps. [2019]

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

Identification of Core Outcome Domains and Design of a Survey Questionnaire to Evaluate Impacts of Digital Health Solutions That Matter to People With Diabetes. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile patient applications within diabetes - from few and easy to advanced functionalities. [2013]

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

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

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

Designing a Self-Management App for Young People With Type 1 Diabetes: Methodological Challenges, Experiences, and Recommendations. [2022]