Intelligent Care Platform - Quasi-Experimental Trial
Canada80 participantsStarted 2026-04-15
Plain-language summary
This study will measure the implementation and effectiveness of an intervention, the use of a digital health tool, Haibu Diabetes, for the management of pediatric type 1 diabetes (T1D), on clinical outcomes. The investigators will use both quantitative (i.e., surveys) and qualitative (i.e., interviews) methods to assess implementation. To measure effectiveness, the investigators will compare users of the technology to a matched comparison group of non-users on relevant clinical outcomes using clinical data. Overall, the investigators hope to understand whether use of this digital tool improves clinical outcomes while also considering factors that affect implementation and clinical operations.
Who can participate
Age range
3 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. must currently be under the care of the clinic and have their endocrinologist participating in the study
. must be between 3 and \<18 years old at the time of recruitment
. require a confirmed diagnosis of type 1 diabetes at least six weeks before recruitment, with at least two clinical appointments anticipated during the study period
. must be using specific glucose monitoring devices, either Dexcom or that are compatible with Glooko (refer to Glooko website link: https://support.glooko.com/hc/en-us/articles/4402302889491-Compatibility-Reference-All-Uploading-Methods) and either use basal-bolus multiple daily injection (MDI) or a Glooko compatible insulin pump for their insulin delivery method as part of their diabetes management.
. Caregivers, defined as the primary individual involved in daily diabetes management (e.g., parent or legal guardian), must also be enrolled, understand verbal and written English, and be able to engage with the study materials.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. As the sharing of data from diabetes devices with the platform is enabled by a connection with a patient's or parent's Glooko account, participants must also either have a Glooko account or be willing to sign-up for a Glooko to be eligible to participate so that this data can be visualized within the Careteam platform.
Exclusion criteria
. Currently in foster care because foster parents/guardians may change without the knowledge of the clinical team, making training of new foster parents/guardians on the platform a challenge. Participation for older youth in foster care who are independently managing their diabetes and have capacity to consent to participate in the study will be assessed for inclusion to participate on a case-by-case basis and in collaboration with the clinical team.
. Using a non-Health Canada-approved "looping do-it-yourself" system for diabetes management.
. Undergoing active treatment for a mental health diagnosis such as an eating disorder or depression.