Intelligent Care Platform - Quasi-Experimental Trial

Purpose:

The purpose of this trial is to implement the use of a digital tool designed to be used for the management of pediatric type 1 diabetes by patients, their parents, and their HCP. The investigators will assess the implementation of this digital tool to understand how the platform is utilized, satisfaction with the platform for this purpose, acceptability, feasibility, and efficiency for managing T1D as reported through surveys and interviews with participants. Importantly, the investigators will assess the effectiveness of the digital tool by examining its impact on clinical outcomes including diabetes management habits (insulin dose adjustments, reviewing glucose data), A1C, TIR, diabetes distress, and quality of life.

Hypotheses:

• Using Haibu Diabetes in the management of type 1 diabetes will lead to improved clinical outcomes, as evidenced by:

• Greater proportion of Haibu Diabetes users who adjusted insulin dose since last visit compared to non-Haibu Diabetes users (+10% difference)
• Greater proportion of Haibu Diabetes users who reviewed glucose data since last visit compared to non-Haibu Diabetes users (+10% difference)
• Lower average A1C among Haibu Diabetes users compared to non-Haibu Diabetes users (-0.5% difference) Increased TIR in Haibu Diabetes users compared to non-Haibu Diabetes users (+10% difference)
• Lower diabetes distress scores in Haibu Diabetes users compared to non-Haibu Diabetes users (-10% difference)
• Higher quality of life scores in Haibu Diabetes users compared to non-Haibu Diabetes users (+10% difference)
• Haibu Diabetes will be feasible to implement, acceptable to both patients/families and HCP, and will demonstrate sustained use.
• Haibu Diabetes patient/family and HCP users will be satisfied with using Haibu Diabetes and will report a perceived improvement in their care experience. Haibu Diabetes will show promise in enhancing operational clinical workflow efficiency.

Justification:

Digital health tools that are used collaboratively by patients, families, and providers are not part of the standard of care. However, these tools may benefit patients and improve the management of T1D.

Objectives:

(The outlined objectives correspond to the 3 hypotheses outlined in order above)

• To evaluate the effectiveness of Haibu Diabetes in improving clinical outcomes in the management of type diabetes by comparing diabetes self-care habits (adjusted insulin since last visit, reviewed glucose data since last visit), A1C, time in range (TIR), quality of life and diabetes distress in Haibu Diabetes users compared to non-Haibu Diabetes users.
• To assess the reach, feasibility, adoption and sustained implementation of Haibu Diabetes among patients, caregivers, and HCP.
• To describe the impact of Haibu Diabetes on healthcare improvement including patient experience, HCP experience, and operational workflow.

Research Design:

This is a quasi-experimental type 1 hybrid implementation-effectiveness trial assessing implementation metrics using surveys and interview methods, and comparing users of a digital health platform to non-users on various clinical outcomes.

Statistical Analysis:

Data analysis will involve both descriptive and comparative statistical methods to evaluate clinical outcomes between Haibu Diabetes users and non-users. Descriptive statistics, including means, standard deviations, medians, proportions, will summarize baseline characteristics, key metrics such as platform reach, fidelity of implementation, and patterns of usage, and summarize patient/caregiver-reported outcomes (e.g., satisfaction, perceived ease of use, patient-centeredness), and healthcare team-reported outcomes (e.g., satisfaction with the platform, workload, stress levels, job satisfaction).

To determine the effectiveness of Haibu Diabetes using comparative statistical methods, the investigators will conduct propensity score matching to select patients from the BC-PDR (non-Haibu Diabetes users) that are as close as possible to those in the study (Haibu Diabetes users). Several matching algorithms will be compared, and the one yielding the best balance as measured by lowest standardized mean differences will be used. Regression analyses of the matched sample will include covariate adjustment for the propensity score to provide 'doubly robust' estimates. Confidence intervals will be computed via the nonparametric bootstrap. Secondary analyses may include the use of entire BC-PDR non-Haibu Diabetes users as a control group with regression adjustment for confounders.

All analyses will be conducted using R statistical software or STATA 15.1 StataCorp. Outcomes for which comparative analyses will be conducted include: diabetes self-care habits, glycemic control (HbA1c levels, time-in-range), and TIDAL and diabetes distress scores.

The planned study sample size is 80 Haibu Diabetes patient/caregiver users and approximately 30 HCP users.

Inclusion criteria

• A. Healthcare providers (HCP) including endocrinologists, endocrinology fellows (trainees), nursing staff and allied health staff (registered dietitians, social worker), currently providing care to pediatric patients in the Diabetes Clinic in the Division of Endocrinology at BC Children's Hospital (BCCH) will be eligible to participate.

B. Patient participants and their caregivers will be recruited based on specific inclusion criteria to ensure the study population aligns with the research objectives. Eligible patients:

• 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.
• 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

• Patients will be excluded from participation if they are:

• 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.

These exclusions are designed to ensure the safety and appropriateness of the intervention for the study population.