Intelligent Care Platform - Quasi-Experimental Trial (UBColumbia)

July 20, 2026 updated by: Shazhan Amed, University of British Columbia

The Intelligent Care Platform (ICP) Trial of Haibu Diabetes - A Quasi Experimental Type 2 Hybrid Implementation-Effectiveness Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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:

  1. 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)
  2. Haibu Diabetes will be feasible to implement, acceptable to both patients/families and HCP, and will demonstrate sustained use.
  3. 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)

  1. 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.
  2. To assess the reach, feasibility, adoption and sustained implementation of Haibu Diabetes among patients, caregivers, and HCP.
  3. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H3N1
        • BC Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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:

  1. must currently be under the care of the clinic and have their endocrinologist participating in the study
  2. must be between 3 and <18 years old at the time of recruitment
  3. 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
  4. 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.
  5. 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.
  6. 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:

    1. 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.
    2. Using a non-Health Canada-approved "looping do-it-yourself" system for diabetes management.
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Haibu Diabetes users
This group will use Haibu Diabetes throughout the trial both independently and in collaboration with their healthcare providers.
Other: Digital Diabetes Care Platform
A digital diabetes care platform (Haibu Diabetes) that aggregates diabetes-related health data and provides a shared dashboard for patients, caregivers, and healthcare providers to support self-management, communication, and clinical care.
No Intervention: Propensity score matched control group
A matched sample will be used to form a comparison group of non-users. These data will be obtained from a clinical registry, the BC Pediatric Diabetes Registry.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycated Hemoglobin (A1C)
Time Frame: 1 year
Mean glycated hemoglobin (A1C) level among pediatric patients with type 1 diabetes using Haibu Diabetes compared with propensity score-matched non-users. A1C values will be obtained from the BC Pediatric Diabetes Registry and used to assess the effectiveness of Haibu Diabetes on glycemic control.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time in Range (TIR)
Time Frame: 1 year
Percentage of continuous glucose monitoring (CGM) readings within the target glucose range among pediatric patients with type 1 diabetes. TIR data will be obtained through diabetes device data integrated into Haibu Diabetes and compared between users and propensity score-matched non-users.
1 year
Reviewed Glucose Data Since Last Visit
Time Frame: 1 years
Proportion of participants reporting that they reviewed their glucose data since their previous clinic visit. This self-care behaviour is collected as part of routine clinical care and recorded in the BC Pediatric Diabetes Registry.
1 years
Adjusted Insulin Dose Since Last Visit
Time Frame: 1 year
Proportion of participants reporting that they adjusted their insulin dose since their previous clinic visit. This self-care behaviour is collected as part of routine clinical care and recorded in the BC Pediatric Diabetes Registry.
1 year
Diabetes Distress
Time Frame: 1 year
Diabetes-related emotional distress measured using age-appropriate validated diabetes distress questionnaires administered to patients and caregivers. Higher scores indicate greater diabetes-related distress.
1 year
Health-Related Quality of Life
Time Frame: 1 year
Diabetes-specific health-related quality of life measured using age-appropriate Type 1 Diabetes and Life (T1DAL) questionnaires administered to patients and caregivers. Higher scores indicate better diabetes-related quality of life.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H25-00649

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Due to the nature of the data collected, including pediatric health information and linked clinical registry data, individual participant data will not be shared with external researchers. Study results will be disseminated in aggregate form through publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Type 1

Clinical Trials on Digital Diabetes Care Platform

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings