Intelligent Care Platform - Quasi-Experimental Trial

NCT07712809 | Enrolling By Invitation

• 1 other identifier: H25-00649
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes in Children; Diabetes Type 1

Keywords

diabetes; diabetes technology; digital health; connected care; implementation science; type 1 diabetes; patient engagement; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Glycated Hemoglobin (A1C)

  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 Outcomes (5)

• Time in Range (TIR)

  1 year

• Reviewed Glucose Data Since Last Visit

  1 years

• Adjusted Insulin Dose Since Last Visit

  1 year

• Diabetes Distress

  1 year

• Health-Related Quality of Life

  1 year

Study Arms (2)

Haibu Diabetes users

EXPERIMENTAL

This group will use Haibu Diabetes throughout the trial both independently and in collaboration with their healthcare providers.

Other: Digital Diabetes Care Platform

Propensity score matched control group

NO INTERVENTION

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.

Interventions

Digital Diabetes Care Platform OTHER

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.

Haibu Diabetes users

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Patients will be excluded from participation if they are:
• 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.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H3N1, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus; Patient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The intervention group will use Haibu Diabetes for the duration of the study period. The control participants will not be directly recruited as the investigators will utilize a matched sample to form a comparison group of non-users. The investigators will obtain data from a clinical registry, the BC Pediatric Diabetes Registry, to compare participants in this trial (users) and matched controls (non-users).

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 20, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)