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Intelligent Care Platform - Quasi-Experimental Trial (UBColumbia)

20 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Inscription sur invitation

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

80

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte

Accepte les volontaires sains

Non

La 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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Haibu Diabetes users
This group will use Haibu Diabetes throughout the trial both independently and in collaboration with their healthcare providers.
Autre: 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.
Aucune 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Glycated Hemoglobin (A1C)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Time in Range (TIR)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of British Columbia

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

15 avril 2026

Achèvement primaire (Estimé)

28 février 2028

Achèvement de l'étude (Estimé)

28 février 2028

Dates d'inscription aux études

Première soumission

13 juillet 2026

Première soumission répondant aux critères de contrôle qualité

13 juillet 2026

Première publication (Réel)

20 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

20 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • H25-00649

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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