Diabetes in ChildrenUBColumbiaNCT07712809
Intelligent Care Platform - Quasi-Experimental Trial
A study testing Digital Diabetes Care Platform in people with Diabetes in Children and Diabetes Type 1, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Diabetes in Children, Diabetes Type 1
- What is being tested?
- Digital Diabetes Care Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2026to 28 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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:
- 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.
- Conditions
- Diabetes in Children, Diabetes Type 1
- Being tested
- Digital Diabetes Care Platform
- Keywords
- diabetes, diabetes technology, digital health, connected care, implementation science, type 1 diabetes, patient engagement, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Diabetes Care PlatformOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Haibu Diabetes users | Experimental | This group will use Haibu Diabetes throughout the trial both independently and in collaboration with their healthcare providers. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (5)
Time in Range (TIR)
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.
Measured: 1 year
Reviewed Glucose Data Since Last Visit
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.
Measured: 1 years
Adjusted Insulin Dose Since Last Visit
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.
Measured: 1 year
Diabetes Distress
Diabetes-related emotional distress measured using age-appropriate validated diabetes distress questionnaires administered to patients and caregivers. Higher scores indicate greater diabetes-related distress.
Measured: 1 year
Health-Related Quality of Life
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start15 Apr 2026
- Primary completion28 Feb 2028 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes in ChildrenStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shazhan Amed, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712809
- Sponsor's protocol ID
- H25-00649
- Acronym
- UBColumbia
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intelligent Care Platform (ICP) Trial of Haibu Diabetes - A Quasi Experimental Type 2 Hybrid Implementation-Effectiveness Study
- ClinicalTrials.gov ID
- NCT07712809
- Acronym / sponsor ID
- UBColumbia / H25-00649
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 15 Apr 2026 (actual)
- Primary completion
- 28 Feb 2028 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Haibu Diabetes users | Experimental | Other: Digital Diabetes Care PlatformThis group will use Haibu Diabetes throughout the trial both independently and in collaboration with their healthcare providers. |
| 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. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
- 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
Key exclusion criteria (5 listed)
- Patients will be excluded from participation if they are:
- These exclusions are designed to ensure the safety and appropriateness of the intervention for the study population.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Diabetes Care PlatformA 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. | Other | Haibu Diabetes users |
Primary outcome
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.
5 secondary outcomes
Time in Range (TIR)
Time frame: 1 year
Reviewed Glucose Data Since Last Visit
Time frame: 1 years
Adjusted Insulin Dose Since Last Visit
Time frame: 1 year
Diabetes Distress
Time frame: 1 year
Health-Related Quality of Life
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: No. 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.
Related trials for Diabetes in Children
Recruiting
Early Detection of Type 1 Diabetes in First Degree Relatives of Type 1 Diabetes Patients (DETECT T1D GULF)
Type 1 Diabetes
Recruiting
SMART GOALS for Youth With Prediabetes
PreDiabetes, Adolescent Obesity
RecruitingPhase 3
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes
Diabetes Mellitus, Type 2
RecruitingPhase 3
A Study of Baricitinib (LY3009104) to Preserve Beta Cell Function in Children and Adults Newly Diagnosed With Type 1 Diabetes (BARICADE-PRESERVE)
Diabetes Mellitus, Type 1
RecruitingPhase 3
A Study of Baricitinib (LY3009104) for the Delay of Stage 3 Type 1 Diabetes in At-Risk Children and Adults
Diabetes Mellitus, Type 1
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Diabetes Care Platform in people with Diabetes in Children and Diabetes Type 1, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycated Hemoglobin (A1C) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.