The Intelligent Care Platform (ICP) Trial of Haibu Diabetes - A Quasi Experimental Type 2 Hybrid Implementation-Effectiveness Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Glycated Hemoglobin (A1C)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Haibu Diabetes users
This group will use Haibu Diabetes throughout the trial both independently and in collaboration with their healthcare providers.
干预措施: Digital Diabetes Care Platform (Other)
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.
结局指标
主要结局
Glycated Hemoglobin (A1C)
时间窗: 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.
次要结局
- 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)
研究者
Shazhan Amed
Clinical Professor
University of British Columbia