At this early, formative stage of our project, the TrustSphere platform existed as a high-level concept and was described to caregivers of children and youths living with T1D as follows:

TrustSphere was described to HCPs as follows:

This study was approved by the University of British Columbia Children’s and Women’s Research Ethics Boards (H20-03105).

For caregivers of children and youths living with T1D in British Columbia (BC), a 35-item web-based survey was developed (Multimedia Appendix 1), which gathered perceptions of digital trust and security, challenges related to caring for their child with T1D, perspectives toward the proposed digital platform, importance of various potential features, and likelihood of future platform use based on the description above.

A 25-item web-based survey was developed for pediatric diabetes HCPs using REDCap (REDCap Consortium) (Multimedia Appendix 2) [17]. Survey items assessed critical current challenges in HCPs’ practice when providing care to children and youths with T1D, essential features in digital tools that support patient care, levels of concern around digital security and data privacy, and the likelihood of use of the digital platform based on the description above.

The surveys had a list of potential features that were compiled through a review of features in existing T1D platforms and apps and consultation with clinical stakeholders on the study team. Free text “other” answer categories were also offered to ensure respondents could describe features that may not be listed if needed.

Using the BC Children’s Hospital (BCCH) Diabetes Clinic database, email invitations with study information and a survey link were distributed to caregivers of patients living with T1D who were younger than 18 years, who were accessing pediatric diabetes care at BCCH (n=760). A total of 99 caregivers of children and youths living with T1D in BC completed the survey with a response rate of 13%.

The HCP survey was distributed to pediatric diabetes HCPs (pediatricians, pediatric endocrinologists, diabetes educators, and dietitians) across the Canadian province of BC using the Annual BC Pediatric Diabetes Day email listserv (maintained by the University of British Columbia’s Continuing Professional Development administrative staff). This conference is attended by pediatric diabetes clinicians, such as physicians, diabetes nurse educators, dietitians, and pharmacists (n=232). The email contained information about the study and a link to the survey. A total of 49 HCPs completed the survey with a response rate of 21%.

Descriptive statistics were used to analyze quantitative survey data results. Qualitative data obtained through open-ended survey questions underwent conventional content analysis by a single coder trained in qualitative analysis to generate preliminary coding categories; 2 researchers then reviewed results independently, after which both researchers worked together to deliberate and finalize the coding guide, resolve inconsistencies, and identify themes.

Table 1 shows the demographics of total caregiver respondents of children and youths living with T1D (n=99), though important to note that not all caregivers completed each section. The breakdown of HCP respondents (n=49), the Health Authority in which they practice within the province of BC, and the number of children and youths younger than 18 years with T1D followed by their practice are shown in Table 2.

Caregivers reported that 66% (65/99) of their children used CGM, and 54% (53/99) used an insulin pump. A total of 27% (27/99) reported that their children used health and well-being monitoring apps on their smartphones, while 34% (33/99) of caregivers used similar apps. Many caregivers (76/99, 77%) also stated that if their child was older than 7 years, they shared the decision-making responsibility when managing their diabetes.

In this study, we found that caregivers of children and youths living with T1D and pediatric diabetes HCPs reported similar challenges in managing T1D as well as desirable features for a digital platform to address these challenges, such as access to data from diabetes devices, laboratory results, mental health support, and resources and tools to support diabetes self-management (including school support). For caregivers, the ability to communicate more easily and frequently with their diabetes care team, particularly between clinic visits, and share their diabetes care plans with others in their circle of care were also emphasized as critical features. Most HCPs and caregivers stated they were likely to use the described platform and that an integrative platform would be helpful for collaborative patient care. The results of our study confirm that a digital platform for collaborative use by both caregivers and HCPs (with some user-specific features) has the potential to address key pain points and ultimately improve the care experience.

Most diabetes health apps only seem to be designed for patients [3] and integrating preferences in the design of the diabetes digital apps from both patients and HCPs is limited [3,9-11,14,19]. To successfully implement digital solutions in health care, it is essential to involve end users in the design and development as early as possible. Our study is novel in addressing the needs of caregivers of children and youths living with T1D and pediatric HCPs, which includes physicians, dieticians, and diabetes nurses, at the conceptual stage in the user-centered design of the TrustSphere Consortium’s digital platform, which will increase its likelihood of meeting end users’ needs. Unique to our study, we found that caregivers would also want to share their child’s diabetes care plan not just with HCPs, but also with others caring for their children. Further, HCPs stated that they would also like to see diabetes complications screening laboratory tests as a feature on this digital platform, which has not been reported before.

Adult patients also desire mental health apps geared toward social support and well-being to be a part of diabetes digital apps [9,19]. In this study, insufficient access to mental health support was identified as one of the key challenges by caregivers and patients cared for by HCPs. Caregivers stated it’d be helpful to have links to peer group and social support networks as a feature on the digital platform (data not shown); however, this was not identified as one of the top 3 key features desired. While addressing unmet mental health needs is clearly a priority in this population, this remains a challenging service to provide safely and effectively through a mobile app. Attempting to meet this widespread need through a virtual provision of support would be outside the scope of the platform being designed as part of this study; however, the data on the current unmet need for mental health support will inform future strategic planning around partner services, resources, information, and peer support apps and links that may be integrated into the platform in future iterations.

Patients’ demographic characteristics play a role in the uptake of diabetes digital health apps. A recent systematic review revealed that younger, female adult patients, those with a higher level of education and higher monthly incomes are more likely to adopt digital health apps [14,19]. Similarly in our study, 76% (71/94) of the caregivers were female, 65% (59/91) had a college or university degree, and 74% (63/85) had an annual income bracket greater than CAD $100,000 (US $ 76,645.50; Table 1).

Apps that offer multiple features, including documentation, reminders, educational resources, consolidation of diabetes data from different diabetes devices, and nutritional support are more likely to foster long term patient engagement and use [14]. Our study results have uncovered key features as noted in Figures 2 and 3 that will guide the design of the integration of various diabetes data devices within our digital platform. Further, our team has adopted an existing digital health platform, Careteam Technologies, a TrustSphere Consortium industry partner, that will support health care coordination and collaboration among patients, their families, and HCPs. This will be done through a dashboard that will contain diabetes care plans (eg, recommendations of insulin doses), real-time data from connected devices, educational resources, and assigned tasks (eg, completion of blood work) to enhance personalization of pediatric diabetes care. Future developments of our app can look into integration with Learn Diabetes [20], a web-based educational platform developed at BCCH for children living with T1D. It has been shown that the successful implementation of innovative medical technologies depends on acceptance by all health care team members; therefore, it is essential to identify and address barriers to adopting a new digital platform in the clinical workflow as early as possible [21]. A study investigating barriers to uptake digital health technology in cardiovascular care identified poor internet connection and difficult-to-use technology as reported by patients and increased workload and perceived app usefulness as reported by HCPs [22]. Facilitators to improve the uptake of digital health technology included improved communication with clinicians, personalized components among patients and improved efficiency and organizational support among HCPs [22]. HCPs in our study identified key barriers that have been considered in the design and development of TrustSphere’s digital platform. For example, the platform must be synergistic with, not duplicative of, EMRs. Further, the onboarding process and workflow must support engagement from all HCPs, as well as caregivers, for the platform to succeed.

Our study involved pediatric HCPs and caregivers of children and youths living with T1D as early as possible in the design and development of a digital integrative platform to optimize its potential to address key pain points, ensure ongoing usability, acceptance and adoption by HCPs and patients, and ultimately improve patient experience and outcomes.

User-centered design and digital app use are prone to selection bias since participants are often Caucasian, female, more educated, tech-savvy, and identify English as their primary language [19,23]. In addition, currently many diabetes management apps are unavailable in languages other than English [4]. This study is limited because caregivers of children and youths living with T1D were only recruited from a tertiary-level pediatric diabetes clinic at BCCH, which provides care to about 40%-50% of children and families living with diabetes in the province of BC. Also, the participants were mostly female and had a higher education and household annual income. We did not collect participant data on race or ethnicity, hence, making it difficult to generalize our findings to more diverse populations. A total of 25% of American adults with household incomes less than CAD $30,000 (US $22,791.85) do not own a smartphone. Of those who do, 27% are smartphone-only internet users, indicating they rely solely on their phone’s cellular data services [24]. The surveys were sent electronically to HCPs and caregivers in this study, so only those with access to a smartphone or the internet could easily participate. It is important to consider critical issues of equity and access so that new technology closes, rather than widens, the current divide in diabetes technology use across socioeconomic and educational levels [25].

The surveys in this study were distributed at 1 point in time to both caregivers and HCPs, to gather their perspectives on the current challenges and key features desired for this digital platform. As part of the user-centered design approach, following the quantitative data gathered through these needs assessment surveys, focus groups and web-based bulletin boards were conducted to collect qualitative data. This will inform the first stage of cocreating a digital platform for children living with T1D. The resulting prototype will be iteratively presented to caregivers of children and youths living with T1D and pediatric diabetes HCPs across BC in multiple rounds of usability testing (data forthcoming) with the integration of feedback and findings into a minimal viable product that will subsequently be tested in a clinical pilot study.

Future strategies to minimize the divide in the uptake of digital technology include automating and standardizing the collection of race, ethnicity, and primary language data, and obtaining input from ethnic minorities and those with limited English proficiency or poor digital literacy early in the usability testing process. Also, improving literacy can involve distributing educational materials in languages other than English, so patients and their families can better understand and interpret the information provided by digital apps [26]. It is challenging to develop policies that allow for equitable access to all forms of technology, such as smartphones or improving cellular data coverage or home internet access in rural areas; however, this can be argued if it relates to digital health technology. The UK National Health Service has extended the coverage of real-time CGM to all children living with T1D, including those from lower socioeconomic groups or ethnic minorities [27]. Similarly, BC PharmaCare, which covers medical devices and prescriptions, has expanded the approval of Dexcom G6 real-time CGM to all patients on intensive insulin therapy who are older than 2 years [28]. Policies such as these will be critical in minimizing and eliminating the digital divide and the associated disparities in health outcomes, and potentially expand the use and usefulness of an integrative T1D digital platform such as the one described here to more diverse populations.

This study demonstrates the importance of implementing user-centered design as early as possible in developing new digital solutions to ensure optimal use, acceptance, and adoption by HCPs and patients alike. It is novel in identifying the needs of both caregivers of children and youths living with T1D and pediatric HCPs to inform the design of an integrative T1D platform. This study will also inform future digital innovation in the T1D space with an ongoing opportunity to use participatory, user-centered design to achieve higher-quality integrated digital health apps.