Type 2 diabetes (T2D) is a complex chronic disease that affects an increasing number of youth and impacts the physical, emotional, and mental well-being of youth and families. Worldwide, the incidence of T2D in youth has risen sharply over the past two decades, particularly among marginalized and low-income populations, reflecting broader trends in obesity and health inequities [1-3]. In 2016, the American Diabetes Association highlighted an urgent need for patient-centered research and care in T2D, which presents as a more aggressive disease in youth [4,5]. Compared to adult-onset T2D, youth-onset T2D is characterized by faster beta cell decline; earlier insulin dependence; and higher risk of complications, such as nephropathy and retinopathy, within a few years of diagnosis [3,6].

The need for youth-centered research is amplified by knowledge that 30% of youth with T2D experience comorbid mental health challenges that are poorly understood and rarely prioritized in clinical practice guidelines, despite their negative impact on self-management [6-9]. These mental health challenges commonly include depression, anxiety, diabetes distress, and disordered eating behaviors, which can further complicate disease management and quality of life [10]. Despite increasing recognition of these challenges, few studies have explored how youth themselves conceptualize the relationship between diabetes and mental health [11]. Existing interventions are largely adult oriented or clinically driven rather than youth informed, limiting their effectiveness and relevance [6,12].

The importance of this gap has been reinforced by a participant advisory group (PAG) associated with our collaborating research team [5], which confirmed that mental health is a priority for youth with T2D and called for greater prioritization in research [13]. Yet, no qualitative or arts-based research exists in this area. This suggests an ongoing need for robust youth-centered research in T2D [6,7]. This proposal responds to this need through the cocreation of a living lab (ie, collaborative user-centered research environments that engage patients, clinicians, and researchers in codeveloping, testing, and refining real-world solutions to health care challenges) [14,15] for mental health in youth-onset T2D. We propose a study incorporating codesign, mixed methods [16-19], and arts-based knowledge translation (KT) [20-26] to open new avenues for patient-centered research in youth-onset T2D and mental health not previously considered.

The high incidence of youth-onset T2D in Manitoba (ie, >20/100,000/year) may serve as an early indicator of trends in other jurisdictions; the incidence of youth-onset T2D is highest in Manitoba but is growing across Canada [27]. In Manitoba, fewer than 30% of youth with T2D have achieved treatment targets of hemoglobin A1c (HbA1c)<7% despite the majority receiving specialized tertiary care—a comparable finding Canada-wide [27,28]. A critical factor influencing this finding is that we lack evidence on youth perspectives and experiences influencing their self-management and treatment outcomes. What is known is that self-management in youth with T2D is complicated by psychosocial morbidity, identity formation, stigma, blame, shame, historical oppression, and structural barriers to health facing minority groups disproportionately affected by T2D [29,30]. These factors increase the likelihood of short- and long-term complications [5,9,31,32], highlighting a need to better understand youth experiences, particularly in relation to mental health.

Mental health comorbidities, including psychiatric disorders and diabetes-specific psychological issues, affect 30% of youth with diabetes [33] but are often not prioritized by clinical care teams [34]. Compared to youth with type 1 diabetes (T1D), youth with T2D face heightened risk of early-onset depression [31,35], and the prevalence of substantial depressive symptoms in youth with T2D is 15%-22%—twice as high as youth with T1D [32]. These comorbidities are associated with higher risk of adverse microvascular and macrovascular complications [36]. Anxiety, fear [30,37], distress, hopelessness, and poor quality of life are prevalent [7,27] and impede self-management targets designed to reduce these comorbidities. Disconnects between youth and care provider priorities may exacerbate low rates of self-management and poor attendance in clinical care visits [35]. However, awareness of the complex relationship between mental health and T2D is lacking [38] and contributes to “diagnostic overshadowing” (ie, stigma in action) [39].

Clinical research into the mental health of youth with T2D is grounded in quantitative cross-sectional studies [40]; existing qualitative research into youth mental health in T2D is limited. Notably, Wicklow et al [41] investigated the determinants of renal complications in youth with T2D by developing a PAG comprising youth and caregivers. They identified themes such as blame and shame, stress and mental health, self-care and systemic issue (food security, support) that enriched their study framework and data collection tools and provided significant insights into the design and processes of the study [41]. Given that patient-centered resource and service design hinges on understanding patients’ perspectives [40] and that patient-driven strategies can empower patients and improve adherence and treatment outcomes [40,42], building upon these initial qualitative findings is critical to moving toward patient-centered models of research and care that connect with youth [39,43].

Living labs are “virtual, collaborative spaces where users create, prototype, and test concepts, innovations, products and systems” [44]. Living labs emerged in the early 2000s as promising collaborative platforms [45,46] and are widely adopted in civil engineering and aging research [14,47,48]. They are often used to support aging-in-place initiatives but have not been widely used in pediatric environments or as knowledge exchange platforms [15]. For instance, a systematic review of living labs for child health [15] provided evidence for living lab approaches for inclusive environments and to reduce health inequalities among vulnerable residents and regions [15]. However, initiatives drawing from living lab principles are poorly reflected in the extant literature.

Although various understandings of living labs have emerged in the literature, the core attributes of living labs have been identified in previous reviews. Technological infrastructure, stakeholder infrastructure, and community and end-user involvement have been identified as key characteristics of living labs [15]. Multimethod approaches, multiple users, user engagement, a real-life setting, and cocreation of an innovation environment are cited as paramount characteristics within the Living Lab Methodology Handbook [46]. Various user roles have also been identified, such as developer, contributor, and tester of an innovation; however, previous reviews of living labs demonstrate that although various roles for users can exist, there is an overreliance on the user as a tester of an innovation. Opportunities for users to be involved as developers or contributors to an innovation, or contribute to more bidirectional knowledge exchange, have been less acknowledged [15]. Considering the diversity, structural disadvantage, and regional variation in T2D across Canada, living labs are an ideal platform for patient engagement and integrated knowledge translation (iKT) in this area. They can support subgroup analysis and regionally specific codesign resources that respond to such variation.

Previous work piloted living labs in pediatrics and has shown their potential as a user-centered model for identifying priorities, collecting data, and codeveloping and evaluating resources and interventions [15] to ultimately support health care delivery and behavior modification [49-51]. Despite their relatively limited scope of application in relation to purpose and user roles, in our previous work, we began expanding this scope and using living lab principles as an innovative infrastructure to support patient registries for longitudinal qualitative and mixed methods research [14], enabling cultivation of rich insights into youth and family experiences in a manner not possible through traditional methods. Within the context of youth-onset T2D, registries and cohorts have been established to understand renal complications (eg, Improving Renal Complications in Adolescents with Type 2 Diabetes through Research [iCARE]) [5,9,27,52], and treatment options (eg, the Pediatric Diabetes Consortium) [53]. The current lab will serve as a complement through its focus on youth experiences and priorities.

This study will help address the need for youth-centered research in youth-onset T2D and mental health. It will investigate youth perspectives and experiences influencing their self-management and treatment outcomes, as well as the complex relationship between mental health and T2D. Through longitudinal, qualitatively dominant mixed methods research, the study will generate understandings of youth experiences across a range of domains, helpful for driving new youth-centered inquiry and models of care. The study will also investigate the potential of living labs as an innovative platform for patient engagement and iKT. As such, the study will engage the following objectives to address these gaps:

This protocol was prepared in accordance with the GRAMMS (Good Reporting of Mixed Methods Studies) framework to ensure complete and accurate reporting [54] (see Multimedia Appendix 1 for the GRAMMS checklist). The research involves a three-stage longitudinal, qualitatively dominant, convergent mixed methods design that combines qualitative and quantitative data to explore the experiences of mental health and resiliency among youth with T2D using a virtual platform called BrightSpark as a living lab. Qualitatively dominant mixed methods research prioritizes the qualitative study strand, centering in-depth explorations that are supplemented by quantitative data. Stage 1 involved adapting a virtual platform for use as a living lab and recruiting youth with T2D and their parents or guardians to the participant registry through multi-phase purposive recruitment. Stage 2 involved recruiting up to 50 youth with T2D from the registry to participate in mixed methods data collection on their experiences of mental health and resiliency. Participants completed baseline and monthly content modules on topics identified as important to youth, including self-image and weight, substance use, wellness, coping, and resiliency. Stage 3 will involve using a convergent mixed methods design to analyze and integrate the qualitative and quantitative data collected in stage 2 to gain a comprehensive understanding of youth with T2D. Overall, this work aims to gain an in-depth understanding of the experiences of youth with T2D and provide support for their mental health and resiliency through exploratory, qualitatively dominant mixed methods research.

The Canadian Institute of Health Research (CIHR) Knowledge-to-Action Ethics framework [48] underpins this research and acknowledges often overlooked ethical considerations in the iterative processes of knowledge creation and translation. This is critical to this research, given the ethical nuances of research with youth, the situational oppression and stigma experienced by youth with T2D, and the underrepresentation of youth voices in T2D research. This framework provides a contextually grounded, inclusive, and respectful foundation for engaging and working with stakeholders. Its principles align closely with this research’s qualitatively dominant mixed methods design: for objective 1, it will guide the ethical development of a virtual living lab platform; for objective 2, it will ensure respectful and inclusive data collection on youth mental health experiences in the context of T2D; and for objective 3, it will inform the translation of youth priorities into research, practice, and policy through arts-based KT methods. Given the participatory, iterative, and translational nature of this research spanning digital innovation, patient engagement, and arts-based KT, the CIHR Knowledge-to-Action Ethics framework will ensure that ethical reflection, relational accountability, and action-oriented outcomes are integrated throughout each stage of the research.

This study will be conducted among youth (10-35 years old) in Canada who received their T2D diagnosis before age 18 years. Data collection will be conducted mainly virtually on BrightSpark, an online living lab, which will allow the research team to reach potential participants across the country.

The inclusion criteria are as follows:

The study is designed based on three research objectives, as outlined in Figure 1.

This study was reviewed and approved by the University of Manitoba Health Research Ethics Board (approval number HE2022-0396) and the Shared Health Approval Committee for Privacy, Impact and Access in Research (approval number SH2023:042). Written consent of participation, to record in stage 3 and to use and disseminate data, was collected from all participants on the virtual living lab platform prior to participation in stages 2 and 3. All identifying information will be removed from the data collected through narratives and art-based modules in stage 2 of the project. Similarly, recordings of the group discussion in stage 3 will be destroyed after transcription, and transcriptions will be kept for 5 years in a secure locked file on a secure and password-protected device only accessible to the principal investigator (author MA) and identified personnel of the research team. The module content and presentation were thoughtfully designed to reflect a supportive orientation and were informed with participant advisory input; context-relevant mental health resource lists were made available to participants at multiple time points within the platform, associated with each module.

This study anticipates that youth with T2D will report a high prevalence of mental health challenges, including stress and anxiety, which are likely to influence their self-management behaviors and treatment outcomes [29,30]. The ordered identification of pertinent response modules, as indicated by participant-led selection and completion, will provide insight into possible domains of perceived relevance for youth, guiding future exploratory and intervention research. It is also expected that the study will provide insights into the feasibility and acceptability of a virtual youth-centered platform for research participation, highlighting potential strategies for engaging this population in patient-centered care and research.

The existing literature underscores that mental health challenges in youth with T2D are underrecognized and poorly addressed, yet they have substantial implications for adherence, glycemic control, long-term complications, and overall wellness [7-9,29,30,89]. Although quantitative research is generating evidence around the prevalence of such challenges, qualitative investigations are less common. A recent interpretive descriptive study [13] with 22 participants diagnosed with T2D before 18 years of age emphasized the pervasive impacts of mental health on T2D experiences and management, highlighting the intersections between blood sugar stability, mood, mental health, and considerations related to growth and development. Similarly, a focus group study [89] involving eight First Nation adolescents identified common experiences around stigma and shame, and the associated weight of managing a T2D diagnosis. However, the specific domains and facets of such mental health experiences have not been explored. This study will significantly extend the limited qualitative investigations emerging in this area.

The anticipated findings from this study may extend prior work by illuminating the nuanced ways in which mental health intersects with self-management in youth, as well as by demonstrating the potential of technology-mediated approaches for capturing these experiences. Living labs have shown promise in adolescent populations for both research participation and health interventions [90], but evidence on their application for qualitatively dominant research with youth with T2D is limited. This work anticipates generating understandings and perspectives that will inform patient-centered strategies that connect with youth. Concurrently, the work will provide insight into the utility of such a virtual platform for youth-centered research, which has high value in an increasingly user-centered and technologically proficient society.

A major strength of this study is the use of a qualitatively dominant, convergent mixed methods approach, which allows for the integration of quantitative and qualitative data to provide a more comprehensive understanding of mental health experiences and self-management behaviors in youth with T2D. This approach can reveal patterns not apparent through a single method and support comprehensive understandings, enhancing the validity of the findings. Additional strengths include the use of a virtual platform, which may increase accessibility for diverse participants, and the direct engagement of youth and the PAG ensures that the findings accurately reflect and are relevant to their lived experiences.

Limitations include a potential for selection bias, as youth with higher digital literacy or motivation may be more likely to participate. However, given that the virtual living lab was codesigned with youth and the PAG representing diverse experiences with technology, socioeconomic backgrounds, and health literacy levels, selection bias was likely reduced. Through iterative codesign sessions, the PAG informed the platform’s accessibility features, plain-language guidance, navigation, and tone ensuring inclusivity and ease of use. The embedded codesign principles and continuous feedback loops lowered potential digital participation barriers and promoted equitable engagement among youth and parents who might otherwise be underrepresented due to varying comfort levels with virtual platforms or differing levels of intrinsic motivation.

Codesigning the virtual living lab environment with youth and the PAG will also serve to mitigate potential biases related to self-reported data and interpretation of mixed methods data integration. The involvement of advisors in shaping the data collection tools, question framing, and engagement formats will foster psychological safety and participant ownership, which are conditions that reduce social desirability bias and encourage authentic sharing of experiences [91]. The inclusion of multimodal reflection options (eg, written, audio, or video responses) will allow participants to provide input in real time or asynchronously, lessening reliance on retrospective recall and associated recall bias. Furthermore, our engagement with youth and the PAG in defining the key constructs and indicators will ensure conceptual alignment between qualitative and quantitative components, thereby strengthening the methodological coherence.

The insights gained from this study are expected to inform the development of targeted, patient-centered interventions for youth with T2D that address both mental health and self-management needs. Future research could explore additional longitudinal outcomes, evaluate intervention effectiveness, and examine strategies to sustain engagement in digital platforms. Additionally, findings may inform clinical guidelines and support the integration of mental health assessment and support into routine T2D care for youth and adolescents. Engaging participants in the dissemination process, such as through cocreated summaries, arts-based KT resources, or infographics, may further enhance the relevance and impact of the findings.

By exploring the mental health experiences of youth with T2D and the feasibility of a virtual living lab for research engagement, this study aims to generate actionable insights to inform youth-centered care and research strategies. Through this innovative living lab, this study will contribute a sustainable structure to understanding and supporting youths’ mental health needs, advancing both research and care practices.