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Abstract

Aim

Type 1 diabetes (T1D) is a complex, chronic condition that requires active and intensive daily self-management, often necessitating specialized and integrated care. Individuals with T1D are at a heightened risk of experiencing diabetes distress (DD) and other mental health challenges, which, when unaddressed, can impair diabetes self-management and diminish quality of life. These challenges are particularly pronounced for young adults with T1D, who must navigate the typical developmental transitions of early adulthood while managing changes in their diabetes care, self-management, and support systems. However, physical and mental healthcare remain fragmented. While previous studies have explored interventions to address DD, many have faced limitations in scalability. This study aims to evaluate the feasibility and acceptability of the co-designed technology-enabled collaborative care model (TECC-T1D3) tailored to young adults with T1D and DD.

Methods

A randomized controlled trial in young adults aged 18–29 years living with T1D in Ontario, Canada (n = 60), to assess the feasibility and acceptability of the co-designed TECC-T1D3 intervention. Secondary objectives include evaluating the preliminary effectiveness of the program in reducing DD, enhancing self-efficacy, improving quality of life, and exploring the impact of the intervention on connectedness to care and community.

Results

This paper presents the trial protocol of the TECC-T1D3 study. Recruitment began in December 2024, and the trial was registered on clinicaltrials.gov (NCT06804694).

Conclusion

The TECC-T1D3 study will determine whether a TECC model is feasible and acceptable for young adults with T1D and DD.

Keywords

Type 1 diabetes diabetes distress healthcare collaborative care technology young adults protocol digital health chronic disease mental health

Background

Mental Health is as equally important as physical health within the circle of care. My struggle with Diabetes Distress would have been very different if my psychological needs were met as a (newly diagnosed) 19-year-old. They weren’t, and 44 years later I still struggle. (Patient partner)

Type 1 diabetes (T1D) is a complex, chronic condition that requires active and intensive daily self-management, often necessitating specialized and integrated care.¹ Historically, diabetes care has prioritized glycemic management, often without fully acknowledging or addressing the psychosocial impacts of living with this complex, chronic condition on individuals, families, and communities. However, resulting from the persistent need to self-manage,² experiences of social stigma,^3,4 and the physiological realities of blood glucose fluctuations,⁵ those who live with T1D are more likely to experience psychosocial challenges compared to those without diabetes. In particular, diabetes distress (DD), the emotional and cognitive distress related to self-managing diabetes, affects approximately 40% of people with T1D.^6,7 When left unaddressed, this can develop into a maladaptive cycle wherein DD can inhibit self-management behavior, lower quality of life, lead to comorbid mental illness (i.e. depression, anxiety, and eating disorders), and increase risk of diabetes complications in later life, with each ultimately leading to heightened DD (see Figure 1).^8–11 Risk factors for developing DD include being younger, female, living alone, and lower perceived provider support.¹⁰ Illustrated by the quote above, these risk factors underscore the need for integrated models of care that support young adults living with T1D in building self-efficacy and developing self-management strategies early in life to promote better health outcomes and quality of life across the life course.

Figure 1.

Diabetes distress cycle.

Fragmentation between metabolic and mental healthcare represents an issue not only of access but also of coordination, as it shifts the burden onto individuals living with T1D to educate healthcare professionals about their condition and navigate disjointed systems.¹² Effective diabetes care and support requires specialized expertise in diagnosis, therapeutics, communication, education, and counseling, for example; however, outside of a small number of specialized centers, there is limited access to one-stop solutions where all these needs are met. Nonetheless, there are 300,000 people living with T1D in Canada today, with this number continuing to rise by 4.4% every year, making it increasingly critical for there to be innovative solutions to support this population.¹³

Several approaches to managing DD have been shown to be effective; however, many have been limited to private care or urban settings, use proprietary technology, or involve high-touch, highly specialized models that challenge scalability.^14,15 To address this critical gap, this project seeks to adapt previous approaches and strategies to chronic condition management by capitalizing on the digital literacy of young adults to address access and scalability. In this study, our multidisciplinary team of healthcare professionals, researchers, and patient partners with lived experience are leading a multi-phase research project wherein we have co-developed and adapted¹⁶ and will pilot test a scalable, technology-enabled mental health intervention to lower DD and enhance self-efficacy and quality of life. The core intervention is based on extant literature on health coaching,^17–20 managing DD, and integrated care models for chronic disease management,^21–23 building on team success in other populations and settings.^19,24,25

Work to date

Building on the technology-enabled collaborative care (TECC) model,^19,24,25 the TECC for young adults living with T1D and diabetes distress (TECC-T1D3) program was co-designed with input from multiple interest-holders, including a Patient Advisory Council (PAC) which consisted of seven patient partners with T1D. In the initial phase of this study, our team co-designed, with PAC members as research partners, the TECC-T1D3 intervention prototype (see Patient involvement). Prototyping was informed by 19 one-on-one qualitative interviews with young adults with lived experience of T1D and 2 co-design events that included a mix of 12 healthcare professionals and those with lived and loved experience²⁶ with T1D. Through these interviews and events, participants shared insights into the diverse strengths and needs of the community, emphasizing specific user requirements for the intervention related to technology and the type of support offered. Through an iterative co-design process in which we validated and re-validating findings, it was determined that the TECC-T1D3 program would provide (1) T1D-specific mental health and well-being support and (2) guidance on T1D-related communication and (3) facilitate T1D connections.

To do this, the TECC-T1D3 program will deliver a virtual, collaborative care model using an omnichannel patient-centered approach that includes web-conferencing, phone calls, and text messaging to address DD, build self-efficacy, and improve quality of life in a real-world setting. Participants in the TECC-T1D3 program are supported by a health coach who is directed by a virtual care team (VCT) of mental health and T1D experts from various institutions and geographical locations.

Purpose

The primary objective of this trial is to test the feasibility and acceptability of the TECC-T1D3 intervention among young adults aged 18–29 years living with T1D. Feasibility domains include recruitment and retention rates, intervention delivery, adherence to core intervention components, and completeness of outcome data. The secondary objective is to explore the preliminary effectiveness of this intervention on improving DD and self-efficacy, enhancing quality of life, and facilitating connectedness to care and community for young adults with T1D.

Research questions

This feasibility trial aims to answer the following research questions:

Feasibility

What is the feasibility of recruiting young adults with T1D into the study (e.g. recruitment rate, reasons for ineligibility or non-participation)?

Can the TECC-T1D3 intervention be delivered as intended (e.g. adherence to scheduled sessions, completion of intervention components)?

What is the retention rate, and are outcome data complete and analyzable?

Acceptability

How acceptable is the TECC-T1D3 intervention to participants, as assessed through participation, engagement, and post-intervention interviews?

Preliminary effectiveness

What are the preliminary effects of the TECC-T1D3 intervention on DD, self-efficacy, quality of life, and connection to care and community among young adults with T1D?

How acceptable is the TECC-T1D3 intervention to participants?

What are the preliminary effects of the TECC-T1D3 intervention on DD, self-efficacy, quality of life, and connection among young adults with T1D?

Methods

Design

This study will use an explanatory sequential mixed methods research design to gather a comprehensive, contextualized understanding of diverse participants’ experiences with the intervention in relation to its feasibility, acceptability, and preliminary effectiveness. Through a 12-week, double-blinded randomized controlled trial, participants will receive one of two study arms: (1) the health coaching intervention (TECC-T1D3) or (2) the education intervention (active control group).

Participants

To be included in the study, participants must be (1) a young adult aged 18–29 years, (2) a resident of Ontario, (3) living with a self-reported diagnosis of T1D for at least 1 year, and (4) community-living. As our aim for this study is to address the everyday distress of living with T1D, rather than the distress associated with a recent T1D diagnosis, those who were diagnosed within the last year will not be eligible to participate. Due to logistical reasons, participants who are unable to participate in the English language and/or participate via phone or web-conferencing will also be excluded from the study.

Setting

This study will be conducted virtually, with the host institution, the Centre for Addiction and Mental Health (CAMH) in Toronto, Ontario, as a centralized location.

Recruitment

Participants will be recruited using a multipronged approach informed by the PAC.¹⁶ Recruitment materials, including posters and email scripts, will be circulated both virtually and in-person by leveraging established diabetes networks and through health clinics and pharmacies throughout Ontario. More specifically, study team members and patient partners will be encouraged to share recruitment materials within and through established networks such as Diabetes Action Canada, Breakthrough T1D, Brain Canada Foundation, Connect1d, and the Diabetes Link. Recruited participants will also be encouraged to share with their connections.

Sample size

Aligned to the study design, 60 participants who meet eligibility criteria and consent to the study will be randomized to the intervention (n = 30) or active control (n = 30) arm. As this is a feasibility study,^27,28 no power calculation was conducted. Instead, the sample size was decided based on our own co-design work to date²⁹ and previous research that suggests recruiting 30 participants per study arm.^30,31 Purposive and maximum variation sampling will be used to ensure equitable representation of specific demographic variables that are not often included in T1D research, including men. This sampling approach was developed with patient partners.

Trial flow

See Figure 2 for an overview of the trial flow, outlining each stage from recruitment to analysis.

Figure 2.

Trial flow.

Interested participants will undergo a prescreening process through either an online eligibility survey that is directly linked in the recruitment materials or a phone call with the Research Coordinator. Participants who meet the eligibility criteria will then complete a consent call over the phone or web-conferencing and provide written e-consent using REDCap. Following this, participants will be requested to complete a baseline survey and upon completion will be randomized to the intervention or active control arm using a simple randomization approach without matching. We chose not to use a matched-pair design, as this feasibility trial is primarily focused on evaluating recruitment, retention, acceptability, and delivery processes rather than controlling for baseline differences between groups. Randomization will be completed using REDCap's Randomization Module by the Research Coordinator (AS), with allocation blinded to the VCT and outcome assessors. Allocation will not affect participants’ usual diabetes care. To maintain blinding throughout the trial, participant identification numbers will be used during VCT and research team meetings. Unblinding is only permissible once a participant has completed the intervention and has consented to take part in the post-intervention interview. As well, in the case of a safety concern for a participant, the distress protocol will be followed, and unblinding will occur if necessary.

Intervention. Participants in the coaching group (TECC-T1D3) will receive 8–10 virtual sessions with a health coach over a 12-week period. Participants will engage in regular, synchronous 1:1 touchpoints with the health coach using the participant's preferred mode of communication. During these coaching sessions, the health coach will offer T1D-specific support in the areas of mental health and well-being. The TECC-T1D3 intervention is semi-structured in that the first few sessions will focus on rapport building and goal setting with the participant, and the last few will focus on maintaining behavior change into the future. However, the intention of the TECC-T1D3 program is for it to be participant-led. The content and approach of each session will be dependent on each participant's needs and preferences. Nevertheless, there are certain topics that commonly arise for young adults with T1D, including communicating with loved ones and healthcare professionals about diabetes and their health needs, coping with stigma, system navigation, and financial stress, that the health coach will prompt for participants who prefer a more structured approach.

Under the guidance of our co-design participants and PAC, we made the intentional decision to omit the requirement for the health coach to be a registered healthcare professional. Instead, the health coach must first and foremost demonstrate excellent interpersonal skills and possess skills in the principles of motivational interviewing and cognitive behavioral therapy. To gain T1D-specific knowledge and counseling skills, the health coach completed the Breakthrough T1D Mental Health + Diabetes Training Program and CAMH's Motivational Interviewing Foundations of Practice course, prior to the commencement of the trial. Nevertheless, the health coach will not provide any medical advice (i.e. glycemic management, insulin dosing) or therapeutic support otherwise outside of their scope of practice. To support the whole-person needs of participants, the health coach will work alongside an interdisciplinary VCT.

The composition of the VCT will be tailored to meet the unique expertise of the health coach, the participants, and the communities the program intends to serve and may include a peer support worker, endocrinologist, social worker, psychotherapist, physician, and translator. The VCT will mainly serve a consultatory role and will not directly inform participant care (e.g. will not support blood glucose management). As necessary, a member of the VCT may meet directly with a participant or facilitate referrals to external healthcare professionals. When requested and given consent by a participant, a participant's primary care providers and/or diabetes care team can be notified of their participation in the study. Should the health coach or the VCT identify a concern, it will be communicated to the primary care provider or endocrinologist with the participant's consent. Through this, the TECC-T1D3 intervention includes the following key components which align with the identified requirements from the co-design work: virtual delivery of the program, utilizing a health coach as the primary delivery person of the program, regular touchpoints with participants, and weekly meetings of a VCT. See Appendix A for a participant's journey through the TECC-T1D3 program.

Active Control Group. Participants in the education group will receive a low-intensity, education intervention consisting of 10 email newsletters over a 12-week period, matching the number of interactions in the intervention group. These preset emails, based on topics identified in co-design work, will provide psychoeducational content aimed at lowering DD and increasing self-efficacy and quality of life, with links to relevant resources. More specifically, the newsletters will include the following topics: (1) Welcome to the TECC-T1D3 Newsletter; (2) Recognizing Signs of Diabetes Distress; (3) Setting Achievable Goals; (4) Living Well with Type 1 Diabetes; (5) Communicating About T1D with Friends and Family; (6) Communicating About Mental Health with your Endocrinologist; (7) Finding a Counselor Who Understands Diabetes; (8) Coping with Financial Stressors; (9) Building your T1D Community; (10) Addressing Self-Stigma and Building Confidence. These newsletters will be a one-way communication from the research team to the participant (see Appendix B). While this educational intervention was not explicitly structured around the “four critical times for DSMES” (i.e. at diagnosis, annually, during new complicating factors, and when transitions in care occur), the selected topics reflect issues that commonly arise during these periods, particularly transitions in care and life stage. Content was informed by co-design findings and aims to support ongoing self-management and mental well-being.

Lost to Follow-Up. A participant will be considered lost to follow-up if they consent and fail to attend a scheduled session. The health coach will make three weekly attempts to contact the participants using the preferred means of communication. If unsuccessful, one last attempt will be made 1 week later using an alternate means of contact. If the person is unreachable for 4 consecutive weeks, they will be considered withdrawn from the study with the primary reason of lost to follow-up. All contact attempts will be documented in the participant's research. Given this is a feasibility study, patients lost to follow-up after being consented but not contacted for one follow-up appointment will be replaced.

Outcomes

Primary outcomes related to study feasibility and acceptability include the recruitment rate, engagement rate, completion of intervention, and intervention engagement. Secondary outcomes include quality of life, which will be assessed using the validated European Quality of Life–5 Dimensions (EQ-5D) scale,^32,33 and DD, measured using the Type 1 Diabetes Distress Assessment System (T1DDAS)³⁴ and the Problem Areas In Diabetes (PAID-5) scale.³⁵ All participants will complete a demographic and health characteristic survey at the baseline, with primary and secondary outcome measures assessed via REDCap survey at both baseline and post-study (12 weeks). Implementation outcomes will also be collected throughout the study. A full list of measures and tools is detailed in Appendix C. All measures have been well-validated in the literature, with the exception of the Connected to Community scale and the Connectedness Scale, which have been adapted to the T1D community as part of the assessment of preliminary effectiveness.

Participants will be invited to complete a post-intervention semi-structured qualitative interview. These semi-structured interviews will be conducted over the phone or web-conferencing and will last about 60 minutes. They will aim to gather a comprehensive summary of participant experiences in the program by exploring participants’ perceptions, experiences, and satisfaction with the intervention. Participants will also be prompted to reflect on their overall health, their motivation for engaging in the TECC-T1D3 program, their thoughts on the intervention, how it impacted their health and well-being, and suggestions for potential improvements. Please see Appendix D and E for a Standard Protocol Items: Recommendations for Interventional Trials Checklist and Timeline.

Analyses

Quantitative. Descriptive statistics will describe the feasibility of the TECC-T1D3 intervention, including the recruitment rate, engagement rate, completion of study assessment, and number, duration, and mode of sessions completed. Descriptive statistics will also describe participant demographic characteristics (e.g. mean age, frequency of household income ranges, sex, gender, etc.) and participant reported clinical outcomes (e.g. mean distress scores, quality of life score, self-efficacy score) collected through the questionnaires.

For secondary and exploratory analysis, inferential statistics, including paired t-tests and regression analyses will be conducted to compare mental and physical health outcomes pre- and post-study and between groups. Distributions of outcomes and change scores will be examined to understand possible patterns of coaching efficacy and potential variations between groups. Missing data will be assessed for patterns (e.g. missing completely at random) and handled using appropriate methods such as multiple imputation or listwise deletion, depending on the extent and nature of the missingness.

Qualitative. An inductive approach to qualitative analysis will be used to analyze post-intervention interviews. All interviews will be transcribed verbatim. Using a constant comparative approach, in which new data will be compared to noted patterns from previous interviews, further understanding and refinement of developed themes will occur. Qualitative data will provide insight into the feasibility and acceptability of the TECC-T1D3 intervention and provide preliminary insight into the impact of the intervention on exploratory outcomes.

Team members will follow the coordinating site's standard operating procedures to store data and promote security of participants’ personal health information. All rights and risks related to data storage and security will be shared with participants during the consent process, and throughout the trial as appropriate. Quantitative data is gathered through REDCap and assessors are trained in the described data techniques, supporting data quality. The trial will be stopped once the target sample size or the funding end date has been reached, whichever is sooner.

Distress protocol

While there are few perceived potential risks to being involved in the study, there is a possibility that participants may experience emotional distress while filling out the questionnaires, discussing their experiences with the health coach, or completing the post-intervention interview. To mitigate this, participants were informed during the consent process that they are welcome to decline any questions they do not wish to answer. As well, to address the potential for emotional distress among both participants and research staff, a distress protocol was developed. This protocol includes relevant crisis lines, peer support resources, and the opportunity for staff to debrief with a qualified professional following a distress event. The health coach has received training in recognizing signs of emotional distress. If acute distress is identified, the health coach will connect with the principal investigator and arrange for emergency services, if necessary.

Ethics

This study was initially approved by the CAMH (065-2024) on 24 September 2024. Protocol version 4.0 is in use at the time of paper submission, which was approved on 14 March 2025. This clinical trial will also be carried out in accordance with the following: (1) International Council for Harmonisation Good Clinical Practice (ICH GCP), (2) Tri-Council Policy Statement 2022 (TCPS 2), and (3) Personal Health Information Protection Act (PHIPA), 2004; Chapter 3 Schedule A (PHIPA) and applicable regulations. It was also registered on clinicaltrials.gov December 2024, Registry ID: NCT06804694.

Discussion

Young adults with T1D experience unique obstacles in managing daily life due to the condition's complex psychosocial and cognitive effects, placing them at an increased risk for heightened DD and other mental health challenges.^15,36 Fortunately, there is growing recognition of the importance of addressing DD to enable effective self-management and, ultimately, support the whole health of people living with diabetes.³⁷ To date, various approaches—including the use of digital technologies, peer support, and collaborative care models—have been explored to manage DD.^7,14,38 However, while this research offers promise, it has primarily focused on the development of novel technologies, such as new health or peer support apps.^39–42

Paradoxically, despite their intended benefits, these approaches—particularly those that rely on technology—may inadvertently exacerbate feelings of burden, exclusion, or unmet needs among young adults with T1D.^43–45 One explanation for this paradox is that while digital health solutions are designed to improve access and engagement, they often prioritize efficiency by delivering information in a structured, unidirectional way, rather than fostering meaningful connection and relational support. This tension is reflected in findings by Garner et al. (2023), which highlight a disconnect between young adults’ openness to mobile health apps and their low prior use (7.3%), suggesting that digital health solutions may not always integrate seamlessly into daily life.⁴⁶ Addressing DD effectively and equitably requires a thoughtful, co-design approach that ensures interventions are not only accessible and scalable but also responsive to the diverse needs and lived experiences of young adults with T1D.^47–49

In collaboration with co-design participants and the PAC,¹⁶ we have sought to co-develop a DD solution that leverages the digital literacy of young adults with T1D while also addressing concerns around digital overload and alarm fatigue, a reduced responsiveness to alarms from medical devices over time (i.e. insulin pumps or continuous glucose monitors).^45,48–51 Many participants shared experiences of being overwhelmed by the constant demands of diabetes technology, reinforcing the need to balance the benefits of digital solutions with a culturally responsive, low-tech approach.^{37,45,52–54} By intentionally limiting cognitive fatigue, we have aimed to ensure that the intervention remains both acceptable and practical for this population.

At the same time, our co-design work underscored the importance of human connection in diabetes and mental health support, highlighting the need to thoughtfully define the role of the health coach to strengthen relational aspects of care while maintaining scalability, accessibility, and cultural responsiveness.⁵⁵ Young adults with T1D emphasized the value of core relational competencies, including trust and respect alongside lived experience with T1D, over formal credentials or professional designations. Building on this insight, our team expanded the potential hiring pool for health coaches, prioritizing relational competency over specific clinical skills that are more typically emphasized in health interventions. This approach ensures that health coaches are well-positioned to provide meaningful, person-centered support while also addressing scalability and accessibility within the intervention.

Taken together, the TECC-T1D3 program uniquely will deliver virtual, patient-centered and comprehensive care to meet the complex needs of young adults with T1D using technologies which are already commonplace in our digital society (i.e. web-conferencing, phone calling, and/or text messaging).⁵⁶ Co-developed with young adults, TECC-T1D3 will support skill-building and self-management strategies that are essential across the lifespan, particularly in fostering effective communication with and connectedness to diabetes care and community. Findings from this study will inform the refinement and scaling of the intervention, laying the groundwork for broader implementation and serving as a model for integrated, technology-enabled care for other chronic conditions.^55,57

Limitations

This study has several limitations. First, while purposive and maximum variation sampling will be used, recruiting a diverse sample, including men, ethnoculturally diverse participants, and individuals across the full eligible age range, may be challenging and could impact the generalizability of findings. Second, as a feasibility trial, the study is not powered to detect statistically significant changes in outcomes; rather, it is designed to assess whether the intervention and trial procedures are practical and acceptable. Finally, only outcome assessors will be blinded to group allocation, which may introduce some risk of performance or detection bias.

Conclusion

This feasibility study will evaluate the feasibility and acceptability of the TECC-T1D3 intervention among young adults living with T1D. Findings from this study will guide the refinement and scale-up of the intervention. Insights from this study will also provide a foundation for future research and implementation efforts, ensuring the intervention's broader impact and sustainability.

Supplemental Material

sj-docx-1-dhj-10.1177_20552076251365134 - Supplemental material for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Supplemental material, sj-docx-1-dhj-10.1177_20552076251365134 for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol by Carly Whitmore, Natalie Mangialardi, Anika Saiva, Joseph A Cafazzo, Tracy McQuire, Linxi Mytkolli, Alex St John, Peter Senior, Diana Sherifali, Gillian Strudwick and Peter Selby in DIGITAL HEALTH

Supplemental Material

sj-docx-2-dhj-10.1177_20552076251365134 - Supplemental material for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Supplemental material, sj-docx-2-dhj-10.1177_20552076251365134 for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol by Carly Whitmore, Natalie Mangialardi, Anika Saiva, Joseph A Cafazzo, Tracy McQuire, Linxi Mytkolli, Alex St John, Peter Senior, Diana Sherifali, Gillian Strudwick and Peter Selby in DIGITAL HEALTH

Supplemental Material

sj-jpg-3-dhj-10.1177_20552076251365134 - Supplemental material for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Supplemental material, sj-jpg-3-dhj-10.1177_20552076251365134 for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol by Carly Whitmore, Natalie Mangialardi, Anika Saiva, Joseph A Cafazzo, Tracy McQuire, Linxi Mytkolli, Alex St John, Peter Senior, Diana Sherifali, Gillian Strudwick and Peter Selby in DIGITAL HEALTH

Footnotes

Acknowledgements

The authors thank Diabetes Action Canada for their support with patient engagement and the members of the Patient Advisory Council for their impactful contributions to the co-design of the TECC-T1D3 intervention.

ORCID iDs

Carly Whitmore

Ethical considerations

This study was approved by the Research Ethics Board (REB) at the CAMH (065-2024) on 24 September 2024. As the coordinating site, CAMH oversees the study to ensure it is carried out in accordance with all relevant policies and procedures. Any protocol amendments must be approved by the REB and communicated with study team members. Each team member must sign a self-attestation agreement to confirm their understanding and accordance with all protocol modifications. This study is also being monitored by a dedicated study monitoring team within the INTREPID Lab at CAMH, who conducts initiation, routine (biannual), and closing out audits of studies being conducted within the department. The study monitoring team is separate from the study's team members.

Consent to participate

All participants who contributed to the co-design of the described program provided written consent prior to participating in co-design interviews and events. All participants of this feasibility trial provided written informed consent prior to participating in this study.

Contributorship

Carly Whitmore: methodology, writing – original draft, writing – review and editing, visualization, supervision; Natalie Mangialardi: writing – original draft, writing – review and editing; Anika Saiva: writing – review and editing, project administration; Joseph Cafazzo: Methodology, Writing – Review and editing, Supervision; Tracy McQuire: Writing – review and editing; Linxi Mytkolli: writing – review and editing; Alex St John: writing – review and editing; Peter Senior: conceptualization, methodology, writing – review and editing; Diana Sherifali: conceptualization, methodology, writing – review and editing; Gillian Strudwick: supervision, Writing – review and editing; Peter Selby: conceptualization, methodology, writing – review and editing, supervision, funding acquisition.

Funding

The authors disclose receipt of the following financial support for the research, authorship, and/or publication of this article: This work was supported by Breakthrough T1D Canada (formerly Juvenile Diabetes Research Foundation Canada); Brain Canada Foundation [2-SRA-2022-1184-S-N]. For more information, Breakthrough T1D can be reached at info@breakthroughT1D.ca and Brain Canada at info@braincanada.ca. Carly Whitmore received additional funding from the AMS Healthcare Fellowship in Compassion and Artificial Intelligence to support her role in the project. Study funders meet with the study team for biannual routine study progress calls and provide support as needed (e.g. with recruitment). However, funders do not have a role in the design, conduct, analysis, or reporting of the trial.

Declaration of Conflicting Interests

The authors declare that they have no conflicts of interests related to this paper. However, some authors have general disclosures to report. Carly Whitmore reports paid consultancy work in research methods for the COPD Foundation. Peter Senior is supported by the Alberta Academic Medicine Health Services Program and holds the Charles A Allard Chair in Diabetes Research. He has received personal fees from Abbott, Bayer, Dexcom, GSK, Novo Nordisk, Sanofi, Vertex, Ypsomed. He is the medical director of Alberta Health Services Clinical Islet Transplant Program. Diana Sherifali is the inaugural holder of the Heather M Arthur Population Health Research Institute/Hamilton Health Sciences Chair in Interprofessional Health Research and has received honouraria from Novo Nordisk for speaking about health coaching. Peter Selby reports receipt of funding from Brain Canada Foundation, Canadian Cancer Society, Canadian Cancer Society Research Institute, Cancer Care Society, Canadian Institutes of Health Research, Canadian Partnership Against Cancer, Health Canada, Juvenile Diabetes Research Foundation, Medical Psychiatry Alliance, National Research Council of Canada, New Frontiers in Research Fund, Ontario Lung Association, Ontario Ministry of Health and Long-Term Care, Ontario Neurotrauma Foundation, Patient-Centred Outcomes Research Institute, Pfizer Inc, Pfizer Canada, Public Health Agency of Canada. Peter Selby also reports that through an open tender process, Johnson & Johnson, Haleon, and Pfizer Inc are vendors of record for having provided smoking cessation pharmacotherapy for research studies for free or at discounted rates. Peter Selby is the vice-chair, research, and is the Giblon Professor in Family Medicine Research, a university named professorship at the University of Toronto.

Patient involvement

Patient engagement approaches were meaningfully integrated throughout the co-design of the TECC intervention and the development of trial processes. Central to this work was a seven-member PAC comprised of young adults living with T1D from across Canada. These individuals served as co-researchers, contributing their lived experience to shape research priorities, guide decision-making, and co-create key study elements.

The PAC played a critical role in shaping both the intervention design and recruitment strategy. For example, their input led to meaningful refinements in the language used throughout the participant-facing intervention materials to ensure relevance and inclusivity. The PAC also compiled a list of patient opinion leaders, community organizations, and Facebook groups across diverse geographies, which informed the study's outreach plan and helped expand reach beyond traditional recruitment channels. Their guidance ensured representation across different diagnosis timelines, including those diagnosed earlier in life and those diagnosed as adults, and emphasized the need for a gender-responsive outreach plan.

This engagement was not limited to a single phase of the research. The PAC continues to be engaged in this research, including receiving and discussing the results of this study, co-designing scaling efforts, and contributing to long-term implementation strategies. They will also play a central role in planning dissemination and publication activities, shaping how results are communicated, and helping identify future partnerships and outreach opportunities to sustain and grow the impact of this model.

Supplemental material

Supplemental material for this article is available online.

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Supplementary Material

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Evaluating the feasibility of a co-designed technology-enabled,collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Abstract

Aim

Methods

Results

Conclusion

Keywords

Background

Work to date

Purpose

Research questions

Feasibility

Acceptability

Preliminary effectiveness

Methods

Design

Participants

Setting

Recruitment

Sample size

Trial flow

Outcomes

Analyses

Distress protocol

Ethics

Discussion

Limitations

Conclusion

Supplemental Material

sj-docx-1-dhj-10.1177_20552076251365134 - Supplemental material for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Supplemental Material

sj-docx-2-dhj-10.1177_20552076251365134 - Supplemental material for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Supplemental Material

sj-jpg-3-dhj-10.1177_20552076251365134 - Supplemental material for Evaluating the feasibility of a co-designed technology-enabled, collaborative care program for young adults with type 1 diabetes and diabetes distress: A protocol

Footnotes

Acknowledgements

ORCID iDs

Ethical considerations

Consent to participate

Contributorship

Funding

Declaration of Conflicting Interests

Patient involvement

Supplemental material

References

Supplementary Material