The overall objective of this study is to examine the effect of a 1-year, person-centered and culturally sensitive intervention on alterations in glycemic control (HbA_1c) in Arabic-, Turkish-, or Urdu-speaking individuals. Secondary objectives describe changes in cardiometabolic risk factors and patient-reported outcomes, including well-being, diabetes management, health literacy, and adherence to diabetes medication.

We hypothesize that a 1-year, person-centered and culturally sensitive intervention added to standard care will be superior for reducing HbA_1c in Arabic-, Turkish-, or Urdu-speaking individuals with T2D. Superiority will be claimed if the baseline-corrected difference between the 2 groups is equal to or surpasses the minimal important difference (5 mmol/mol) in favor of the intervention group and if the P<.05.

Women and men aged 75 years or younger with T2D whose native language is Urdu, Arabic, or Turkish will be considered eligible based on the specified inclusion and exclusion criteria.

The inclusion and exclusion criteria are listed in Textbox 1. The eligibility criteria, including the age limit, were carefully selected based on several considerations. The language criteria were chosen to focus on the largest language groups at Steno Diabetes Center Copenhagen (SDCC), as individuals who speak fluent Danish generally face fewer challenges in managing their treatment and T2D compared with those with limited Danish proficiency. Regarding the age limit, participants older than 75 years were excluded as they are typically offered a different, combined approach to care. However, we recognize that older individuals need support, and it is believed that those younger than 75 years have the potential to become more self-sufficient with the right intervention. Therefore, the age limit was set to target those who could most benefit from this specific approach.

We plan to recruit 96 Arabic-, Turkish-, or Urdu-speaking individuals with T2D from the outpatient T2D clinic at SDCC. During the latest visit to the usual course of treatment at SDCC, potential participants will receive a brief introduction to the person-centered and culturally sensitive course of treatment in the type 2 diabetes (ACCT2) study. If interested, potential participants will be met by a project worker who will provide an oral introduction and, if interested, play an audio recording containing study information in Urdu, Arabic, or Turkish, depending on the participant’s preference. All study participants will receive written study information in their native language. The information will be given in quiet surroundings at SDCC. The ability to bring one companion is allowed.

The project worker will have a written informed consent ready to sign and be available to address any questions. Participants may have at least 24 hours to consider participation. A participant folder containing the written study information and the written informed consent will be handed to the potential participant, and a project worker will follow up with a phone call within a week. If the participant wishes to take part in the study, the written informed consent must be signed and forwarded to the project worker. By January 16, 2025, a total of 88 out of 96 participants were recruited. The recruitment process will continue until March 2025.

To ensure accessibility, all written information is translated into Urdu, Arabic, or Turkish by international standards [30]. Study participants are informed that they can always withdraw their commitment to participate. The individual participant’s right not to know their data will be respected.

After obtaining written informed consent, participants will be randomized to either the intervention or control group in a 1:1 ratio using block randomization (Figure 1). Block randomization is used to secure an equal distribution of participants in the 2 groups if the study, for unexpected reasons, should be terminated before inclusion of all participants, and further to account for potential seasonal confounding.

Randomization will be performed by the investigator before the first visit using the randomization module in the software REDCap (Research Electronic Data Capture; Vanderbilt University). The randomization list is created by a researcher not involved in the trial, who will be the sole person to access it throughout the trial. Should this person be unable to continue this function, a new person not involved in the trial will be appointed to store and access the sequence. Participants are recruited continuously.

The intervention was developed in collaboration with the target group and HCPs from the outpatient T2D clinic at SDCC. Overall, the ACCT2 study consists of three phases: (1) needs assessment, (2) intervention development and element testing, and (3) RCT.

Phase 1 (needs assessment) included interviews and workshops with Arabic-, Turkish-, or Urdu-speaking individuals with T2D (n=18) and 2 workshops and individual interviews with HCPs (nurses, physicians, and dieticians) from the SDCC outpatient clinic (n=33). The findings from the needs assessment suggested adjustments in the standard course of treatment by focusing on (1) extended time in consultations, (2) use of technology for diabetes monitoring, (3) awareness of language barriers, (4) meeting the same HCP, (5) use of accurate communication and dialogue tools, and (6) a need for increased levels of health literacy. A culturally sensitive approach of HCPs was also considered vital to increase understanding and engagement in diabetes management among the target group while emphasizing a whole-person approach rooted in individual everyday life.

Based on the results from the needs assessment (unpublished), a 1-year intervention was designed to target the target group’s needs. Visits in the intervention design were tested on 3 individuals speaking Urdu, Arabic, and Turkish as their native languages to test if the flow, content, and overall design match their needs. Tools and methods included in the intervention are partly inspired by the research-based diabetes self-management education, Culturally Sensitive Tools and Methods (CUSTOM) for individuals with non-Western backgrounds [31,32]. The RCT design is described in this study (phase 3). The CONSORT-EHEALTH (Consolidated Standards of Reporting Trials of Electronic and Mobile Health Applications and Online Telehealth) reporting guidelines were applied (Multimedia Appendix 1) [33].

The ACCT2 study is a 1-year pragmatic randomized controlled parallel group open-label effectiveness trial including 96 Arabic-, Turkish-, or Urdu-speaking individuals with T2D (Figure 2). The intervention consists of 6 visits to SDCC. All visits are based on specific values and competencies of HCPs, which are important in the organization, implementation, and completion of the intervention.

The intervention is based on a person-centered approach [34,35]. A person-centered approach is characterized as a collaborative process between the participant and the HCP, wherein the participant’s priorities, preferences, and needs are incorporated into decisions regarding their diabetes treatment. It focuses on understanding the patient’s capacity and pace for change [34,35], where cultural competence among HCPs is crucial. This includes adapting attitudes to individual needs and recognizing the implications of emotional, cultural, social, and psychological consequences [17]. Striking a balance, HCPs must acknowledge potential cultural differences without letting them dominate encounters. The intervention’s visits consider individual circumstances, resources, expectations, and prerequisites for changes. In addition, it aligns with the empowerment treatment philosophy, where well-informed participants actively engage in diabetes management. The HCP’s role is to support the participant in making decisions, achieving goals, and overcoming obstacles [36].

The visits will be run by the same diabetes nurse and endocrinologist under the responsibility of the investigator. Visits with dieticians will be arranged if requested by participants (up to 60 min per visit). For logistical reasons, windows are allowed for the visits (±30 days). The intervention staff includes the same diabetes nurse and endocrinologist, each overseeing the 48 participants in the intervention group. The 48 control participants will continue their care with their usual HCPs. A detailed visit flow is presented in Figure 2.

Participants in the control group will follow the standard course of treatment, which includes regular visits with a physician, often an endocrinologist, and a nurse at the T2D outpatient clinic at SDCC 3-4 times per year (Figure 3). These visits can be in-person or computer-based, depending on the preferences of the participant and HCPs. The standard course of treatment also often includes visits with a podiatrist and eye screening, and it may also include visits with a dietician and psychologist.

All equipment used in the study meets the requirements for patient safety and has previously been used in research projects. Participants will have blood samples taken before visits (maximum 18 mL). The total amount of blood collected during the entire study period is at the same level as during the standard course of treatment and is considered safe.

Participants will not have any study-specific clinical measurements taken besides three 2-week periods of CGM measurement. During the sensor placement, participants may experience minor and brief discomfort. The sensor is generally well-tolerated, and only a few potential discomforts are associated with its use. Some participants may experience mild skin irritation or redness where the sensor is inserted. There may be a slight discomfort during the insertion process, although it is generally brief. In rare cases, an allergic reaction to the sensor adhesive or materials may occur, leading to more significant skin irritation. It is also worth noting that the sensor needs to be replaced twice, which involves removing the old sensor and applying a new one, which can cause minor discomfort. However, these discomforts are small and temporary. A rare complication is a superficial skin infection obtained in connection with penetration of the skin. The risk of superficial phlebitis is minimized by following hygiene standards, including double cleansing of the skin with an alcohol swab and using sterile materials. Superficial phlebitis is not dangerous. Medication will be reviewed and adjusted according to current clinical guidelines. Participants can contact the physician and diabetes nurse or use the hotline at SDCC about medical issues, for example, concerns related to medication use.

Appointed researchers affiliated with SDCC will be granted access to data. The principal investigator will facilitate direct access to source data and documents for regulatory inspection. Since we anticipate no adverse effects associated with the intervention, recording of harm or side effects will be conducted. Positive and negative study results and inconclusive findings will be presented at conferences and published in international peer-reviewed journals. All coauthors are expected to adhere to the guidelines of the International Committee of Medical Journal Editors, and no professional writers will be involved in the writing process.

The study has been approved by the Ethics Committee of the Capital Region of Denmark (H-23042245) and the Research Legal Affairs of the Capital Region of Denmark (P-2023-14503). The study will be conducted following the Declaration of Helsinki and will comply with the Danish Data Protection Agency and the General Data Protection Regulation. Adequate blinding of all personal data during data processing and publication will be ensured. The participants are covered by the Patient Compensation Association according to the Danish Act on the Right to Complain and Receive Compensation within the Health Service.

Despite the existing gaps in the literature, it is well-established that the target group faces an elevated risk of T2D [1-3], often attributed to factors such as health behavior, limited health care access, social determinants of health, low health literacy, cultural norms, and language barriers [4,9-16]. Our study aims to build on this understanding by using several robust methodologies. The use of a scientifically rigorous design, power calculation for sample size estimation, and a replicable intervention are among the strategies used. A control group allows for a meaningful comparison to “usual care,” enhancing the reliability of our findings. In addition, administering the intervention through the same HCPs ensures continuity in care and familiarity for participants, which may reduce dropout rates. A distinctive feature of our approach is the systematic involvement of the target group and HCPs in the intervention’s design. By incorporating their insights into their needs, barriers, and potential solutions, we aim to create an intervention that better addresses their challenges than previous research. This tailored approach could lead to improved diabetes management, enhanced well-being, and reduced obstacles that typically hinder care within this high-risk population.

The interdisciplinary nature of our study, coupled with feasibility assessments, offers valuable insights into the experiences of both participants and HCPs, shedding light on potential barriers and effective strategies for implementing the intervention in outpatient clinics. However, it is important to acknowledge certain limitations. The 1-year duration of the trial restricts the exploration of long-term effects. In addition, the broad inclusion criterion, while facilitating a more representative study population, may introduce heterogeneity in some secondary outcomes. Also, the inherent challenge of blinding participants poses a potential for performance bias, which we cannot eliminate from the study design.

Moreover, we compare the intervention group to the usual care group, which, by definition, represents the standard treatment available. The intervention group, however, received additional resources and structured support, which may have led to greater improvements. This is a common approach in intervention studies, where the objective is to assess the added value of the intervention. While the observed benefits in the intervention group may be partly attributed to the enhanced support provided, it is essential to evaluate whether these improvements can be directly linked to the intervention itself. Therefore, intervention scalability, if it proves effective, includes further evaluations. Key considerations for scalability include assessing cost-effectiveness, resource allocation, and how the intervention can be integrated into routine clinical practice. We also plan a comprehensive realist evaluation, which will provide additional insights into the implementation and feasibility of the intervention. This evaluation will explore the perspectives of participants, their relatives, and HCPs with a focus on understanding what works for whom, why, and under what circumstances. By examining the mechanisms driving the intervention’s success or failure, we aim to identify the conditions and contexts necessary for effective implementation.

The intervention design, tailored to address the needs of both the target group and HCPs, is poised to maximize its potential for acceptability within the target group, particularly should the outcomes prove positive. This study is expected to provide knowledge translatable to clinical settings, with the anticipated clinical impact extending to the future development and implementation of interventions adapted to preferences, needs, and satisfaction.