Facilitators and Barriers to Smart Insulin Pen Use: A Mixed-Method Study of Multidisciplinary Stakeholders From Diabetes Teams in the United States

This was a mixed-method study conducted in two phases between November 2020 and June 2021. It was approved as nonexempt by the Western Institutional Review Board. Participants were recruited within the TIDX-QI. Centers participating in the T1DX-QI strive to improve care delivery and health outcomes and reduce barriers to care for everyone with type 1 diabetes by sharing best practices and data benchmarking (10).

In the first phase, six multidisciplinary clinic care teams—two adult clinics and four pediatric clinics—within the T1DX-QI participated in semistructured focus group discussions. Care team members included providers, nurses, educators, data analysts, and coordinators (Table 1). In addition, the design included a mix of pediatric and adult clinics with very high to very low SIP prescribing habits. Recruitment e-mails were sent to all member clinics of the collaborative inviting them to participate in focus groups. Of those that responded, we randomly selected six clinics to participate.

The first and second authors (E.O. and N.N.) conducted the interviews. Both interviewers were experienced in conducting qualitative interviews. Participants were aware of the goals of this research and provided verbal consent before the interviews. The focus group semistructured questions were tested and refined by a pilot group before the interviews. The focus group findings were shared with participants afterward via various meetings to ensure that the main themes identified reflected the conversations. Participants were not offered any financial compensation.

Focus group sessions were audio-recorded via the Zoom meeting platform. The audio recordings were de-identified and transcribed using TranscribeMe software (TranscribeMe, San Francisco, CA) and exported into NVivo, v. 1.4, software (QSR International, Burlington, MA) for analysis. A force-field analysis was conducted analyzing high-, medium-, and low-impact forces identified in the analysis. Forces were identified as high-impact forces if they were mentioned at least once in five of the six focus groups or at least twice in a single focus group. Medium-impact forces were mentioned in three or four focus groups, and low-impact forces were mentioned in one or two focus groups.

Seven codes were created that reflected focus group questions and were based on an extensive literature review. These included Prescribing Comfort Level, Useful or Beneficial Tools, Provider Barriers, Quality of Visit, Operational Challenges, Patient Barriers, and Tools or Clinical Support to Increase Confidence Among Clinics. Coding occurred within NVivo for all transcripts. Any disagreements in coding were resolved among the authors. Themes were identified within each primary code, and direct quotes were pulled from the transcripts that reflected and supported these themes.

In the second phase of the study, clinics participating in the T1DX-QI were invited to complete an online survey on the research topic. Seventeen pediatric clinics (77%) and five adult clinics (23%) participated in the study’s second phase. Clinics varied in the size and demographics of their patient populations. Table 2 summarizes the number of patients from clinics participating in the phase 2 survey and their racial/ethnic breakdown. The survey was administered using Qualtrics XM (Qualtrics, Provo, UT). Categorical data were represented as percentages of responses. Summary statistics, including frequency and percentage for categorical variables, were calculated for all clinical characteristics. This study adhered to the Consolidated Criteria for Reporting Qualitative Research standards (12). Supplementary Tables S1 and S2 provide the focus group guide and survey questions, respectively.

Barriers and facilitators identified in focus groups and survey results were organized into three categories: 1) provider-related, 2) patient-related, and 3) clinic- and operational-level. The classification for some factors as facilitator or barrier varied depending on clinic resources or providers’ and patients’ knowledge or skills and were therefore categorized as both barriers and facilitators. Table 3 provides sample direct quotes from focus groups illustrating the identified themes.

A key theme within the category of provider-related barriers was provider and care team training and awareness. Low provider and care team awareness of the utility of SIPs and a lack of training on SIP use were considered a high-impact barrier. Sixty-three percent of clinics reported that provider preferences or limited training was a significant barrier to using SIPs in their practices (Figure 1). Low provider awareness often resulted in SIPs not being routinely mentioned when clinicians discussed other diabetes technology devices such as insulin pumps and continuous glucose monitoring (CGM) systems with their patients.

Key themes in the category of patient-related barriers included 1) insurance coverage and cost, 2) patient education and training, 3) smartphone availability and functionality, and 4) pediatric-specific barriers. Eighty-two percent of surveyed clinics identified patient health insurance and associated copay costs as barriers to SIP technology uptake in their clinics (Figure 2). Knowledge of insurance coverage for SIPs and how to navigate this process after prescribing the device was a significant concern to multiple providers. Additionally, 73% of the clinics identified education and training for SIP use as the most significant barriers observed among patients (Figure 2). Clinics underscored a lack of direct patient education and training during the SIP setup process. Care teams mentioned that having demonstration SIPs available in the clinic would facilitate a more meaningful discussion and setup process with their patients. Smartphone availability and functionality were considered a high-impact barrier among clinics serving a high proportion of low-income patients. During focus groups, care teams stated that issues with smartphone functionality and access to the Internet were more concerning than whether their patients owned a smartphone. Pediatric-specific issues included concerns expressed during focus group sessions about children living in multiple households, bringing their SIPs to school, and having access to a smartphone versus needing to rely on a guardian or parent to facilitate SIP use. Care teams described how miscommunication among family members and children moving between multiple households could lead to discrepancies in dosing and improper use of the SIP application (app). In addition, parents have shared concerns about their children bringing their SIPs to school and losing them.

In the category of clinic- and operational-level barriers, the following themes emerged: 1) clinic workflow, 2) care team prescribing comfort level, and 3) telemedicine. Forty-one percent of clinics reported that obtaining and using data reports was a barrier in their practice (Figure 2). Clinic workflow was viewed as a barrier in many clinics, as issues arose with report retrieval, prescribing, and education for SIP use. In addition, during focus groups, clinics highlighted their lack of knowledge regarding how to download information and a disconnect between the prescribing process and patient retrieval of pens from the pharmacy. As one respondent put it, “Prescriptions go off into a black hole.” Twenty-seven percent of clinics highlighted providers’ comfort level in prescribing SIPs as a barrier, a finding amplified during the focus group discussions. In addition, prescribing comfort level was lower for clinics that do not regularly prescribe SIPs to their patient population. Eighteen percent of clinics stated that remote monitoring during the coronavirus disease 2019 pandemic was a barrier for their clinic (Figure 3). During focus groups, clinics with low prescribing comfort and a limited number of patients already prescribed SIPs viewed telemedicine visits as a barrier to quality care.

Key themes related to the category of provider-related facilitators included 1) improved quality of the clinic visit and 2) reports (Figure 3). With regard to improved visit quality, 82% of clinics selected data visualization in real-time as a benefit of SIP use, 73% selected shifting to constructive conversations and problem-solving, and 50% selected improvements in child/parent/guardian relationships (Figure 4). With regard to reports, 77% felt very confident interpreting reports from SIPs. No respondents reported limited or no confidence in interpreting reports. During focus groups, providers mentioned that patients can send reports between visits, allowing providers to make dosing adjustments in a timely manner.

Under the category of patient-related facilitators, researchers found themes including 1) used as an alternative to pump therapy, 2) improvements in diabetes management, and 3) pediatric-specific facilitators. During focus groups, SIPs were seen as a tool to engage patients in their diabetes self-management and increase accountability for diabetes care. Improvements in adolescent engagement were reported. In addition, SIPs were viewed as an acceptable alternative to pump therapy. Respondents identified specific improvements in diabetes management, including dose visibility and accountability and dose calculations and adjustments. Fifty percent of clinics reported seeing improved medication adherence and improved glycemic management in patients using SIPs; 64% reported seeing improved dose accuracy, and 59% reported seeing improved confidence in dosing (Figure 4). Features of SIPs such as dose reminders and dose calculator functions were viewed as facilitators, and care teams mentioned the positive effects these functions had on their patients, allowing them to take ownership and accountability of their disease. Respondents also noted that some SIP features can facilitate improved care for pediatric and adolescent patients. Fifty percent of clinics reported that SIP use can potentially improve relationships between caregivers and children/adolescents with diabetes, as well as visit quality. During focus groups, providers mentioned witnessing increased ownership and accountability for diabetes self-care among adolescent patients and said that reports allowed for constructive conversations and the potential for positive communication within families. Care teams mentioned that children prescribed SIPs who are living in multiple households can benefit from these reports as they provide visibility and a platform for communication among family members and guardians living in separate homes.

In the category of clinic- and operational-level facilitators, researchers identified themes including 1) care team prescribing comfort level and 2) telemedicine. Fifty-nine percent of centers reported high comfort with prescribing and using SIPs, and 27% reported a mild comfort level. During focus groups, clinics with a higher rate of SIP prescribing reported having a higher comfort level with both prescribing and educational opportunities. Fifty percent of clinicians stated that the virtual care opportunities (i.e., telemedicine) afforded by SIP use were a benefit. During focus groups, care teams noted that, for patients already prescribed SIPs, telemedicine appointments were enhanced.

Overall, 63% of clinics stated that they were able to observe minor or major improvements in health outcomes after prescribing SIPs to their patients. Clinic respondents stated that they would like to see more SIP prescribing within their practice, with >90% reporting this in survey results. In addition, 91% indicated either strongly or somewhat agreeing that potential improvements in the care of patients with type 1 diabetes from SIP use outweigh the barriers identified (Table 4).

This study identified provider-related, patient-related, and clinic- and operational-level barriers and facilitators to successful SIP prescribing and use. These findings varied depending on clinics’ knowledge, capacity, and resources. These results demonstrate that major barriers to successful SIP use and training include lack of provider training and awareness, cost, limited insurance coverage, lack of direct patient education and training, and cumbersome prescribing processes within clinics. Major facilitators and benefits of SIP use include enhanced quality of endocrinology visits both in-person and virtually, reports that provide dose visibility, and the use of SIPs as an alternative to pump therapy.

The need for provider and care team education and training on SIP features, use, and prescribing was highlighted in the findings. Providers reported that their unawareness and lack of training were major barriers in their clinic and contribute to SIPs not being at the forefront of patient conversations in the clinic. Pediatric-specific barriers include multiple caregivers and concerns about losing pens at school. A recent study exploring pediatric SIP use highlighted the possible concern that, if the device is lost or the app is malfunctioning, users will need to perform calculations manually, which could function as a barrier (13).

In general, diabetes providers had a favorable view of SIPs. They viewed them as a tool to increase dose accuracy and improve patient confidence in calculating insulin doses, medication adherence, and glycemic management (Figure 4). These are all key components of successful diabetes management and may lead to improved quality of life for patients living with diabetes. The data reports generated by SIPs were viewed as helpful for both patients and providers, providing dose visibility and helping to shift to constructive conversations and thereby enhance visit quality. Having a complete picture of glucose levels, meal intake, and insulin doses was identified as a benefit for both in-person and telemedicine visits and as a means of limiting provider-patient or caregiver-child conflict around diabetes management. This aspect of SIP use may be particularly helpful because consistent engagement in diabetes self-management has been found to be correlated with the attainment of positive health outcomes, including blood glucose control, fewer complications, improved quality of life, and reduced risk of diabetes-related death (14).

Telemedicine was considered both a barrier to and facilitator of SIP use. For patients who are already using SIPs, telemedicine was considered to be a facilitator during remote patient care, allowing providers the opportunity to visualize patients’ insulin dosing. However, for patients who are less savvy regarding technology or those who are good candidates for SIPs but not yet using them, telemedicine was viewed as a barrier to patient care. In addition, providers’ and care teams’ comfort level with SIPs was directly associated with their current prescribing habits and viewed as both a barrier to and facilitator of SIP use. Providers who were aware of SIPs and comfortable prescribing them reported often recommending them to patients. However, providers lacking awareness reported a lower comfort level with prescribing, leading to lower likelihood of recommending and prescribing them in their clinics.

SIPs may be viewed as a more user-friendly option for older adults who do not want devices such as an insulin pump attached to their body. The functionality of SIPs and their app-generated reports increase visibility of missed or extra doses for patients who may have cognitive impairments or other ailments. This information can be used by nurses or caregivers to remind patients to take their insulin and to more closely monitor dosing (15).

A previous study demonstrated multilayered barriers related to technology use in diabetes self-management. Walker et al. (16) found that the most commonly described barriers for technology use in the endocrinology setting were related to provider-level factors and interpersonal communications during clinical encounters. These findings were comparable to ours; however, these results were assessed from patients’ perspective, whereas ours are unique in that they were assessed from the perspective of multidisciplinary endocrinology care teams.

Although there are barriers to successful prescribing and use of SIPs for both providers and patients, the potential benefits of adhering to SIP therapy may outweigh the identified barriers. Diabetes self-management requires significant effort from patients and caregivers. For example, Cavanaugh et al. (17) discussed how a single dose calculation for rapid-acting insulin requires multiple mathematical skills, and lower numeracy skills have been associated with reduced perceived self- efficacy and fewer diabetes self-management behaviors. The generated reports and dosing calculation features of SIPs may help to alleviate the burden of such calculations for patients and caregivers. Future enhancements of SIP technology are expected to offer built-in advanced decision support, including weight-based insulin dosing settings, data-driven education, and dynamic dose titration (18). Offering more tools for diabetes management will further enhance support for people living with diabetes, leading to advancements in care and overall improvements in quality of life.

Targeted intervention areas may be identified to address barriers to while emphasizing facilitators of SIP use. Providing such intervention could restructure patterns of SIP prescribing and use, help to redesign clinic workflows, and improve efficiency and intentionality regarding improving patient access by reducing identified barriers. In a previous study carried out by the T1DX-QI (19,20), clinics implemented various interventions to increase the use of insulin pumps and CGM systems.

Additionally, there are implications for health equity in efforts to reduce barriers and facilitate the use of SIPs. A previous study by the T1DX-QI (21) found that use of advanced diabetes technology varies by population. Such inequity may be exacerbated with the proliferation of new technologies if barriers to access are not addressed (22,23).

Limitations of this study include bias that is present when conducting focus groups. Additionally, patient- related barriers and facilitators were reported by providers rather than by patients themselves. The findings of this study are not generalizable on a national basis because both phases of the study were conducted with academic diabetes centers. Despite these limitations, this work increases understanding of the current state of SIP use and standing in the United States in 22 clinics providing care for patients with type 1 or type 2 diabetes.

This study assessed the perspectives of multidisciplinary diabetes care teams who treat adult, adolescent, and pediatric patient populations. This triangulated approach provides a detailed look into SIP use among varying patient demographics and geographically located clinics. Findings can shed light on targeted areas for intervention to reduce barriers to and accelerate facilitators of SIP use in endocrinology clinics. Future studies investigating patient perspectives and addressing barriers to SIP use through implementing interventions or quality improvement methodologies may be beneficial.

This study was funded by Medtronic Foundation. The funder was not involved in the decision to publish and did not play any part in manuscript preparation/review. The authors thank the Leona M. and Harry B. Helmsley Charitable Trust for funding the T1DX-QI. The authors acknowledge the contributions of patients, families, diabetes care teams, and collaborators within the T1DX-QI who continually seek to improve care and outcomes for people with diabetes.

O.E. is a Health Equity Advisory Board member for Medtronic Diabetes. No other potential conflicts of interest relevant to this article were reported.

E.O. wrote the manuscript and researched data. E.O. and N.N. analyzed the data and reviewed/edited the manuscript. J.Sa., G.N., N.R., F.S.M., M.B., J.I., and F.V. contributed to the discussion and reviewed/edited the manuscript. J.Sc., M.L.S., and O.E. conceptualized the study. E.O. is the guarantor of this work and, as such, had access to all of the data and take responsibility for the integrity of the data and the accuracy of the data analysis.

Portions of this article were presented in abstract form at the virtual 47th Annual ISPAD Conference, 13–15 October 2021.