Development of a Diabetes Navigator Toolkit to Support Diabetes Technology Uptake: The IMPACT Toolkit Free

We used rapid qualitative analysis, a pragmatic approach that gathers targeted qualitative data in a more time- and resource-efficient manner than traditional qualitative research methods (18–21). Because the toolkit was being developed specifically for use by a diabetes navigator in a randomized controlled trial, this was an ideal method to more rapidly obtain feedback and carry out iterative refinements of the toolkit in the formative phase. This approach increases efficiency while maintaining study rigor. This study was approved by the Johns Hopkins Institutional Review Board and was conducted from January to June 2023.

Participants included 1) people with type 1 diabetes and caregivers of people with type 1 diabetes, 2) HCPs, and 3) community and commercial partners. For the people with diabetes and caregiver category, participants were adults with type 1 diabetes, caregivers of children (<18 years of age) with type 1 diabetes, and both users and nonusers of ADTs. Purposeful sampling was used to promote diversity of age, race, ethnicity, insurance type, and diabetes duration. HCPs included members of the pediatric and adult diabetes care teams within the institution, including medical doctors, nurse practitioners (NPs), diabetes nurses, certified diabetes care and education specialists (CDCESs), nutritionists, prior authorization specialists, and social workers. Community and commercial partners were clinical representatives from diabetes technology companies, insurance companies, durable medical equipment (DME) companies, and advocacy organizations.

Adults with type 1 diabetes and caregivers of children with type 1 diabetes were recruited by several methods, including Epic electronic medical record MyChart messages, flyers placed in the diabetes clinics, and face-to-face information provided by the research team in the clinics. HCPs and community and commercial partners were invited to participate through a recruitment e-mail message.

Based on the known barriers to ADT use, and after thoroughly outlining the process of prescribing, receiving, and using ADTs (Supplementary Appendix S1), we constructed the diabetes navigator toolkit describing the potential interventions of the diabetes navigator. The initial toolkit was developed by two adult endocrinologists, one pediatric endocrinologist, one adult CDCES, and two pediatric CDCESs.

The interview guide was developed by investigators (R.M.W., A.S., K.A.R., and N.M.) and adapted for each participant group (Supplementary Appendix S2). Participants were presented with the initial version of the diabetes navigator toolkit and the process maps for CGM and insulin pumps (Supplementary Appendix S1). They were queried about the barriers they faced with their existing ADTs or any ADTs they were considering, potential real-world challenges the toolkit might face when deployed, whether the toolkit would aid in overcoming known patient and health system barriers to using ADTs, and recommendations for enhancing the toolkit concerning specific challenges and solutions.

Qualitative interviews were conducted via Zoom (a Health Insurance Portability and Accountability Act–compliant digital platform) and involved the participant and two research coordinators (D.A. and B.P.). Oral consent was obtained before starting the interviews and was audio recorded. For interviews with people with diabetes, caregivers, and HCPs, one coordinator directed the interview, while the other took real-time notes on the conversation using rapid analysis procedure (RAP) sheets. The RAP sheets included categories of process (various sections of the toolkit), concerns or challenges (What went wrong? Why did it happen? What made it worse?), facilitators or supports (What helped? What was tried but did not help?), and thoughts on the toolkit (including suggestions for items to add or remove). The interviews were 30–45 minutes in duration. After interviews, both research coordinators reviewed the audio recording and either refined their notes (note taker) or took notes (interviewer) on separate RAP sheets, after which they met to corroborate and harmonize their notes. Exemplary quotes were noted on the RAP sheets with the audio recording consulted to ensure accuracy. The research team met weekly to review the RAP sheets and discuss the interview feedback, after which the toolkit was iteratively updated. The most updated toolkit was then used for future interviews.

One group meeting was conducted via Zoom at a mutually agreed upon time for all community and commercial partners. Two investigators (R.M.W. and N.M.) led the interview process, sharing the proposed toolkit for feedback, after which the discussion was transcribed and categories were identified and iteratively applied to refine the toolkit. To protect proprietary interests, responses from community and commercial partners are not identified by name or entity.

Interviews continued until information saturation was achieved and no further novel insights or substantive toolkit revision recommendations emerged. The Consolidated Criteria for Reporting Qualitative Research were used to report the findings (22).

As shown in Table 1, 51 individuals participated in this qualitative study, including 23 people with diabetes or caregivers, 18 HCPs, and 10 community and commercial partners. Of the people with diabetes and caregivers (which included three people with diabetes who were also caregivers of a child with diabetes), nine used both CGM and an insulin pump, 10 used only CGM, and four did not use any ADTs. HCP participants from pediatric and adult diabetes centers included six endocrinologists, three NPs, six nurses/CDCESs, one prior authorization specialist, one nutritionist, and one pediatric social worker. There were 10 community and commercial partner participants who were designated by their respective entities to attend the discussion. These included five individuals from two diabetes technology companies, two representatives from one insurance company, and one person each from a DME company and a diabetes advocacy organization (JDRF). Seventeen additional people with diabetes or caregivers who expressed interest in participating did not complete the interview because of communication barriers, including seven who could not be reached, four who were unable to schedule an interview, one who had no Internet service, and five who had no reason identified for not participating.

Five topic categories emerged from all participant groups related to CGM and pump prescribing and education processes: 1) communication challenges and opportunities, 2) understanding insurance and cost, 3) device education and training, 4) reducing technological and device-related issues, and 5) complex processes around prescribing and obtaining diabetes devices. Table 2 summarizes the reported barriers along with their proposed solutions and recommended adjustments to the toolkit based on interview feedback.

A recurring sentiment among people with diabetes was the need for improved communication and the value of having a dedicated contact person to address insurance-related problems in the process of acquiring their diabetes devices. “I had to make three different calls to them [referring to billing], and by the time you spend all the time on the phone, go through multiple people to get things straightened out, that can be a headache,” a 60-year-old man said. People with diabetes also expressed confusion about the designated pharmacy assigned for their prescriptions and supplies, especially with mail-order pharmacies, leading to delays in acquiring their CGM devices and sensors and pump supplies. They also reported encountering issues with missing prescriptions and uncertainty about whether supplies and refills were coming from a pharmacy or DME company. A 40-year-old woman said, “That was a big hiccup for me, trying to figure out where to get refills.”

HCPs described spending an extensive amount of time liaising with pharmacies and insurance companies to secure CGM and pump devices for their patients. For insulin pumps, they said they often do not receive notifications of when patients receive their pump, causing delays in scheduling pump training. The responsibility largely falls on patients to notify their HCP. This gap, as one female NP put it, leaves “everyone in the dark until a pump package arrives.”

Representatives from diabetes technology companies and advocacy groups identified the initial interaction between pharmacies/suppliers and patients as a significant obstacle, noting that patients often miss calls from health care entities, ignore calls from toll-free numbers, or are unaware of the possibility that they may receive such calls. As a commercial representative put it, “A lot of times, the initial outreach, at least from a pump company or for a sensor, is that initial reaching of the patient, and nobody picks up 800 numbers.” Representatives from DME companies and pharmacies also reported a slow response time on paperwork from HCP offices. As one said, “It’s like dropping a paper off the top of the building and hoping it lands on someone’s desk.” Additionally, all participants noted that there was uncertainty among patients regarding who to contact once they received their pump supplies and highlighted that these challenges compound disparities in technology access.

Feedback from people with diabetes and caregivers underscored the importance of having an easily reachable point of contact, such as a diabetes navigator, who is capable of answering questions and offering clear explanations for device-related problems. A 53-year-old man with diabetes suggested “maybe [having] someone at the office to talk to [about how to use the device when first starting].” A 60-year-old man with diabetes stated, “If somebody is able to even reduce the number of times I have to call insurance companies, that’s a big benefit—someone who knows the ropes and how to navigate processes better. Ideally, [that person] would have a relationship with the companies—someone who is educated in the processes and able to expedite and streamline things.”

HCP feedback suggested encouraging patients to answer calls from toll-free numbers such as 800 numbers to maintain smooth communication and avoid delays in device-related processes. A male adult CDCES said, “The patient has to talk to the DME [supplier] for the device to be sent. Prepare the patient; ‘Hey, you’re going to get a call from this company. Do not ignore them.’” HCPs recommended streamlining paperwork and ensuring efficient communication between patients, pharmacies, DME companies, and HCPs to reduce delays in the pump prescription process. People with diabetes and HCPs suggested that navigators could play a crucial role in monitoring progress, being aware of pump supply deliveries, and facilitating the pump training process.

Commercial and community partners suggested that care teams ensure that patients receive contact information for the company receiving their CGM prescription orders, particularly for mail-order DME suppliers, along with clear instructions on whom to contact and what steps to take if there are communication challenges. This proactive approach empowers patients to stay informed about their orders, helps companies establish initial contact with patients, and provides the necessary information to send reminders to patients to refill supplies. One participant suggested “providing the patient with the phone number to wherever [providers] are sending the order [DME company or pharmacy]. So that way, if we [DME company or pharmacy] can’t reach the patient, then they [patients] have a way to reach us. Because one of the hiccups is just being able to reach the families.”

Based on this feedback, the toolkit was updated to include sections that inform patients about the destination and phone number for their device order prescription, emphasize the importance of answering phone calls related to the prescribed device, and provide follow-up outreach to patients to make sure their device has been picked up or received.

Another concern raised by all participants was related to the complexities surrounding insurance coverage and the cost of devices. Even with insurance coverage, the substantial out-of-pocket costs associated with CGM systems posed a significant burden to people with diabetes, and even more so for those with inadequate insurance coverage. Notably, people with diabetes consistently observed that the insurance process is time-consuming. A 35-year-old man with diabetes mentioned that “that [insurance process] was the most annoying, trying to get them to do what they needed to do to get me my insulin, my pump.”

Depending on the insurance plan and coverage, some CGM systems are available at commercial pharmacies, whereas others must be acquired through a DME supplier, and clinicians must determine the appropriate procedure based on the insurance and the specific device. HCPs also noticed a lack of clarity among patients regarding the processes for obtaining a device after it was prescribed. As a female pediatric diabetes nurse said, “There [are] a of lot times when they are not sure when to pick it up, or sometimes even though the insurance has approved the CGM, if they haven’t checked back with the pharmacy, they’ll still think it’s denied, so they don’t pick it up.”

Community and commercial partners also noted that HCPs sometimes struggle to obtain current insurance coverage information for directing device orders, especially with commercial payers. Constant shifts in insurance plans exacerbate the confusion about CGM coverage. As one said, “We know that there are plans in the state that [require that] you must be an endocrinologist to prescribe certain CGMs on some plans, and then others allow primary care [providers to prescribe]. So, this is a very complex category.”

HCPs suggested educating patients about insurance coverage requirements and processing times, tailoring tips and tricks to each insurance category to help navigate coverage complexities, and discussing potential out-of-pocket costs for devices. A female pediatric dietitian said, “I think the out-of-pocket cost might actually be something that needs to be clarified and communicated before, because what you don’t want is somebody gets their heart set on [having an] insulin pump that they can’t legitimately afford or access. So, [it is] probably helpful to have that information fairly soon after the patient expresses interest.” Similarly, a commercial partner suggested that “when they’re looking at the pumps, I think they just feel insurance is going to cover it 100%. If you feel like there’s a patient who might be pump eligible down the line, start preparing them for that possibility that there may be some possible [costs].”

Community and commercial partners emphasized the importance of proactive patient follow-up to ensure order receipt and promptly address concerns. To enhance preparedness for insurance changes, commercial partners recommended creating dedicated communication channels or a point of contact (such as a diabetes navigator or technology specialist) to relay new information to health care teams that could be disseminated to patients interested in ADTs. Furthermore, insurance formularies are not updated as quickly as new technologies are deployed, and that can delay receipt of devices for patients, requiring greater HCP advocacy at the insurance level.

From these suggestions, the toolkit was updated to include resources around CGM and pump prescribing to ensure that prescriptions are sent to the preferred and appropriate pharmacy or DME supplier. The toolkit also ensures that patients are aware of where devices are being sent and tracks prior authorization paperwork to expedite responses for requested paperwork and the timeline for approvals. The toolkit outlines specific steps to enhance communication with pharmacies and insurance companies and between patients and HCPs.

People with diabetes and caregivers identified a lack of education on the benefits of using CGM, understanding CGM readings, and the differences between blood glucose levels and CGM readings, which often leads to confusion and anxiety. HCPs similarly emphasized that inadequate education poses a significant obstacle to the successful adoption and use of CGM, particularly related to initial education, where there is a lack of consistency in setting up CGM alarm thresholds, knowledge gaps on the interpretation of trend arrows and directionality, and patient education on the interpretation of overall CGM data. A male adult CDCES said, “If [patients] set the CGM up on their own at home, they do not connect to the portal. Some people having high sugars don’t even realize that they can change the alarm and get really agitated because they did not know due to lack of proper training.”

Like participants with type 1 diabetes and caregivers, community and commercial partners noted that patients often needed the necessary education to interpret CGM data. As a representative of a community advocacy organization said, “A lot of times, when putting on the CGM [sensor], there’s images and great directions of how to insert it, how to set an alarm. But not a lot on interpretation.”

Similar concerns arose with insulin pumps. People with diabetes and caregivers reported that they did not have a full understanding of the insulin pump options and what the training process entails. A 56-year-old man with diabetes said, “A lot of people don’t know about the pump. Give more details, because I heard about the wires and said no.” Moreover, once the pump was obtained, they faced challenges in completing and comprehending pump training sessions, especially when they were conducted virtually or just included online videos to watch. New pump users expressed concern over the first pump change and were not aware of the different sites to place pump infusion sets.

HCPs noted that pump training is inconsistent and can vary based on type of pump, whether the training is online or in person, and inconsistent discussion of key safety issues, infusion set options, and strategies to handle a pump malfunction. A male adult endocrinologist said, “The more knowledgeable they are going to be, the easier the training will be.” Community and commercial partners added that patients often struggle to find information on how to access pump training and who to contact for enrollment. Furthermore, once the training is scheduled, patients often arrive unprepared for the training session, resulting in incomplete training that leads to further delays in pump use. As one participant put it, “Just because, oftentimes, the worst thing for a patient is, for instance, showing up to a pump training. They think they have everything, [but] the CGM device is not in hand, or nothing’s with them, and they assume [all the CGM and pump supplies for training were] all together.”

People with diabetes, caregivers, and HCPs all proposed a comprehensive educational approach, prioritizing in-person CGM placement and education, with supplemental video guides to be added to the toolkit. They stressed the importance of education on CGM setup and the use of CGM and device alarm settings to reduce alarm fatigue. As a female pediatric CDCES mentioned, “If anything [ways to improve the process], it would be to provide the necessary education for patients so that, when they receive the CGM, they know how to use it, and, typically, what we’re doing as an educator team, we have [Epic] SmartPhrases that have videos attached to it.”

For insulin pumps, people with diabetes and caregivers recommended more advice on which specific pump to choose. A 40-year-old woman with diabetes said, “It [the use of an insulin pump] is so much more of a commitment, so I think there needs to be a lot more [of] a sit down of, ‘Here are your options. We [HCPs] will tell you which [available insulin pumps] we have and what we recommend.’”

People with diabetes, caregivers, and HCPs also emphasized the importance of standardized, comprehensive, and easily understandable pump training that reviews the operational aspects of the insulin pump, options for pump infusion sites, key safety issues, and troubleshooting pump malfunctions. For new pump users, people with diabetes and caregivers suggested in-person training opportunities, whereas brief refreshers were suggested for experienced pump users. It was recommended that the toolkit include follow-up by a navigator or technology specialist to coordinate with the diabetes team and pump trainers to ensure that patients’ training has been completed and their pump has been started.

Community and commercial partners also recommended creating a resource repository, including manufacturer training videos and tip sheets to increase ADT utilization. A community partner representative suggested, “Providing a tip sheet on what the [CGM] trend arrows mean [and] inquiring about the frequency of alarms going off during that first check-in call and then giving a tip sheet to the patient on how to adjust those alarms and when to call their diabetes care team.”

The toolkit was enhanced to include educational resources on all CGM systems and insulin pumps, with video links, and navigator follow-up to make sure devices are received and started.

People with diabetes and caregivers reported several device-related barriers. People with diabetes frequently noted challenges maintaining a secure attachment of the CGM sensor to the arm and that the sensor falling off is an inconvenience and disruption to the continuity of their monitoring and treatment. A 41-year-old man with diabetes said, “Sometimes the tape doesn’t hold.” People with diabetes also reported anxiety and fatigue from frequent CGM alarms. A 35-year-old man with diabetes said, “The constant reminders [high glucose alarms] were annoying at times. Constant 5-minute reminders for high alarms—‘Your sugar level is high,’ ‘I know it’s high, stop beeping.’”

Issues of connectivity between device and app and between device and clinic data portal were brought up by people with diabetes, caregivers, and HCPs. Many HCPs cited connectivity issues as a barrier, including patients not having their CGM system connected to the clinic portal, bringing a smartphone or receiver to the clinic that is out of battery power, or forgetting their login and password. Troubleshooting these mobile app issues can be time-consuming for the medical team. Additionally, after pump starts, sometimes patients are not set up for data-sharing with the clinic, and this presents a barrier to later HCP data review and interpretation and dose adjustments.

Commercial and community partners similarly said that actionable changes to diabetes care are often limited because patients’ devices are not being connected to clinic portals for data review and because of a lack of staff to troubleshoot connectivity and sensor concerns.

People with diabetes and caregivers highlighted the practicality of tips for device adhesion using overlay patches for secure sensor attachment and the value of knowing how to contact vendors for replacement sensors. HCPs similarly recommended educating people with diabetes on options for device adhesives and protective measures for the skin to promote sustained sensor attachment. People with diabetes also suggested including information on coping with alarm fatigue and the mental impact of constant blood glucose monitoring. It was recommended that the toolkit include technology assistance with clinic portal setup, as well as follow-up support addressing technology challenges as they arise after device initiation. A 40-year-old woman with diabetes said, “That online portal is definitely super helpful. Emphasizing the importance of [the] online portal and how [sharing pump data with the clinic] can be more valuable than [patients] think is essential.” HCPs also suggested prioritizing setting up connectivity to the clinical portal and offering video demonstrations of CGM sensor insertion and pump use.

Feedback from all participants helped develop the educational resources provided through the toolkit to address concerns about device adhesion, appropriate skin care, and adjusting and responding to CGM alarms; offer links to manufacturer videos demonstrating device insertions and changes, and include information on connecting to the clinic portal. Additionally, participants appreciated the idea of the 2-week check-in as part of the toolkit, to assist patients in the first sensor change.

For people with diabetes and caregivers, navigating the CGM and pump prescription process was often complicated, especially with regard to challenges with insurance approvals and timely responses from the health care team. A female caregiver of a 15-year-old child with diabetes stated, “As a new patient, it is definitely tough to navigate and get used to [the process of prescribing and using a CGM device].” HCPs also identified numerous challenges related to the complexity of the process of prescribing, starting, and maintaining use of a CGM system or insulin pump. In addition to the need to coordinate prescriptions, there is an extensive amount of time spent on following up and communicating with patients around obtaining their device, training them on its use, and supporting its ongoing use.

Participants also noted that many patients are unfamiliar with the timelines associated with acquiring their devices.

People with diabetes and caregivers suggested having a dedicated point of contact to streamline paperwork, liaise between the clinic and insurance and pharmacies or DME companies, and provide guidance on ordering and obtaining refills.

HCPs also suggested the toolkit could benefit from an electronic tracking system for the authorization process, streamlining the CGM and pump prescribing process and ensuring that both patients and HCPs receive timely updates and that communication is efficient among all parties. Like people with diabetes, HCPs also suggested that navigators could play a crucial role in this monitoring progress to be aware of pump supply delivery and assist patients by facilitating the pump training process. A female pediatric endocrinologist said, “A navigator could communicate to the patients the typical time it takes to schedule trainings and provide realistic expectations [and] be a point person for the companies and ask, ‘Do you expect this region to have lots of availability [of device trainers]?’ You know how, for a delivery, you have an estimated delivery time? Maybe a navigator can communicate and identify an estimated training time to give people an understanding.”

Community and commercial partners suggested that the toolkit could include a map detailing the steps to pump initiation and education, with contact information to support patients at every stage and information about the respective responsibilities of all key contacts. This strategy would empower patients with decision-making tools by including resources that compare available pumps and visual displays with informative material to educate patients about the distinctions among various infusion sets, enabling them to make informed choices on their pump use. A commercial partner suggested, “[It would be helpful] if we could have some displays that we could provide to all of our accounts with the differences on infusion sets. So, if they could just have an idea, and they can look at it and see how they’re inserted, I think that might be a good step.” The diabetes navigator role could facilitate this flow of information and guide patients toward relevant resources, streamlining their journey.

It was recommended that the toolkit include follow-up by a navigator or technology specialist to ensure that patients’ training is complete and their pump has been started. Assistance with clinic portal setup and follow-up support to address technology challenges as they arise after pump initiation were also recommended.

The toolkit was updated to include process maps for both CGM and pump initiation (specific to each device) such that the steps on the maps could be followed in sequence and help patients, HCPs, and the navigator understand where patients are in the process and what should happen next. Supplementary Figure S1 shows the final updated diabetes toolkit.

In this study using a rapid qualitative analysis method, we obtained participant input on a diabetes navigator toolkit, a novel approach aimed at reducing disparities in the adoption and use of ADTs. Key stakeholders in diabetes care, including people with type 1 diabetes, caregivers of people with type 1 diabetes, HCPs, and commercial and community partners, provided insights on barriers to ADT adoption and potential solutions to overcome them. This feedback was integral to the toolkit’s final design. Although there exists a large body of qualitative research describing barriers to ADT use, our study is among the first, to our knowledge, to actively seek stakeholder insights on potential solutions.

The findings from this research provided clarity on the potential roles, responsibilities, and resources that should be addressed in a diabetes toolkit to guide patients through the intricate process of acquiring and using ADTs. Patient navigators, often specialized laypeople, have historically served in various health care domains, aiding patients in navigating complex systems, addressing barriers, coordinating care, educating, advocating, and offering support (23–26). Navigators are non-HCPs who need communication skills, problem-solving abilities, an understanding of relevant processes, and practical experience in navigating complex systems. The categories identified in our analysis underscore the potential value of a diabetes toolkit designed to be used by a diabetes navigator, technology specialist, or other member of the diabetes care team, especially given the complex landscape of today’s health care environment concerning the prescription and utilization of ADTs.

Several key overlapping categories emerged from the qualitative analysis, with consensus observed across all participant groups. The primary identified obstacles to the adoption of ADTs were communication lapses, hurdles related to insurance and cost, inadequate education and training, technological issues, and complex processes around prescribing and obtaining diabetes devices. Generally, participants believed that many of the suggested strategies, especially the introduction of a diabetes toolkit to be used by a diabetes navigator or other diabetes team member, could effectively address these barriers.

With regard to communication gaps, appointing a diabetes navigator as a central liaison, facilitating follow-up interactions, and aiding in connecting patients to clinic portals were deemed pivotal. For the challenges associated with insurance and costs, suggested solutions included monitoring prior authorization paperwork, providing clear information about potential out-of-pocket expenses, and delivering consistent updates on insurance alterations. For device education and training, participants highlighted the importance of hands-on demonstrations and face-to-face training sessions. Additionally, they recommended phone or video assistance during device transitions and consistent follow-up to ensure continued usage. To simplify the intricate processes involved in implementing ADTs, there was a general sentiment in favor of adopting a comprehensive tracking system from the point of device prescription to confirmation of its ongoing usage to ensure that no patients are overlooked. Finally, to combat resource-related confusion, the role of a diabetes navigator as an informative guide who is equipped with straightforward device instructions was identified as a potential solution.

Much of the prior qualitative research on ADT usage in type 1 diabetes has centered on barriers and used various qualitative approaches such as focus groups, interviews, and surveys. Our findings resonate with past research emphasizing barriers, including monetary constraints and insurance-related factors (27,28), physical discomfort (29), and diabetes-related distress (30). Limited research on potential solutions has demonstrated that early CGM initiation and on-the-spot placement and education are effective strategies (13–15). Additionally, a quality improvement (QI) study found that adhesive over-patches to prevent CGM devices from detaching offer promise (31).

Systematic studies addressing the broader complexity of acquiring diabetes devices are scant. Our study underscores the necessity of establishing tracking systems and resources to guide patients from obtaining to troubleshooting problems with ADT devices. We aim to assess the efficacy of the diabetes toolkit in helping patients adopt and use ADTs in a randomized controlled trial (ClinicalTrials.gov ID NCT06229236). However, in the meantime, the toolkit could be deployed in clinical care or through QI initiatives, piecemeal or in its entirety, and used by one or more diabetes team members, as appropriate. Primary care providers also often prescribe CGM systems and therefore could use parts of the toolkit as applicable to their practice.

This study had several strengths, most notably its use of a rapid qualitative analysis method that facilitated quick refinement of the diabetes navigator toolkit, a task that might have been more protracted with traditional qualitative research methods. However, one of the limitations of using this method was that showing participants a prototype of the toolkit, although likely facilitating the conversation, may also have inhibited them from suggesting strategies or processes that would have required substantial revisions. Additionally, because this approach relied on note-taking, it is possible that important feedback was missed. This possibility was mitigated by having the interviewer and a second research coordinator listen to the interviews and harmonize their notes. Another limitation was the study’s single-site recruitment, which may have limited the generalizability of the experiences and processes. Researchers sought to mitigate this by purposefully recruiting participants from diverse and marginalized populations central to the intervention.

Future studies may require tailoring the intervention to local settings or different target groups, such as people with type 2 diabetes. In addition, the ADT landscape is evolving rapidly, so the results of this study may require continuous adapting to be relevant to future tools. One of the challenges in developing a standardized approach to initiation of ADTs is that each device, manufacturer, and payer has its own processes for prescribing, delivering, training, and refilling supplies. The lack of national standards in this area makes it difficult to navigate even for seasoned diabetes specialists.

This study has identified foundational strategies compiled into a comprehensive diabetes toolkit that can be deployed by a diabetes navigator or other member of the diabetes care team to tackle the multifaceted barriers hindering the use of CGM and insulin pump therapy in people with type 1 diabetes. Future research will ascertain whether a diabetes navigator, armed with this comprehensive toolkit, can empower people with type 1 diabetes to maximize ADT use for optimal outcomes. Continued studies are imperative to evaluate and develop new solutions as ADTs evolve.

The authors thank the patients and providers at the Johns Hopkins Diabetes Centers for their participation and the community and commercial partners for their contributions.

This study was supported by the National Institutes of Health under award R01-DK134955 to R.M.W. and N.M. The content is solely the responsibility of the authors and does not necessarily represent the official views of the funding agency.

R.M.W. has received research support from Novo Nordisk unrelated to this work. No other potential conflicts of interest relevant to this article were reported.

R.M.W., N.P., D.A., B.P., and N.M. completed the interviews. R.M.W., A.S., K.A.R., and N.M. conceived of the study. R.M.W., N.P., A.L., T.L., A.S., K.A.R., and N.M. analyzed the data. R.M.W., N.P., A.L., T.L., M.K., and N.M. wrote the manuscript. All authors critically reviewed the manuscript and approved it for submission. R.M.W. and N.M. are the guarantors of this work and, as such, had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

This study was presented in abstract form at the American Diabetes Association’s 84th Scientific Sessions in Orlando, FL, 21–24 June 2024.