Increasing Access to Connected Insulin Pens by Promoting Shared Decision-Making Through Collaborative Quality Improvement Free

The T1D Exchange Quality Improvement Collaborative (T1DX-QI) is a multicenter initiative that was established in 2016 as a means of improving outcomes in diabetes care through sharing of data and best practices among member centers and execution of iterative quality improvement (QI) testing cycles within a collaborative learning environment (1–3). The T1DX-QI continues to grow in size and scope from an initial 10 pilot centers to now 62 centers across the United States (41 pediatric clinics and 21 adult clinics), where more than 100,000 people with type 1 diabetes receive specialized care (2,4,5). The organization also recently initiated a pilot effort to improve care for individuals with type 2 diabetes as well (4). Among the focused efforts of the T1DX-QI is improving equitable utilization of evidence-based diabetes technology, including insulin pumps, continuous glucose monitoring (CGM), and connected insulin pens (CIPs) (6–8).

CIPs, also known as smart insulin pens, are reusable insulin injection devices that integrate with a smartphone app via Bluetooth and can help with insulin bolus dose calculations and dose reminders to help prevent insulin stacking and missed doses (9,10). Additional CIP features vary by device but may include insulin temperature monitoring, half-unit dosing, direct integration with CGM, and data sharing with providers. Studies have suggested that CIP use can significantly decrease time spent in hypoglycemia while improving glycemic time in range and decreasing the frequency of missed bolus doses (11,12). CIPs were included in the American Association of Clinical Endocrinology 2021 clinical practice guidelines on the use of advanced technology; CIPs were recommended for any people with diabetes treated with intensive insulin management to optimize their insulin regimen and avoid rapid-acting insulin dose stacking, which could result in hypoglycemia (13). The potential benefit of CIPs was also noted in the American Diabetes Association’s Standards of Care in Diabetes starting in 2022 (14).

Despite the benefits of CIPs, there appears to be a gap in their use by people with diabetes on multiple daily injection insulin therapy, who could potentially benefit from the technology (8). There also appear to be racial, ethnic, and socioeconomic disparities in CIP utilization rates (15). Proposed explanations for low utilization rates and disparities include lack of provider awareness, lack of awareness among people with diabetes, insurance coverage/cost limitations, device training requirements, and implicit bias on the part of care providers (8,16).

Eight member centers of the T1DX-QI (five adult clinics and three pediatric clinics) were recruited to join a collaborative QI project with a goal of increasing CIP use among people with type 1 or type 2 diabetes. One key strategy to achieve this goal was through shared decision-making or dialogue between clinicians and people with diabetes to identify and implement the best management plan to meet the individualized needs of each person (17). Shared decision-making in this project specifically referred to engaging in a collaborative conversation between a person with diabetes (and a parent/guardian, when applicable) and the health care provider to explore available diabetes technology, review device options based on the person’s values and preferences, and make a shared decision about technology use.

Three of the eight centers’ interventions are highlighted as Quality Improvement Success Stories within this T1DX-QI special article collection (18–20). The participating centers used QI methodology, including process mapping and implementation of Plan-Do-Study-Act (PDSA) cycles to improve CIP utilization, and the centers met virtually on a monthly basis to discuss progress and challenges. Each center was encouraged to use a standardized Diabetes Technology Attitudes (DTA) questionnaire to promote shared decision-making (21). Each center designed and executed center-specific QI interventions with the overarching goal of improving CIP prescribing and utilization with a focus on equity. Aggregate monthly data were collected from February 2022 to February 2023. Ages of the people with diabetes who participated in this project ranged from 6 months to 94 years.

Unique individual center interventions are highlighted in the articles of this collection (18–21) and include strategies such as the Northwestern University clinic’s use of a standardized workflow to pre-screen eligible people with diabetes and notify clinic providers of their eligibility through targeted weekly messages (18). Participating clinics within the Stanford Health Care system referred people with diabetes directly to primary care and endocrinology clinical pharmacists for expedited CIP initiation and diabetes management (19). Clinicians at Le Bonheur Children’s Hospital provided people with diabetes and their families a specialized shared decision-making tool paired with technology handouts to encourage dialogue between providers and patients (20).

Each center successfully demonstrated an increase in CIP prescribing and utilization. There is no one-size- fits-all approach when it comes to increasing diabetes technology prescribing and utilization, and these multifaceted QI strategies demonstrate that doing so requires both creativity and adaptability to determine which approaches might work best for a particular clinical center or even for a particular person with diabetes, taking individualized needs and desires into account through shared decision-making.

Throughout this project, documentation of shared decision-making increased to 12% from a baseline of 0% (Figure 1A). Additionally, a majority of individuals who completed the DTA questionnaire reported having a positive perception of diabetes technology. Although not tracked in this study, some people with diabetes also expressed interest in using an insulin pump after participating in shared decision-making about diabetes technology and thus were not prescribed a CIP because they were started on a pathway toward pump initiation instead.

Over the course of the project, CIP use collectively increased by 3% (from 9 to 12%) among participating centers, affecting 270 people with diabetes (Figure 1B). This finding suggests that shared decision-making tools related to diabetes technology, such as the DTA questionnaire, can play an effective role in improving technology prescribing, potentially by serving as a conversation-starter between patients and providers.

Project limitations include a lack of nonacademic or rural centers included in the study, limiting the generalizability of the findings. Other limitations included a small convenience study sample of short duration, with the possibility of bias, and varying levels of QI infrastructure and resources available among participating centers. Additionally, the project’s focus was solely on increasing utilization of CIPs; thus, it did not assess insulin dose adherence or diabetes-related outcomes such as A1C or CGM-derived metrics.

We applaud the ongoing efforts of the T1DX-QI to increase diabetes technology utilization, with a particular focus on improving equity in diabetes care. The overall findings from this project suggest that shared decision-making and the offer of diabetes technology should be done within a standardized workflow that minimizes provider biases in prescribing. Additionally, collaborative multicenter QI work appears to be feasible as a means of increasing CIP utilization among people with either type 1 or type 2 diabetes and also provides value to participating centers through cross-learning and sharing of results and lessons learned from PDSA cycles. Future studies could further assess various strategies for increasing CIP utilization over time, while evaluating important diabetes outcomes, including A1C and CGM metrics, as well as quality of life and diabetes-related distress with the use of a CIP.