Irl B. Hirsch

Aims/Hypothesis: Atypical forms of diabetes often provide diagnostic challenges and are suboptimally treated. We sought to determine whether type 1 and 2 diabetes polygenic scores (PS) would help improve classification of islet autoantibody-negative (IAb-) atypical diabetes cases. Methods: We implemented type 1 diabetes PS (T1D PS) and type 2 diabetes PS (T2D PS) in 309 IAb-individuals’ genome sequencing from the Rare and Atypical Diabetes Network (RADIANT), the largest and most comprehensively phenotyped collection of unsolved and atypical diabetes cases. We performed regression analyses to assess associations between PS, clinical characteristics, and glycemic measures. Results: Both T1D and T2D PS were significantly higher in RADIANT than in ancestry-matched controls from UK Biobank. Both PS were associated with C-peptide measures throughout participant oral glucose tolerance tests (OGTT), although in opposite directions; T1D PS was associated with lower C-peptide measures, while T2D PS was associated with higher measures. Participants with T1D PS above a previously established optimal PS value for differentiating cases and controls (T1D PS GRS2>12.88) had 13-fold higher odds of both insulin deficiency on OGTT and use of both basal and bolus insulin therapy. Conclusions/Interpretation: Individuals in RADIANT with ambiguous diabetes subtypes displayed genetic enrichment for both type 1 and type 2 diabetes, despite ascertainment to remove standard type 1 and type 2 diabetes. T1D PS identified individuals with an unrecognized “type 1 diabetes- like ” phenotype with insulin deficiency and need for intensive insulin in the absence of islet autoantibodies. PS may help identify individuals with atypical diabetes who will ultimately benefit from insulin therapy.

Insulin has been used for over a century for the treatment of diabetes and, since the mid-1980s, there has been a rapid development of insulin administration tools. Over the last decade, several medical products used for diabetes management have been connected to a digital ecosystem. This connectivity includes sophisticated monitoring of not only glucose levels but also of insulin delivery (type, dose, time of dosing). It facilitates interactions between people with diabetes, various diabetes technology devices and healthcare professionals. This white paper aims to discuss and categorise different types of insulin pens, connected insulin pens and caps, as well as smart insulin pen systems (SPSs) that are available on the market. Connected pens capture data to provide information about the details of the insulin applied. SPSs are paired with a continuous glucose monitoring (CGM) system and, by means of integrated algorithms, can provide individualised dose calculation based on a variety of factors. These SPSs can also recommend insulin doses based on current and projected glucose and insulin data; this feature requires a connection to a CGM system. Yet what are the clinical advantages of SPSs? What added value does this system bring to individuals living with diabetes and their healthcare providers? In a narrative review, we discuss the current regulatory pathways and market environment as well as the influencing factors of connected insulin pens vs SPSs. We aim to provide a rationale and justification for this categorisation based on (smart) design aspects, regulatory considerations and clinical outcomes. This review concludes that while standard insulin pens remain a safe and commonly offered option, connected insulin pens and SPSs are likely to show improvement in glycaemic management, treatment adherence and patient satisfaction, and represent a significant advancement in diabetes care. However, further research including high-quality clinical and health economic studies will be vital in substantiating the value of both connected insulin pens and SPSs and driving broader acceptance among payers and healthcare systems. Graphical Abstract

There is an urgent and unmet need for a practical clinical guideline addressing the use of continuous glucose monitoring (CGM), insulin pumps, and automated insulin delivery (AID) systems in hospital settings. The goal with this position statement is to facilitate effective and safe use of these devices to improve glycemic management, enhance outcomes, and contribute to standardization efforts in initiating or continuing the use of these devices in hospitals for non–critically ill hospitalized adults. The topics covered include selection criteria for management with diabetes technologies, CGM-derived glycemic metrics and goals for adults with diabetes, insulin titration and administration guidelines, perioperative care, CGM alarm settings for hypoglycemia and hyperglycemia, clinical staff training and workflows, integration of device data with the electronic health record, imaging tests considerations, and discharge planning.

There is an urgent and unmet need for a practical clinical guideline addressing the use of continuous glucose monitoring (CGM), insulin pumps and automated insulin delivery (AID) systems in hospital settings. The goal with this position statement is to facilitate effective and safe use of these devices to improve glycaemic management, enhance outcomes and contribute to standardisation efforts in initiating or continuing the use of these devices in hospitals for non-critically ill hospitalised adults. The topics covered include selection criteria for management with diabetes technologies, CGM-derived glycaemic metrics and goals for adults with diabetes, insulin titration and administration guidelines, perioperative care, CGM alarm settings for hypoglycaemia and hyperglycaemia, clinical staff training and workflows, integration of device data with the electronic health record, imaging tests considerations and discharge planning. Graphical Abstract

This 2026 consensus report from the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) builds on the 2021 consensus report to provide guidance for managing type 1 diabetes in adults. Reflecting the rapid advances in the field, this update places particular emphasis on the integration of new technologies, while all sections have been revised to incorporate new evidence, advances in clinical practice, and novel therapies, including interventions to delay the onset of stage 3 type 1 diabetes. It also broadens its scope to screening for long-term diabetes complications, and the management of obesity and cardiovascular risk factors. Psychosocial care and diabetes self-management education and support (DSMES) remain key elements.

Pharmacy benefit managers (PBMs) administer prescription drug benefits for insurers, employers, and other payers through formulary design, rebate negotiation, pharmacy network management, and utilization controls. In diabetes care, cost-containment strategies such as formulary-driven medication switching, step therapy, and formulary exclusivity have increasingly restricted access to essential medications and technologies. These rebate-driven practices often prioritize financial incentives over clinical appropriateness, leading to forced nonmedical switching, higher out-of-pocket costs, reduced adherence, and poorer glycemic outcomes. This narrative review examines how PBM-driven policies undermine patient-centered, evidence-based diabetes care and disrupt continuity of treatment. Greater transparency, preservation of patient and clinician choice, and policies that align PBM incentives with clinical outcomes are needed to reduce harm and improve access to appropriate diabetes therapies.