EASD Diabetes Technology Meeting: Medical Associations Are on Track

The first diabetes technology meeting organized by the European Diabetes Association covers the range from regulatory aspects, patient safety, about registries to clinical studies. After an intensive discussion about the evidence required for registration and reimbursement on new medical devices and in vitro diagnostics it becomes clear that more and better clinical trials will be required in the future. This was also highlighted by representatives of the American Diabetes Association. The 2 associations will be active in this field of research by a joint committee. This meeting is intended not to become a large-scale meeting focused on education but to provide a platform for an open discussion of experts involved in all areas that are relevant to achieve a meaningful usage of diabetes technology.     

Safe glycemic management during closed-loop treatment of type 1 diabetes: the role of glucagon, use of multiple sensors, and compensation for stress hyperglycemia

Patients with type 1 diabetes mellitus (T1DM) must make frequent decisions and lifestyle adjustments in order to manage their disorder. Automated treatment would reduce the need for these self-management decisions and reduce the risk for long-term complications. Investigators in the field of closed-loop glycemic control systems are now moving from inpatient to outpatient testing of such systems. As outpatient systems are developed, the element of safety increases in importance. One such concern is the risk for hypoglycemia, due in part to the delayed onset and prolonged action duration of currently available subcutaneous insulin preparations. We found that, as compared to an insulin-only closed-loop system, a system that also delivers glucagon when needed led to substantially less hypoglycemia. Though the capability of glucagon delivery would mandate the need for a second hormone chamber, glucagon in small doses is tolerated very well. People with T1DM often develop hyperglycemia from emotional stress or medical stress. Automated closed-loop systems should be able to detect such changes in insulin sensitivity and adapt insulin delivery accordingly. We recently verified the adaptability of a model-based closed-loop system in which the gain factors that govern a proportional-integral-derivative-like system are adjusted according to frequently measured insulin sensitivity. Automated systems can be tested by physical exercise to increase glucose uptake and insulin sensitivity or by administering corticosteroids to reduce insulin sensitivity. Another source of risk in closed-loop systems is suboptimal performance of amperometric glucose sensors. Inaccuracy can result from calibration error, biofouling, and current drift. We found that concurrent use of more than one sensor typically leads to better sensor accuracy than use of a single sensor. For example, using the average of two sensors substantially reduces the proportion of large sensor errors. The use of more than two allows the use of voting algorithms, which can temporarily exclude a sensor whose signal is outlying. Elements such as the use of glucagon to minimize hypoglycemia, adaptation to changes in insulin sensitivity, and sensor redundancy will likely increase safety during outpatient use of closed-loop glycemic control systems.     

Patch-Pump Technology to Manage Type 2 Diabetes Mellitus: Hurdles to Market Acceptance

The recent development of novel “patch”-type insulin infusion pump (IIP) technologies has created an opportunity to improve the quality of life for a broader type 2 diabetes patient demographic. At first glance, type 2 diabetes patients represent a large percentage of the total diabetes patient population; however, adoption of traditional IIP products and multiple daily injection (MDI) therapy has remained limited amongst this patient segment. With an insulin reservoir, delivery system, and cannula integrated into a small, wearable, disposable or semidisposable device, patch pumps simplify traditional IIP therapy, while potentially offering therapeutic benefits over traditional MDI therapy. Herein, potential benefits of patch-pump technology for type 2 diabetes patients are considered while outlining the hurdles to broad product adoption that will likely limit the near term commercial opportunity.