Automation and standardization of the glucose measurement process have the potential to greatly improve glycemic control, clinical outcome, and safety while reducing cost. The resources required to monitor glycemia in hospitalized patients have thus far limited the implementation of intensive glucose management to patients in critical care units. Numerous available and up-and-coming technologies are targeted for the hospital patient population. Advantages and limitations of these devices are discussed herewith in.
The world leaders in glycemia modeling convened during the Eighth Annual Diabetes Technology Meeting in Bethesda, Maryland, on 14 November 2008, to discuss the current practices in mathematical modeling and make recommendations for its use in developing automated insulin-delivery systems. This report summarizes the collective views of the 25 participating experts in addressing the following four topics: current practices in modeling efforts for closed-loop control; framework for exchange of information and collaboration among research centers; major barriers for the development of accurate models; and key tasks for developing algorithms to build closed-loop control systems. Among the participants, the following main conclusions and recommendations were widely supported: Physiologic variance represents the single largest technical challenge to creating accurate simulation models. A Web site describing different models and the data supporting them should be made publically available, with funding agencies and journals requiring investigators to provide open access to both models and data. Existing simulation models should be compared and contrasted, using the same evaluation and validation criteria, to better assess the state of the art, understand any inherent limitations in the models, and identify gaps in data and/or model capability.
Background: Worldwide, ∼1 million people manage their type 1 diabetes with an insulin pump and a continuous subcutaneous insulin infusion (CSII) catheter. Patients routinely insert a new catheter every 2–3 days due to increasing variability of insulin absorption over time. Catheter insertion and maintenance damage capillaries, lymphatics, cells, and connective tissue leading to an acute inflammatory response.Methods: We compared an investigational CSII catheter (IC) and a commercial CSII catheter (CC) regarding insulin absorption pharmacokinetics (PK) and tissue inflammation. The two different catheter designs were implanted into the subcutaneous tissue of six swine for 5 days. Insulin boluses were given on days 1, 3, and 5 of wear-time to assess PK. Tissue around catheters was excised and stained to visualize inflammation and morphological changes of adjacent tissue.Results: Insulin absorption was better when infused through a CC with highest Cmax and fastest tmax values on day 5 of catheter wear-time. Both catheter types produced high intra- and intersubject day-to-day insulin absorption variability. The IC caused significantly more tissue disruption and lead to irregular changes in tissue morphology. Both catheter types were surrounded by a layer of inflammatory tissue that varied in composition, thickness, and density over time. A catheter that was manually inserted by pushing a sharp tip through the skin caused more trauma and variability than a 90° Teflon cannula with automated insertion.Conclusions: Insulin absorption variability could be attributed to the layer of inflammatory tissue, which may function as a mechanical barrier to insulin flow into adjacent vascular tissue. The impact of the acute inflammatory tissue response on insulin absorption has to be considered in future catheter designs. A catheter that was manually inserted by pushing a sharp tip through the skin caused more trauma and variability than a 90° Teflon cannula with automated insertion.
Data from the CGMS iPro Recorder illustrate the potential benefit of using a real-time CGM in the hospital to detect hypoglycemia in a more timely fashion compared to infrequent point-of-care glucose meter measurements.
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