Journal of diabetes science and technology
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J Diabetes Sci Technol · Mar 2013
Considerations for an institution for evaluation of diabetes technology devices to improve their quality in the European Union.
All medical devices used for self-monitoring of blood glucose (BG), insulin injection, continuous subcutaneous insulin infusion, and continuous glucose monitoring in the European Union (EU) must have a Communauté Européenne (CE) mark. However, the approval process for obtaining this mark is different from that used by the European Medicines Agency in the EU for drugs or by the Food and Drug Administration in the United States for such medical and in vitro diagnostic devices. The notified bodies involved in the CE mark process perform this evaluation in cooperation with the manufacturers. ⋯ The work of such an institution would focus on BG test systems (these represent two-thirds of the market of medical devices for diabetes treatment) but would also evaluate the performance of other devices. It has to be clarified what legal framework is required for such an institution and how it can be financed; probably this can be done in a shared manner by the manufacturers of such devices and the health insurance companies. Positive evaluation results should be a prerequisite prior to any reimbursement for such devices.
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J Diabetes Sci Technol · Jan 2013
Associations of youth and parent weight status with reported versus predicted daily energy intake and hemoglobin A1c in youth with type 1 diabetes mellitus.
The epidemic of overweight/obesity affects youth with type 1 diabetes mellitus (T1DM) and their families. In youth with T1DM and their parents, we examined weight status with reported and expected energy intake and with youth hemoglobin A1c (HbA1c). ⋯ Similar to the general population, overweight and obesity are prevalent among families of youth with T1DM. Weight status appears to influence self-REI in parents and glycemic control in youth with T1DM, suggesting the need for family-based dietary interventions.
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J Diabetes Sci Technol · Jan 2013
ReviewBlood glucose measurement in the intensive care unit: what is the best method?
Abnormal glucose measurements are common among intensive care unit (ICU) patients for numerous reasons and hypoglycemia is especially dangerous because these patients are often sedated and unable to relate the associated symptoms. Additionally, wide swings in blood glucose have been closely tied to increased mortality. ⋯ In this review, the method of glucose measurement will be reviewed for each device, and the important characteristics, including accuracy, cost, speed of result, and sample volume, will be reviewed, specifically as these are used in the ICU environment. Following evaluation of the individual measurement devices and after considering the many features of each, recommendations are made for optimal ICU glucose determination.
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J Diabetes Sci Technol · Jan 2013
ReviewFood and Drug Administration regulation of diabetes-related mHealth technologies.
mHealth smartphone applications (apps) offer great promise for managing people with diabetes, as well as those with prediabetes. But to realize that potential, industry needs to get clarity from the U. S. ⋯ Further, should the app simply receive data from a blood glucose meter and graph that data for easier comprehension by the patient, the app would become a class II medical device that requires FDA clearance. Again, we submit that such simple software functionality should not be so discouraged. In this article, we identify the issues that we believe need to be clarified by the FDA in order to unleash the potential of mHealth technology in the diabetes space.
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J Diabetes Sci Technol · Jan 2013
ReviewThe future is now: software-guided intensive insulin therapy in the critically ill.
Since the development of intensive insulin therapy for the critically ill adult, tight glycemic control (TGC) has become increasingly complicated to apply and achieve. Software-guided (SG) algorithms for insulin dosing represent a new method to achieve euglycemia in critical illness. ⋯ The current milieu is disorganized, with little research that incorporates newer variables of dysglycemia, such as glycemic variability. To develop and implement better algorithms, scientists, programmers, and clinicians need to standardize measurements and variables.