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.

Advanced glycation end products strongly activate platelets.

Background: Diabetes mellitus is characterized by hyperglycemia that plays an important role in the pathogenesis of diabetic complications including cardiovascular diseases. Moreover, hyperglycemia induces increased generation of advanced glycation end products (AGEs). The activation of platelets is associated with the development of cardiovascular diseases.

Skin autofluorescence increases postprandially in human subjects.

Background: Skin autofluorescence (SAF) is a property used for the noninvasive assessment of skin advanced glycation end products (AGEs) and concentration of redox-regulated fluorophores. SAF was shown to closely mirror cardiovascular risk and to constitute a more sensitive parameter for diabetes screening than fasting glucose and hemoglobin A1c. It has also been suggested that SAF measurement is independent of fasting status.

Dietary advanced glycation endproducts and oxidative stress: in vivo effects on endothelial function and adipokines.

Advanced glycation endproducts (AGEs) and oxidative stress (OS) contribute to the development and progression of diabetic complications. We have reported that dietary AGEs and OS induce acute endothelial dysfunction in vivo, but little is known about their effects on adipokines. Twenty inpatients with type 2 diabetes mellitus (mean age: 55.

Parameters affecting postprandial blood glucose: effects of blood glucose measurement errors.

Background: The Diabetes Error Test Model (DETM) has been developed to characterize the clinical relevance of the large and varying margins of error of parameters affecting postprandial blood glucose (BG) levels, which increase the risk for hypo- or hyperglycemia.

Methods: The DETM is based on a treatment concept aimed at normoglycemia after meals. The model includes as parameters (a) preprandial BG measurement by patient self-monitoring (SMBG), (b) patient estimate of carbohydrate amounts (CARB-P) in food, (c) effect of CARB-P on maximum BG increase, (d) effect of insulin on maximum BG decrease, and (e) insulin dosage.

Effects of low- and high-advanced glycation endproduct meals on macro- and microvascular endothelial function and oxidative stress in patients with type 2 diabetes mellitus.

Background: An advanced glycation endproducts (AGEs)-rich diet induces significant increases in inflammatory and endothelial dysfunction markers in type 2 diabetes mellitus (T2DM).

Objective: The aim was to investigate the acute effects of dietary AGEs on vascular function in T2DM patients.

Design: Twenty inpatients with T2DM [x (+/-SEM) age: 55.

Benfotiamine prevents macro- and microvascular endothelial dysfunction and oxidative stress following a meal rich in advanced glycation end products in individuals with type 2 diabetes.

Objective: Diabetes is characterized by marked postprandial endothelial dysfunction induced by hyperglycemia, hypertriglyceridemia, advanced glycation end products (AGEs), and dicarbonyls (e.g., methylglyoxal [MG]).

Glucose sensors and the alternate site testing-like phenomenon: relationship between rapid blood glucose changes and glucose sensor signals.

In the last few years blood glucose meters have been developed allowing glucose measurements in capillary blood samples collected at sites other than the fingertips. The main reason for establishing this so-called alternate site testing (AST) was to sample blood from locations with reduced pain perception. It is well known that capillary blood glucose is closely correlated to systemic (i.

Hypoglycemia warning signal and glucose sensors: requirements and concepts.

Hypoglycemia is the most feared side effect of diabetes therapy with blood glucose-lowering agents. The fear of hypoglycemia often contributes to poor metabolic control of patients with diabetes. Therefore, integration of a hypoglycemia warning signal into continuous glucose monitoring systems represents an important additional help for patients with diabetes.

Continuous glucose monitoring: an overview of today's technologies and their clinical applications.

The first glucose sensors that allow continuous glucose monitoring are now available. It is important that physicians understand the special clinical and technical aspects that are key to successful implementation of these sensors--and of other sensors being under clinical development--into the daily practice of patients with diabetes. One important question is whether under all circumstances changes in blood glucose are paralleled by glucose changes in the interstitial fluid, in terms of both absolute values and time.

Glucose monitoring at the arm: risky delays of hypoglycemia and hyperglycemia detection.

Objective: We have examined whether rapid changes in blood glucose (BG) result in clinically relevant differences between capillary BG values measured at the forearm and the fingertip and whether local rubbing of the skin before blood sampling can diminish such differences.

Research Design And Methods: Capillary BG samples were collected every 15 min for 3-5 h from the fingertip and the forearm of 17 insulin-treated diabetic patients and analyzed with different glucose monitors (FreeStyle, One Touch Ultra, and Soft-Sense). In a subgroup of patients (n = 8), local rubbing of the forearm skin was performed before blood sampling.