Entity

Time filter

Source Type

Heidelberg, Germany

Muller A.J.,EyeSense GmbH | Knuth M.,EyeSense GmbH | Nikolaus K.S.,EyeSense GmbH | Krivanek R.,EyeSense GmbH | And 3 more authors.
Journal of Diabetes Science and Technology | Year: 2013

Background: To evaluate the feasibility of an implantable subconjunctival glucose monitoring system (SGMS) for long-term glucose monitoring, we investigated the in vivo performance of the system. Method: The SGMS consists of an implantable ocular mini implant (OMI) and a handheld fluorescence photometer. A clinical study was performed on 47 diabetes patients split into two cohorts. Two different types of OMI were used, with and without a biocompatible surface coating. Duration of the study was 1 year. Correlation between capillary blood glucose and SGMS-derived interstitial fluid glucose was investigated during the first 6 months of the study. Results: Both OMI types were tolerated well in the eyes of the patients. At the beginning of the study, the SGMS of both cohorts revealed a high accuracy with mean absolute relative difference (MARD) values of 7-12%. The performance of the uncoated OMIs deteriorated within 3 months of wearing time, exhibiting a MARD value of 20%. The performance of the surface-coated OMIs was preserved longer. Glucose correlation measurement with reasonable results (MARD of 14%) could be performed for up to 6 months of wear. Conclusions: The biocompatible surface coating on the OMIs enabled a longer duration of action of up to 6 months compared with 3 months for uncoated implants in a clinical trial. © Diabetes Technology Society.


Muller A.J.,EyeSense GmbH | Knuth M.,EyeSense GmbH | Nikolaus K.S.,EyeSense GmbH | Krivanek R.,EyeSense GmbH | And 2 more authors.
Journal of Diabetes Science and Technology | Year: 2013

Background: This article describes a new fiber-coupled, percutaneous fluorescent continuous glucose monitoring (CGM) system that has shown 14 days of functionality in a human clinical trial. Method: The new optical CGM system (FiberSense) consists of a transdermal polymer optical fiber containing a biochemical glucose sensor and a small fluorescence photometer optically coupled to the fiber. The glucose-sensitive optical fiber was implanted in abdominal and upper-arm subcutaneous tissue of six diabetes patients and remained there for up to 14 days. The performance of the system was monitored during six visits to the study center during the trial. Blood glucose changes were induced by oral carbohydrate intake and insulin injections, and capillary blood glucose samples were obtained from the finger tip. The data were analyzed using linear regression and the consensus error grid analysis. Results: The FiberSense worn at the upper arm exhibited excellent results during 14 wearing days, with an overall mean absolute relative difference (MARD) of 8.3% and 94.6% of the data in zone A of the consensus error grid. At the abdominal application site, FiberSense resulted in a MARD of 11.4%, with 93.8% of the data in zone A. Conclusions: The FiberSense CGM system provided consistent, reliable measurements of subcutaneous glucose levels in human clinical trial patients with diabetes for up to 14 days. © Diabetes Technology Society.


Hasslacher C.,Diabetesinstitut Heidelberg
Nieren- und Hochdruckkrankheiten | Year: 2012

Metabolic control in diabetic patients with declining kidney function is complicated by several factors such as altered pharmacokinetic properties of most of the antidiabetic drugs, changing insulin resistance, impaired renal gluconeogenesis as well as hypoglycemia unawareness. Risk of cardiovascular complications and of severe hypoglycemia is strongly elevated. Incretin-based therapies with DDP-4 inhibitors or incretin analogs represent a new therapeutic option with high potential for diabetic patients with renal insufficiency due to low hypoglycemic risk and probably cardioprotective effects. First studies on patients with diabetic nephropathy showed a glucose-lowering effect comparable with other antidiabetic drugs and a good safety and tolerability. © 2012 Dustri-Verlag Dr. Karl Feistle.


Declining kidney function is usually associated with altered pharmacokinetic properties of most of the antidiabetic drugs. Metabolic control of these patients is furthermore complicated by several other factors such as changing insulin resistance, impaired renal gluconeogenesis as well as hypoglycemia unawareness. Risk of hypoglycemia and cardiovascular complications is strongly elevated. Incretin-based therapies with DPP4-inhibitors or incretin-analogs represent a new therapeutic option with high potential for diabetic patients with renal insufficiency due to low hypoglycemic risk and probably cardioprotectiv effects. Studies on patients with diabetic nephropathy showed a glucose lowering effect comparable with other antidiabetic drugs and a good safety and tolerability.


Diabetic nephropathy is a serious complication of diabetes mellitus leading to renal insuffiency. A well adjusted metabolic control is of utmost importance for primary and secondary prevention of diabetic nephropathy. Reaching this is more difficult in diabetics with renal insufficiency than in other diabetic patients. In case of renal insufficiency dosing of antidiabetic drugs is sophisticated, because hypoglycemia is more common than in patients without renal insufficiency and patients with diabetic nephropathy often don't sense it. Hence reliable methods for examination of metablic situation are essential for effective and save treatment of diabetic patients with renal insufficiency. To examine actual metabolic situation hand-held glucometers or continuous glucose monitoring can be used. For long-term monitoring different laboratory values are utilized: HbA1c, fructosamin and glycosylated albumin. In patients with renal insufficiency there exist some particularities, which have to be accounted when interpreting these parameters; e. g. HbA1c is influenced by changes in hematopoiesis. ©2003-2011 MMP, Medizinische Monatsschrift für Pharmazeuten, Wissenschaftliche Verlagsgesellschaft Stuttgart und Deutscher Apotheker Verlag.

Discover hidden collaborations