Diabetesinstitut Heidelberg

Heidelberg, Germany

Diabetesinstitut Heidelberg

Heidelberg, Germany
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Hasslacher C.,Diabetesinstitut Heidelberg | Kulozik F.,Diabetesinstitut Heidelberg | Platten I.,Diabetesinstitut Heidelberg
Clinical Laboratory | Year: 2013

Background: The accuracy of glucose meters (GMs) for self-monitoring of blood glucose (BG) is essential for preventing insulin dosage errors in insulin injecting diabetic patients. We evaluated the accuracy of 19 commercially available GMs in a clinical setting applying the new planned ISO criteria. Methods: Capillary blood was taken at 10-minute intervals in insulin dependent patients during induction of a BG increase and decrease by administration of a standardized carbohydrate rich meal and/or injection of an appropriate dosage of insulin under medical supervision. BG was measured simultaneously by GMs and a laboratory method (Hitado Super GL). The GM results were compared with a laboratory reference method according to the current ISO criteria (ISO 15197:2003) and the proposed (more stringent) criteria. Results: Evaluating GM results according to the current ISO criteria, all GMs reached the minimum acceptable system accuracy criteria. Analysing GM results according to the more stringent planned ISO standard criteria, only 8 of 19 GMs reached the minimum acceptable accuracy criteria, i.e. ≥ 95% of the individual glucose results fell within ± 15 mg/dL of the results of the reference value at glucose concentrations < 100 mg/dL and within ± 15% at glucose concentrations ≥ 100 mg/dL. When results obtained in BG ranges < and ≥ 100 mg/dL were separately analysed, readings of 10 and 8 GMs, respectively, fell in the area of acceptable accuracy. Conclusions: The study shows that more than half of the tested GMs would fail the proposed tighter ISO criteria. Most GMs reveal similar accuracy in BG measurement when compared at lower and higher BG ranges.


Kulozik F.,Diabetesinstitut Heidelberg | Hasslacher C.,Diabetesinstitut Heidelberg | Hasslacher C.,University of Heidelberg
Diabetes, Stoffwechsel und Herz | Year: 2015

Background: The development of vascular diabetic complications depends on HbA1c levels as well as intermittent hyperglycaemic states. 1, 5-anhydroglucitol (1, 5-AG) is an established marker for short-term glycaemic excursions; the aim of this study was to analyse the correlation between 1, 5-AG and HbA1c as well as antidiabetic therapy. Methods: We analysed 1, 5-AG levels using an enzymatic test (GlycoMark®) alongside other parameters in 377 outpatients with type 2 diabetes. Results: 1, 5-AG decreased in correlation with increasing HbA1c levels. After classifying HbA1c levels into groups, a third of the patients with HbA1c < 6.5% and half of the patients with HbA1c 6.5-7.5 % showed significantly reduced levels of 1, 5-AG (≤ 5 μg/ml). Almost all of the patients with HbA1c >8.5% showed 1, 5-AG levels ≤ 5μg/ml. Conclusion: Measuring 1, 5-AG is an uncomplicated alternative to frequent postprandial and intermittent blood glucose (self) measurement or continuous glucose monitoring in addition to routine HbA1c testing in identifying type 2 diabetes patients with intermittent hyperglycaemia despite favourable HbA1c levels.


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.


Hasslacher C.,Diabetesinstitut Heidelberg | Hasslacher C.,St. Josefskrankenhaus GmbH
Diabetologe | Year: 2013

Good metabolic control positively influences the renal as well the life prognosis of diabetics with nephropathy in all stages of the course of the disease. In cases of reduced renal function it is difficult to achieve the therapeutic aim, particularly due to the changed pharmacokinetics of the substances involved in blood glucose reduction. Antidiabetic drugs excreted via the kidneys in an unchanged form are contraindicated in cases of renal insufficiency (e.g. metformin) or have to be adjusted with respect to the dose (e.g. glibenclamide, glimipiride and nateglinide). The same applies to antidiabetic drugs producing renal eliminated active metabolites in the course of the catabolism. Among the insulin secretion stimulating substances only gliquidone and repaglinide are unproblematic up to a creatinine clearance of approximately 30 ml/min. Recently dipeptidyl peptidase 4 (DPP4) inhibitors have become available for treatment in cases of renal insufficiency in appropriate doses. Insulin therapy should be started if hypoglycemia frequently occurs or the condition of the patient deteriorates. Sometimes it may be difficult to find the right dose due to changing insulin resistance as well as altered insulin degradation. Safe methods of blood glucose control are necessary for short and long-term metabolic control of patients with renal insufficiency due to the high risk of hypoglycemia. Special features of blood glucose measurement with glucose meters for self-control as well as interpretation of HbA1c values should be considered. © 2013 Springer-Verlag Berlin Heidelberg.


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.


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.


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.


Kulozik F.,Diabetesinstitut Heidelberg | Hasslacher C.,Diabetesinstitut Heidelberg
Therapeutic Advances in Endocrinology and Metabolism | Year: 2013

Objectives: In diabetic nephropathy the decline of renal function causes modifications of the insulin and carbohydrate metabolism resulting in changed insulin requirements. The aim of the present study was to identify potential differences in the requirements of human insulin and various insulin analogues in patients with type 1 diabetes mellitus and renal dysfunction. Methods: The insulin requirements of 346 patients with type 1 diabetes mellitus under everyday life circumstances were assessed in an observational study. Simultaneously, laboratory parameters were measured and the estimated glomerular filtration rate (eGFR) was calculated using the formula by Cockcroft-Gault. Medical history and concomitant medication were recorded. The insulin requirements of long- and short-acting insulin were tested for a relationship with the eGFR and laboratory parameters. Results: The dosage of long-acting human insulin did not show any relation to eGFR. In contrast, a strong positive relation between dosage and renal function was found for insulin glargine and insulin detemir. After classification according to renal function, the insulin dosage at eGFR less than 60 ml/min was 29.7% lower in glargine-treated and 27.3% lower in detemir-treated patients compared with eGFR greater than 90 ml/min. Considering the whole range of eGFR, short-acting human insulin did not show a relation with renal function. Only after classification according to renal function was a dose reduction found for human insulin at eGFR less than 60 ml/min. In contrast, requirements of insulin lispro were significantly related to eGFR over the whole range of eGFR. At eGFR less than 60 ml/min the insulin dosage was 32.6% lower than at eGFR greater than 90 ml/min. The requirements of insulin aspart did not show any association with the eGFR. Conclusions: Patients with type 1 diabetes mellitus show different insulin requirements according to the renal function depending on the applied insulin. This finding is essential for the adjustment of insulin therapy in patients with diabetic nephropathy to achieve balanced glycemic control. To determine the underlying mechanisms, further studies on the pharmacokinetics and pharmacodynamics of the different insulins in patients with diabetic nephropathy are needed. © The Author(s), 2013.


Good metabolic control positively influence the renal as well the life prognosis of the diabetic with nephropathy in all stages of the nephropathy course. In case of a reduced renal function, antidiabetic medication has to be adjusted due to the changed pharmacokinetics of the blood glucose reducing substances. Antidiabetic drugs being unchangedly excreted via the kidneys are contra-indicated in case of renal insufficieny (e.g. metformin) or have to be adjusted regarding the dose (glibenclamide, glimipiride, nateglinide). The same applies to antidiabetic drugs producing renally eliminable active metabolites in the course of their catabolism. Recently, DPP4-Inhibitors are available for treatment in renal insufficiency, the dosage has to be adjusted. Administration of SGLT2-inhibitors is not recommended in patients with reduced kidney function. Insulin therapy should be started if hypoglycemias frequently occur or a reduced condition of the patient is stated. Sometimes it may be difficult to find the right dose through changing insulin resistance as well as altered insulin degradation. Furthermore, a different metabolic activity of insulines should be considered in case of reduced renal function. © 2014, Georg Thieme Verlag. All rights reserved.


Hasslacher C.,Diabetesinstitut Heidelberg | Kulozik F.,Diabetesinstitut Heidelberg | Platten I.,Diabetesinstitut Heidelberg
Journal of Diabetes Science and Technology | Year: 2014

We investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between 50 and 150 mg/dl, whereas 19 (70.3%) met these criteria at BG levels above 250 mg/dl. The overall frequency of outliers was low. The assessment of analytical accuracy of GMS at a number of BG level ranges made it possible to further differentiate between devices with regard to overall performance, a process that is of particular importance given the user-centered nature of the devices' intended use. © 2014 Diabetes Technology Society.

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