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Pfutzner A.,Pfutzner Science and Health Institute
Journal of Diabetes Science and Technology | Year: 2015

The article by Cobb et al represents solid research work applying the most sophisticated laboratory technologies, a very sound clinical research methodology, and valid statistical analysis procedures. The authors have identified a combination of metabolites suitable to replace the oral glucose tolerance test procedure in the identification of patients with impaired glucose tolerance (IGT) from a fasting blood draw. However, the discussed pathophysiological, clinical, and economic aspects may induce mechanisms restricting the probability of a global acceptance of this test for daily routine. © 2015 Diabetes Technology Society. Source


Katz L.B.,LifeScan Inc. | Macleod K.,LifeScan | Grady M.,LifeScan | Cameron H.,LifeScan | And 2 more authors.
Expert Review of Medical Devices | Year: 2015

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch® VerioVue™ met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting. Performance of OneTouch® Verio IQ™, OneTouch® Verio Pro™, OneTouch® Verio™, OneTouch® VerioVue™ and Omni Pod each met or exceeded accuracy standards for user performance and system accuracy in a clinical setting set forth in ISO15197:2013(E). © 2015 Informa UK, Ltd. Source


Pfutzner A.,Pfutzner Science and Health Institute
Endocrine Development | Year: 2016

Diabetes technology is an evolving field. The research started with the development of blood glucose meters for patient self-testing and the introduction of insulin pen injection devices. Modern devices employ new technological features, such as the use of computer simulations and mathematical algorithms, connectivity and signal transfer, and the use of modern (space research-derived) materials. With these innovations, the goal to develop an artificial pancreas by closing the loop between a continuous glucose sensor and a continuous insulin-delivering device via insulin delivery algorithms is coming closer to reality. As a consequence, interim achievements on this way result in the commercialization of innovative new diabetes technology devices, which help to facilitate the daily life of the affected people with diabetes. © 2016 S. Karger AG, Basel. Source


Pfutzner A.,Pfutzner Science and Health Institute | Weissmann J.,Roche Holding AG | Mougiakakou S.,University of Bern | Daskalaki E.,University of Bern | And 2 more authors.
Diabetes Technology and Therapeutics | Year: 2015

Introduction: The ProAct study has shown that a pump switch to the Accu-Chek® Combo system (Roche Diagnostics Deutschland GmbH, Mannheim, Germany) in type 1 diabetes patients results in stable glycemic control with significant improvements in glycated hemoglobin (HbA1c) in patients with unsatisfactory baseline HbA1c and shorter pump usage time. Patients and Methods: In this post hoc analysis of the ProAct database, we investigated the glycemic control and glycemic variability at baseline by determination of several established parameters and scores (HbA1c, hypoglycemia frequency, J-score, Hypoglycemia and Hyperglycemia Indexes, and Index of Glycemic Control) in participants with different daily bolus and blood glucose measurement frequencies (less than four day, four or five per day, and more than five per day, in both cases). The data were derived from up to 299 patients (172 females, 127 males; age [mean±SD], 39.4±15.2 years; pump treatment duration, 7.0±5.2 years). Results: Participants with frequent glucose readings had better glycemic control than those with few readings (more than five readings per day vs. less than four readings per day: HbA1c, 7.2±1.1% vs. 8.0±0.9%; mean daily blood glucose, 151±22? mg/dL vs. 176±30? mg/dL; percentage of readings per month >300? mg/dL, 10±4% vs. 14±5%; percentage of readings in target range [80-180? mg/dL], 59% vs. 48% [P<0.05 in all cases]) and had a lower glycemic variability (J-score, 49±13 vs. 71±25 [P<0.05]; Hyperglycemia Index, 0.9±0.5 vs. 1.9±1.2 [P<0.05]; Index of Glycemic Control, 1.9±0.8 vs. 3.1±1.6 [P<0.05]; Hypoglycemia Index, 0.9±0.8 vs. 1.2±1.3 [not significant]). Frequent self-monitoring of blood glucose was associated with a higher number of bolus applications (6.1±2.2 boluses/day vs. 4.5±2.0 boluses/day [P<0.05]). Therefore, a similar but less pronounced effect on glycemic variability in favor of more daily bolus applications was observed (more than five vs. less than four bolues per day: J-score, 57±17 vs. 63±25 [not significant]; Hypoglycemia Index, 1.0±1.0 vs. 1.5±1.4 [P<0.05]; Hyperglycemia Index, 1.3±0.6 vs. 1.6±1.1 [not significant]; Index of Glycemic Control, 2.3±1.1 vs. 3.1±1.7 [P<0.05]). Conclusions: Pump users who perform frequent daily glucose readings have a better glycemic control with lower glycemic variability. © 2015, Mary Ann Liebert, Inc. Source


Funke K.,IKFE Potsdam | Behnke T.,Diabetes Kompetenzzentrum | Segiet T.,Diabeteszentrum | Haak T.,Diabetesforschungszentrum FIDAM | Pfutzner A.,Pfutzner Science and Health Institute
Diabetes, Stoffwechsel und Herz | Year: 2014

The InsuPad device enhances insulin absorption by standardized injection site modulation. The Barmer study, a controlled threemonth trial, showed the InsuPad device to reduce the frequency of hypoglycaemia by 46% and prandial insulin requirements by about 30%. The aim of this follow-up investigation was to explore the effect of using InsuPad for more than twelve months. After the Barmer study, patients were provided with the device and disposables for them to continue using the device for at least a year. Patients in the previous control group were also allowed to use the device. Fifty-two patients (22 female, 30 male, age (mean±SD): 65±8yrs, HbA,1c: 7.1 ±0.7% at start) took part in this long-term follow-up investigation at one study site. Of the 52 patients, 50 completed a standardized questionnaire after a minimum of 13 months. The mean usage time was 17.8 ±2.5 months (range: 13-21 months); body weight (3 months: 100 ±23 kg, 18 months: 100± 18kg) and HbA1c (baseline: 7.2 ±0.7%; 3 months: 6.4±0.7%, 18 months: 6.3 ±0.6%) were stable; total daily insulin dose decreased even further (change vs. baseline: 3 months: -16.5%, 18 months: -25.3%, p>0.001). These results indicate that the glycaemic control achieved in the Barmer study was maintained with further reductions in prandial and basal insulin dose requirement and high treatment adherence in all of the patients that used the device for 18 months or longer. Source

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