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Pfutzner A.,Pfutzner Science and Health Institute | Raz I.,Pfutzner Science and Health Institute | Nagar R.,Insuline Medical Ltd | Hermanns N.,Diabetes Center | Haak T.,FIDAM Institute for Diabetes Research
Journal of Diabetes Science and Technology | Year: 2015

Temperature changes on the surface of the skin lead to modifications of subcutaneous microcirculation. This phenomenon is employed in a standardized way by the InsuPad device to stabilize skin conditions before injections, which is associated with enhanced prandial insulin absorption. Three programmed warming cycles to 40C within 50 minutes are resulting in faster insulin appearance in the plasma. Early standardized meal tolerance studies indicated a substantial improvement in postprandial glucose control when the same short-Acting insulin analog dose was applied using InsuPad, and a dose reduction by 20% resulted in comparable glucose excursions. Similar results were obtained when patients applied the device under realworld conditions for 1 month. The InsuPad device was also tested in a prospective, controlled, parallel 3-month real-world study with 145 well-controlled but insulin-resistant patients with type 1 or type 2 diabetes. Patients were treated to target in both treatment arms (6.2 0.5% in each group), with or without the device. However, patients with InsuPad needed 28% less prandial insulin, needed 12.5% less total insulin, and had 46% less confirmed hypoglycemic events (blood glucose 63 mg/dL) as compared to the control group. Except for very few inflammatory or allergic skin reactions, there were no device-specific adverse events reported from these studies. In conclusion, use of InsuPad when applying prandial insulin doses may result in a safer and more efficient treatment of type 1 or type 2 diabetes. © 2015 Diabetes Technology Society.


Demircik F.,Pfutzner Science and Health Institute | Ramljak S.,Sciema Science and Marketing UG | Hermanns I.,University Hospital | Pfutzner A.,Sciema Science and Marketing UG | Pfutzner A.,Pfutzner Science and Health Institute
Journal of Diabetes Science and Technology | Year: 2015

In previous studies, meters employing dynamic electrochemistry (DE), have been shown to correct for hematocrit (HCT) interference. This laboratory investigation assessed the HCT stability of MyStar Extra (Sanofi) in comparison to 7 competitive devices (Accu-Chek Aviva Nano & Accu-Chek Performa, Roche Diagnostics; Contour XT and Contour Link, Bayer; FreeStyle Freedom Lite, Abbott; MyLife Pura, Ypsomed; OneTouch Verio Pro, LifeScan). Venous heparinized blood was freshly drawn, immediately aliquoted, and manipulated to contain 3 different blood glucose concentrations (50-80 mg/dL, 150-180 mg/dL, and 350-400 mg/dL) and 5 different HCT levels (20-25%, 30-35%, 40-45%, 50-55%, and 60-65%). After careful oxygenation to normal blood oxygen pressure, each of the 15 different samples was measured 8 times with 2 devices and 2 strip lots of each meter (32 measurements/meter/sample). YSI Stat 2300 served as laboratory reference method. Next to determination of the mean absolute relative deviation (MARD), stability to HCT influence was assumed, when less than 10% difference occurred between the highest and lowest mean glucose deviations in relation to HCT over all tested glucose ranges (HIF: hematocrit interference factor). Four of the devices showed stable performance: Contour XT (MARD: 1.3%/HIF: 6.1%), MyStar Extra (4.7%/7.1%), OneTouch Verio Pro (4.5%/7.3%), and Contour Link (6.3%/9.3%). The 4 other meters were influenced by HCT (Accu-Chek Performa: 4.7%/20.9%, Accu-Chek Aviva Nano: 4.5%/22.4%, FreeStyle Freedom Lite: 4.8%/24.5%; MyLife Pura: 6.4%/28.7%). In this study, all meters showed a good accuracy, but only 50% of them, including MyStar Extra, were shown to reliably correct for potential hematocrit influence on the meter results. © 2014 Diabetes Technology Society.


Pfutzner A.,Pfutzner Science and Health Institute | Pfutzner A.,Bingen University of Applied Sciences | Pfutzner A.,PharmACT AG | Pfutzner A.,InsulinNG LLC | And 4 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2016

Intact proinsulin is a biomarker for pancreatic β-cell dysfunction. Elevated intact proinsulin predicted development of type 2 diabetes and/or macrovascular events up to seven years in advance in large prospective studies on non-diabetic participants. We performed this study to evaluate a new semi-quantitative lateral flow-based point of care rapid test (POCT) for elevated intact proinsulin (cutoff: 11 pmol/l).The test requires 10 μl of capillary whole blood and produces a visual read-out after five minutes, and is best applied two hours after a glucose challenge or a meal. Health care professionals collected POCT results from sixty patients and healthy participants (33 female, 27 male, 28 type 2 diabetes, age: 53.6 ± 14.6 years) as well as an additional venous blood sample from all participants to measure intact proinsulin using a quantitative ELISA laboratory reference method. Elevated intact proinsulin levels (> 11 pmol/l) were determined in twenty-six participants by the reference method; twenty-two of these patients also tested positive using POCT (sensitivity: 85%). All thirty-four participants with low intact proinsulin levels tested negative using POCT (specificity: 100%). The test correctly detected postprandial intact proinsulin levels in 93 % of the participants tested without any false positives, so this POCT may serve as a simple screening tool in identifying patients with prevalent β-cell dysfunction at high risk of developing type 2 diabetes and/or macrovascular events within the next five to seven years.


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.


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.


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.


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.


Demircik F.,Sciema UG | Klonoff D.,Mills Peninsula Health Service | Musholt P.B.,Sanofi S.A. | Ramljak S.,Sciema UG | And 2 more authors.
Diabetes Technology and Therapeutics | Year: 2016

Background: Devices employing electrochemistry-based correction algorithms (EBCAs) are optimized for patient use and require special handling procedures when tested in the laboratory. This study investigated the impact of sample handling on the results of an accuracy and hematocrit interference test performed with BG∗Star, iBG∗Star; OneTouch Verio Pro and Accu-Chek Aviva versus YSI Stat 2300. Methods: Venous heparinized whole blood was manipulated to contain three different blood glucose concentrations (64-74, 147-163, and 313-335 mg/dL) and three different hematocrit levels (30%, 45%, and 60%). Sample preparation was done by either a very EBCA-experienced laboratory testing team (A), a group experienced with other meters but not EBCAs (B), or a team inexperienced with meter testing (C). Team A ensured physiological pO2 and specific sample handling requirements, whereas teams B and C did not consider pO2. Each sample was tested four times with each device. In a separate experiment, a different group similar to group B performed the experiment before (D1) and after (D2) appropriate sample handling training. Results: Mean absolute deviation from YSI was calculated as a metrix for all groups and devices. Mean absolute relative difference was 4.3% with team A (B: 9.2%, C: 5.2%). Team B had much higher readings and team C produced 100% of "sample composition" errors with high hematocrit levels. In a separate experiment, group D showed a result similar to group B before the training and improved significantly when considering the sample handling requirements (D1: 9.4%, D2: 4.5%, P < 0.05). Conclusions: Laboratory performance testing of EBCA devices should only be performed by trained staff considering specific sample handling requirements. The results suggest that healthcare centers should evaluate EBCA-based devices with capillary blood from patients in accordance with the instructions for use to achieve reliable results. © Copyright 2016, Mary Ann Liebert, Inc.


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.


PubMed | Pfutzner Science and Health Institute
Type: | Journal: 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.

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