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Bergedorf, Germany
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In addition to patient convenience, the device is slimmer than currently available ICMs. The Confirm Rx ICM also offers intuitive one-touch indication-based programming, and remote monitoring via the Merlin.net™ Patient Care Network, making the technology convenient for clinicians involved in procedure and follow up. "The Confirm Rx ICM device will be an important tool for diagnosing patients with suspected arrhythmias, such as those who have experienced fainting or palpitations," said Georg Nölker, M.D., head of electrophysiology at the Herz-und Diabeteszentrum NRW, Ruhr-University of Bad Oeynhausen, Germany. Dr. Nölker was one of the first physicians to implant the Confirm Rx ICM after it received CE Mark. "The simple insertion procedure and small device size make this technology convenient for both patients and providers. Patients can record symptoms directly on their smartphone without the need for a bedside transmitter or separate activator." Christopher Piorkowski, M.D., head of the Department of Electrophysiology at the University of Dresden Heart Center in Dresden, Germany, and one of the first implanters, added: "The Confirm Rx ICM will be particularly useful in monitoring for atrial fibrillation in my patients with paroxysmal AF, following AF ablation and with stroke of an unknown cause. It allows an objective way to quantify AF events to guide treatment decisions. The smartphone compatibility engages patients and allows better compliance to remote monitoring through a simple and intuitive user interface. This allows clinic staff to reduce follow-up burden and focus on reviewing transmitted data for AF." The myMerlin mobile app, available in over 35 languages, makes it easy for patients to stay connected to their physicians. Patients can record their symptoms on their own smartphone and specify events such as fainting or if they experience a fast heart rate. Patients can also confirm their data was transmitted to their physician and get automatic alerts when they have missed a scheduled transmission, saving the clinic from having to follow up with the patient. The device also offers secure transmission of patient data. Recently, Abbott's Merlin.net Patient Care Network received one of the medical device industry's first Service Organization Control certifications (SOC2 certification), further confirming the safety and security of the company's remote monitoring network. "Incorporating wireless technology directly into our devices enhances the quality of remote monitoring and patient compliance," said Mark D. Carlson, M.D., chief medical officer of Abbott's cardiac arrhythmias and neuromodulation businesses. "The Confirm Rx ICM addresses a broad range of indications, such as syncope, palpitations and atrial fibrillation. The technology has been designed with robust data privacy and security measures to ensure peace of mind for both patients and providers." Currently the Confirm Rx ICM is available in select countries in Europe, with full European release expected during the second quarter of 2017.  The device is currently under review by the U.S. Food and Drug Administration. The estimated 2017 worldwide insertable cardiac monitor market is approximately $800 million and is growing by more than $100 million a year. About Abbott: At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/abbott-announces-ce-mark-and-first-use-of-the-worlds-first-smartphone-compatible-insertable-cardiac-monitor-300452673.html


Ratner R.,MedStar Research Institute | Nauck M.,Diabeteszentrum | Kapitza C.,Profil Institute fur Stoffwechselforschung GmbH | Asnaghi V.,Hoffmann-La Roche | And 2 more authors.
Diabetic Medicine | Year: 2010

Aims The study objective was to investigate the safety and tolerability of up-titration to high doses of taspoglutide, a once-weekly human glucagon-like peptide-1 analogue, in subjects with Type 2 diabetes inadequately controlled on metformin alone. Methods In this double-blind phase II trial, subjects were randomized to placebo or taspoglutide (20 mg; three separate groups) administered once weekly by subcutaneous injection for 4 weeks. This was followed by dose maintenance at 20 mg, or titration to 30 mg (20/30) or 40 mg (20/40) once weekly with matched placebo for an additional 4 weeks. Subjects were monitored for adverse events (AEs) throughout the study and 4-week follow-up. Results One hundred and twenty-nine subjects were randomized and treated [mean age 57 years, mean baseline glycated haemoglobin (HbA 1c), 7.9%]. The most frequently reported AEs were nausea and vomiting. The number of patients reporting gastrointestinal AEs did not increase following titration to higher doses of taspoglutide or when continuing the initial 20 mg regimen. Three subjects were withdrawn from the study as a result of gastrointestinal AEs (one before and two after titration to higher doses). Although not designed to investigate efficacy, improvement in glycaemic control was observed in all active arms of the study. The proportion of subjects achieving HbA1c < 7.0% after 8 weeks of treatment was 72, 53 and 70% in the 20/20-, 20/30- and 20/40-mg arms, respectively, vs. 19% for placebo. Conclusions Taspoglutide was safe, well tolerated at high doses and efficacious for lowering HbA1c. Up-titration of dose was not associated with a worsening AE profile. © 2010 Diabetes UK.


Gastaldelli A.,National Research Council Italy | Nauck M.A.,Diabeteszentrum | Balena R.,Hoffmann-La Roche | Balena R.,Eli Lilly and Company
Metabolism: Clinical and Experimental | Year: 2013

Objective Loss of pancreatic function is pivotal to the deterioration of fasting and postprandial glycemic control in type 2 diabetes (T2D). We evaluated the effects of a long-acting, human glucagon-like peptide-1 analog, taspoglutide, added to metformin, on pancreatic function and peripheral insulin sensitivity. Materials/methods We studied 80 T2D patients inadequately controlled [glycosylated hemoglobin (HbA1c), 7.0%-9.5%] receiving stable metformin for ≥ 12 weeks. They were a subset of participants to a phase 2 trial that received also a 240-min mixed-meal tolerance test (MTT) at baseline and study end. Patients received once weekly (QW) sc injection of taspoglutide 5, 10, or 20 mg (n = 21, 19, or 19), or placebo (n = 21), plus metformin, for 8 weeks. We measured postprandial plasma glucose (PPG) and insulin profiles, insulin secretion rate (ISR), oral glucose insulin sensitivity (OGIS) index; β-cell glucose sensitivity, glucagon/glucose and insulin/glucagon ratios, and insulin sensitivity-to-insulin resistance (or disposition) index. Results After 8 weeks of treatment, taspoglutide 5, 10, and 20 mg QW doses vs. placebo improved mean PPG0-240 min (relative change from baseline: - 22.1%, - 25.9%, and - 22.9% vs. - 8.1%; P < 0.005) and mean postprandial ISR0-240 min (+ 14%, + 18%, and + 23% vs. + 1%; P < 0.005 vs dose). Taspoglutide at 20 mg QW dose also resulted in improvements from baseline in OGIS, β-cell glucose sensitivity, glucagon/glucose and insulin/glucagon ratios and the disposition index during the MTT. Conclusion Taspoglutide QW significantly improved pancreatic function in patients with T2D treated with metformin. © 2013 Elsevier Inc.


Dissemond J.,University of Duisburg - Essen | Assadian O.,Medical University of Vienna | Gerber V.,Schulung und Beratung im Wundmanagement | Kingsley A.,North Devon District Hospital | And 12 more authors.
Skin Pharmacology and Physiology | Year: 2011

Currently, there are no generally accepted definitions for wounds at risk of infection. In clinical practice, too many chronic wounds are regarded as being at risk of infection, and therefore many topical antimicrobials-in terms of frequency and duration of use-are applied to wounds. Based on expert discussion and current knowledge, a clinical assessment score was developed. The objective of this wounds at risk (W.A.R.) score is to allow decision-making on the indication for the use of antiseptics on the basis of polihexanide. The proposed clinical classification of W.A.R. shall facilitate the decision for wound antisepsis and allow an appropriate general treatment regimen with the focus on the prevention of wound infection. The W.A.R. score is based on a clinically oriented risk assessment using concrete patient circumstances. The indication for the use of antiseptics results from the addition of differently weighted risk causes, for which points are assigned. Antimicrobial treatment is justified in the case of 3 or more points. © 2011 S. Karger AG, Basel.


Objective: Although initially effective, sulfonylureas are associated with poor glycemic durability, weight gain, and hypoglycemia. Dapagliflozin, a selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), reduces hyperglycemia by increasing urinary glucose excretion independent of insulin and may cause fewer of these adverse effects. We compared the efficacy, safety, and tolerability of dapagliflozin with the sulfonylurea glipizide in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Research design and methods: This 52-week, double-blind, multicenter, active-controlled, noninferiority trial randomized patients with type 2 diabetes (baseline mean HbA1c, 7.7 %), who were receiving metformin monotherapy, to add-on dapagliflozin (n = 406) or glipizide (n = 408) up-titrated over 18 weeks, based on glycemic response and tolerability, to ≤ 10 or ≤ 20 mg/day, respectively. Results: The primary end point, adjusted mean HbA1c reduction with dapagliflozin (-0.52 %) compared with glipizide (-0.52 %), was statistically noninferior at 52 weeks. Key secondary end points: dapagliflozin produced significant adjusted mean weight loss (-3.2 kg) versus weight gain (1.2 kg; P < 0.0001) with glipizide, significantly increased the proportion of patients achieving ≥ 5 % body weight reduction (33.3 %) versus glipizide (2.5 %; p < 0.0001), and significantly decreased the proportion experiencing hypoglycemia (3.5 %) versus glipizide (40.8 %; p < 0.0001). Events suggestive of genital infections and lower urinary tract infections were reported more frequently with dapagliflozin compared with glipizide but responded to standard treatment and rarely led to study discontinuation. Conclusions: Despite similar 52-week glycemic efficacy, dapagliflozin reduced weight and produced less hypoglycemia than glipizide in type 2 diabetes inadequately controlled with metformin. Long-term studies are required to further evaluate genital and urinary tract infections with SGLT2 inhibitors. © Georg Thieme Verlag KG Stuttgart . New York.


Buse J.B.,University of North Carolina at Chapel Hill | Garber A.,Baylor College of Medicine | Rosenstock J.,Dallas Diabetes and Endocrine Center at Medical City | Schmidt W.E.,Ruhr University Bochum | And 4 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2011

Context: Therapeutic proteins/peptides can produce immunogenic responses that may increase the risk of adverse events or reduce efficacy. Objective: The objectives were to measure and characterize antibody formation to liraglutide, a glucagon-like peptide-1 receptor agonist, to investigate the impact on glycemic control and safety, and to compare it with exenatide, an agent in the same class. Design: Antibody data were collected during six Liraglutide Effect and Action in Diabetes (LEAD) trials (26-104 wk duration). Setting: Samples for determination of antibody formation were collected at LEAD trial sites and analyzed at central laboratories. Participants: Antibodies were measured in LEAD trial participants with type 2 diabetes. Interventions: Interventions included once-daily liraglutide (1.2 or 1.8 mg) or twice-daily exenatide (10 μg). Main Outcome Measures: The main outcome measures included the proportion of patients positive for anti-liraglutide or anti-exenatide antibodies, a glucagon-like peptide-1 cross-reacting effect, and an in vitro liraglutide- or exenatide-neutralizing effect. Change in glycosylated hemoglobin A1c (HbA1c) by antibody status and magnitude [negative, positive (high or low level)]. Results: After 26 wk, 32 of 369 (8.7%) and 49 of 587 (8.3%) patients had low-level antibodies to liraglutide 1.2 and 1.8 mg, respectively [mean 3.3% antibody-bound radioactivity out of total radioactivity (%B/T), range 1.6-10.7%B/T], which did not attenuate glycemic efficacy (HbA1c reductions 1.1-1.3% in antibody-positive vs. 1.2% in antibody-negative patients). In LEAD-6, 113 of 185 extension patients (61%) had anti-exenatide antibodies at wk 26 (range 2.4-60.2%B/T). High levels of anti-exenatide antibodies were correlated with significantly smaller HbA1c reductions (P = 0.0022). After switching from exenatide to liraglutide, anti-exenatide antibodies did not compromise a further glycemic response to liraglutide (additional 0.4% HbA1c reduction). Conclusions: Liraglutide was less immunogenic than exenatide; the frequency and levels of anti-liraglutide antibodies were low and did not impact glycemic efficacy or safety. Copyright © 2011 by The Endocrine Society.


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.


Daniels G.H.,Harvard University | Hegedus L.,University of Southern Denmark | Marso S.P.,Southwestern University | Nauck M.A.,Diabeteszentrum | And 7 more authors.
Diabetes, Obesity and Metabolism | Year: 2015

Aims: To report preliminary data on baseline serum calcitonin concentrations and associated clinical characteristics in a global population with type 2 diabetes before liraglutide or placebo randomization. Methods: The ongoing LEADER trial has enrolled 9340 people with type 2 diabetes and at high risk of cardiovascular disease at 410 centres worldwide. People with baseline serum calcitonin ≤50ng/l were randomized to liraglutide once daily or placebo and will be followed for up to 5years. Serum calcitonin was measured at baseline and will be measured annually thereafter. An independent committee of thyroid experts will oversee calcitonin monitoring throughout the trial and will review all calcitonin concentrations ≥20ng/l. Results: The mean age of participants was 64.3±7.2years, 64.3% were men, and mean the body mass index was 32.5±6.3kg/m2. The median (interquartile range) baseline serum calcitonin values were 3.9 (1.0 to >7.6)ng/l in men and 1.0 (1.0 to >1)ng/l in women. Serum calcitonin was>10ng/l in 14.6% of men and in 0.96% of women. In sex-specific multivariable linear analysis of covariance models, a reduced glomerular filtration rate (GFR) was associated with higher serum calcitonin concentrations that were statistically significant. A 20ml/min/1.73m2 decrease in estimated GFR (eGFR) was associated with a 14% increase in serum calcitonin in women and an 11% increase in men. Conclusions: In the LEADER population, the prevalence of elevated serum calcitonin concentrations at baseline was high, and there was an inverse association between eGFR and serum calcitonin concentrations. © 2015 The Authors. Diabetes, Obesity and Metabolism published by JohnWiley & Sons Ltd.


Informed shared decision making is suitable to increase self-management skills of diabetes patients when applied in therapeutic, diagnostic and preventive options. At the same time it is indispensable that information is based on recent scientific evidence, is unbiased and generally understandable. Diabetes educators could play a key role in the concept of informed shared decision making by establishing individual preferences of patients and provide scientific evidence in a unbiased way. However, it is necessary that diabetes educators are also trained to acquire a critical health competence themselves. Regarding the vocational training it is therefore important to systematically implement the contents of the principals and methods used in evidence-based medicine. © Springer-Verlag 2012.


Introduction: The word "compliance" describes the following of behavioural instructions from doctors. Most often these instructions apply to more or less intensive lifestyle changes for the patient. Discussion: Attempts to change the lifestyle of patients have been, on the whole, unsuccessful. Non-compliance results in poor treatment outcomes. This leads to various reactions on the part of the therapist from frustration to aggression. The expression "noncompliant" often has negative connotations and implies that the patient has such a thing as a free will or - assuming he has a free will - a lack of will to behave in a healthy way. This problem complex will be described with regard to the treatment of chronic wounds. © Schattauer 2013.

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