Abbott Patients Grow Impatient for Libre 2 Approval

Abbott Laboratories has been wildly successful with its FreeStyle Libre continuous glucose monitor (CGM) since winning FDA approval in 2017, but it seems some investors and patients may be getting restless as the U.S. market waits for the second-generation of the blockbuster technology. We first noted some signs of impatience for Libre 2 in our coverage of Abbott's third-quarter earnings call in October. One reader commented on that article that "I don’t particularly care about investors becoming impatient, as a Freestyle Libre user I am growing impatient." If a recent email to MD+DI is any indication, that patient is not alone. "What can we consumers do to get this product approved for American use? The hold up by the FDA is ridiculous," John Grosse, an MD+DI reader, asked us in an email late last week. Abbott won CE mark approval to launch the Libre 2 system in Europe in October 2018. The second-generation system offers optional customizable glucose alarms for patients who need them, using Bluetooth technology. The system can be set up to alert the user if their glucose is low or high, for example, or if there is a signal loss between the sensor and the reader. The user continues to be able to scan their sensor as often as desired to see their glucose reading, trends and patterns, and eight-hour history. The company filed for FDA approval of Libre 2 as a...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news

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This study aims to investigate the gamma and neutron attenuation properties of several OAD (oral anti-diabetic drugs) samples. Our sample consists of seven different OAD films with different elemental compositions. The data were evaluated with Monte Carlo (MATLAB, WinX) techniques by SEM (Scanning electron microscopy) and EDS (Energy Dispersive X-Ray Spectroscopy) analysis. By using WinXCOM in the energy range from 0.02 MeV to 20 MeV, the mass attenuation coefficients (μ/ρ) for OAD samples are calculated. Additionally, both effective removal cross-section and effective atomic numbers (Zeff) for the sample films ...
Source: Radiation Physics and Chemistry - Category: Physics Source Type: research
This study was conducted to define the maximum gap-size criteria for osseous union to occur at osteotomy sites in fibula free flap reconstruction of the mandible.Study designRetrospective chart review.SettingTertiary care academic center.Subjects and methodsA retrospective chart review of computed tomography and medical records was conducted on patients who underwent fibula free flap surgery and had imaging of the mandible at 6 months after surgery. Distances between osteotomies were measured and evaluated for interval healing. Secondary data included subject age, sex, smoking status, diabetes, number of osteotomies, com...
Source: American Journal of Otolaryngology - Category: Endocrinology Source Type: research
ConclusionsThe risk of adverse pregnancy outcome increases with advancing maternal age. Women aged ≥40, have an increased risk of adverse perinatal and maternal outcome when pregnancy goes beyond 41 weeks. Gestational age was more strongly associated with adverse perinatal and maternal outcomes than maternal age, but the difference was non‐significant.
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: ORIGINAL RESEARCH ARTICLE Source Type: research
Back in March 2018, I co-authored (along with Scott King, the former editor ofDiabetes Health magazine) an article (catch the article athttps://www.diabeteshealth.com/good-bad-diabetes-advocacy-world/ for reference) about some patient advocacy wins and challenges ahead. One of the challenges ahead was about runaway insulin prices.We started to see action on runaway insulin prices in state capitals happen a few years ago.Nevada got an early start in 2017, introducing a transparency bill that requires drugmakers who made insulin specifically to report pricing, costs, and rebates. It was signed into law by the state's Republi...
Source: Scott's Web Log - Category: Endocrinology Tags: 2020 insulin insulin prices legislation state laws Source Type: blogs
Back in March 2018, I co-authored (along with Scott King, the former editor ofDiabetes Health magazine) an article (catch the article athttps://www.diabeteshealth.com/good-bad-diabetes-advocacy-world/ for reference) about some patient advocacy wins and challenges ahead. One of the challenges ahead was about runaway insulin prices.We started to see action on runaway insulin prices in state capitals happen a few years ago.Nevada got an early start in 2017, introducing a transparency bill that requires drugmakers who made insulin specifically to report pricing, costs, and rebates. It was signed into law by the state's Republi...
Source: Scott's Web Log - Category: Endocrinology Tags: 2020 insulin insulin prices legislation state laws Source Type: blogs
AbstractIntroductionMaternal perception of fetal movements has long been considered an indicator of fetal well ‐being. A sudden decrease in the number of fetal movements is suggestive of fetal compromise. We aimed to determine whether the maternal perception of reduced fetal movements (RFM) is associated with placental pathological lesions in a low‐risk term population.Material and methodsOur study was a case ‐control study that was performed in a single university center. Placental histopathology, maternal demographics, labor characteristics, and neonatal outcomes of term, singleton pregnancies with maternal percept...
Source: Acta Obstetricia et Gynecologica Scandinavica - Category: OBGYN Authors: Tags: ORIGINAL RESEARCH ARTICLE Source Type: research
The objective of this study is to document innovations in providing diabetes care for individuals experiencing homelessness.MethodsUsing directed snowball sampling, we recruited a sample of service providers (family physicians, nurses, social workers, endocrinologists, diabetes educators, and shelter workers) in 5 Canadian cities (Vancouver, Calgary, Edmonton, Toronto, Ottawa). Data was collected using detailed open-ended interviews. Transcripts and field notes were analyzed using thematic analysis.ResultsWe interviewed 96 program managers and providers representing 38 organizations. While many of the same challenges were ...
Source: Canadian Journal of Diabetes - Category: Endocrinology Source Type: research
Authors: Maejima T, Kumagai K, Yabe K, Yasuno K, Ishikawa K, Okado K, Sasaki N, Kai K, Mori K Abstract A 40-week-old male spontaneous diabetic Torii rat, an animal model of type 2 diabetes mellitus, was found to have marked urinary calculi with hematuria in the urinary bladder on necropsy. Histological findings in the urinary bladder included a papillary growth pattern with a fibrovascular stroma without atypia. Fine granular materials in the bladder lumen were positive for Von Kossa staining but negative for periodic acid-Schiff or Gram staining, indicating no apparent bacterial infection in the urinary bladder. S...
Source: Journal of Toxicologic Pathology - Category: Toxicology Tags: J Toxicol Pathol Source Type: research
There could be an opportunity to gain more insight into how the continuous glucose monitoring (CGM) market will pan out this year at the 2020 International Conference on Advanced Technologies &Treatments for Diabetes (ATTD). The leading companies in the space are slated to release data and give investors more clarity about CGM offerings, according to a report from Canaccord and Genuity analyst Kyle Rose. Abbott Laboratories’ upcoming Freestyle Libre 2 will be a major topic in the CGM conversation during ATTD because it will reshape the market’s landscape. Already patients and investo...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Digital Health Source Type: news
Conclusion: The FAZ area and perimeter showed excellent reproducibility. The macular perfusion parameters are not interchangeable despite automated estimation. The variability is more with changes in the vascular network like DR. This variability should be considered while comparing different scans.
Source: Indian Journal of Ophthalmology - Category: Opthalmology Authors: Source Type: research
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