Breaking News
November 21, 2018 - Pulmonologists want more information on inhalation devices for COPD
November 21, 2018 - Cessation fatigue predicts relapse rate after attempts to quit smoking
November 21, 2018 - Special care should be taken with drugs that inhibit epigenetic factors, study suggests
November 21, 2018 - More than one in ten heavy cannabis users experience withdrawal after quitting cannabis
November 21, 2018 - Reflections on the California fires
November 21, 2018 - Donna Lynne Appointed to Key Leadership Role at CUIMC
November 21, 2018 - Smoke-free laws associated with reduced systolic blood pressure
November 21, 2018 - Achieving new guideline blood pressure goals may prevent 3 million cardiovascular events
November 21, 2018 - LDR brachytherapy for treating early-stage prostate cancer lacks conclusive data
November 21, 2018 - Purified omega-3 and aspirin reduce pre-cancerous bowel polyps, shows study
November 21, 2018 - Study warns that potential epigenetic therapy may boost lung cancer stem cells
November 21, 2018 - Noise pollution in hospital impact quality and safety of healthcare
November 21, 2018 - Higher Risk for Amputation, DKA With SGLT2 Inhibitors for T2DM
November 21, 2018 - Researchers stop ‘sneaky’ cancer cells in their tracks
November 21, 2018 - People who are afraid to draw their blood over-estimate the risk of fainting
November 21, 2018 - Personalized physical exercise reverses functional, cognitive deterioration in the elderly
November 21, 2018 - COPD linked to obesity in older women who have never smoked
November 21, 2018 - AHA: Cold-Weather Drinks Are Here, But Watch Out for the Calories
November 21, 2018 - Crowds line up at 1st East Coast pot shops
November 21, 2018 - Merck declares 2018 Life Science Award winners
November 21, 2018 - Many people underestimate the impact of sprains, say foot scientists
November 21, 2018 - Lower levels of protein make squamous carcinoma cells more invasive
November 21, 2018 - Study highlights a new predictor of type 2 diabetes
November 21, 2018 - NTU and TTSH join forces to improve doctor-patient communication
November 21, 2018 - New low-cost injectable hydrogel could help wounds heal faster
November 21, 2018 - Merck Announces Winners of 2018 Life Science Awards
November 21, 2018 - Check your medical records for dangerous errors
November 21, 2018 - Amount of weight regain after bariatric surgery helps predict health risks
November 21, 2018 - Heart failure patients with stronger hearts have more depressive symptoms, lower quality of life
November 21, 2018 - Women can be as resilient as men in undertaking arduous physical activity
November 21, 2018 - Receptor structure could be key to developing new osteoporosis drugs
November 21, 2018 - Researchers identify human white matter pathway associated with individual variability in human stereoacuity
November 21, 2018 - Vitamin D critical to early development of vertebrates, study suggests
November 21, 2018 - Myriad biological, societal factors that impact CKD severity for children of African descent
November 21, 2018 - Isofol Announces Initiation of a Pivotal Phase 3 Clinical Trial of arfolitixorin for the Treatment of Metastatic Colorectal Cancer
November 21, 2018 - Experts offer more clarity on managing common ankle fractures
November 21, 2018 - About 300 million bits of DNA are missing from basic reference genome, report scientists
November 21, 2018 - Study explores how the moving brain processes visual information
November 21, 2018 - Biomedical engineers stop cancer cells from moving and spreading
November 21, 2018 - Gut protein mutations protect against spikes in blood glucose levels
November 21, 2018 - First probabilistic atlas of thalamus nuclei to better understand the brain
November 21, 2018 - Peanut allergies could soon have a drug treatment
November 21, 2018 - Vanderbilt researchers isolate antibody that can neutralize West Nile virus
November 21, 2018 - KHN’s ‘What the Health?’ Health nerd books for the holidays
November 21, 2018 - MDMA could help gain trust but does not make one naive find researchers
November 21, 2018 - Study uncovers new mechanism controlling the master cancer regulator
November 21, 2018 - Online communication technologies could stave off depression among seniors, shows study
November 21, 2018 - FDA Approves Gamifant (emapalumab-lzsg) for Primary Hemophagocytic Lymphohistiocytosis
November 21, 2018 - Artificial intelligence predicts treatment effectiveness
November 21, 2018 - A bicyclist’s road to recovery after traumatic brain injury
November 21, 2018 - New research project to combat obesity, type 2 diabetes receives NIH funding
November 21, 2018 - Humans play key role in distribution and transmission of Bartonella bacteria
November 21, 2018 - First modeling system developed for testing age-specific human immune responses to vaccines
November 21, 2018 - FDA Alert: Gilenya (fingolimod): Drug Safety Communication
November 21, 2018 - Uric Acid Test: MedlinePlus Lab Test Information
November 21, 2018 - Researchers use genetics to predict response to antipsychotic medications
November 21, 2018 - Proposal to include the price of drugs in television ads is flawed, Stanford scholar writes
November 21, 2018 - Disrupting reproduction strategy of disease-causing parasites could help fight malaria
November 20, 2018 - ACAAI: Almost 2 Percent of Children Have Milk Allergy
November 20, 2018 - Congenital anomalies of kidney and urinary tract – Genetics Home Reference
November 20, 2018 - Can video games improve the health of older adults with schizophrenia?
November 20, 2018 - Can flicking a molecular switch restore the aging immune system’s competence?
November 20, 2018 - Restek launches new Oregon cannabis pesticide standards
November 20, 2018 - Health sector coalition urges Government to safeguard patients in future UK-EU relationship
November 20, 2018 - Study evaluates second-hand marijuana smoke exposure among children
November 20, 2018 - Scientists identify three genes responsible for recurrent molar pregnancies
November 20, 2018 - Researchers identify multisystem disorder caused by bi-allelic variants in CCDC47 gene
November 20, 2018 - Dining Out With Allergies Is Tough, But These Steps Can Help
November 20, 2018 - Breastfeeding protects infants from antibiotic-resistant bacteria
November 20, 2018 - AI matched, outperformed radiologists in screening X-rays for certain diseases | News Center
November 20, 2018 - Adolescents increasingly choose marijuana over cigarettes, alcohol
November 20, 2018 - World’s first medical imaging scanner produces diagnostic scan of the whole human body
November 20, 2018 - Cytocybernetics receives NIMH award to move into neuronal drug development
November 20, 2018 - Researchers discover new information on pathological mechanisms of Alzheimer’s disease
November 20, 2018 - ‘Unknown’ enzyme may be key to new treatment for inflammatory diseases
November 20, 2018 - Recreational drug may help people regain trust in others
November 20, 2018 - Researchers identify gene vital for post-stroke recovery
November 20, 2018 - Scientists identify novel target for neuron regeneration, functional recovery in spinal cord injury
November 20, 2018 - Potential new therapeutic approach developed for synovial sarcoma
November 20, 2018 - Skeletal imitation reveals how bones grow atom-by-atom
FDA approves Eversense CGM system for use in adults with diabetes

FDA approves Eversense CGM system for use in adults with diabetes

image_pdfDownload PDFimage_print

The U.S. Food and Drug Administration today approved the Eversense Continuous Glucose Monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.

“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said FDA Commissioner Scott Gottlieb, M.D. “These technologies allow patients to gain better control over their health. This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms. The FDA is creating a new and more carefully tailored regulatory approach for software products, including mobile medical apps, that will enable efficient oversight of these digital technologies and maintain FDA’s gold standard for product review. We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities.”

People with diabetes either do not make enough insulin (type 1 diabetes) or cannot use insulin properly (type 2 diabetes). When the body does not have enough insulin, or cannot use it effectively, sugar builds up in the blood. High blood sugar levels can lead to heart disease, stroke, blindness, kidney failure and amputation of toes, feet or legs. Individuals living with diabetes must regularly monitor their glucose levels as part of the management of the disease. This includes making sure that diabetes management accessories, like most current glucose sensors, are replaced on a regular basis (generally, every seven days) to ensure that an overall CGM system is properly functioning.

The Eversense CGM system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia). The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (e.g., smart phone or tablet) that is running a device-specific mobile app.

The FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and reviewed the device’s effectiveness by comparing readings obtained by the Eversense CGM system to those obtained by a laboratory-based glucose analyzer. The safety of the Eversense CGM system’s 90-day implantable sensor, and the procedure used to implant it, was also evaluated during the clinical studies. During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1 percent. The safety of this novel system will also be evaluated in a post-approval study. The FDA held an Advisory Committee meeting to provide an independent assessment of the safety and effectiveness of the Eversense CGM system. In an 8 to 0 vote, the committee recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.

Potential adverse effects related to insertion, removal and wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, skin inflammation, thinning, discoloration or redness. Other risks associated with use of the CGM system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate or where alerts are missed.

The FDA granted approval of the Eversense Continuous Glucose Monitoring System to Senseonics, Inc.

Source:

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611454.htm

Tagged with:

About author

Related Articles