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The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approval to market this version of the system.
Observational Model: Cohort, Time Perspective: Prospective
FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5
Diablo Clinical Research
Abbott Diabetes Care
Published on BioPortfolio: 2014-08-27T03:15:36-0400
The purpose of this study is to determine if the incidence and duration of hypoglycaemia (low blood sugar) is reduced through the use of the FreeStyle Navigator Continuous Glucose Monitori...
The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for th...
The purpose of doing this study is to see if continuous glucose monitoring can help people with type 1 diabetes who are sometimes unable to feel if they have a low blood glucose reading. F...
This is a pivotal, non-randomized, single arm, multi-center, prospective, non-significant risk study to evaluate the FreeStyle Libre Flash Glucose Monitoring System.
The usability, skin reactions and accuracy of the FreeStyle Libre glucose monitoring system in children will be evaluated by questionnaires, pictures of the insertion site and comparison o...
The FreeStyle® Libre Flash Glucose Monitoring System (FGM, Abbott) measures glucose concentrations in the interstitial fluid for up to 14 days. It has been approved for use in children aged > 4 years...
FreeStyle Libre (Abbot Diabetes Care Ltd) has been launched as a novel glucose monitoring system called flash glucose monitoring (FGM) in Europe. Several reports are becoming available on its usefulne...
Recently Diabetic Medicine, Reddy and colleagues published the original article 'A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1...
Glucose variability (GV) remains a key limiting factor in the success of diabetes management. While new technologies, for example, accurate continuous glucose monitoring (CGM) and connected insulin de...
Persistent use of real-time continuous glucose monitoring (CGM) improves diabetes control in individuals with type 1 diabetes (T1D) and type 2 diabetes (T2D).
Self evaluation of whole blood glucose levels outside the clinical laboratory. A digital or battery-operated reflectance meter may be used. It has wide application in controlling unstable insulin-dependent diabetes.
A glucoside-derived SODIUM-GLUCOSE TRANSPORTER 2 inhibitor that stimulates urinary excretion of glucose by suppressing renal glucose reabsorption. It is used to manage BLOOD GLUCOSE levels in patients with TYPE 2 DIABETES.
The state of PREGNANCY in women with DIABETES MELLITUS. This does not include either symptomatic diabetes or GLUCOSE INTOLERANCE induced by pregnancy (DIABETES, GESTATIONAL) which resolves at the end of pregnancy.
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.
A pathological state in which BLOOD GLUCOSE level is less than approximately 140 mg/100 ml of PLASMA at fasting, and above approximately 200 mg/100 ml plasma at 30-, 60-, or 90-minute during a GLUCOSE TOLERANCE TEST. This condition is seen frequently in DIABETES MELLITUS, but also occurs with other diseases and MALNUTRITION.
Food is any substance consumed to provide nutritional support for the body. It is usually of plant or animal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingested by an organism ...
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...