Devices and Drug Updates
Abbott FreeStyle Libre Flash Continuous Glucose Monitoring System
European authorities have issued the CE Mark to Abbott to market its FreeStyle Libre Flash Glucose Monitoring System. This continuous glucometer consists of a water resistant sensor that is attached to the back of the upper arm and a device that copies and displays the readings from the sensor. The sensor records blood glucose levels every minute, sampling the interstitial fluid using a 5mm long and .4 mm wide filament that penetrates the skin. It doesn’t require any finger prick calibration, unlike all other currently available continuous glucose monitors. The display device takes only a second to copy the readings from the sensor and shows up to 90 days of historical trends. |
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| A recent study conducted by Abbott has shown that the FreeStyle Libre System is clinically proven to be accurate, stable and consistent over 14 days without the need for finger prick calibration. |
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Ozurdex approved in EU for treatment of Diabetic Macular Edema
The European Commission has extended marketing authorization for Ozurdex for the treatment of diabetic macular edema in certain patients.
Under the marketing authorization extension, the dexamethasone 0.7 mg intravitreal implant (Ozurdex, Allergan) is indicated for adult patients with visual impairment due to diabetic macular edema who are pseudophakic, or who were unable to undergo noncorticosteroid therapy.
The implant is already indicated for the treatment of macular edema following branch retinal vein occlusion and central retinal vein occlusion, as well as for the treatment of noninfectious uveitis. It was approved by the U.S. Food and Drug Administration on June 30.
FDA allows marketing of first ZnT8Ab autoantibody test to help diagnose type 1 diabetes
U.S. Food and Drug Administration allowed marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test that can help determine if a person has type 1 diabetes and not another type of diabetes. When used with other tests and patient clinical information, the test may help some people with type 1 diabetes receive timely diagnosis and treatment for their disease.
The immune system of many people with type 1 diabetes produces ZnT8Ab, but patients with other types of diabetes (type 2 and gestational) do not. The KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay detects the presence of the ZnT8 autoantibody in a patient’s blood.
Early treatment of type 1 diabetes is important in helping to prevent further deterioration of insulin producing cells.
FDA approves once weekly injection for type 2 diabetes: Dulaglutide
The US Food and Drug Administration (FDA) has approved dulaglutide (Trulicity) as a once a week injection for the treatment of adults with type 2 diabetes. Dulaglutide is a member of the glucagon-like peptide (GLP-1) receptor agonist class, along with liraglutide, exenatide, and albiglutide. The starting dose for dulaglutide is 0.75 mg and can be increased to 1.5 mg.
The drug’s safety and effectiveness were evaluated in six clinical trials in which 3,342 patients with type 2 diabetes received Trulicity. Patients receiving Trulicity had an improvement in their blood sugar control as observed with reductions in HbA1c level. The most common side effects that were observed in clinical trials were nausea, diarrhea, vomiting, abdominal pain, and decreased appetite. Trulicity should not be used to treat people with type 1 diabetes. Trulicity is manufactured by Indianapolis-based Eli Lilly and Company.
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