FDA Approves Diabetes Sensing System

Arm patch provides continuous glucose monitoring

The FDA has given the green light to the FreeStyle Libre Pro system (Abbott), a continuous glucose monitoring system for diabetes patients.

The system provides health care professionals with a visual snapshot of glucose data, known as the ambulatory glucose profile, thereby offering a more-simplified and clearer overview not only of glucose levels, but also of patterns and trends within those levels, according to Abbott. This information helps health care professionals make customized treatment decisions for their patients.

The FreeStyle Libre Pro system is applied to diabetes patients by health care professionals in a clinical setting. The clinician applies a small, round sensor to the back of the patient’s upper arm. The water-resistant, disposable sensor is held in place with a self-adhesive pad and remains on the back of the arm for up to 14 days, requiring no patient interaction with the device or the need for the patient to draw blood via a finger stick to calibrate the sensor.

The sensor continuously measures glucose in interstitial fluid through a small (5-mm long and 0.4-mm wide) filament that is inserted under the skin. This filament records glucose levels every 15 minutes, capturing up to 1,340 glucose results for up to 14 days, giving doctors comprehensive data for complete glycemic profiles of the patients they are treating. After 14 days, the patient returns to his or her doctor’s office, where the doctor uses a FreeStyle Libre Pro reader to scan the sensor and to download the 14 days’ worth of glucose results, which are stored in the sensor. The process takes as little as five seconds.

According to the International Diabetes Federation, the United States has one of the highest diabetes prevalence rates, with 29.1 million people (9% of the U.S. population) affected by the disease. A recent survey of 1,527 people with type-2 diabetes found that 40% did not test glucose levels as often as was recommended by their doctors. Reasons for testing less often than recommended included the expense of testing strips (31%); dislike of pricking fingers to draw blood for testing (29%); and forgetting to test because the patient feels fine (26%).

Traditionally, continuous glucose monitoring devices have been used mainly by people with type-1 diabetes who are required to take insulin. However, both type-1 and type-2 diabetes patients can experience hypoglycemia, which can be life-threatening, especially when not detected. With the FreeStyle Libre Pro system, glucose-level excursions can be detected and managed, Abbott says.

The system will be available to U.S. health care professionals in the coming weeks. 

Source: Abbott; September 28, 2016.