“The important part of improving the management of diabetes is to understand glucose trends with the goal of minimizing fluctuations. We are always looking for new tools like these to enable diabetes people to monitor their glucose continuously so that they can take action according to the blood glucose levels whether it is high or low and by putting them in offense not defense” said Richard Bergenstal, M.D. endocrinologist and Director of ‘International Diabetes Center (IDC)’.
“Free Style Navigator Continuous Glucose Monitoring System” was approved by ‘The Food and Drug Administration (FDA)’ in the United States for people with diabetes. Abbott’s “Free Style Navigator “system provides minute by minute information of the changes in the blood sugar level, how quickly and which way. This instrument is designed in a way to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen. This information can lead to positive adjustments resulting in tighter glucose ranges. Traditional tests of blood glucose should be done before adjusting therapy for diabetes management based on the results and alarms from the “Free Style Navigator” system.
The “Free Style Navigator” system measures glucose levels continuously which can lead to better diabetes management because it is designed to provide information than traditional finger stick glucose measurements.
For people with diabetes who require insulin and want to tightly manage their disease, Abbott’s “Free Style Navigator” system offers a number of key advances. The system can be clipped to a belt or can be carried in a pocket or a purse monitors the glucose levels by measuring and transmitting glucose information once per minute to the pager sized receiver. Before the glucose levels become too high or too low it provides audible or vibrating alarms. If the glucose is rising and falling it displays five directional trend arrows to help people understand and also stores historical data and glucose trend information for up to 60 days. In addition to these features the sensor and the transmitter are designed to accommodate showering, swimming and a range of normal physical activities.
In two separated pivotal clinical trials the accuracy, safety and efficacy of the “Free Style Navigator” system have been demonstrated including five-day in-clinic study and a study of people with type1 and type2 diabetes at home.
‘Five-day in-clinic study’, a specific research study was conducted with 58 people from the age 18-64. By demonstrating accuracy over five days of wear the study met it primary endpoint. According to this study the measurements allowed patients to make either correct or safe treatment decisions, benign treatment decisions or no treatment decision.
The ‘home use study’ was also conducted with the people having type1 and type2 diabetes who used this system at home. The study participants with type1 diabetes spent less time in hypoglycemic state that is serious condition for this population. In participants with type2 diabetes spent less time in hyperglycemic state which is a serious problem for type 2 diabetic people.