Analyte monitoring system and method

Abstract

Devices and methods for monitoring an analyte are provided. Embodiments include continuous analyte sensors having a high degree of accuracy.

Description

RELATED APPLICATIONS [0001] This application claims priority under 35 USC § 119 to Provisional Application No. 60 / 804,170 filed Jun. 7, 2006 entitled “Analyte Monitoring”, and to Provisional Application No. 60 / 804,169 filed Jun. 7, 2006 entitled “Analyte Monitoring System” the disclosure of each of which are incorporated in their entirety by reference for all purposesBACKGROUND OF THE INVENTION [0002] The association of chronic hyperglycemia and the devastating long-term complications of diabetes was clearly established by the Diabetes Control and Complication Trial (DCCT) (The Diabetes Control and Complications Trial Research Group. “The effect of intensive treatment of diabetes on the development and progression of long-term complications of insulin-dependent diabetes mellitus” N Engl J Med 329: 978-986, 1993; Santiago J V “Lessons from the Diabetes Control and Complications Trial” Diabetes 1993, 42: 1549-1554). [0003] The DCCT found that in patients receiving intensive insulin th...

AI Technical Summary

Benefits of technology

[0010] Generally, the present disclosure relates to methods and devices for monitoring of the level of an analyte using a continuous and / or automatic in vivo monitoring analyte sensor. Embodiments include sensors in which at least a portion of the sensor is adapted to be positioned beneath the skin of a user and which are adapted for providing clinically accurate analyte data, i.e., data with accuracy sufficient so that a user may confidently rely on the sensor results, e.g., to manage a disease condition and / or make a healthcare decision based thereon. Accordingly, sensors capable of providing clinically accurate (i.e., clinically relevant) analyte information to a user are provided.

Problems solved by technology

However, the DCCT found that patients receiving intensive insulin therapy were at a threefold increased risk of severe hypoglycemia.

Patients adhering to intensive insulin therapy regimens were found to have lowered thresholds for activation of neurogenic warning systems and consequently were at increased risk for more severe hypoglycemic events.

The increased risk of hypoglycemia and the fear associated with patients' perception of that risk has been cited as the leading obstacle for patients to achieve the targeted glycemic levels (Cryer P E.

In addition to the problem of chronic hyperglycemia contributing to long-term complications and the problem of acute iatrogenic hypoglycemia contributing to short-term complications, recent research suggests that transient episodes of hyperglycemia can lead to a wide range of serious medical problems besides previously identified microvascular complications as well as macrovascular complications such as increased risk for heart disease.

However, the development of this technology has proceeded more slowly than anticipated.

For example, two recent comprehensive reviews of decades of research in the field cited the lack of accuracy and reliability as the major factor limiting the acceptance of this new technology as well as the development of an artificial pancreas (Chia, C. W. and Saudek, C. D., “Glucose sensors: toward closed loop insulin delivery” Endocrinol. Metab. Clin. N. Am., 33, 174-195, 2004; Hovorka, R.

Images