Integrated Glucose Sampling and Monitoring System Will Leverage High-Throughput Sensor Technology

This content is excerpted from Sensor Technology Alert and Newsletter, a sensor intelligence service published by the Technical Insights unit of Frost & Sullivan.


In developing innovative sensors for significant or emerging applications, it is vital to ensure that the sensor technology can be cost-effectively manufactured and is well-suited to the system or original equipment manufacturer (OEM) product in which it will reside. In addition to focusing on manufacturability, sensor technology developers are advised to also focus on applications that can significantly benefit from new sensor technology and represent key growth markets for sensors or sensor-based systems.

Diabetes--a disease characterized by high blood glucose levels caused by the body's inability to produce or properly use insulin--afflicts about 18.2 million Americans, according to the American Diabetes Association. While about 13 million people have been diagnosed with diabetes, 5.2 million individuals are unaware that they have the disease. If the body does not properly produce or use insulin, elevated levels of glucose appear in the blood, which can lead to various medical problems.

About 5% to 10% Americans who are diagnosed with diabetes have "type 1" diabetes, where they do not produce insulin and, therefore, cannot properly process glucose. Most Americans diagnosed with diabetes have "type 2" diabetes, which results from insulin resistance (a condition in which the body fails to process glucose because it cannot properly use the insulin it produces), combined with relative insulin deficiency. Insulin-using diabetics (encompassing all of type 1 and some of type 2 diabetics) must administer insulin to manage their disease; whereas non-insulin dependent individuals (the majority of type 2 diabetics) can control their diabetes through diet, exercise, or oral medications. Historically, blood glucose monitoring has been a relatively cumbersome and invasive process.

Pelikan Technologies Inc. is helping to drive the realization of more seamless, streamlined, and less painful blood glucose sampling and monitoring systems that will use glucose sensors, which can be efficiently manufactured and can provide the speed, accuracy, and precision required for use in the company's single-step solution for glucose monitoring.

Dirk Boecker, Pelikan Technologies' president and CEO, noted that the system, designed to provide very accurate results while reducing the pain and improving the disposable handling associated with conventional blood glucose testing systems, will be unique in that it will integrate all of the steps of glucose measurement, starting from blood generation to data presentation and recording into a single, comprehensive solution. A prototype of the system is expected to be available for US Food and Drug Administration (FDA) approval around 2006. The system will be primarily aimed at self testing and will be priced competitively with respect to the per-test cost of existing systems (that is, lancets plus glucose test strips).

In Pelikan's proprietary, one-step, less painful blood glucose sampling and measurement system, an integrated disposable disk cartridge replaces inconvenient and individual lancets, glucose strips, and a multistep process, thereby facilitating safety and convenience. The system will include electronically-controlled lancing technology (first introduced in the Pelikan Sun lancing device), which makes the sample acquisition process more comfortable, and a screen-printed electrochemical glucose sensor based on GlucoSens technology developed by Albatros (former Inventus Biotec) GmbH & Co. KG of Germany.

Pelikan Technologies acquired Inventus BioTec around December 2004, thereby gaining the required blood glucose sensing technology to finalize the development of its glucose sampling and monitoring system. The acquisition also afforded Pelikan access to Inventus' sensor manufacturing facilities and processes. The Inventus electrochemical sensor technology could also be used to measure analytes other than blood glucose. Other sensor technology developed by Inventus could potentially be used in such applications as measuring point-of-care parameters and immunoassays. The former Inventus Biotec has been renamed Albatros Technologies.

Albatros has a European patent for a disposable electrochemical biosensor for the quantitative determination of analyte concentrations in fluids. The biosensor includes a support material, electrical conductors, an electrode system (with a counter electrode and a working electrode), a dielectric insulating layer, and a bi-component for recognition of the analyte. The reaction layer of the device (from which the electrode system is formed) comprises a lightly subliming electron transfer mediator along with electron-conducting material.

The invention also pertains to a method for determination of analytes in the fluid sample via the biosensor, the use of lightly subliming compounds as electron transfer mediators in an electrochemical sensor for the transfer of electrons from an enzyme to an electron-conducting material, and the use of the aforementioned biosensors for determining analyte concentrations in body or sample fluids.

Boecker noted that the Inventus electrochemical sensor technology is most suitable for use in the one-step sensing and lancing system, which will be optimized with respect to speed, blood volume, accuracy, and precision. In this electrochemical sensing technology, which includes an immobilized glucose-consuming enzyme, the efficiency for the electron transfer process has been optimized. Prior to the acquisition, Pelikan worked with Inventus on glucose sensor technology development and thoroughly validated the merits of Inventus' sensor technology.

Pelikan continues to spearhead further refinements and advancements in its sensing technology, including supporting the work on microfabricated biosensor arrays at Cranfield University in England. Anthony Turner, head of Cranfield University at Silsoe is also head of Pelikan's Advisory Board. Previous research undertaken by Pelikan and involving Cranfield University has demonstrated a generic approach to oxygen-coupled enzyme biosensors (for example, for glucose determination) that is compatible with single-step, high-throughput manufacture. The approach uses a polymerizable liquid emulsion incorporating a dispersed oxygen sensing phase (containing an oxygen-sensitive fluorescent dye) and an enzyme-containing phase. This approach involves only a single liquid emulsion handling/deposition step into an appropriate disposable molded polymer for production.

A more recent project at Cranfield, cosponsored by Pelikan, will focus, within the context of the emulsion-based biosensor concept, on: the establishment of a standardized, robust biosensing emulsion system for further study; understanding the physio-chemical issues of incorporating biosensing emulsion within microfabricated structures and elaboration of underlying principles (for example, compatibility of the emulsion biosensing approach with a variety of enzyme oxidases and elaboration of underlying principles of compatibility); and exploration of novel emulsion sensing formats.

Pelikan's Sun lancing device, which received FDA clearance in 2003 and is slated for launch in mid-2005, uses a 50-lancet disk (eliminating the need to hold, load, and unload exposed lancets) and technology that allows intelligent, precise control of the lancing process--with 30 depth settings available to enable individuals of diverse ages and skin types to lance their skin to the lowest depth possible while still obtaining a blood sample.

Pelikan Technologies, founded in 2001, has roots at HP Labs and Agilent Technologies. At HP Labs, two of Pelikan's founders, Dominique Freeman and Don Alden worked on developing a novel blood sampling technology that eliminates unnecessary pain and inconvenience. During this time period, Boecker became head of the medical department and principal research scientist at HP Labs and oversaw development of a state-of-the-art handheld device for diverse point-of-care applications. In 1999, Agilent Technologies, including the medical department, was spun off from HP. In 2000, reflecting a strategic shift, Agilent sold its Health Solutions Group to Philips. In response to this strategic shift, Boecker, Freeman and Alden acquired the sensor and seamless sampling technology they developed at Agilent and founded Pelikan Technologies in 2001.

Revenues for the US glucose self-monitoring devices market (that is, glucose test strips and meters) are projected to reach about $5.4 billion in 2009, according to Frost & Sullivan's US Diabetes Glucose Self-Monitoring Devices Markets research service (published in 2003).

Details: Dr. Dirk Boecker, President and CEO, Pelikan Technologies Inc., 1072 East Meadow Circle, Palo Alto, CA 94303. Phone: 650-842-1000. E-mail: [email protected].