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Driving innovation in diabetes care: new diabetes treatment and monitoring technology means opportunity for both patients and medical device companies.

The ideal solution for any disease would be a product--whether device, drug or both--that cures the problem. In the case of diabetes, a cure is not a viable solution and probably won't be for a very long time (if ever). Despite its efforts, the pharmaceutical industry has not yet been able to overcome the hurdle of replicating islet cells, which generate insulin and could provide a possible cure for the disease. For now, then, drug and medical device manufacturers are left to explore options that monitor and treat diabetes.

In terms of devices, the ultimate product for diabetes treatment would be one that continuously checks glucose levels and automatically delivers the correct dose of insulin regardless of whether the patient is active, eating or sleeping. Known in the industry as an "artificial pancreas"--though it performs only one of the functions of a healthy pancreas--this type of device remains just out of reach with currently available technology.

Armed with this knowledge, device manufacturers are continuing their quest for the ultimate device.

Let's give them credit--until 1923, diabetes was invariably fatal. That year, Indianapolis, IN-based Eli Lilly and Company introduced the first commercial insulin, followed in 1982 by the first injectable human insulin. Since then, the number of people living with diabetes worldwide has reached 200 million, and the World Health Organization (WHO) has estimated that this number will reach 300 million by 2025.

In the United States, 7% of the population, or 20.8 million people, have diabetes, according to WHO estimates. Data from the Centers for Disease Control and Prevention (CDC) also show that nearly one third of these individuals, or about 6 million people, do not know they have the disease.

While the increasing incidence of diabetes is bad news, it also illustrates that technology has helped make great strides in improving the length and quality of patients' lives.

The Patient Perspective

The estimated economic cost of diabetes in 2002 was $132 billion, according to the CDC. Of this amount, $92 billion was related to direct medical costs and represented 11% of national healthcare expenditures. Breaking it down even further, the average annual medical expenditure for a person with diabetes was $13,243. Industry observers estimate the market for diabetes devices alone currently is $7.5 billion worldwide and $3 billion in the United States.

Diabetes care differs from many other medical specialties because, ultimately, the patient is responsible for monitoring glucose levels and administering treatment such as insulin injections.

Medtronic spokesman Steve Sabicer explained, "The business model is a little different for Medtronic Diabetes from other divisions because of the interaction with the patient; the other divisions communicate directly with the physician and the hospital."

Thus, some of the latest devices appeal to aesthetics (eg, syringes that masquerade as fountain pens) or help minimize pain (eg, new generations of needles and lancets).

The devices used to administer insulin today demonstrate the leaps technology has taken over the past century. The more antiquated product would be a syringe that a patient has to carefully fill with a prescribed dose and inject manually. The product of the future, however, is a pre-filled insulin cartridge (not yet on the market) that is inserted in an automatic pump attached to or implanted in the body. Manufacturers also are holding out hope for alternative insulin delivery methods, such as inhalers (as was seen with Pfizer's launch of Exubera last year).

According to John Buse, MD, PhD, president-elect for medicine and science for the American Diabetes Association (ADA), the important thing to remember about the future of diabetes technology is that the individual patient always will be a factor. In fact, he noted that the innovators of diabetes technology include many people who themselves have diabetes or who have experienced it in their families.

"While there are tremendous profits to be made," he noted, "compared to other sectors, most people [in this industry] believe in their work."

The Nature of the Beast

Treatment of diabetes requires that human ingenuity mimic a complex chemical process. Without dwelling on the science, it is important to note that normal digestive function has two components: the ingestion of glucose and the production of insulin that allows the brain and body to use that glucose, which is necessary for survival.

Type 1 diabetes, formerly known as juvenile diabetes, results from an autoimmune reaction that destroys the capacity of the pancreas to produce insulin. It represents about 10% of cases, and susceptibility may be genetically inherited.

Type 2 diabetes, formerly called adult onset, is the most common form of the disease. It is associated with age and obesity, may not require insulin for control and is caused by inadequate sugar metabolism.

A rare form of the disease is gestational diabetes. It occurs during pregnancy and may predispose a woman to later onset of Type 2 diabetes.

Treatment of diabetes has two major components: measuring the amount of glucose in the blood at various intervals and administration of insulin or another regulating drug as necessary to maintain a healthy glucose level.

The Monitors

Abbott Park, IL-based Abbott Laboratories is one company that has expanded its capacity in recent years to better target the needs of patients with diabetes. In April 2004, Abbott consolidated its diabetes business in Alameda, CA--home of its new acquisition, TheraSense.

Abbott produces the FreeStyle line of blood glucose monitors, which consist of Flash, Freedom and Precision Xtra. Currently under FDA review is Abbott's latest monitor, the FreeStyle Navigator.

"We are committed to connecting this system to an insulin delivery system," Abbott spokeswoman Tama Donaldson said. "We are exploring a number of connectivity options."

Meanwhile, the company is preparing to reissue its FreeStyle CoPilot system for recording glucose readings. The company withdrew the system earlier this year because of a software problem affecting the display of data in the logbook.

Another data recording system, Precision Link, is available for use with most Abbott meters. The company also provides its monitor technology to St. Paul, MN-based Smiths Medical MD Inc. for the latter's Deltec Cozmo insulin pump.

Since these types of traditional monitors rely on blood drawn from a patient's finger, there is an ongoing search for other, less painful methods of assessing blood glucose. One method, developed by the University of Toledo and licensed by Freedom Meditech (a San Diego, CA-based early stage medical device company), uses a polarized laser to detect glucose levels from the eye's aqueous humor. The company has not yet begun production but hopes to market the noninvasive device within five years.

Already on the market are several types of wrist monitors, such as the Gluco Watch G@ made by Cygnus Inc in Medina, OH. Sources said the device has had trouble catching on because of skin irritation and because readings may be affected by perspiration and body temperature.

Insulin pumps also contain increasingly sensitive glucose monitors and indicators, but most still rely on separate devices to produce the readings accurate enough for dose adjustment.

As part of its new MiniMed system, Minneapolis, MN-based Medtronic Inc. includes a continuous sensor in the form of a microfilament inserted under the skin. According to the company's Web site, "Values are not intended to be used directly for making therapy adjustments but rather to provide an indication of when a fingerstick may be required."

Worldwide glucose monitoring product sales are growing by about 11% annually and are projected to reach $5.4 billion by 2009, according to research firm Frost & Sullivan.

"The blood glucose self-monitoring market is in its growth stage. The degree of competition is intense," said Sangeetha Prabakar, a research analyst for Frost & Sullivan who authored Emerging Therapies for Diabetes, the firm's report on diabetes technology.

One reason for the boom in glucose monitoring, she noted, is that the market is destined to grow as more people become aware that they have diabetes. "Overall, the market situation reflects huge untapped potential as a vast pool of diabetics remains undiagnosed," Prabakar concluded.

The most common types of monitors sell for between $45 and $150. For glucose meters and test strips alone, US annual spending is about $80 million, while spending for minimally and noninvasive glucose measurement devices is projected to reach about $390 million in 2008, based on estimates by industry sources.

Prabakar said Roche Group, headquartered in Basil, Switzerland, leads the market in glucose monitoring products with its Accu-Chek line of lancets, handheld meters and software for tracking results.

In the United States, one group purchasing organization accounts for about $40 million in purchases of meters and strips. Novation, based in Irving, TX, has contracts with Roche and Lifescan; the company gives physician practices and clinics access to those contracts through its affiliates. According to Gregg Knapp, senior director of contract services at Novation, the deals include software that runs the devices. Novation also offers contracts with Abbott for its I-Stat laboratory analyzers for diabetes testing.

Meanwhile, smaller companies are springing up wherever a niche, and the technology to support it, appears. An example is Dallas, TX-based Diabetech, which, in March, began a clinical study of its GlucoMON system, a handheld wireless device that picks up glucose monitor readings and transmits them to a cell phone or e-mail address.

The device, according to Diabetech CEO Kevin McMahon, is designed for young patients with Type 1 diabetes, as it allows parents to receive timely readings from their school-age children.

McMahon, who founded the company after his daughter was diagnosed with Type 1 diabetes, has discovered that the medical community places most of the responsibility for care with patients and often doesn't take into account the need for other support. "That is the number one thing: You don't manage it by yourself," McMahon said. He added that traditionally, the driving force behind new technology has been reimbursement--either government or private--rather than patient needs. With the firsthand perspective of a family affected by diabetes, McMahon developed the GlucoMON as a means of promoting compliance.

In January, Dallas, TX-based Zyvex Corporation, a specialist in micro- and nanomanufacturing, selected Diabetech as its medical device development and commercialization partner for a wireless glucose sensor. This next-generation handheld device, the companies said, will display glucose readings from an implanted sensor and then automatically relay that information in real time to a data transmission device.

The system will be called the Glucose Nanobiosensor Implant.

But How Good Are the Data?

McMahon said another problem with current testing technology is that readings are not reliable. An error of 10% or 15% in recorded glucose levels is not unusual or alarming, he said, but he estimated that up to 50% of monitors are giving false readings because their internal clocks were not set properly.

He would like continuous monitoring devices to become more widely available, freeing patients from the need to proactively test their blood.

McMahon's view is getting support from the Diabetes Technology Society (DTS), an organization based in Foster City, CA. In the society's efforts to promote innovation in diabetes care and treatment, the DTS teamed up last year with the Clinical Laboratory Standards Institute to develop a consensus guideline for continuous glucose monitoring. According to David Sterry, a member of the joint standards committee, proposed standards may be ready for release as soon as this month.

In a statement, the DTS said the standards would address the fact that "there is no current consensus on how to compare [continuous glucose monitoring] CGM devices, how to define the appropriate level of agreement given the time lag between blood and interstitial fluid levels [that the CGM devices are designed to measure] or how to display and interpret data."

The DTS, which publishes the Journal of Diabetes Science and Technology, recently reviewed errors in glucose testing at the point of care and reported in its March issue that "imprecision of plus or minus 16%" is considered acceptable. Elsewhere in the same issue, researchers who studied the accuracy of data from devices for self-monitoring concluded that "the recommended allowable meter error ... can be realistically set at 10%."

Delivering Insulin

Along with monitoring their blood sugar, many patients with diabetes must contend with the need for administering daily insulin. Manufacturers know that devices that release insulin into the body continuously, at rates computed to correspond to changing glucose levels related to food intake and physical activity, are far more effective at managing diabetes than are periodic injections. However, at $6,000 for some of the latest models, automatic pumps barely have penetrated the market, leaving most patients to inject themselves with needles. For the moment then, making injections as safe, painless and convenient as possible is the key to winning customers.

As one example of a growing trend toward safety needles, in late March, BD Medical-Diabetes Care, a unit of BD (Becton, Dickinson and Company) in Franklin Lakes, NJ, began offering its AutoShield safety pen needle in the United States. The pen has passive needle-shielding technology designed to reduce accidental injuries.

To increase patient comfort, the company also markets the Ultra-Fine III Mini Pen Needle as "the shortest pen needle in the world." BD's Dun Laoghaire, Ireland plant produces two billion diabetes pen needles annually and expects to double that number by 2010.

With the need to respect consumer preferences, many syringes/needles used to administer insulin are designed to resemble writing pens, as they are more attractive than clinical hypodermics. The latest innovation in pen needles is the HumaPen line that Lilly introduced in February. The HumaPen Memoir resembles a fountain pen and allows the user to bring up a display showing the time and dosage of the last 16 injections.

In April, Lilly introduced the HumaPen Luxura HD model, manufactured by Phillips Plastics in Phillips, WI. The Luxura delivers insulin in smaller increments, ranging from one to 30 units. Phillips Plastics has partnered with Lilly for more than 10 years to develop and manufacture devices for diabetes treatment and care. Dr. John Lechleiter, president and chief operating officer of Eli Lilly, recently visited Phillips Plastics' facility to recognize the company's efforts in helping to create and launch the Luxura HD.

At the top of the insulin delivery scale are pumps that release continuous, finely calibrated doses of insulin throughout the day. Insulin pumps deliver rapid- or short-acting insulin 24 hours a day through a catheter placed under the skin and taped in place. Patients program them to set basal rates and schedule bolus doses before meals. Unlike manual injections, pumps use faster-acting forms of insulin. The ability to deliver a consistent level of the hormone results in better glucose management and, therefore, less chance of complications.

The US insulin pump market, according to an estimate by Frost & Sullivan, was $564.4 million in 2003 and will reach $1.58 billion by 2010.

Medtronic, which currently claims 80% of the insulin pump market, recently unveiled its MiniMed Paradigm system. The MiniMed, with a $6,000 price tag, uses disposable infusion sets that the patient changes every two or three days. The most recent upgrade approaches the goal of an automatic closed-loop system by incorporating a glucose monitoring component that alerts patients to recheck their glucose and recalibrate their dosage.

The next generation, the company predicts, will include pre-filled insulin reservoirs and an implantable insulin pump that already has been approved for marketing in Europe. Medtronic also offers an implantable pump (the Model 2007) in Europe that releases short pulses of highly concentrated insulin into the peritoneal cavity.

Abbott, along with manufacturing partner Smiths Medical, has introduced a combination product based on the Deltec Cozmo insulin pump and CoZmonitor powered by

Abbott's FreeStyle glucose monitoring software.

Along with these examples of innovation in insulin delivery, other devices are in the works, including jet injectors and transdermal patches.

The Holy Grail

Looking back to the beginning of this article, where the "ultimate device for diabetes" was described, there is one in development--and industry sources predict it could be a reality within three to seven years. The closed-loop pump-monitor system is considered the most efficient and effective way to manage diabetes.

The monitoring and pump technology already exist, but the missing link at this point is a computer algorithm that can accurately translate glucose levels into insulin doses and administer them without input from the patient.

"A closed-loop system, also commonly referred to as an 'artificial pancreas,' is the holy grail of diabetes technology," said Donaldson of Abbott. "However, the development of sophisticated algorithms to calculate insulin requirements in a closed-loop system to effectively mimic a functioning pancreas would be the next step, and this is a complex endeavor."

Prabakar agreed, having noted, "Integration to achieve a closed-loop system is the main challenge here."

However, Buse of the ADA sees it differently. He believes that the computer technology already is in place, but that it's a matter of experience. "I think what we don't have is the experience to feel comfortable with the technology ... it's a leap of faith," he said.

According to Diabetech's McMahon, the important thing is to keep trying. "We may never get to that endpoint," he said, "but there will be a lot of innovation along the way."

Paula DeJohn has written about manufacturing and healthcare supply-chain topics for more than a decade, and has served in editorial positions at Wire Journal International and Hospital Materials Management. She lives in Aurora, CO.

Paula DeJohn

Contributing Writer
COPYRIGHT 2007 Rodman Publishing
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Author:DeJohn, Paula
Publication:Medical Product Outsourcing
Date:May 1, 2007
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