Overview

Insulin
Insulin Syringes 
For now, insulin is injected subcutaneous (under the skin) to be effective. Injection with a needle and syringe—which, for years, was the only available option—remains the predominant choice for most insulin-treated patients in the United States today. Fortunately, the devices currently available—disposable, lightweight syringes, with shorter, ultra fine needles—have made daily injections more convenient and less painful than ever before. With proper training and practice, most people with diabetes become extremely proficient at self-injection. One advantage of syringes is the wide variety of sizes and styles. When deciding what is most appropriate for diabetics needs, consider the syringe capacity, ease of use, and readability. Syringes may also be best for those who must mix different types of insulin into one dose; pen injectors offer less flexibility. Syringes and insulin vials are bulkier than insulin pens, and may not be convenient for people with active lives. In addition, manipulating syringes and vials may be too difficult for people with limited manual dexterity—for example, those with arthritis or tremors. 
Insulin Pen
s
Insulin pen injectors combine an insulin container and syringe into one compact device. Two types are available: reusable and prefilled. With reusable pens, patients load a cartridge of insulin into the pen, attach a needle, and "dial in" the dose before pressing a plunger to administer the injection. The prefilled pens are easier to use—they contain a built-in insulin cartridge, and are discarded after the insulin is gone—but they may be more costly than reusable pens. Insulin pens are more convenient and portable than syringes and bottles of insulin. In addition, patients are often more accurate at measuring doses with pens than with syringes. Some patients find using insulin pens more comfortable than using syringes; because the pen needle does not have to penetrate a rubber stopper first, it is sharper and the injection may be less painful. However, the pen needle must be left in the skin slightly longer than with a syringe injection. Pens may be easier to use than syringes for people with poor physical coordination. Some pens have large-print numbers and audible clicks to measure the dose as it is dialed in, which may benefit those with impaired vision. Pens may not be the best choice for people who must take very large insulin doses. A major drawback to most pens is that they do not permit you to mix different types of insulin; thus, two injections are needed. One new model, however, allows patients to fill the pen from a standard insulin vial, and thus to personalize mixtures of insulin.  Pens are somewhat more expensive than syringes.
Jet Injectors
Jet injectors use a high-pressure jet of air to send a fine stream of insulin through the skin. While the elimination of needle sticks may sound appealing, these devices have had only limited use so far. Jet injectors deliver accurate doses that are more rapidly absorbed than subcutaneous injections. They may be of particular benefit for patients who have an extreme fear of needles. These devices are bulkier than syringes, however, and also require the user to carry vials of insulin. They must be cleaned every two to three weeks (though newer models have disposable nozzles). Some people find jet injectors no less painful than needles. They may still cause pain and bruising at the injection site, and can damage the skin if not used properly. Jet injectors are expensive.
External Insulin Pumps
Recent technological advances have lead to smaller, easier to use, and more comfortable external insulin pumps—making them an ideal option for carefully selected patients. About the size of a pager, these computerized devices are usually worn discreetly on a belt or placed in a pocket. Insulin passes from a reservoir within the pump, through a thin, flexible tube, to a fine needle inserted beneath the skin and taped in place. Also known as continuous subcutaneous insulin infusion, this method delivers a constant, measured amount of insulin throughout the day; in addition, patients simply press a button on the pump to release a supplemental dose before each meal. Patients adjust the size and timing of these bolus doses.  The basal rate of insulin can be adjusted. The pump also makes it easier to adjust mealtime bolus doses. Often, therefore, better blood glucose control may be achieved than with standard self-injections. In addition, the pump offers greater convenience and a more flexible meal schedule, which may particularly benefit people who are very active or who travel frequently. Most people find the pump quite comfortable, even during vigorous activity. The pump unit is waterproof, or has a waterproof pouch, and so can be worn during bathing. It can also be removed for brief periods, like during exercise or for special occasions. However, pump therapy is only appropriate for people who are highly committed and responsible. Since the pump uses only rapid-acting insulin, any sort of malfunction such as a detached needle, blocked tubing, or battery failure—causes a rapid drop in blood insulin levels; dangerously high blood glucose levels can develop within hours. For this reason, patients must frequently monitor blood glucose levels throughout the day, and diligently keep their pump in working order. This includes making sure the basal rate is set correctly, checking the tubing for blocks or kinks, keeping the insulin reservoir full, and changing the infusion needle every two to three days to prevent infection. Moreover, Pump therapy is expensive.
Insulin Patch
Development of the patch, or U-Strip, began in February 2000, and the group will soon be sending its data to the Federal Drug Administration to gain permission to begin human clinical testing. The patch is about to begin its second round of animal testing, and hopes to be able to begin human clinical trials of the product by the end of the year. U-Strip works somewhat like a nicotine patch and is one of the first non-invasive insulin treatment devices ever. The patch is placed on the arm and activated by an ultrasound device. "Ultrasound waves cushion the drug through your hair follicles," Redding said. "Usually the molecule size is too large to allow [insulin] to pass through, but with our technology it can." Unlike other non-invasive procedures currently under experimentation, the patch would not cause damage to the area of the body it is applied to. "We have already done tests for rashes," he said, "and there has been no discoloration, no burning, no itching, no reaction. The ultrasound device used to transport the insulin from the patch into the pores is low in voltage -- only one-fifth the power of a sonic toothbrush. "This is generally not enough power to cause damage to skin tissue," he said. "We have done tests on animals and human skin samples, but some things you never can tell."
Glucose Monitor - GlucoWatch Biographer
The GlucoWatch could be the next step towards an artificial pancreas, releasing both type 1 and type 2 diabetes patients from a lifetime of monitoring blood sugar levels, adjusting insulin and other medications, and freeing up diabetes patients from worries about hypoglycemia. Cygnus' GlucoWatch enables people with diabetes and their physicians to identify trends and track patterns in fluctuating glucose levels that would be difficult to detect with current testing techniques alone. The GlucoWatch Biographer is comprised of two components: a durable component known as the Biographer, and a consumable component known as the Auto Sensor, which measures glucose for up to 12 hours. The GlucoWatch Biographer differs from other glucose measuring systems in several important ways.

Cygnus' GlucoWatch Biographer: is non-invasive, collecting glucose through the skin, not from blood, automatically measures and displays glucose levels, detects trends and tracks patterns in glucose levels as opposed to a single, discrete reading, alerts a patient when glucose levels are too high, too low, or declining too rapidly, stores up to 4,000 glucose values in an electronic diary that can be reviewed at the touch of a button. The GlucoWatch Biographer is designed to be worn during the day or night for glucose monitoring and is expected to mitigate the lack of frequent monitoring due to the pain and disruption of repetitive finger sticking. The Biographer uses proprietary algorithms and performs multiple data integrity checks in order to effectively track trends and patterns in glucose levels. The GlucoWatch Biographer has been designed to recognize fluctuating skin conditions, such as perspiration, and will automatically exclude a reading in order to preserve the integrity of the data.
Components
Technical Plan
Management Plan
Testing Plan
Budget
Risks and Mitigators
Home