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New Tools 2009
All year long, research and development teams work to top themselves, coming up with new ways to empower people to better control their diabetes. More than a few notable products came out of this year’s efforts — including some new drugs and devices, as well as improvements on existing ones. Several devices were aimed at making insulin injections easier and less painful, an array of new meters offered specific features for a variety of special needs, and a new insulin pump manufacturer joined the marketplace while another exited.
Blood glucose meters
Product: Accu-Chek Compact Plus
Manufacturer: Roche Diagnostics
What it does: The Accu-Chek Compact Plus’s “all in one” design includes a drum of 17 preloaded test strips and a detachable Accu-Chek Softclix Plus lancing device, which offers 11 different depth settings. The meter requires a 1.5-microliter blood sample, which can be drawn from the fingertips, palms, forearms, upper arms, thighs, or calves, and delivers results in 5 seconds. The Accu-Chek Compact Plus saves up to 500 readings in its memory, and can provide 7-, 14-, and 30-day blood glucose averages. The meter does not require coding when starting a new drum of test strips.
Availability: The Accu-Chek Compact Plus is available in most pharmacies.
Product: Contour USB meter
What it does: The design of Bayer’s no-code Contour USB meter, in a first for blood glucose meter technology, incorporates a USB connector that allows the user to connect it directly to a personal computer without the use of a cable. The meter is preloaded with Bayer’s Glucofacts Deluxe diabetes management software, which offers several different glucose data reports when the meter is plugged in to a computer. The meter requires a 0.6-microliter blood sample and returns readings in 5 seconds. It can store up to 2,000 glucose readings that can be marked as pre- or postmeal or by physical condition, such as “sick” or “stressed,” using the Notes feature. The user can also set an alarm on the meter to go off when it’s time to take another reading. It includes 500 MB of additional memory to store other diabetes information — the extra space appears as a separate disk on the desktop of a personal computer — which can be edited while the meter is connected to the computer.
Availability: The Contour USB meter will be available in November 2009 at select online pharmacies; a list of these pharmacies can be found at www.bayercontourusb.com.
Product: Fora D10, D15g, V10, V20, and G20
Manufacturer: ForaCare, Inc.
What it does: ForaCare’s D10, D15g, V10, V20, and G20 family of blood glucose meters are all very similar to each other, but each has a feature or two to separate it from the pack. Most notably, the D10 and D15g are both two-in-one blood glucose and blood pressure monitors. The D15g comes with a detachable blood pressure cuff that fits around the upper arm — at the push of a button, it displays heart rate and blood pressure information. The D10’s cuff fits around the wrist.
All of the meters except the D15g (which has a memory of 352 readings) have a talking function that voices instructions and readings in Spanish or English and can store up to 450 readings with date and time in their memories. The V20 has navigation buttons that allow the user to search through or repeat readings and instructions. The V10, V20, and G20 are no-code meters, and the V20 and G20 include an ejection button, making it possible to remove used strips from the meter without touching them.
All five of the meters require a 0.7-microliter blood sample, provide results within 7 seconds, and allow for alternate site samples from the palms, forearms, upper arms, calves, and thighs. All five can be connected to a personal computer via a USB port (or, in the case of the D15g, wirelessly using ForaCare’s Gateway data transfer system) to upload and analyze data with the company’s FORA Health Care System software.
Availability: ForaCare meters are available through durable medical equipment providers.
Product: Glucocard 01 and Glucocard 01-mini
What it does: The Glucocard 01 is an auto-coding meter requiring a 0.3-microliter blood drop, which can be drawn from the fingertips or palms. Readings are returned in 7 seconds, and up to 360 results can be held in the memory. Additionally, averages can be calculated for 14- and 30-day periods.
The Glucocard 01-mini shares its required blood sample size and time needed to return a reading with its larger sister pump, but has some notable features of its own. It is smaller than the Glucocard 01, and users can order colorful, interchangeable faceplates to customize it. The meter can calculate a 7-day average as well as a 14- or 30-day average and can hold 50 readings in its memory; these readings can be “flagged” to indicate whether they were taken pre- or postmeal.
Availability: The Glucocard 01 and the Glucocard 01-mini are available from many online retail stores.
Manufacturer: Entra Health Systems
What it does: The auto-coding MyGlucoHealth meter is equipped with Bluetooth technology that allows it to transfer blood glucose readings wirelessly to a computer, where they can be analyzed and sent to health-care providers using the MyGlucoHealth Patient Analytics Portal at www.myglucohealth.net. The Patient Analytics Portal includes an online logbook program, as well as online meter support and guides. The MyGlucoHealth meter requires a 0.3-microliter blood sample, which can be obtained from multiple sites, and returns results in 3 seconds or less. More blood can be applied to the test strip for up to a minute if the first sample isn’t enough.
Availability: The MyGlucoHealth meter is available from the MyGlucoHealth online store at www.myglucohealthstore.com.
Product: Prodigy AutoCode and Prodigy Pocket
What it does: The redesigned Prodigy AutoCode meter offers audible readings in English or Spanish within 7 seconds of applying a blood sample to the test strip. The new design includes one-button navigation and a USB port for uploading readings to a computer. As its name implies, it is not necessary to code the meter when starting a new batch of test strips. The meter stores up to 120 blood glucose results with time and date and gives 7-, 14-, and 28-day averages that can be graphed with free software, available for download at www.prodigymeter.com. The meter requires a 0.7-microliter blood sample, which can be drawn from the fingertips, palms, forearms, upper arms, thighs, and calves.
Diagnostic Devices has also introduced the Prodigy Pocket, which includes all the same technology as the AutoCode — minus the option of audible readings — and comes in six different colors.
Availability: The Prodigy Auto-Code and Prodigy Pocket are available through selected major pharmacies.
Product: Apidra SoloStar
What it does: The Apidra SoloStar is a disposable insulin pen that is prefilled with rapid-acting insulin glulisine (Apidra). Injections of rapid-acting insulins are generally taken at mealtimes. The pen holds 300 units of glulisine; once opened, it is safe to use for 28 days if kept at room temperature (below 86°F). Unopened pens should be refrigerated. The Apidra SoloStar is color-coded to differentiate it from Sanofi-aventis’s other SoloStar pen, which is prefilled with long-acting insulin glargine (Lantus).
Availability: Apidra SoloStar is available by prescription only.
Product: Next Generation Levemir FlexPen, NovoLog FlexPen, and NovoLog Mix 70/30 FlexPen
Manufacturer: Novo Nordisk
What it does: The Next Generation FlexPens are a redesign of Novo Nordisk’s older FlexPens, with some key upgrades. The newer, prefilled pens require 30% less force to inject insulin, and their labels, packaging, and the pens themselves are all color-coded by insulin type to prevent dosing mix-ups. Each pen holds 300 units of insulin, and all three pens can deliver up to 60 units of insulin at a time. The NovoLog Mix 70/30 FlexPens can be kept at room temperature for up to 14 days, the NovoLog pens up to 28 days, and the Levemir pens up to 42 days. If too high a dose is dialed accidentally, the dosage knob can be turned back to correct it. The knob also returns itself to zero to indicate a successful injection.
Availability: Next Generation FlexPens are available by prescription only.
Pen needles and lancets
Manufacturer: Can-Am Care
What it does: Clickfine pen needles can either be screwed on to an insulin pen in the traditional manner or snapped on with an audible click, a feature intended to make attaching a pen needle faster and easier, especially for users with visual impairment. The needles come in three sizes and are compatible with all major brands of insulin pens.
Availability: Clickfine needles are available online and in pharmacies.
Manufacturer: Novo Nordisk
What it does: NovoTwist needles are designed with a fitting that allows the user to twist the needle onto a pen in one motion, instead of having to screw it on with repeated twists. When the needle is attached, the user can both hear a click and feel the connection. NovoTwist needles are available in two lengths (5 mm and 8 mm) and have extra-thin walls to deliver more insulin in a smaller needle gauge with less effort. The needles are currently compatible with the Next Generation FlexPen, and future versions of Novo Nordisk pens will be designed to work with them.
Availability: NovoTwist needles are available in most pharmacies.
Product: Tiniboy lancets
What it does: Tiniboy lancets are designed to appear less intimidating, especially to children, and are shorter and thinner than other lancets on the market. They are 36 gauge and 0.7 mm long. Tiniboy lancets are compatible with most lancing devices.
Availability: Tiniboy lancets can be ordered directly from the Tiniboy Web site at www.tiniboy.com/lancet.php.
Product: UltiCare Short Pen Needles and UltiCare Insulin Syringes with sharps container
Manufacturer: UltiMed, Inc.
What it does: These individually wrapped, single-use needles and syringes are packaged in a plastic receptacle that doubles as a sharps container. The bottom chamber stores and dispenses unused needles or syringes; the top chamber is a receptacle into which used sharps can be safely discarded. UltiCare short pen needles use the company’s 31-gauge, latex-free Ulti-Fine IV design, and fit onto many popular insulin pens. The UltiCare syringes hold up to 50 units of insulin and have Ulti-Fine II 31- gauge needles. Each container holds 100 needles or syringes.
Availability: A downloadable request form is available at www.ulti-care.com/ultiguard_insulinsyringes.html.
Product: A1CNow Selfcheck system
What it does: The A1CNow Selfcheck test allows users to check their own glycosylated hemoglobin, or HbA1c, levels (a measure of average blood glucose control over the past 2–3 months) at home, without a prescription. The test provides results in 5 minutes, without having to mail a blood sample to a lab, as previous home HbA1c tests have required. Each box contains two tests, the yearly recommended minimum number for people who are consistently meeting their blood glucose goals.
Continuous glucose monitors
Product: Seven Plus
What it does: The Seven Plus, like its predecessor the Seven System, is composed of three separate elements — a sensor, a transmitter, and a receiver. The Seven Sensor Pod contains the sensor, a tiny wire (the thinnest on the market) that is inserted just under the skin to measure glucose levels for up to 7 days. The transmitter snaps into the Sensor Pod (which is secured to the abdomen with water-resistant adhesive) and sends readings to the receiver, which must be within 5 feet of the pod.
The receiver’s home screen can display graphs of 1-hour, 3-hour, 6-hour, 12-hour, and 24-hour glucose trends as well as current glucose readings, and can store up to 30 days of information. Readings can also be uploaded to a computer with DexCom Data Manager 3 software, available for free at the DexCom Web site.
The Seven Plus includes a set of alarms that can be customized by glucose level and alert tone, including a Hypo-Safety-Alarm that lets the user know if his glucose level has fallen below 55 mg/dl.
Availability: The Seven Plus is available by prescription only and can be ordered by calling (888) SEVENGO (738-3646).
Product: Dex4 Glucose Liquid Blast
Manufacturer: Can-Am Care
What it does: Dex4 Glucose Liquid Blast is a quick, easy way to treat hypoglycemia — each 2-ounce bottle contains 15 grams of carbohydrate to quickly raise blood glucose level. The premeasured portion prevents users from consuming more carbohydrate than is needed and ending up with high blood glucose. Dex4 also makes glucose gels (15 grams of carbohydrate per tube), tablets (4 grams per tablet), and soft glucose chews (1 gram per chew) in several flavors and sizes.
Availability: Dex4 products are available at Costco, Target, many pharmacies, and online through the Dex4 Web site.
Manufacturer: MMJ Labs
What it does: Invented by a pediatric emergency physician, Buzzy is a vibrating motor in a small, bee-shaped plastic housing with optional supplementary ice pack “wings,” designed to alleviate the pain of injections. When turned on and pressed against the skin somewhere between the brain and the area to receive the injection for 10–15 seconds, Buzzy’s thermal and mechanical stimulation confuses the brain, interrupting its ability to process pain. MMJ Labs also offers child-friendly accessories for Buzzy, including decorative stickers, a carrying case, and a set of flash cards with age-appropriate questions to distract children during injections.
Availability: Buzzy is available for purchase at www.needle-pain-management.com.
Product: Solo MicroPump
Manufacturer: Medingo Ltd.
What it does: The Solo MicroPump is comprised of three parts: the MicroPump itself (a reservoir and a pump base that snap together), an infusion set that holds the MicroPump and a cannula in place (called the cradle), and a remote control device. It requires no tubing. The MicroPump’s reservoir holds up to 200 units of insulin, and the pump base stores information about the user’s basal rates, so the right amount of insulin is delivered. The reservoir must be replaced every 2–3 days, but the pump base can be used for 90 days before being replaced.
The cradle delivers insulin through either a 6- millimeter or 9-millimeter cannula and, like a standard infusion set, needs to be replaced every 2–3 days. Medingo recommends placing the pump and cradle on the abdomen or buttocks, but they can also be placed on the upper thighs or upper arms.
Users program the MicroPump with the remote control, which transmits commands to the pump wirelessly; boluses can be delivered by remote or by pushing two buttons on the pump itself. The pump can be easily removed from the cradle for showering or other situations that could damage either the pump or the insulin in the reservoir (using a sauna, for example). In the case of a bad insertion site, only the cradle has to be replaced, not the entire pump and reservoir. The Solo MicroPump is 2.4 inches long, 1.5 inches wide, and 0.54 inch thick; it weighs 0.8 ounces when full, making it slightly smaller and lighter than Insulet’s similar OmniPod.
Availability: The Solo will not be available for purchase until May 2010, but a free demo kit can be ordered from www.solo4you.com.
Product: Bromocriptine mesylate (Cycloset)
Manufacturer: VeroScience, Inc.
What it does: Cycloset is a new version of an old drug, bromocriptine, that has long been used to treat Parkinson disease. It was approved by the Food and Drug Administration (FDA) in May. When used for Type 2 diabetes, Cycloset is taken once daily in the morning with food and within two hours of waking. The drug raises levels of dopamine, a chemical in the brain that affects metabolism, among other processes. The exact mechanism by which Cycloset improves blood glucose control and helps to lower HbA1c is not known, but the drug’s manufacturers believe — based on studies done on hibernating animals and migratory birds, which develop a form of seasonal insulin resistance that allows them to fast for long periods of time — that boosting levels of dopamine once in the morning can “reset” the body’s biological clock for the rest of the day and regulate metabolic processes.
Availability: VeroScience, Inc., which manufactures Cycloset, anticipates its release in early 2010.
Product: Pioglitazone HCl and metformin HCl (ACTOplus met XR)
What it does: The FDA has approved an extended-release formulation of combined pioglitazone and metformin for the treatment of Type 2 diabetes. It is designed to be taken once daily. The two components of the product lower blood glucose in different ways: Pioglitazone (Actos) lowers insulin resistance, and metformin works on the liver to reduce the amount of glucose released into the bloodstream.
ACTOplus met XR should not be taken by people who have heart failure, kidney disease, or metabolic acidosis (excessive acidity of the blood), or by people who drink excessive amounts of alcohol. People who take ACTOplus met XR should be screened for liver problems before and periodically while taking it, and people who already have liver disease should not take ACTOplus met XR.
Availability: ACTOplus met XR is available by prescription only and is expected to be on the market by the end of 2009.
Product: Saxagliptin (Onglyza)
Manufacturer: Bristol-Myers Squibb
What it does: Onglyza is the second drug — joining Merck’s sitaglipin (Januvia) — in a class called DPP-4 inhibitors to be approved by the FDA for the treatment of Type 2 diabetes. Like Januvia, it is currently approved only for use in adults. Onglyza can be taken alone or in combination with other diabetes drugs, including metformin, Actos, Avandia, and those in the sulfonylurea class, which includes glimepiride, glipizide, and glyburide. When taken with a sulfonylurea, a lower dose of Onglyza is recommended to prevent hypoglycemia (low blood glucose). Its use in combination with insulin has not been studied. Onglyza is taken once daily.
Availability: Onglyza is available in 2.5-mg or 5-mg tablets.
Drug labeling changes
Product: Glimepiride (Amaryl)
Reason for label change: Several classes of drugs that can increase the blood-glucose–lowering abilities of Amaryl, a sulfonylurea, to dangerous levels have already been identified by the FDA. This year the agency approved a labeling change that added disopyramide (Norpace and Rythmodan), fluoxetine (Prozac), and the quinolone family of antibiotics to the drugs that could cause hypoglycemia when taken in combination with Amaryl.
Product: Glyburide (Diabeta, Glynase, Micronase)
Reason for label change: The drug glyburide, a sulfonylurea, is what is called “protein bound.” If taken with other drugs that are also protein bound — such as the non-steroidal anti-inflammatory drugs (NSAIDs), which include Celebrex, Motrin, Aleve, and aspirin — the risk of developing hypoglycemia is increased. The labeling change states that people who use glyburide with other protein-bound drugs should be observed closely for low blood glucose.
Product: Insulin aspart (NovoLog)
Manufacturer: Novo Nordisk
Reason for label change: NovoLog, a rapid-acting insulin that can be injected or used in insulin pumps, was originally approved by the FDA to be kept in pumps for no more than two days at a time. The FDA’s labeling change for NovoLog allows the insulin to be stored in pump reservoirs for six full days. The new approval also extends the length of time between pump infusion set changes from two days to three.
Product: Metoclopramide (Reglan, Maxolon, Octamide)
Reason for label change: The drug metoclopramide, which can be used to treat gastroparesis (slowed stomach emptying caused by nerve damage), now must carry a stronger warning to alert doctors and users that people who take the drug for longer than recommended are at risk of developing the neurological disorder tardive dyskinesia. Symptoms of the disorder include repetitive and involuntary movements of the hands, feet, and face, such as lip smacking, excess blinking, and grimacing — these symptoms may persist even after the drug is stopped. Metoclopramide had already carried a warning about the risk of tardive dyskinesia, but the FDA has chosen to intensify that warning in light of continued reports of the disorder associated with its use.
Product: Repaglinide (Prandin)
Manufacturer: Novo Nordisk
Reason for label change: The FDA found that gemfibrozil (Lopid, Jezil, Gen-Fibro) and drugs that block the activity of the protein OATP1B1, such as cyclosporine, decrease the rate at which the body metabolizes Prandin, potentially resulting in too-high levels of the drug in the bloodstream. Prandin’s labels have been updated to indicate that these drugs should not be taken in combination with it.
Product: Deltec Cozmo
Manufacturer: Smiths Medical
Details: Smiths Medical suspended manufacture and sales of the Deltec Cozmo insulin pump in March. The company is honoring warranties for existing pumps (including replacement pumps, if necessary), and providing clinical and customer support. Smiths Medical is no longer directly filling orders of Deltec Cozmo insulin cartridges, infusion sets, and other pump accessories, but these items will continue to be available through distributors.
Product: Humulin 50/50 insulin
Manufacturer: Eli Lilly and Company
Details: According to Eli Lilly and Company, because use of Humulin 50/50 (a premixed insulin consisting of 50% human insulin isophane suspension and 50% human insulin injection) has been steadily declining, the product was discontinued in August. The existing stock of Humulin 50/50 will be sold with a notice on the packaging warning customers of the discontinuation; Lilly expects this supply to last until the end of April 2010.
Product: Novolin InnoLet disposable insulin pen and Novolin PenFill 3-ml insulin cartridges
Manufacturer: Novo Nordisk
Details: The Novolin InnoLet and Novolin PenFill, both previously available in Regular, NPH, and 70/30 (70% NPH, 30% Regular) versions, were discontinued in July. Drugstores will continue selling their inventory of these items until December 31, 2009, but will receive no new product.
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