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New Tools 2010
Despite the economic downturn, diabetes research and development continued in 2010, although fewer new drugs and products came on the market than in recent years. Manufacturers aimed to make blood glucose monitoring and insulin injections more comfortable with a new lancing device and a shorter pen needle. In blood glucose meters, a gaming system–compatible meter was released, with the goal of encouraging kids to monitor more frequently and learn how to manage their diabetes. The new drugs and devices included in this article were released after the publication of our 2009 round-up, or in some cases have projected release dates early in 2011. Contact information for each product manufacturer is included so you can find out more if you wish.
Blood glucose meters
What it does: The no-code Didget is designed to make diabetes self-management fun and rewarding for children. It comes packaged with a video game and is compatible with the Nintendo DS and Nintendo DS Lite gaming systems. The Didget also allows the user to connect to a password-protected online community, Didget World (http://didgetworld.us). Children win points for checking their blood glucose regularly and for reaching target blood glucose levels. These targets can be customized through the Didget World Web site, and points can be redeemed there to progress through the game.
The Didget requires a 0.6-microliter blood sample and delivers results in 5 seconds. The meter saves up to 480 results in its memory. The Didget also includes two testing levels: one for use with younger children, and one that includes more customizable features for older kids. Basic Mode (L1) provides a 14-day blood glucose average and a 7-day summary of high and low blood glucose readings. Advanced Mode (L2) offers the same features, as well as 7- and 30-day blood glucose averages, the ability to tag results as pre- or post-meal, and personalized blood glucose target levels, as well as a customizable reminder to check after-meal blood glucose. The Didget is not approved for alternate-site testing.
Product: Fora D20 and G90
Manufacturer: ForaCare, Inc.
What it does: ForaCare’s D20 meter is a two-in-one blood glucose and blood pressure monitor that comes with an auto-inflating upper arm cuff. It displays heart rate and blood pressure information as well as blood glucose level. The D20 can keep up to 450 results, marked with date and time, in its memory and can calculate 7-, 14-, 21-, 28-, 60-, and 90-day averages. The meter also has a talking function that voices instructions and results in English or Spanish. The G90, which measures only blood glucose, uses an animated navigation menu of pictures in addition to words. The meter can also display charts of blood glucose trends. The G90 has a rechargeable battery and a one-touch strip ejection button that makes it possible to remove strips from the meter without touching them. It can store 400 results, which can be marked as pre- or postmeal.
Both the D20 and the G90 meters are no-code and require a 0.7-microliter blood sample, which can be drawn from the palms, forearms, upper arms, calves, and thighs, and provide results in 7 seconds. These results can be uploaded to a computer wirelessly or via a USB or Ethernet port and analyzed using ForaCare’s TeleHealth system.
Availability: ForaCare meters are available through www.amazon.com and durable medical equipment providers.
Product: Glucocard Vital
What it does: The auto-coding Glucocard Vital requires a 0.5-microliter blood sample that can be drawn from the palms or the fingertips and delivers results in 7 seconds. Up to 250 results can be stored in the meter’s memory, including time and date information for each result. The Glucocard Vital also provides 14- and 30-day blood glucose averages.
Availability: The Glucocard Vital is available from many online retail stores.
Product: GM100 (pictured above) and GM550
What it does: The GM100 meter requires a blood sample volume of 1.4 microliters and provides results in 8 seconds. It can store up to 150 results in its memory, along with time and date information for each.
The GM550 is smaller than the GM100 and requires a smaller blood sample (1.0 microliter) and less time to return results (5 seconds). It has a memory capacity of 500 results with time and date information, and it provides 7-, 14-, 30-, and 90-day blood glucose averages. Neither meter requires coding, and blood samples for either can be drawn from the finger, palm, or forearm.
Availability: The GM100 and GM550 are available at independent pharmacies and retailers.
Product: OneTouch Delica
Manufacturer: LifeScan, Inc.
What it does: The OneTouch Delica lancing device has seven different depth settings, uses 33-gauge OneTouch Delica lancets, and is engineered to insert and withdraw the lancet from the skin smoothly, with minimal vibration, for less painful blood sampling.
Availability: OneTouch Delica lancets and lancing devices are available online and in pharmacies.
Product: Ultra-Fine Nano
What it does: The short length of Ultra-Fine Nano pen needles — 4 millimeters — is intended to make them appear less intimidating to users and to make injections less painful. The 32-gauge needles screw on to pens and are compatible with all insulin pens sold in the United States.
Availability: Ultra-Fine Nano pen needles are available by prescription.
Product: Freestyle and FreeStyle Lite (pictured above)
What it does: The new FreeStyle and FreeStyle Lite test strips use an enzyme that prevents them from reacting to any sugar other than glucose, lowering the risk of an incorrect test result. Many other test strips use what is called the GDH-PQQ enzyme to measure blood glucose, but after reports of health problems linked to false high blood glucose readings in people being monitored with these strips, the FDA recommended last year that use of these strips be avoided in certain situations. To bypass the issue entirely, the Freestyle series of strips uses a GDH-FAD enzyme to determine blood glucose levels.
Availability: FreeStyle Lite test strips are available online and in pharmacies.
What it does: AmbiMed, Inc. has rereleased the Inject-Ease, which was originally manufactured by Palco Labs. Designed for people, especially children, who are afraid of needles or reluctant to perform injections, the Inject-Ease is a plastic housing that fits around BD 30-, 50-, or 100-unit disposable syringes. The user holds the Inject-Ease against the skin and presses a button to quickly insert the needle, reducing the risk of injections made more painful by hesitation or uncertain technique. Spacer rings on the injector allow for customizable depth of injections.
Availability: The Inject-ease is available at many online retailers.
Product: MiniMed Paradigm REAL-Time Revel System
What it does: The REAL-Time Revel System pairs either the Revel 523 or Revel 723 insulin pump with a glucose sensor. (The two pumps are identical, except that the Revel 523’s reservoir holds 176 units of insulin, and the Revel 723 holds up to 300 units. Both pumps can deliver insulin in increments of as small as 0.025 units per hour.) The glucose sensor is inserted into the abdomen at least two inches away from the pump cannula. It measures glucose levels in the interstitial fluid in the fatty tissue under the skin using a tiny electrode. The sensor is attached to a battery-operated transmitter, which sends information to the pump. As long as the transmitter is within 6 feet of the insulin pump, information from the glucose sensor will be displayed on the pump’s screen in real time. However, to use the pump’s bolus-calculator program to help determine how much insulin to administer, if any, the user must check his blood glucose level with a conventional meter and enter the result.
The REAL-Time Revel System offers a series of customizable alerts, including alerts for high or low glucose targets set by the user, and rate-of-change alerts that let the user know when his glucose level is changing quickly. The pump can also display 3-, 6-, 12-, and 24-hour graphs of glucose levels. Both the infusion set for the pump and the glucose sensor must be replaced every three days.
Availability: For information on how to get the MiniMed Paradigm REAL-Time Revel system, visit www.minimed.com/products/insulinpumps/start/index.html
Manual insulin delivery system
Product: IQ Patch
What it does: Prodigy’s IQ Patch includes a 200-unit insulin reservoir that attaches to the body with an adhesive. Basal insulin is delivered through a needle on the back of the Patch; bolus insulin is delivered by sliding a blue “activator” on the corner of the Patch that releases one unit of insulin at a time. The IQ Patch is waterproof and tubeless; it can be attached to the body continuously for three days, after which the Patch must be replaced, just like a standard infusion set.
Availability: The Prodigy IQ Patch is expected to be available in March 2011.
Product: Humulin ReliOn
Details: Lilly and Walmart have joined forces to offer Lilly’s Humulin (human insulin) under the name Humulin ReliOn in all Walmart stores. Insulins available in dual-branded versions will include Humulin R, Humulin N, and Humulin 70/30 (70% human insulin isophane suspension, 30% human insulin injection). Humulin ReliOn is part of Walmart’s ReliOn series of diabetes management products, which offer brand-name drugs and devices at lower prices.
Availability: Humulin ReliOn is available in WalMart stores nationwide.
Product: Liraglutide (Victoza)
Manufacturer: Novo Nordisk
What it does: Victoza is the second drug in the class known as GLP-1 agonists — joining exenatide (brand name Byetta) — to be approved by the US Food and Drug Administration (FDA) for the treatment of Type 2 diabetes. These drugs stimulate the pancreas to release insulin and to stop releasing glucagon, a hormone that signals the liver to release stored glucose. They also signal the pancreas to release amylin, a hormone that sends feelings of fullness to the brain, and they slow gastric emptying, which prolongs feelings of fullness. Like Byetta, Victoza is only approved for adults. The drug is injected once a day under the skin of the abdomen, thighs, or upper arms from a prefilled pen. (The pen takes only Novo Nordisk’s NovoFine pen needles, which are sold separately.) Victoza can be taken alone or with oral diabetes medicines, but it has not been studied in combination with insulin.
Victoza should not be used by people at high risk for developing pancreatitis or at risk for developing medullary thyroid cancer. Common side effects include headache, nausea, and diarrhea, as well as allergic symptoms such as hives.
Availability: Victoza is available in doses of 0.6, 1.2, and 1.8 mg.
Drug labeling change
Product: Orlistat (Xenical, Alli)
Reason for label change: The FDA is adding safety information about the risk of severe liver damage to the labels of both Genentech’s prescription Xenical and GlaxoSmithKline’s over-the-counter Alli. The labeling directs people taking orlistat to be alert to signs and symptoms of liver damage, such as yellow eyes or skin, itching, light-colored stools, dark urine, or loss of appetite. If any of these develop, users should stop taking orlistat and contact their doctors.
Product: Sibutramine (Meridia)
Reason for discontinuation: Abbott has withdrawn the weight-loss drug Meridia from the US market as a result of a request from the FDA. Earlier in 2010, the FDA asked Meridia to add a contraindication to its label that states in stronger terms that people with a history of cardiovascular disease (including coronary artery disease, stroke, congestive heart failure, peripheral arterial disease, or uncontrolled high blood pressure) should not use the drug. However, after reviewing data from a clinical trial intended to evaluate the drug’s safety that indicated an increased risk of heart attack and stroke, the FDA requested the withdrawal in October 2010. Health-care providers are advised to stop prescribing Meridia; people taking it should stop immediately and talk to their doctors.
Product: Lilly Prefilled Pen
Details: Lilly will stop manufacturing its original Prefilled Pens on January 1, 2011 — these include pens containing Humalog (insulin lispro), Humalog Mix 75/25 (75% insulin lispro protamine suspension and 25% insulin lispro injection), and Humalog Mix 50/50 (50% insulin lispro protamine suspension and 50% insulin lispro injection). There is currently a limited supply of these pens: Availability depends on your local pharmacy’s stock, and the pens may already be unavailable in some areas. Humalog insulin is still available in Lilly’s KwikPen line of prefilled pens.
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