This year was a busy one for the diabetes market; many more new tools and medicines won FDA approval in 2012 than in recent years. Several drugs combining previously approved diabetes medicines hit the market, as did some new options to treat conditions, such as obesity and macular edema, that often go along with diabetes. On the tools side, a number of new blood glucose meters and insulin pumps debuted, with an emphasis on sleek design and ease of use.
Product: ACCU-CHEK Combo System
Manufacturer: Roche Diabetes Care
What it does: The ACCU-CHEK Combo system includes the ACCU-CHEK Spirit Combo insulin pump and the ACCU-CHEK Aviva Combo meter; Bluetooth technology links the two. The ACCU-CHEK Aviva Combo meter has a color screen that can display the pump’s current screen, if desired. When the user checks his blood glucose level, the meter’s Bolus Advice function helps calculate a bolus to correct it (if necessary). The meter can also display full-color graphs of blood glucose data and calculate averages from time periods of 1 to 90 days with a memory of 1,000 results. It requires a 0.6-microliter sample, and returns results in 5 seconds. The ACCU-CHEK Aviva Combo meter can also set a temporary basal rate function to allow for quick changes in basal rate. The system offers customizable reminders and warnings, including high/low blood glucose results and reminders to check before and after meals.
The corresponding pump can deliver insulin in increments of as small as 0.01 units, with basal rates as low as 0.05 units per hour. (The cartridge itself holds up to 315 units.)
Availability: The ACCU-CHEK Combo system is available from durable medical equipment providers, or you can order it from Roche directly by calling (866) 382-2355.
Manufacturer: Tandem Diabetes Care
What it does: The t:slim is designed to be both easy to use and attractive; it has a backlit color touch screen, is roughly the size of a credit card, and mimics the look of a smartphone. It holds a 300-unit reservoir, and can deliver insulin in increments as fine as 0.001 units per hour. The t:slim can store up to 90 days of data, and programmable alarms can prompt the user to check his blood glucose level, bolus, or change infusion sets. The t:slim also has a micro-USB port for battery charging and data transfer to t:connect, Tandem’s Mac- and PC-compatible diabetes management software.
Availability: For information on how to get the t:slim insulin pump, visit www.tandemdiabetes.com/Products/t-slim/Get-Started.
Insulin delivery device
Manufacturer: Valeritas, Inc.
What it does: The V-Go insulin delivery device is designed to deliver insulin over a 24-hour period and then be discarded; the V-Go 20, 30, and 40 deliver 20 (0.83 units/hour), 30 (1.25 units/hour), and 40 (1.67 units/hour) units of insulin in the course of a day, respectively. Each V-Go also has the capacity to deliver on-demand boluses in 2-unit increments. The V-Go should be used with a fast-acting insulin; Valeritas has successfully tested it with Humalog and NovoLog. The V-Go is only intended for use by adults.
Availability: For information on how to get the V-Go insulin delivery system, visit www.valeritas.com/authorized_distributors.shtml.
Blood glucose meters
Product: ACCU-CHEK Nano SmartView system
Manufacturer: Roche Diabetes Care
What it does: The no-code ACCU-CHEK Nano meter requires a 0.6-microliter blood sample from the fingertip or palm and takes 5 seconds to return results. Each result can be tagged as pre- or postmeal. The meter has a 500-value memory and can calculate 7-, 14-, 30-, and 90-day blood glucose averages. It offers four customizable test reminders and a backlit display.
Availability: The ACCU-CHEK Nano SmartView system can be ordered through many pharmacies and online retailers.
Product: Contour Next EZ
Manufacturer: Bayer Diabetes Care
What it does: The no-code Contour Next EZ uses Contour Next test strips and requires a 0.6-microliter blood sample. It can calculate 7-, 14-, and 30-day blood glucose averages, and blood glucose readings can be marked as pre- or postmeal. The meter allows for customizable high and low blood glucose ranges.
Availability: The Contour Next EZ can be ordered through many pharmacies and online retailers.
Product: Contour Next Link
Manufacturer: Bayer Diabetes Care
What it does: The no-code Contour Next Link meter communicates wirelessly with compatible Medtronic insulin pumps and uses Contour Next test strips. Wireless communication with the Bolus Wizard feature on Medtronic pumps enables the user to modify bolus dosing and calibrate a continuous glucose monitor. It features a full-color display and an autolog feature that allows the user to tag blood glucose results with information about when monitoring was done and how the user was feeling at the time. It also has a USB connection for charging and downloading readings to a Mac or PC computer. The meter requires a 0.6-microliter blood sample; it has a memory of 480 readings and can calculate 7- and 14-day averages.
Availability: The Contour Next Link is only available with Medtronic’s compatible integrated diabetes management systems; the MiniMed Paradigm REAL-Time Revel, the MiniMed Paradigm Real Time insulin pump, and the Guardian REAL-Time continuous glucose monitoring system.
Product: EasyMax V2, EasyPlus R13N, EasyPlus T1, EasyPlus Voice, EM50, EME, EMMU, FortisCare15
Manufacturer: Oak Tree Health
What it does: Oak Tree’s latest meters all share some traits, but each has a feature or two that separates it from the rest. All eight meters require a 0.6-microliter blood sample, and return results in 5 seconds. The EasyPlus R13N, the EasyPlus Voice, and the EasyMax V2 are not approved for alternate site testing, but the other five meters can use blood samples from the fingertip, palm, or forearm. The EasyPlus T1 is a read-only meter with no memory capacity, while the EasyPlus R13N has a memory capacity of 300 results and can alert the user to low blood glucose. The EasyPlus Voice speaks results in English or Spanish and has a memory of 480 results. The EasyMax V2 can store 480 results; the meter also has a light on its strip port (as does the FortisCare 15). The EMMU and EME offer strip ejectors, and the EM50’s design includes a lancing device at one end of the meter and a USB port for connection to a PC computer; the meter is preloaded with diabetes management software. The FortisCare 15, EMMU, EME, and EM50 meters all have a memory of 480 readings. None of the meters requires coding.
Availability: Oak Tree meters are available from durable medical equipment providers and from pharmacies.
Product: FreeStyle InsuLinx
Manufacturer: Abbott Diabetes Care
What it does: The no-code FreeStyle InsuLinx blood glucose meter requires a 0.3-microliter blood sample and returns results in 4 seconds. It has a USB port to connect to a computer (PC or Mac) for uploading results, and its large touch screen with optional backlight allows the user to read three consecutive blood glucose results at a time. The meter allows marking of results as pre- and postmeal, as well as logging of insulin doses. It has a memory of 165 days, assuming three blood glucose readings and three insulin doses daily, and offers a number of customizable alerts and blood glucose ranges.
Availability: The FreeStyle InsuLinx is available at pharmacies and online retailers.
Product: Glucocard Expression
Manufacturer: ArkrayUSA, Inc.
What it does: The auto-coding Glucocard Expression requires a 1-microliter blood sample taken from the fingertip, palm, or forearm, and returns results in 6 seconds. Results can be spoken aloud in English or Spanish, and the meter uses oversized buttons and picture icons to make it easier to use. The meter is capable of storing 300 results in its memory, and can calculate 7-, 14-, and 30-day blood glucose averages.
Availability: The Glucocard Expression is available from many online retailers.
Product: On Call Vivid
Manufacturer: ACON Laboratories
What it does: The On Call Vivid has both a backlight and a strip port light, making it possible to check blood glucose in the dark. The meter also has a strip ejector to allow for strip disposal without touching used strips. The no-code meter provides results from a 0.8-microliter sample in 5 seconds, and can store 500 results and provide 7-, 14-, 30-, 60-, and 90-day averages. The On Call Vivid can alert the user to highs, lows, and the presence of ketones, and offers five customizable test reminders.
Availability: Find distributors of ACON products, including the On Call Vivid, at >www.aconlabs.com/distribution.html.
Product: OneTouch VerioIQ
Manufacturer: LifeScan, Inc.
What it does: The OneTouch VerioIQ’s Pattern Alert system shows full-color, backlit dialog screens alerting the user to blood glucose trends of highs and lows. The user can personalize “high” and “low” thresholds; after two (for lows) or three (for highs) results within the same 3-hour window over a 5-day period, the meter warns of the pattern. The meter has a 750-result memory, and can calculate 7-, 14-, 30-, and 90-day averages. The meter requires a 0.4-microliter blood sample and delivers results in English or Spanish. In low light, the meter automatically lights up for use when a test strip is inserted.
Availability: The OneTouch VerioIQ is available at many retailers.
Phone compatible devices
Product: Glooko Logbook and MeterSync Cable
What it does: Glooko is a cable connector paired with an app; the cable connector links the user’s blood glucose meter or meters to an iPhone, and the app allows information to be downloaded and read on the phone. The Glooko app acts as a logbook, with the ability to tag results with the time and situation in which they were taken and other useful information. The logbook can be e-mailed or faxed to health-care professionals.
Availability: The Glooko app is free to download from Apple’s App Store; the MeterSync cable connector is available from the Glooko Web store. Check to see if your meter is compatible with it by visiting www.glooko.com/purchase/logbook.
Manufacturer: Sanofi Diabetes
(855) iBGStar (424-7827)
What it does: Sanofi’s iBGStar meter connects directly to an iPhone or iPod Touch for analyzing monitoring results. The no-code meter requires a 0.5-microliter sample taken from the fingertip, palm, or forearm and can store 300 results in its memory. (A complementary iBGStar app allows the user to store more results on his Apple device.) The meter can calculate 7-, 14-, and 30-day averages, and with the app, the user can tag results with information, including carbohydrate intake and insulin doses. This data can then be shared with family members or health-care providers.
Availability: The iBGStar is available from Walgreens and DiabeticCareServices.com.
Product: BD Ultra-Fine Nano
Manufacturer: BD Diabetes
(888) BDCARES (232-2737)
What it does: The redesigned BD Nano pen needle is only 4 millimeters (mm) long, and has a PentaPoint, or five-bevel, needle tip (bevels are the slanted surfaces on a needle that create a sharp point; most needles have three bevels) resulting in a flatter overall needle surface. This is intended to decrease the force required to pierce the skin, and thus minimize any associated pain. BD Nano pen needles are compatible with all diabetes pens.
Availability: BD pen needles are available at pharmacies and online retailers.
Product: Unifine Pentips Plus
Manufacturer: Owen Mumford
What it does: The Unifine Pentips Plus pen needle includes a needle remover in its packaging. It can be used with any diabetes medicine injection pen, and the used needle can be discarded into a removal container in the back of the pen package. The needles are lubricated with silicone for less-painful injections, and are available in 5-mm, 6-mm, 8-mm, and 12-mm lengths.
Availability: Unifine Pentips Plus pen needles are available from a number of online retailers.
Remote glucose monitor
Product: mySentry Remote Glucose Monitor
Manufacturer: Medtronic, Inc.
What it does: Medtronic’s mySentry system is designed to allow parents and other caretakers of people with diabetes, who often must wake up several times a night to perform a blood glucose check, to do so from their bedsides. The mySentry system consists of an Outpost that transmits blood glucose information from a MiniMed Paradigm REAL-Time Revel pump to the other part of the system, the Monitor, which has a color screen that displays the information. The mySentry system can be placed up to 50 feet away from the pump, making it possible to remotely monitor readings from a person in another room. The system receives the same alerts as the pump does, including threshold alerts for when high or low settings have been exceeded and predictive alerts up to 30 minutes in advance of highs or lows. The mySentry’s touch-sensitive screen has an adjustable light setting and a privacy setting that hides blood glucose readings.
Availability: The mySentry system is available from diabetes product distributors, or you can order it directly from Medtronic at http://my.medtronicdiabetes.com.
Product: ACCU-CHEK FastClix
Manufacturer: Roche Diabetes Care
What it does: The ACCU-CHEK FastClix lancing device works with the ACCU-CHEK FastClix lancet drum, which is preloaded with six lancets. The Comfort Dial at the bottom of the lancing device allows the user a choice of 11 different depth settings that determine how far the lancet penetrates into the skin. A lancet counter at the bottom of the device shows how many lancets are left. To use the lancing device with alternate sites, call the ACCU-CHEK Customer Care Service Center at (800) 858-8072 to receive a free alternate site testing cap that fits over the front of the device.
Availability: The ACCU-CHEK FastClix is available from the ACCU-CHEK eStore (www.accu-chek.com/us/estore/index.html) and from pharmacies.
Product: BD Insulin Syringes
Manufacturer: BD Diabetes
(888) BDCARES (232-2737)
What it does: BD insulin syringes have been redesigned this year with new 6-mm Ultra-Fine needles, designed to cause less pain and to reduce the risk of accidentally injecting medicine into muscle.
Availability: BD insulin syringes are available at pharmacies and from online retailers.
Product: Level Life Glucose Gel
Manufacturer: Level Foods
What it does: Level Life Glucose Gel is a new version of the Gluco-Pouch, which was included in “Tools of the Trade” in 2011. Level Life still contains 15 grams of fast-acting carbohydrate in a pouch designed to be strong, yet easy to open; however, the product’s formula has changed, and it is now available in four flavors.
Availability: Level Life products are available at Walmart, Rite Aid, and CVS stores.
Product: Quick Sticks
Manufacturer: Quick Sticks
What it does: Each Quick Sticks pouch contains 10 grams of fast-acting carbohydrate in powder form, as well as 230% of the Recommended Daily Allowance (RDA) of vitamin C. Quick Sticks come in watermelon and sour apple flavors.
Availability: Quick Sticks are available from the Quick Sticks online store; find your nearest distributor at www.quicksticks.com/where-to-buy.
Product: Avanafil (Stendra)
Manufacturer: Vivus, Inc.
What it does Stendra joins sildenafil (Viagra and others), tadalafil (Cialis), and vardenafil (Levitra and others) in the PDE5 inhibitor class of drugs, prescribed to treat erectile dysfunction and certain other conditions. These drugs work by blocking the function of a specific enzyme in the blood vessels; this allows blood vessels to expand and improves blood flow. For men with erectile dysfunction, this translates to improved ability to maintain an erection. Do not take Stendra if you are also taking nitrates for chest pain; if you experience a sudden decrease or loss of vision or hearing, contact your doctor immediately. Headache, flushing, runny nose, and congestion are the most commonly reported side effects of Stendra.
Availability: Stendra is available in 50-, 100-, and 200-milligram (mg) tablets, and should be taken 30 minutes before sexual activity.
Product: Exenatide extended-release for injectable suspension (Bydureon)
What it does: Bydureon is an extended-release version of Byetta, which was approved by the FDA in 2005, and also joins liraglutide (Victoza) in the GLP-1 agonist class. These drugs work by stimulating the pancreas to release insulin and to stop releasing glucagon, a hormone that raises blood glucose level. Bydureon is injected once a week, with or without food, under the skin of the abdomen, thighs, or backs of the upper arms. People who are at risk for developing thyroid cancer, or who have had thyroid cancer, should not use Bydureon. The FDA has required Amylin, the drug’s manufacturer, to perform further studies on the drug’s effect on thyroid cancers and on a person’s risk of having a cardiovascular event (such as a heart attack). Pancreatitis (inflammation of the pancreas) is a serious side effect of exenatide; the most common side effects include nausea, diarrhea, headache, vomiting, and constipation.
Availability: Bydureon is available in a 2-mg dose, packaged in a dosing tray that includes a syringe, a vial of medicine, a vial connector to attach the medicine vial to the syringe, and a needle.
Product: Linagliptin and metformin (Jentadueto)
Manufacturer: Boehringer Ingelheim
What it does: Jentadueto combines linagliptin and metformin in a single tablet. Linagliptin (Tradjenta) is a drug in the DPP-4 inhibitor class; these medicines work by stimulating release of insulin from the pancreas and restricting glucose production, delaying stomach emptying, and protecting the health of the body’s remaining beta cells. Metformin (Glucophage and others) works by decreasing glucose production and increasing insulin sensitivity. People with metabolic acidosis (excessive acidity of the blood) or who have kidney problems should not take Jentadueto, and metformin in any combination raises a person’s risk of developing lactic acidosis (a dangerous condition involving a buildup of acid in the blood).
Availability: Jentadueto is available in tablets of 2.5 mg linagliptin/500 mg metformin, 2.5 mg linagliptin/850 mg metformin, and 2.5 mg linagliptin/1000 mg metformin, and should be taken twice a day.
Product: Lorcaserin (Belviq)
What it does: Belviq is approved for long-term weight management, as an addition to a reduced-calorie diet and exercise. The drug works by activating a specific serotonin receptor in the brain; serotonin may help a person eat less and feel fuller longer. People who are obese (with a body-mass index [BMI] of 30 or greater) or who are overweight (BMI 27—29) and have at least one weight-related condition, such as Type 2 diabetes, can take Belviq. Belviq should not be used by women who are pregnant or anyone who is taking certain antidepressants or medicines to treat migraines, and it should be used with caution by people with heart problems. Common side effects in people with diabetes include low blood glucose, headache, back pain, cough, and fatigue.
Availability: Belviq is available in 10-mg doses, and is usually taken twice a day.
Product: Phentermine and topiramate extended-release (Qsymia)
Manufacturer: Vivus, Inc.
What it does: Qsymia is also approved for long-term weight management, as an addition to a reduced-calorie diet and exercise. Qsymia combines two drugs – phentermine, an appetite suppressant, and topiramate, usually prescribed to control seizures. Phentermine was originally prescribed as part of the unsafe diet drug fen-phen; topiramate makes people feel full longer, increases calorie burning, and makes food taste less appealing. Like Belviq (see above), Qsymia is approved for people with a BMI of 30 or greater or who have a BMI between 27 and 29 and have at least one weight-related condition. People with glaucoma, overactive thyroid, recent or unstable heart disease, recent stroke, or who are taking a type of antidepressant known as an MAOI should not take Qsymia. The drug can cause birth defects and should not be used by women who are pregnant. The most common side effects of Qsymia are tingling of the hands and feet, dizziness, insomnia, constipation, and dry mouth.
Availability: Qsymia is available in tablets of 7.5 mg phentermine/46 mg topiramate extended-release and 15 mg phentermine/92 mg topiramate extended-release, and should be taken once a day.
What it does: Pioglitazone is a drug in the class known as thiazolidinediones (the use of the other, rosiglitazone [Avandia], was restricted by the FDA in 2010), which works by increasing the body’s insulin sensitivity. Pioglitazone has been available since 1999 under the brand name Actos, but this year Mylan Pharmaceuticals and Ranbaxy Labs reached a settlement with Takeda, the manufacturer of Actos, to produce a generic version. Generic pioglitazone will carry the same boxed warnings about increased risk of heart failure and bladder cancer as the brand-name version.
Availability: Pioglitazone is available in 15-, 30-, and 45-mg tablets.
Product: Sitagliptin and metformin extended release (Janumet XR)
What it does: Janumet XR combines the DPP-4 inhibitor sitagliptin (Januvia) with the extended-release version of metformin. Like all drugs that contain metformin, Janumet XR comes with a boxed warning about lactic acidosis. The drug should not be taken by people with existing kidney problems, and people taking it should be monitored regularly for pancreatitis and worsening kidney function.
Availability: Janumet XR should be taken with food once a day, preferably in the evening, and is available in tablets of 100 mg sitagliptin/1,000 mg metformin extended-release, 50 mg sitagliptin/500 mg metformin extended-release, and 50 mg sitagliptin/1,000 mg metformin extended-release.
Product: Sitagliptin and simvastatin (Juvisync)
What it does: Juvisync combines sitagliptin (Januvia) and simvastatin (Zocor) in one pill; sitagliptin is a DPP-4 inhibitor, and simvastatin, a statin, lowers LDL (“bad”) cholesterol. Common side effects of Juvisync include upper respiratory infection, stuffy or runny nose and sore throat, headache, muscle and stomach pain, constipation, and nausea.
Availability: Juvisync is available in tablets of 100 mg sitagliptin/10 mg simvastatin, 100 mg sitagliptin/20 mg simvastatin, and 100 mg sitagliptin/40 mg simvastatin.
Drug labeling changes
Product: Tapentadol extended release (Nucynta ER)
(800) JANSSEN (526-7736)
Reason for label change: Nucynta ER (a drug in the class known as opiate analgesics) was approved in 2011 to treat moderate to severe chronic pain that necessitates constant pain management. The FDA has approved it this year specifically to treat pain from diabetic peripheral neuropathy (nerve damage in the feet, legs, and hands). Nucynta ER is taken twice daily and is available in 50-, 100-, 150-, 200-, and 250-mg tablets.
Product: Exenatide (Byetta)
Reason for label change: The FDA has approved the use of Byetta in combination with insulin glargine (Lantus, a long-acting insulin).
Product: Insulin detemir (rDNA origin) injection (Levemir)
Manufacturer: Novo Nordisk
Reason for label change: The FDA has approved Levemir for use by pregnant women with diabetes after the results of a clinical trial indicated that the drug did not increase the risk of harm to the fetus.
Product: Ranibizumab injection (Lucentis)
Manufacturer: Genentech USA, Inc.
(866) LUCENTIS (582-3684)
Reason for label change: The FDA has approved Lucentis for use in treating diabetic macular edema (swelling of the central part of the retina in the eye). Lucentis had already been approved for the treatment of age-related macular degeneration.
Product: Linagliptin (Tradjenta)
Manufacturer: Boehringer Ingelheim
Reason for label change: The FDA has approved Tradjenta for use in combination with insulin by people with Type 2 diabetes, and for use by people with Type 2 diabetes who also have severe, chronic kidney problems.