Many of 2013’s new diabetes tools are redesigns of earlier products: A pen needle, a continuous glucose monitor, and an insulin delivery device all received upgrades. In addition, a new neuropathy treatment device hit the market, as well as a first-in-class diabetes drug and several remote health monitoring systems and Web applications that make it easier than ever to understand and share health information.
Diabetes management app
Manufacturer: Tandem Diabetes Care
What it does: The t:connect app allows users to upload data from their glucose meters via USB and view it on a Mac or PC. The app includes a built-in logbook with space for note-taking, and can generate charts in a number of different formats to indicate blood glucose trends and averages. The reports the app generates can be saved, printed, and e-mailed to caregivers and health-care providers. The t:connect app is compatible with meters from OneTouch, FreeStyle, and Accu-Chek, as well as Tandem’s own meter, the t:slim.
Availability: Visit https://tconnect.tandemdiabetes.com/GettingStarted to download the program and create a t:connect account .
Blood glucose meter
Product: On Call Vivid Pal
Manufacturer: ACON Laboratories
What it does: The no-code On Call Vivid Pal provides results in 5 seconds from an 0.8-microliter blood sample taken from the fingertip, palm, or forearm. It has a 500-value memory and can calculate 7-, 14-, 30-, 60-, and 90-day averages. The On Call Vivid Pal automatically tags readings as before or after meals, and users can set as many as five customizable reminders to check their blood glucose level.
Product: BD Ultra-Fine Nano
Manufacturer: BD Diabetes
(888) BDCARES (232-2737)
What it does: The new 4-millimeter BD Ultra-Fine Nano needles are designed to allow liquid to flow through them more easily. This should make injections quicker and require less force, improving overall ease of use for people with limited hand dexterity. BD Nano pen needles are compatible with all diabetes pens sold in the United States.
Availability: BD pen needles are available at pharmacies and online retailers.
Product: Asante Snap
Manufacturer: Asante Solutions, Inc.
What it does: The Asante Snap uses prefilled insulin cartridges that hold 300 units of Humalog insulin; these snap into a disposable body containing the pump’s battery. The pump body is replaced after seven days (or sooner, for people who use more than 300 units of insulin per week), so the battery never needs to be charged. The pump body connects to a controller that allows users to calculate boluses and provides a number of safety features, including a “drop detector” alarm that alerts the user when the pump has been dropped from a height that could damage it, as well as an alert that indicates when water has gotten into the pump body. The Asante Snap also automatically “primes” itself (fills the tube leading to the insertion set) when used with Asante’s tubing connector.
Availability: Call Asante’s customer service number for information on distributors.
What it does: Insulet’s “next-generation” OmniPod is 34% smaller and 25% lighter than the original OmniPod, with the same 200-unit reservoir capacity. The OmniPod System consists of the Pod, which combines an insertion device, infusion set, pump motor, and insulin reservoir in one disposable unit, and a separate Personal Diabetes Manager (PDM) that also includes a blood glucose meter. The Pod is waterproof (though the PDM is not) and tubeless. A new pink slide insert allows visual confirmation that the cannula has deployed and insulin can be delivered. The PDM has a color screen with a “bright mode” option and a test strip port light to make checking blood glucose easier in low light. It also calculates boluses and insulin-on-board levels, and can send information to the Pod from up to five feet away. The PDM uploads data to a computer using Insulet’s CoPilot software, free to download at www.myomnipod.com/customer-care/download-software.
Availability: The Insulet OmniPod is available at www.myomnipod.com/getstarted.
Continuous glucose monitor
Product: Dexcom G4 Platinum
What it does: The Dexcom G4 Platinum consists of a sensor, a transmitter, and a receiver. The sensor (a tiny wire about the thickness of a human hair) is inserted under the skin of the abdomen, and the transmitter sends data wirelessly from distances of up to 20 feet to the receiver. The sensor’s overall accuracy is improved by 19% (by 30% in cases of hypoglycemia) from its predecessor, Dexcom’s Seven Plus. The transmitter sends a glucose reading to the receiver every 5 seconds; the receiver alerts the user with customizable alarms whenever these readings stray outside specified ranges. The receiver displays a real-time graph of a person’s glucose level, with arrows that indicate whether and how quickly it is rising or falling. The receiver has a color display and is available in three colors. Readings can also be uploaded to a computer with Dexcom Studio software, available for download at the Dexcom Web site.
Availability: The Dexcom G4 Platinum is available by prescription only and can be ordered by following the instructions at www.dexcom.com/customer-care/getting-started.
Remote health monitoring system
Product: Ambio Remote Health Monitoring System
Manufacturer: Ambio Health
What it does: The Ambio system wirelessly streams readings from compatible devices to the computer-based Ambio Health portal. Once you set up an account, you can log in to the portal to look over your readings and set customized alert levels for any devices you’re using with the system; for example, if you’re using the Ambio system with a blood glucose meter and you register a reading that’s out of the desired range, the Ambio system can alert selected recipients (such as a doctor, parent, or other caregiver) via text message or e-mail. It’s also possible to set reminders for readings and taking medicines from the Portal.
Availability: A list of compatible devices, including a blood pressure monitor and a digital scale as well as a blood glucose meter, is available at www.ambiohealth.com/products. Subscription to the Ambio Portal costs $4.99 a month; each additional device has a separate fee.
Manufacturer: Visual Medical
What it does: Tartoos are temporary tattoos designed to prevent lipohypertrophy, or lumps of fat and scar tissue that develop when a person injects insulin in the same place too many times. People who inject insulin are encouraged to rotate injection sites to avoid this. Tartoos come in sheets of 20, and are placed one inch apart in a 4.5″ by 6.5″ grid; a person applies one full sheet at a time, providing 20 injection sites all placed a safe distance apart. Users remove each Tartoo with an antiseptic wipe just before injection.
Availability: Tartoos are available for purchase at http://myvisualmedical.com/tartoos-2/shop-for-tartoos.
Product: Sensus Pain Management System
What it does: The Sensus Pain Management System is a transcutaneous electrical nerve stimulator for the treatment of neuropathy (nerve damage). It sends electrical impulses to healthy nerves in the legs to carry non-painful signals to the brain, interrupting the pain signals sent by the damaged nerves. The system consists of an electrode and a stimulator mounted on a Velcro strap. When the electrode is snapped onto the stimulator and secured just below the knee on one or both legs, pressing a button starts a 60-minute therapy session.
Pain relief usually starts about 15 minutes into the session; users can repeat sessions as needed. The Sensus system is also approved for use during sleep.
Availability: The Sensus Pain Management System is available by prescription only.
Product: Alogliptin (brand name Nesina)
What it does: Alogliptin joins saxagliptin (Onglyza), sitagliptin (Januvia), and linagliptin (Tradjenta) in the DPP-4 inhibitor class. These drugs work by stimulating the release of insulin from the pancreas and restricting glucose production by the liver, delaying stomach emptying, and protecting remaining beta cells. The FDA is requiring Takeda to conduct five postmarketing trials of Nesina, including a study on cardiovascular events; a program monitoring liver abnormalities, pancreatitis, and hypersensitivity to the main ingredients; and three trials on the drug’s effects in children. The most common side effects of Nesina are stuffy or runny nose, headache, and upper respiratory tract infection.
The combination drugs Kazano (alogliptin and metformin [Glucophage and others]) and Oseni (alogliptin and pioglitazone [brand name Actos]) were approved with Nesina. Both metformin and pioglitazone work by increasing insulin sensitivity; metformin also decreases insulin production by the liver. Like all drugs containing metformin, Kazano carries a box warning for lactic acidosis, a potentially fatal buildup of lactic acid in the bloodstream. The most common side effects of Kazano are those of Nesina, as well as sore throat, diarrhea, high blood pressure, back pain, and urinary tract infection. Oseni carries a box warning for heart failure due to its pioglitazone content; common side effects of Oseni are the same as those of Nesina.
Availability: Nesina should be taken once daily and is available in 6.25-, 12.5-, and 25-milligram (mg) doses. Kazano should be taken once daily and is offered in doses of 12.5 mg alogliptin/500 mg metformin and 12.5 mg alogliptin/1,000 mg metformin. Oseni should be taken once daily and is available in doses of 12.5 mg alogliptin/15 mg pioglitazone, 12.5 mg alogliptin/30 mg pioglitazone, 12.5 mg alogliptin/45 mg pioglitazone, 25 mg alogliptin/15 mg pioglitazone, 25 mg alogliptin/30 mg pioglitazone, and 25 mg alogliptin/45 mg pioglitazone.
Product: Canagliflozin (Invokana)
Manufacturer: Janssen Pharmaceuticals
(877) INVOKAN (468-6526)
What it does: Canagliflozin is the first FDA-approved drug in the sodium-glucose cotransporter 2 (SGLT2)-inhibitor class. SGLT2 allows the kidneys to filter glucose from the bloodstream, then reabsorb it into the bloodstream; SGLT2-inhibitors prevent this action, causing excess glucose to be excreted in the urine and lowering blood glucose levels. SGLT2-inhibitors may also lower blood pressure, promote weight loss, and lower postmeal blood glucose levels. People with kidney problems should take a lower dose of canagliflozin; people with severe kidney problems should not take canagliflozin. The most common side effects of canagliflozin are yeast infections (for both men and women), urinary tract infections, and a need to urinate more often and in larger amounts. Serious side effects include kidney problems, low blood glucose (especially when taken with another blood-glucose-lowering medicine), excess potassium in the blood, and dehydration. Canagliflozin can react with certain other medicines, especially diuretics (often prescribed for high blood pressure), rifampin (Rifadin), phenytoin or phenobarbital (used to control seizures), ritonavir (Norvir and others), and digoxin (Lanoxin). Tell your doctor if you are taking these or any other drugs before starting canagliflozin.
Availability: Canagliflozin is available in 100- and 300-mg tablets, and should be taken once daily before breakfast.
Drug labeling changes
Product: Insulin detemir (rDNA origin) injection (Levemir)
Manufacturer: Novo Nordisk
Reason for label change: After analyzing the results of a clinical trial, the FDA has approved Levemir for use in children as young as 2 years old. Levemir has also been approved for use with metformin and a GLP-1 receptor agonist.