ACCU-CHEK Bluetooth-Powered Blood Glucose Meter Insulin Pump Combo System Receives FDA Approval

ACCU-CHEK Bluetooth-Powered Blood Glucose Meter Insulin Pump Combo System Receives FDA Approval

The system will be available in the United States in the second half of 2012

FDA clears Accu-Chek Combo system – Roche’s new interactive insulin pump system for people with diabetes. (PRNewsFoto/Roche Diabetes Care)

INDIANAPOLIS, July 18, 2012 /PRNewswire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) for the Accu-Chek Combo system for insulin pump therapy. The Accu-Chek Combo system seamlessly combines a blood glucose meter with an insulin pump, which are able to exchange data in both directions via Bluetooth wireless technology. The meter not only enables the user to quickly test blood glucose levels: It allows for operating the insulin pump remotely and by means of an easy-to-handle bolus advisor it provides support in defining the right amount of insulin. With this the Accu-Chek Combo system not only supports a more targeted therapy management, but it also allows for a discreet insulin administration without the need to touch the pump.

(Photo: http://photos.prnewswire.com/prnh/20120718/DE42716)

“We are very pleased to announce that our new insulin pump system will soon be available for people with diabetes in the U.S.,” said Daniel O’ Day, COO Roche Diagnostics. “With this clearance we are now looking forward to launch the second device in the U.S. this year, after the successful clearance of the Accu-Chek Nano SmartView system in the first quarter. Both launches represent a significant milestone for our Diabetes Care business.”

According to the 2011 National Diabetes Fact Sheet published by the Centers for Disease Control and Prevention, more than 25 million people in the U.S. live with diabetes. It is also estimated that 79 million people live with pre-diabetes in the U.S.

“The Accu-Chek Combo system clearly demonstrates Roche’s dedication to integrated diabetes management solutions, combining the technical components for blood glucose monitoring, data management and insulin delivery. This new system is designed to support insulin pump patients in managing diabetes easily and discreetly in their everyday life,” said Luc Vierstraete, Head of Roche Diabetes Care.

The Accu-Chek Combo system has been launched successfully in several European and APAC(Asia-Pacific) countries already – including France, Germany, UK, and Australia.

About the Accu-Chek Combo system:

In addition to being discreet and easy-to-use, the Accu-Chek Combo system also features:

Bluetooth technology for two-way wireless communication between the smart meter and the insulin pump;

A full-color display that brings to life blood glucose data, insulin dose information and pump settings;

A bolus advice function on the meter to allow users to easily calculate and deliver a bolus without touching the pump;

Flexibility to adjust the basal rate to as low as 0.05 units per hour – in increments as precise as 0.01 units; and

An insulin cartridge that holds up to 315 units of insulin, the largest capacity among pumps sold in the U.S.

About Roche Diabetes Care

Roche Diabetes Care is a pioneer in the development of blood glucose monitoring systems and a global leader for diabetes management systems and services. For more than 35 years, the Accu-Chek brand has been dedicated to enable people with diabetes to live life as normal and active as possible as well as to empower healthcare professionals manage their patients’ condition in an optimal way. Today, the Accu-Chek portfolio offers people with diabetes and healthcare professionals innovative products and impactful solutions for convenient, efficient and effective diabetes management spanning from blood glucose monitoring through information management to insulin delivery. The Accu-Chek brand encompasses blood glucose meters, insulin delivery systems, lancing devices, data management systems and education programs – leading to an improved medical outcome.

For more information, please visit www.accu-chek.com.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

All trademarks used or mentioned in this release are protected by law.

Roche Group Media Relations

Phone: +41 -61 688 8888 / e-mail: basel.mediaoffice@roche.com

- Alexander Klauser (Head)

- Silvia Dobry

- Daniel Grotzky

SOURCE Roche Diabetes Care

System Features and Benefits

Bluetooth technology provides 2-way wireless communication to let you control your pump with your meter

Lets you quickly view many insulin pump screens on the meter

Bolus advisor lets you quickly and easily calculate and administer a bolus from the meter

Personalized bolus advice is based on insulin already in your system, your current blood sugar level, carb intake and other important factors, including how long it can take for insulin to begin lowering your blood sugar

Lets you or your healthcare team customize settings to match your individual needs

Boluses are completely delivered even if you set the meter down and walk out of the 6-foot wireless communication range (or if you’re a parent who operates the pump for a child who wanders out of range)

Pump Features and Benefits

Place the ACCU-CHEK Spirit Combo insulin pump in a discreet location, and you might not touch it again until bedtime.

Minimum basal rate of 0.05 units helps meet the needs of those who require a very low amount of basal insulin

Lets you or your healthcare team set hourly basal rates in increments as precise as 0.01 units of insulin

Can always be operated independently in case the meter is misplaced or accidentally damaged

Temporary basal rate function lets you quickly adjust basal rate delivery to match changing conditions (illlness, exercise, stress, etc.)

Makes it easy for you to precisely set hourly basal rates using 3 different increments (0.01, 0.05 or 0.1 units), depending on amount of basal insulin required

Meter Features and Benefits

Full-color display – with a color display, graph clarity is enhanced and key items are highlighted.

Discretion and convenience when delivering an insulin dosing command – wirelessly send your bolus 6.5 feet (2 meters) from the pump via Bluetooth® wireless technology

Scroll menu with 3 user menu levels and menu-driven user interface – Easy-to-use and intuitively designed functionality lets you grow in the features you use as you get more comfortable with pump therapy

Bolus Advice function on smart meter – straightforward and “intuitive” bolus calculation process from blood glucose to insulin delivery.

Customizable reminders – for changing infusion sets, making doctor and lab visits, retesting following meals and/or out-of-range blood glucose incidents

Confidence—You don’t have to keep track of everything in your head—you can program reminders into the system.

Discretion—You don’t have to get the pump out to see and act on reminders

View insulin pump screens via meter

This product is not cleared or available for use in the U.S. A 510(k) submission is pending

Your ACCU-CHEK Combo system provides automatic safety features to help make sure you get the right amount of insulin at the right time.

Some of these features include:

A Bolus Advice function that accounts for the amount of insulin that’s already active in the body and calculates a bolus based on a variety of factors, including:

Your current blood sugar level

Your carb intake

And, when applicable, variables such as:

Exercise level

Stress

Illness

Premenstrual

Automatic occlusion detection that alerts you to a blockage in the infusion set so action can be taken to avoid high blood sugars

An on-screen Status Bar that immediately shows if blood sugar is in/out of range so you can respond quickly.

Warnings and error alerts* to prompt you to take action when necessary, including:

High/low and hyper/hypo blood sugar warnings

Insulin cartridge low error

Meter/pump battery low warning

Programmable reminders*, including those to:

Test after a meal

Test after high/low result

Change infusion set

A key lock feature that temporarily disables all keys on your meter and/or pump to prevent accidental activation of functions.

*Critical warnings, error alerts and reminders (e.g., battery low or test after meal) automatically turn on the meter so you can respond quickly; less-critical reminders (e.g., change infusion set) appear the next time you power the meter on.

This product is not cleared or available for use in the U.S. A 510(k) submission is pending

ACCU-CHEK Spirit Combo Insulin Pump

Maximum Dimensions: (without Adapter) Approx. 3.2 x 2.2 x 0.8 inches (82.5 x 56 x 21 mm)

Weight:

Empty insulin pump: approx. 2.8 ounces (80 grams)

Insulin pump with battery, full plastic cartridge and infusion set: approx. 3.9 ounces (110 grams)

Pump Casing:

Shock- and scratch-resistant plastic

Resistant to pharmaceuticals

All edges rounded

Temperature Ranges:

During operation: 41°F–104°F (5°C–40°C)

Storage in shipping case: 41°F–113°F (5°C–45°C)

During transport: –4°F–122°F (–20°C–50°C)

Air Humidity (Relative Humidity):

During operation: 20%–90%

Storage in shipping case: 5%–85%

During transport: 5%–95%

Barometric Pressure:

During operation or storage in its shipping case: 70–106 kPA (700–1060 mbar) (do not exceed 3000 meters [10,000 feet] above sea level)

During transport: 50–106 kPA (500 to 1060 mbar)

Basal Rate: Min. = 0.05 U/h, Max. = 50 U/h. There are 24 hourly basal rates, adjustable in unit increments of 0.01 (up to 1.00 U/h), 0.05 (up to 10.0 U/h) and 0.1 (up to 50.0 U/h).

Bolus:

Max.: 50 insulin units

Quick Bolus: adjustable in unit increments of 0.1, 0.2, 0.5, 1.0 and 2.0

Standard Bolus, Extended Bolus and Multiwave Bolus: adjustable in fixed increments of 0.1 units

Duration of Extended Bolus and Multiwave Bolus: adjustable in intervals of 15 minutes (from 15 minutes up to 12 hours)

Temporary Basal Rate Adjustable in 10% increments, 0%–90% (decreases), 110%–500% (increases). The duration is adjustable in 15-minute intervals, up to a maximum of 12 hours. The last programmed duration is given by default for the next Temporary Basal Rate change programmed.

Maximum Pressure 400 kPa (4.0 bar), for plastic and Aventis Insuman® Infusat glass cartridges*** and infusion sets

Flow (Delivery Rate) During infusion-set priming and bolus: 0.2 U/sec.

Maximum Quantity Delivered at a Single-Fault Condition ? 1.0 U

Data Transfer Infrared interface

Water Tightness IPX 8—Protected against the effects of temporary immersion in water under standardized conditions (? 60 minutes and ? 2.5 meters [8 feet])

Power Supply One 1.5-volt AA Alkaline (LR6) or lithium (FR6) battery or One 1.2-volt rechargeable NiMH AA (HR6) battery. Batteries should have a minimum capacity of 2500 mAh. Use only a battery charger officially recommended by the battery manufacturer.

Lifetime of Battery If used in a typical usage pattern (50 U/day using U100 insulin; operating temperature 73°F ±4°F [23°C ±2°C]) the battery life is approximately:

Alkaline 15 days 30 days

Lithium 25 days 50 days

NiMH 10 days 20 days

Data Storage Time The time and date are safely stored in the memory for about 1 hour after the battery has been removed. Other insulin pump settings (the hourly basal rates, remaining cartridge content, bolus increments and active user menu) and the event memory (bolus history, history of daily insulin totals, Temporary Basal Rate history, alarm history) are saved, regardless of battery voltage and the time your insulin pump has been without a battery.

Cartridges ACCU-CHEK® Spirit 3.15 mL cartridge system and ACCU-CHEK® 3.15 mL plastic cartridge with a luer-lock connection.

Infusion Sets ACCU-CHEK® infusion sets with a luer-lock connector. (ACCU-CHEK® infusion sets are PVC and latex free.)

Safety Systems Alert system, beeps, information on the display, vibrations, dual microprocessors. Your insulin pump is controlled by two microprocessors. The safety concept is based on one processor (supervisor processor) supervising the other (main processor). Whenever a defect or fault occurs in the main processor, it is identified by the supervisor processor. The motor is immediately switched off and an “Error E7: ELECTRONIC ERROR” occurs. Conversely, the main processor can also determine at any time whether the supervisor is working correctly. The motor also constitutes an important safety component, as the combination of the main and supervisor processor and brushless motor provides the best possible reliability and accuracy in insulin delivery.

ACCU-CHEK Aviva Combo Blood Glucose Monitor

Display Color dot matrix

Automatic Power

Auto-on with correct strip insertion

Auto-off after removing strip (2 minutes)

Auto-off after 2 minutes if meter not used

Power Supply 3 AAA alkaline batteries

Battery Life Battery life depends on specific use (number of connections to the pump, data downloads, blood glucose tests, etc.)

System Operating Conditions See ACCU-CHEK® Aviva/Performa test strip package insert

Meter Storage Conditions –10°C to 50°C with batteries inserted

Relative Humidity Operating Range 10%–90%

Memory Capacity 1000 diary records

Dimensions 94 x 55 x 25 mm (3.7 x 2.1 x 1 in)

Weight Approx. 3.6 oz (103 grams) with batteries

Construction Handheld

Data Port Infrared (IR) window to download to information management solutions

Test Principle Electrochemical

Coding Code key

Test Averages • 7, 14, 30, 60, 90 days

Data Management

Logbook

Trend graph

Target Report

Standard Week

Standard Day

New Features

Remote control: Control ACCU-CHEK® Spirit Combo insulin pump via Bluetooth®wireless technology (RF)

Bolus advice:

Bolus calculator

Up to 5 Timeblocks that are associated with bolus advice

Reminders

Event-based reminders (after low blood glucose, after high blood glucose and after meal)

Alarm clock (up to 8 times—e.g., use to remind for blood glucose test)

Date reminders (e.g., doctor visit, lab visit, infusion change)

Entry for health events (e.g., exercise, stress, illness, etc.)

Customizable parameters

Vibrate and beep feature (one must be on at all times)

12-hr vs. 24-hr clock

Keylock

Select carbohydrate units (g, KE, BE, CC)

Select language from a list loaded to the meter (holds up to 4)

Hyper and hypo warning limits (beep and/or vibrate)

Backlight—low, med, high

Blood Sample Volume 0.6 ?L

Measuring Range 10–600 mg/dL (0.6–33.3 mmol/L)

Sample Types Capillary, venous, arterial, neonatal

Sample Dosing Capillary-fill function; suitable for AST

Storage Conditions 35°F–84°F (2°C–30°C)

Hematocrit Range 20%–70%

Quality Control 2 levels of ACCU-CHEK® Aviva control solution

Stability 18 months at room temperature

Source : http://www.prnewswire.com/news-releases/fda-clears-accu-chek-combo-system—roches-new-interactive-insulin-pump-system-for-people-with-diabetes-162931906.html

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