Lilly Diabetes Launches Mobile Application for Those Who Support People with Type 1 Diabetes

App serves as a teaching tool and can provide guidance for treatment with Lilly Glucagon for Injection (rDNA origin) during severe hypoglycemic events

INDIANAPOLIS – September 4, 2012 – Lilly Diabetes today announced the release of a new mobile application designed for caregivers and healthcare providers who support people with type 1 diabetes. The Lilly Glucagon Mobile App is a tool to teach how to use Glucagon for Injection, through simulated practice. Glucagon, 1 mg (1 unit), is indicated to treat severe hypoglycemia (low blood sugar). Severe hypoglycemia due to insulin may result in loss of consciousness (insulin coma). The app is designed to help people be more prepared, and also provide an opportunity to store locations and expiration dates of their Lilly Glucagon Emergency Kits. The Lilly Glucagon Mobile App is now available on the iTunes^® storeas a free download for iPhone^® or iPad^®mobile devices.

People with type 1 diabetes who experience severe hypoglycemia during insulin treatment may require glucagon, a hormone produced in the pancreas to raise blood sugar levels. Glucagon. U.S. Library of National Medicine. NIH. Updated September 2010. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0000691/. Although Glucagon is rarely needed and only used during a severe hypoglycemic event, individuals in the person’s support network, such as family members, teachers, coaches, trusted friends and colleagues, should be trained to give the medicine, which is injected with a syringe. The app can also be used by diabetes educators and school nurses as a teaching tool.

In type 1 diabetes, the body does not produce insulin, a hormone produced by the pancreas in response to an increase in blood sugar, such as after a meal. As many as three million Americans may have type 1 diabetes. Each year more than 15,000 people under age 20 are diagnosed with the disease. Glucagon should not be used in patients who have pheochromocytoma or patients who are allergic to Glucagon. Patients must inform relatives or close friends that if they become unconscious, medical assistance must always be sought. If a patient is unconscious, Glucagon can be given while awaiting medical assistance.

“Lilly Diabetes is committed to developing personalized solutions to help people with diabetes achieve their treatment goals and improve their outcomes,” said Matt Caffrey, U.S. Product Brand Director, Marketing Specialty, Lilly Diabetes. “The Lilly Glucagon Mobile App leverages the power and reach of mobile technology, providing another opportunity to support people living with type 1 diabetes. Lilly Diabetes is constantly striving to create new and better tools to support the diabetes community in a variety of ways.”

The Lilly Glucagon Mobile App is an interactive tool to help caregivers better understand Glucagon’s role in diabetes management. Its purpose is to educate and prepare the caregiver on how to use Glucagon in the event of an emergency. The app was developed with input from healthcare providers and people with diabetes.

The Lilly Glucagon Mobile App includes:
· Information about severe hypoglycemia and Glucagon
· Simulated practice demonstrating how to prepare and inject Glucagon
· Visual and audio emergency instructions
· Tools to keep track of kit locations and alerts for expiration dates
· Important safety information

Important Safety Information for Glucagon

What is the most important information about Glucagon?
· Glucagon should not be used in patients with pheochromocytoma or who may be allergic to glucagon.
· Patients need to tell their healthcare provider if they have been diagnosed with or have been suspected of having an insulinoma as glucagon should be used cautiously in this situation.
· Anyone who may need to help patients during an emergency should become familiar with how to use glucagon before an emergency arises. Read the Information for the User provided in the kit.
· Patients need to make sure that relatives or close friends know that if they become unconscious, medical assistance must always be sought. If a patient is unconscious, glucagon can be given while awaiting medical assistance.
· The kit must not be used after the date stamped on the bottle label.
· Questions concerning the use of this product should be directed to a doctor, nurse or pharmacist.

WARNING: PATIENTS MAY BE IN A COMA FROM SEVERE HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) RATHER THAN HYPOGLYCEMIA. IN SUCH A CASE, THE PATIENTS WILL NOT RESPOND TO GLUCAGON AND WILL REQUIRE IMMEDIATE MEDICAL ATTENTION.

Who should not use glucagon?
Glucagon should not be used in patients who have pheochromocytoma or who are allergic to glucagon.

What should patients tell their doctor before taking glucagon?
Patients should tell their doctor about all medical conditions and prescription and over-the-counter drugs. Patients should tell their doctor if they have been diagnosed with or have been suspected of having pheochromocytoma or an insulinoma.

How should glucagon be used?
· It is important to act quickly. Prolonged unconsciousness may be harmful.
· Family and friends need to know to turn the patient on their side to prevent choking if they are unconscious.
· The contents of the syringe are inactive and must be mixed with the glucagon in the accompanying bottle immediately before giving injection. Glucagon for Injection must not be prepared until it is ready to be used.
· Glucagon should not be used unless the solution is clear and of a water-like consistency.
· The usual adult dose is 1 mg (1 unit). For children weighing less than 44 lbs (20 kg), 1/2 adult dose (0.5 mg) is used. For children, 1/2 of the solution from the bottle (0.5 mg mark on syringe) should be withdrawn. The unused portion should be discarded.
· Patients should eat as soon as they awaken and are able to swallow. A doctor or emergency services must be informed immediately.

What is some important Information about Low Blood Sugar (Hypoglycemia)?
· Early symptoms of low blood sugar include: sweating, drowsiness, dizziness, sleep disturbances, palpitation, anxiety, tremor, blurred vision, hunger, slurred speech, restlessness, depressed mood, tingling in the hands, feet, lips, or tongue, irritability, lightheadedness, abnormal behavior, inability to concentrate, unsteady movement, headache, and personality changes. These symptoms may be different for each person and can happen suddenly.
· If low blood sugar is not treated, it may progress to severe low blood sugar that can include: disorientation, seizures, unconsciousness, and death
· Low blood sugar symptoms should be treated with a quick source of sugar which should always be carried with the patient. If symptoms do not improve or if the patient is unable to take a quick source of sugar, they should be treated with glucagon or with intravenous glucose at a medical facility.

What are the possible side effects of glucagon?
· Severe side effects are very rare, although nausea and vomiting may occur occasionally.
· A few people may be allergic to glucagon or to one of the inactive ingredients in glucagon, or may experience rapid heart beat for a short while.
· Patients who experience any other reactions which are likely to have been caused by glucagon should contact their doctor.

Patients and caregivers are encouraged to report negative side effects of Prescription drugs to the FDA. Visit http://www.fda.gov/medwatchor call 1-800-FDA-1088.

How should glucagon be stored?
· Before dissolving glucagon with diluting solution, the kit should be stored at controlled room temperature between 20° to 25°C (68° to 77°F).
· After glucagon is dissolved with diluting solution, it should be used immediately. Any unused portion should be discarded. Glucagon should be clear and of a water-like consistency at time of use.

For more safety information, please access Information for the User and Information for the Physician.

HI GLUC PR ISI [17JUL12]

The glucagon design is a trademark of Eli Lilly and Company. Glucagon is available by prescription only.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions—from medicines to support programs and more—to make lives better. For more information, visit http://www.lillydiabetes.com.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers — through medicines and information — for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.