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Many people with diabetes take insulin to control their blood sugar (glucose). Insulin cannot be taken by mouth because it would be destroyed by digestion. Instead, most people who need insulin take insulin shots. Other ways to take insulin include insulin pens, insulin jet injectors, and insulin pumps. Someday people with diabetes may no longer need needles or shots to take insulin; researchers are testing news ways to get insulin into the bloodstream.

Insulin

• Background Information about Insulin
  
• Types of Insulin
  
• FDA Consumer Information about Insulin
  
• Package Inserts for Insulin
  
• FDA's Role in Regulating Insulin
  
• Other Resources for Insulin

Insulin Delivery Devices

• Types of Insulin Delivery Devices
  
• Insulin Delivery Devices Under Development
  
• FDA's Role in Regulating Insulin Delivery Devices
  
• Other Resources for Insulin Delivery Devices

Insulin

Background Information about Insulin

When we eat, our bodies break food down into organic compounds, one of which is glucose.
The cells of our bodies use glucose as a source of energy for movement, growth, repair, and other functions. But before the cells can use glucose, it must move from the bloodstream into the individual cells. This process requires insulin.

Insulin is produced by the beta cells in the islets of Langerhans in the pancreas. When glucose enters our blood, the pancreas should automatically produce the right amount of insulin to move glucose into our cells. People with type 1 diabetes produce no insulin. People with type 2 diabetes do not always produce enough insulin.

Types of Insulin

There are more than 20 types of insulin products available in four basic forms, each with a different time of onset and duration of action. The decision as to which insulin to choose is based on an individual's lifestyle, a physician's preference and experience, and the person's blood sugar levels. Among the criteria considered in choosing insulin are:

• how soon it starts working (onset)
  
• when it works the hardest (peak time)
  
• how long it lasts in the body (duration)

To compare the features of the different types of insulin, use the following link:

FDA Consumer magazine, Chart of Insulin Preparations (January-February 2002)
http://www.fda.gov/fdac/features/2002/chrt_insulin.html

The insulin products used by people with diabetes are either taken from animals (pigs or cows) or manufactured in labs to be identical to human insulin. Beef insulin is no longer available in the United States.

For information about importing beef insulin for personal use, use the following link:

Frequently Asked Questions about Importing Beef Insulin for Personal Use
http://www.fda.gov/cder/drug/beefinsulin/default.htm

FDA Consumer Information about Insulin

FDA has consumer information about several new types of insulin products. Pharmacists from CDER's Drug Information Branch prepare these information sheets based on the products' approved package inserts. For consumer information about each of these products, use the following links:

Novolog Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/novolog.htm

Lantus Consumer Information
http://www.fda.gov/cder/consumerinfo/druginfo/lantus.htm

To search the Consumer Drug Information Page for another medication, use the following link:

FDA Consumer Drug Information
http://www.fda.gov/cder/consumerinfo/default.htm

Package Inserts for Insulin

FDA has labels (package inserts) for several types of insulin products. Package inserts are written for health care providers. They contain very detailed information about different drugs. The manufacturers prepare this information, and FDA approves it. You can print or read copies of package inserts for any of the products listed below. These documents are in PDF format and require Adobe Acrobat to read.

Humalog (lispro) Label
http://www.fda.gov/cder/foi/label/2000/20563S10-11-12-13LBL.PDF

Humalog Mix 50/50 Label
http://www.fda.gov/cder/foi/label/1999/21018lbl.pdf

Humalog Mix 75/25 Label
http://www.fda.gov/cder/foi/label/1999/21017lbl.pdf

Lantus (glargine) Label
http://www.fda.gov/cder/foi/label/2000/21081lbl.pdf

Novolin R, N, and 70/30 Label
http://www.fda.gov/cder/foi/label/2002/19-938S30lbl.pdf

NovoLog (aspart) Label
http://www.fda.gov/cder/foi/label/2000/20986lbl.pdf

You can search for information about other drugs on the CDER New and Generic Drug Approvals web page. This is an alphabetical listing of most recently approved prescription drugs. It is updated on a daily basis and contains links to labels, approval letters, and reviews for approved drugs.

To go to the New and Generic Drug Approval web site, use the following link:

CDER New and Generic Drug Approvals
http://www.fda.gov/cder/approval/index.htm

FDA's Role in Regulating Insulin

FDA's Center for Drug Evaluation and Research (CDER) oversees drug products, including insulin. CDER makes sure that drugs sold in the U.S. are safe and effective. The center evaluates new types of insulin products, and it regulates the manufacturing, labeling, and advertising of insulin products.

Companies wanting to market insulin products are responsible for testing their products and submitting data showing they are safe and effective. At CDER, teams of doctors, statisticians, and scientists review new drug applications (NDAs). In some cases, FDA seeks help from advisory committees made up of outside experts.

Once a new insulin product is on the market, CDER monitors its quality and makes sure that its manufacturer follows FDA laws and regulations. CDER also monitors insulin products carefully after they are approved to identify any unexpected side effects. Through a system called MedWatch, health professionals and consumers can report serious adverse reactions to any medical product. CDER collects information from MedWatch and the drug industry and conducts statistical evaluations on drug usage, adverse reactions, poisonings, safety, and effectiveness. If necessary, CDER shares information with patients and health professionals.

For general information about the MedWatch program and instructions for reporting problems with medical devices, use the following link:

MedWatch: The FDA Safety Information and Adverse Event Reporting Program
http://www.fda.gov/medwatch/how.htm

For more information about how FDA regulates insulin and other drugs, use the following links:

FDA Consumer Magazine, Inside FDA: The Center for Drug Evaluation and Research (July-August 1996)
http://www.fda.gov/fdac/features/696_cder.html

CDER's Division of Metabolic and Endocrine Drug Products Home Page
http://www.fda.gov/cder/dmedp/index.htm

CDER: The Center for Drug Evaluation and Research Home Page
http://www.fda.gov/cder

Other Resources for Insulin

American Diabetes Association: About Insulin, the ins and outs of the hormone you need.
http://www.diabetes.org/main/application/
commercewf?origin=*.jsp&event=link(C4_3)

NIDDK: Medicines for People with Diabetes
What Do I Need to Know About Insulin?
http://www.niddk.nih.gov/health/diabetes/pubs/med/index.htm#6

Insulin Delivery Devices

Types of Insulin Delivery Devices

All insulin delivery devices inject insulin through the skin and into the fatty tissue below.
Most people inject the insulin with a syringe that delivers insulin just under the skin. Others use insulin pens, jet injectors, or insulin pumps. Several new approaches for taking insulin are under development.

Syringes
Syringes are hypodermic needles attached to hollow barrels that people with diabetes use to inject insulin. Insulin syringes are small with very sharp points. Most have a special coating to help the needles enter the skin as painlessly as possible. Insulin syringes come in several different sizes to match insulin strength and dosage.

For more information about insulin syringes, use the following link:

Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
http://www.fda.gov/cdrh/ode/odegr821.html

Insulin Pens
Insulin pens look like pens with cartridges - but the cartridges are filled with insulin rather than ink. They can be used instead of needles for giving insulin injections. Some pens use replaceable cartridges of insulin; other models are totally disposable after the pre-filled cartridge is empty. A fine short needle, like the needle on an insulin syringe, is on the tip of the pen. Users turn a dial to select the desired dose of insulin and press a plunger on the end to deliver the insulin just under the skin.

To search FDA's 510(k) database for syringes and insulin pens, use the following link:

FDA 510(k) Database Search (Syringes and Insulin Pens)

Jet Injectors
Insulin jet injectors may be an option for people who do not want to use needles. These devices use high pressure air to send a find spray of insulin through the skin. Jet injectors have no needles.

To search FDA's 510(k) database for insulin jet injectors, use the following link:

FDA 510(k) Database Search (Insulin Jet Injectors)

Insulin Pumps
Insulin pumps are small pumping devices worn outside of your body. They connect by flexible tubing to a catheter that is located under the skin of your abdomen. You program the pump to dispense the necessary amount of insulin. Usually, you set the pump to give a steady small dose of insulin, but you can give an additional amount in a short time if needed, such as after a meal. If adjusted properly, these pumps allow close control of your insulin levels without multiple injections. You should not use this type of pump during physical activities that may damage the pump or disrupt the pump's connection to the body. You still need to monitor your blood glucose levels regularly if you use this type of device.

For more information about insulin pumps, use the following links:

Medical Encyclopedia--Insulin Pump Illustration
http://www.nlm.nih.gov/medlineplus/ency/imagepage/18035.htm

Guidance on the Content of Premarket Notification [510(K)] Submissions for External Infusion Pumps
http://www.fda.gov/cdrh/ode/odegr823.html

To search FDA's 510(k) database for insulin pumps, use the following link:

FDA 510(k) Database Search (Insulin Pumps)

Insulin Delivery Devices Under Development

Researchers are now developing several new methods for delivering insulin. These include the insulin patch and inhaled insulin. The insulin patch, when placed on the skin, will give a continuous, low dose of insulin. To adjust insulin doses before meals, users will pull off the tab on the patch to release insulin. Inhaled insulin delivery systems will give insulin as a dry power, inhaled through the mouth directly into the lungs where it passes into the bloodstream. This aerosol delivery system will likely be about the size of a flashlight and use rapid-acting insulin.

FDA's Role in Regulating Insulin Delivery Devices

Companies that want to sell insulin delivery devices must show FDA that their devices are "substantially equivalent" to drug delivery devices already for sale. For information about how FDA regulates medical devices, use these links:

CDRH General Information on Medical Device Regulations - 510(k) and Premarket Approval (PMA)
http://www.fda.gov/cdrh/consumer/geninfo.html

Overview of Medical Device Regulations
http://www.fda.gov/cdrh/devadvice/overview.html

Other Resources for Insulin Delivery Devices

Devices for Taking Insulin--National Diabetes Information Clearinghouse
http://www.niddk.nih.gov/health/diabetes/summary/altins/altins.htm