Diabetes Supplies

All Diabetics that use insulin, especially children with Type 1 Diabetes, should have access to an emergency glucose kit, also known as a Glucagon Emergency Kit. When a Diabetic misses a dose of insulin, takes too much insulin, or, for any reason, has a very low blood sugar level, the person can lose consciousness and go into shock.

Diabetes test strips are used with a blood sugar level meter to help measure the level of sugar in the blood stream. Test strips are designed to be paired with specific meters. In order to use a test strip properly, one must draw a small blood sample from the body using a lancet. The person should place a drop of blood on the test strip and then run the test strip through the meter.

Meters, often called Self-Monitoring of Blood Glucose (SMBG) tools, are small battery-operated devices that Diabetics use to measure their blood sugar levels. There are over 25 types of meters available. If you have been recently diagnosed with Diabetes and are now looking for the right meter for you, feel free to experiment with several types before you select one. Your doctor may also be able to help you find the perfect meter.

Insulin Pumps
Insulin pumps provide an easy and effective method of delivering insulin to the bloodstream without having to inject insulin using a needle. A pump is a small device, about the size of a pedometer,that you control to send the right amount of insulin into your system. You can set the pump to automatically and continually deliver minute amounts of insulin to your bloodstream to handle small rises of blood glucose. You also manually control the pump to deliver a larger amount of insulin (a bolus) after a meal or snack; or when your sugar level unexpectedly gets too high. This manual and automatic control simulates how a non-diabetic's system controls their blood glucose levels.

FDA learns about problems with products through a system called "MedWatch". Consumers can report any problems they have with FDA-regulated products through the MedWatch system. You can find information and instructions for reporting problems with medical devices at the MedWatch web site.

FDA's Center for Biologics Evaluation and Research (CBER) has received a number of Investigational New Drug applications to study the use of cell therapy, monoclonal antibodies, and recombinant proteins to treat Type 1 and Type 2 Diabetes. It is still too early to know how promising these methods will be in treating Diabetes.

Researchers are investigating new technologies to measure glucose without fingersticks. In one method, near-infrared spectroscopy measures glucose through the skin. Essentially, this amounts to measuring glucose by shining a beam of light on the skin and is painless. Many reports in the scientific literature describe the challenges, strengths, and weaknesses of this and other new approaches to testing glucose without fingersticks.

There are many sources of information about medical devices and procedures including information on the Internet from health care organizations, medical centers, and consumer organizations. One accurate source of information about the risks and benefits of the product is the patient labeling prepared by the manufacturer and reviewed by FDA. Patient labeling is available for many of the devices listed in the premarket approval database.

Manufacturers wishing to sell any new products that contain new materials or differ in design from products already on the market must submit a Premarket Approval (PMA) application to FDA. A PMA must provide valid scientific evidence that includes data from human subjects showing the product does what it claims to do effectively, and it does not present any unreasonable risks to the patient.

The majority of medical devices are cleared through the premarket notification process (also called 510(k)), a less rigorous process than the premarket approval process. Some devices are exempt from both processes.