Questions and Answers about
Diabetes and FDA
Q. What is diabetes?
A. Diabetes mellitus is
a chronic disease in which blood glucose (sugar) levels are too high.
Cells in the body break down glucose in order to provide energy for
movement, growth, and repair. The hormone insulin is responsible for
regulating glucose levels in the blood. Abnormally high levels of glucose
can damage the small and large blood vessels, leading to diabetic blindness,
kidney disease, amputations of limbs, stroke, and heart disease.
There are three common types of diabetes. Type 1 diabetes is
usually (but not always) diagnosed in children and young adults. Persons
with type 1 diabetes make no insulin and must take insulin every day.
Type 2 diabetes is usually (but not always) diagnosed in adults
over the age of 45. In type 2 diabetes, either the person is not making
enough insulin, or the body is resistant to insulin and cannot use it
properly. Gestational diabetes occurs during pregnancy: 2-4 percent
of all pregnant women have gestational diabetes. If a woman has gestational
diabetes, she has about a 40 percent chance of having type 2 diabetes
later in her life.
About 17 million persons in America have Diabetes mellitus,
but five million of them don't even know it. Nearly 1 million new cases
are diagnosed each year. The disease affects men and women of all ages
and ethnic groups. African Americans, Latinos, American Indians, Alaskan
Natives, Asian Americans, and Pacific Islanders are more greatly affected
than other groups.
For more information about diabetes, use the following links:
National
Institute of Child Health and Development: Understanding Gestational
Diabetes
MedlinePlus
Health Information on Type 1 Diabetes
MedlinePlus
Health Information on Type 2 Diabetes
HealthFinder:
Diabetes
Q. How do I know if I have diabetes?
A. As many as 50 percent (one-half)
of persons with type 2 diabetes are unaware that they have the disease.
For this reason, it is particularly important to pay attention to the
signs and symptoms of diabetes and its risk factors.
Some of the signs of either type 1 or type 2 diabetes are:
- being very thirsty
- urinating often
- feeling very hungry or tired
- losing or gaining weight without trying
- having sores that heal slowly
- having dry, itchy skin
- losing the feeling in your feet or having tingling in your feet
- having blurry eyesight
Symptoms of type 1 diabetes often develop over a short period of time.
In type 2 diabetes, symptoms develop more slowly, and some persons never
have any symptoms of the disease. If you are regularly having any of
these signs and symptoms, you should tell your doctor.
For more information about the signs or symptoms of diabetes, use the
following link:
American
Diabetes Association: Symptoms
Q. What factors increase my
risk of getting diabetes?
A. Although researchers don't fully
understand why some persons get diabetes and others don't, it is clear
that certain factors increase your risk. You are at risk for having
diabetes if:
- Your mother, father, sister, or brother has diabetes;
- You are African American, Hispanic American/Latino, American Indian,
Native Alaskan, Asian American, or Pacific Islander;
- You have high blood pressure (at or above 130/80);
- You have a history of diabetes during pregnancy (gestational diabetes)
or gave birth to a baby weighing more than nine pounds at birth;
- You are overweight or obese;
- You are inactive or have a sedentary lifestyle; or
- You are older than 45 years of age.
If you have one or more of these risk factors, even if you are experiencing
no symptoms, your doctor may want to test you for diabetes.
For more information about your risk of getting diabetes, use the link
below to take the diabetes risk test:
American
Diabetes Association Diabetes Risk Test
Q. How will my doctor test me
for diabetes?
A. Although the amount of glucose
in your blood varies depending on when and what you eat, the range should
be relatively narrow. In general, your blood sugar is highest after
you eat and lowest after you have not eaten for 8-10 hours. After fasting
all night, most persons have blood glucose levels between 70 and 110
milligrams of glucose per deciliter of blood (mg/dL). After eating a
large meal, a person's blood sugar will rise, but generally not above
140 mg/dL. People with untreated diabetes will have higher blood sugars
after fasting and after eating.
To check if you have diabetes, your doctor will test your blood sugar
levels. The results of these tests and other clinical findings will
be used to decide if you have diabetes and what type. Doctors cannot
diagnose diabetes on the basis of one single test. Instead, they will
perform two or more glucose tests before confirming your diagnosis.
The most common tests to measure glucose are the fasting plasma glucose
test, the random blood sugar test, and the oral glucose tolerance test.
- Fasting plasma glucose test. Most experts recommend
using a fasting plasma glucose test to diagnose diabetes. Before taking
this test, you cannot eat anything for 8 to 10 hours. Blood will be
drawn from a vein in your arm and sent to a laboratory for testing.
If your fasting blood glucose is 126 mg/dL or higher, your doctor
will probably diagnose you with diabetes.
- Random blood sugar test. Many cases of diabetes are
found during routine physical exams when blood is drawn for other
tests. Since you don't necessarily fast before these physical exams,
you may have just eaten and your blood sugar may be high. Even so,
it shouldn't be higher than 200 mg/dL. If your random blood glucose
is higher than 200 mg/dL, your doctor will probably suspect diabetes
and may want to give you a fasting plasma glucose test.
- Oral glucose tolerance test. In this test, a person
consumes a drink containing glucose dissolved in water. Blood is then
drawn in timed intervals over a three-hour period. If plasma glucose
levels rise more than expected, the person is diagnosed with diabetes.
This test is often used to check pregnant women for gestational diabetes.
It is rarely used to diagnose diabetes in other patients, because
it is cumbersome and time-consuming.
For more information about diagnosing diabetes, use the following
link:
NIDDK:
Diabetes Diagnosis
Q. How can I reduce my chance
of getting diabetes?
A. A recent study funded by the
Federal government of 3,234 persons at high risk for diabetes showed
that diet and exercise can sharply lower the risk of getting type 2
diabetes.
The Diabetes Prevention Program (DPP) was a major clinical study of
ways to prevent or delay diabetes in persons at high risk for type 2
diabetes. Patients were overweight and had higher than normal levels
of blood glucose, called impaired glucose tolerance. Both conditions
are strong risk factors for type 2 diabetes. Because of the high risk
among some minority groups, about half of the DPP participants were
African American, American Indian, Asian American, Pacific Islander,
or Hispanic.
The DPP compared two methods for preventing diabetes: (1) an intensive
program of healthy eating and exercise and (2) the use of metformin,
a diabetes drug. Persons who engaged in moderate physical activity for
about 30 minutes a day, followed a low-fat and low-calorie diet, and
lost 5 to 7 percent of their body weight (or about 12 pounds for someone
who weighs 200 pounds) cut their risk of getting type 2 diabetes by
about one half (58%). Those persons receiving metformin reduced their
risk by one third (31%).
For more information about reducing your risk of getting type 2 diabetes,
use the following link:
NIDDK
Diabetes Prevention Program
Q. Does FDA develop or test
new medicines or other treatments for diabetes?
A. FDA does not develop or test
new medicines or other treatments. Instead, FDA evaluates the information
from manufacturers who have tested their medicines. FDA does give substantial
advice to the companies who are developing the drugs or other products.
Q. How are new drugs approved
by FDA?
A. Since 1938, every new drug has
been the subject of an approved New Drug Approval (NDA) application
before it is sold in the U.S. The NDA application is the vehicle through
which drug sponsors formally propose that the FDA approve a new pharmaceutical
for sale and marketing in the U.S. The data gathered during the animal
studies and human clinical trials of an Investigational New Drug (IND)
become part of the NDA.
The goals of the NDA are to provide enough information to permit FDA
reviewers to reach the following key decisions:
- whether the drug is safe and effective in its proposed use or uses.
- whether the benefits of the drug outweigh the risks.
- whether the drug's proposed labeling (package insert) is appropriate
and what it should contain.
- whether the methods used in manufacturing the drug and the controls
used to maintain the drug's quality are adequate to preserve the drug's
indentity, strength, quality, and purity.
Phases of Clinical Trials
After a drug is shown to have promise in terms of effectiveness and
an adequate measure of safety for humans during animal studies, it moves
into clinical trials to test for effects in humans. Clinical trials
are categorized into the following phases:
Phase I - Small studies, usually involving 20 to 80 patients, for
the purpose of determining safety.
Phase II - Larger studies, involving up to several hundred subjects,
to further explore safety and to determine effective dosage for a
specific indication.
Phase III - Still larger studies, involving up to several thousand
subjects, for the purpose of gathering additional information about
safety, efficacy, and dosage that is needed to determine the overall
benefit-risk relationship of the drug and to characterize the drug
for its intended use.
Q. How does FDA review medical
devices before they can be sold?
A. 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.
For more information about FDA's review of medical devices, use the
following link:
FDA Device Advice: Overview
of Regulations
Q. How can I find more information
about clinical trials?
A. For more information about clinical
trials of new diabetes drugs and devices, use the following link:
ClinicalTrials.Gov
Q. What Do FDA Advisory Committees
Do? How do I find out when they meet?
A. FDA enlists the aid of non-government
experts from across the country to help the agency reach decisions,
particularly concerning controversial issues or new and unusual products.
This group is called a "panel" or "Advisory committee."
Advisory committees consist of medical professionals, scientists and
researchers, industry leaders, consumers, and patients.
For more information about advisory committees, including lists of
committees and meeting dates, use the following link:
FDA Advisory Committees
Q. How do I know if my diabetes
medicines are working?
A. Monitor your blood sugar daily
to see if your diabetes medicines are working properly. Consult your
doctor if you think your medicines are not working correctly. For best
results, oral medications must be taken regularly every day, not irregularly
or started and stopped according to blood sugar. Since many dosages
are available, a physician can change the dosage if blood sugars are
running too high or too low. Some of these drugs can be used in combination
with one another. You should change your diabetes medicines only when
your doctor advises you to.
Q. What is the best medicine
to take for diabetes?
A. FDA does not "rate"
the effectiveness of different medications. If you have questions about
which diabetes pill is best for you, you should ask your doctor.
Q. How can I get more information
about medical devices?
A. 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.
To access this database, use the following link:
CDRH
Premarket Approval Database
Q. What does the claim "fat
free" mean on a food label?
A. The nutrient content claim "fat
free" on a food label means that the serving of food contains an
insignificant amount of fat (less than 0.5 g per serving). Foods that
are naturally fat-free (i.e., need no special processing or reformulation
to lower fat content) must disclose that fat is not usually present,
for example, "broccoli, a fat-free food."
Fat-free or low-fat foods often contain high amounts of added sugars
or sodium to compensate for the loss of flavor that occurs when fat
is removed. Consumers should pay close attention to the calories in
a single serving to avoid concluding that fat-free is synonymous with
low in calories.
Reference: Title 21 of the Code of Federal Regulations (CFR); Total
Fat: 21 CFR 101.62(b)
http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=101&SECTION=62&YEAR=2001&TYPE=TEXT
For more information on claims, use the following link:
Claims That
Can Be Made for Conventional Foods and Dietary Supplements
Q. What do the claims "sugar
free" and "no sugar added" mean on a food label?
A. The nutrient content claim "sugar
free" on a food label means that the serving of food contains an
insignificant amount of sugar (less than 0.5 g per serving).
The claim "no added sugars" or "no sugar added"
is allowed if no sugar or sugar-containing ingredient (such as jam,
jellies, or concentrated fruit juice) is added during processing. This
claim is only to be used on foods that substitute for foods that normally
contain sugars. Also, unless the food meets the criteria for a "low
calorie" (i.e., 40 calories or less per serving) or "calorie
reduced" (i.e., 25% reduction in calories) claim, it must say it
is "not a low-calorie food" or "not a reduced-calorie"
food.
Reference: Title 21 of the Code of Federal Regulations (CFR); Sugars
- 21 CFR 101.60(c)
http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=101&SECTION=60&YEAR=2001&TYPE=TEXT
For more information on claims, use the following link:
Claims That
Can Be Made for Conventional Foods and Dietary Supplements
Q. What is the status of new
treatments for diabetes?
A. 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.
Q. Where can I report a product
that doesn't work?
A. 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.
To access the MedWatch web site, use the following link:
The FDA Safety Information and Adverse
Event Reporting Program
Q. Where can I find other people's
complaints about medical devices?
A. FDA collects reports of adverse
events involving medical devices in the MAUDE database. The data consists
of all voluntary reports since June, 1993, user facility reports since
1991, distributor reports since 1993, and manufacturer reports since
August, 1996.
To search the MAUDE database of medical devices which may have malfunctioned
or caused a death or serious injury, use the following link:
Manufacturer and User Facility Device Experience
Database (MAUDE)
Updated 4/16/02
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