Federal regulators are proposing guidelines for approving diabetic blood glucose testing monitors to help distinguish between monitors sold over the counter and ones intended for professional use. The approval recommendations were made because, the Food and Drug Administration (FDA) said, the different types of devices pose different risks depending on whether they are used at home or in a medical setting.
Blood glucose monitors designed for self-use should be easier to use and understand than those designed for use by medical professionals, the agency said. For example, patients are less likely to have the expertise or health to properly used more complicated devices. Other issues, such as vision or cognitive problems, could impede their ability to properly use a meter or read the results.
Personal-use monitors should be labeled so that patients know not to share them with other people because of the risk of spreading disease. These devices should also be more durable in order to withstand more-than-expected wear and tear.
On the other hand, medical professionals are more proficient at running appropriate controls and understanding the test limitations. These devices are also used on multiple patients, thus they must have design features and cleaning capabilities that minimize the risk of contamination.
The FDA’s recommendation also laid out specific guidelines for how studies can be carried out for each type of blood glucose monitor.
Diabetes is a chronic condition in which the body does not produce enough or any insulin to regulate blood sugar levels. Blood glucose monitors measure the amount of sugar in the blood. More than 25 million Americans are living with diabetes, and billions of dollars are spent on blood glucose monitors each year.
Source: Law 360