High tech has come to diabetes management. When it comes to your blood sugar, keeping things on an even keel is better than a roller-coaster ride — and several devices may help diabetes patients do just that.
The US Food and Drug Administration (FDA) issued a new report Dec. 1 that described technology for blood sugar management in people with diabetes. These devices can keep blood sugar more stable, which can prevent diabetes complications like heart disease, blindness and kidney failure.
“These devices are an important technological advance to address some of the challenges people with diabetes face in managing their blood sugar,” said Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, in the new FDA report.
What Is Diabetes?
There are two types of diabetes. In the first — called type 1 diabetes — the organ called the pancreas suddenly or gradually stops secreting insulin. Insulin is a hormone that regulates blood sugar. In type 2 diabetes, people become less sensitive to insulin, and their blood sugar remains higher than normal. Chronic high blood sugar can cause heart disease, strokes, kidney failure and blindness. Very low blood sugar can cause shock, a rapid heart rate and shakiness.
In healthy people, blood sugar stays within a fairly narrow range. People with diabetes who need insulin typically manage their blood sugar by adjusting their daily dose of insulin based on blood sugar readings. The new technology outlined in this new FDA report is usually prescribed for people who have trouble keeping their blood sugar under control with conventional techniques. However, all treatments have risks, and overtreatment with any method can cause extremely low blood sugar and other complications.
Patients must follow a diet prescribed to provide the correct amounts of fat, carbohydrates and protein for their height, weight and activity level. Throughout the day, patients check their blood sugar levels by pricking their finger and testing the resulting drop of blood with a blood glucose monitor. They then adjust the dose of insulin according to a formula that includes factors like caloric intake, activity and past blood sugar levels.
Insulin pumps have been available for some time. These computerized pumps deliver insulin through a small tube implanted under the skin.
"Insulin pumps allow diabetics to receive continuous insulin with intermittent [doses], similar to what non-diabetics receive from a healthy pancreas," said David Winter, MD, MSc, MACP, Chief Clinical Officer, President and Chairman of the Board of HealthTexas Provider Network (HTPN), a division of Baylor Health Care System.
The advantage of an insulin pump is that the insulin levels remain stable, instead of rising and falling according to the time the patient last took a dose of insulin.
These pumps also work during the night when the patient is asleep. This can keep blood sugar levels stable. Most pumps are about the size of a pocket pager.
"Patients must be carefully supervised, as the machine does not know when to cut down on insulin," Dr. Winter told dailyRx News. "When meals are skipped or stomach disorders limit the absorption of food, as in nausea or vomiting states, life-threatening low blood sugar can occur if the pump is not manually turned down or stopped."
Continuous Glucose Monitors
A newer device is the continuous glucose monitor, or CGM. Another small device, the CGM has sensors that can measure the blood sugar in the fluid around the body's cells.
The CGM readings are sent wirelessly to a receiver, which shows whether blood sugar levels are rising or falling. The patient must still use a separate blood glucose monitor test to double-check his or her blood sugar and determine the correct dose of insulin. The CGM has not been approved to calculate insulin doses. The CGM must also be frequently checked against the blood glucose monitor to ensure accuracy.
Some CGMs can communicate wirelessly with insulin pumps. The CGM's sensor readings are displayed on the insulin pump.
Artificial Pancreas Device Systems
Researchers are also working on devices that would perform the same functions as the pancreas. Called artificial pancreas device systems (APDS), these devices would monitor blood sugar and automatically deliver the correct dose of insulin the body needs.
Ideally, APDS would keep the blood sugar stable in the same way a healthy pancreas does. Keeping the blood sugar under control is a very delicate and complex process. To ensure accuracy, researchers must test many different devices to find one that works. Much more research is necessary to refine APDS for patient use.
The FDA says it will continue to monitor changes in diabetes management and issue consumer updates.