Estimated Timeline Announced For Availability Of Artificial Pancreas For Type 1 Diabetes Patients

artificial pancreas for type 1 diabetes expected to pass FDA approval in 2017

An artificial pancreas that will continuously measure blood glucose levels and deliver insulin to patients with type 1 diabetes has been on the horizon for years. Breakthrough studies investigating beta cell islet transplantation show that this treatment is still promising, but these transplants require major surgery and require the use of immunosuppressant medication, because the transplanted insulin-producing cells are taken from healthy donors.

A new report, which was published in the medical journal Diabetologia, Drs. Roman Hovorka and Hood Thabit of the University of Cambridge in the United Kingdom explain why an artificial pancreas could be a less invasive and more effective treatment for type 1 diabetes.

“There are alternatives to the artificial pancreas, with improvements in technology in both whole pancreas transplantation and also transplants of just the beta cells from the pancreas which produce insulin. However, recipients of these transplants require drugs to supress their immune systems just as in other organ transplants. In the case of whole pancreas transplantation, major surgery is required; and in beta cell islet transplantation, the body’s immune system can still attack the transplanted cells and kill off a large proportion of them (80% in some cases). The artificial pancreas of course avoids the need for major surgery and immunosuppressant drugs.”

The doctors say that an artificial pancreas would eliminate the need for continuous monitoring of blood glucose levels and would deliver insulin to the Type 1 diabetic only when needed. They say that the technology is no longer a far off possibility.

The various forms of an artificial pancreas that are undergoing clinical trials work on the idea of a “closed-loop” system wherein the system continuously monitors glucose and, by following algorithms, deliver the proper amount of insulin without help from the patient or caregiver.

They say that type 1 diabetics should expect the artificial pancreas to be available within 2 years, and possibly as early as next year, according to Medical News Today.

Type 1 diabetes affects about 1.25 million children and adults in the United States alone. It does not arise from improper eating or activity habits.

“The exact cause of type 1 diabetes is unknown. In most people with type 1 diabetes, the body’s own immune system — which normally fights harmful bacteria and viruses — mistakenly destroys the insulin-producing (islet) cells in the pancreas,” the Mayo Clinic explains. “Genetics may play a role in this process, and exposure to certain environmental factors, such as viruses, may trigger the disease.”

Type 1 diabetics require insulin injections throughout the day and blood sugar levels are tested multiple times a day.

The current insulin delivery methods have to account for the extreme variability of insulin needs. For example, the amount of insulin needed can change daily depending on the amount of exercise, stress levels, food intake, menstruation, and exposure to viruses. Improper glucose control can lead to heart disease, vision problems, coma, and even death; so, patients with type 1 diabetes monitor their blood levels very regularly.

In the new report, Drs. Hovorka and Thabit explain that an artificial pancreas could completely eliminate the need for patients to continuously measure their blood sugar. If tests prove accurate, patients with type 1 diabetes could expect a twofold reduction of time spent in a hypoglycemic state and an 11 percent greater incidence of maintaining the optimal blood glucose range.

“In trials to date, users have been positive about how use of an artificial pancreas gives them ‘time off’ or a ‘holiday’ from their diabetes management, since the system is managing their blood sugar effectively without the need for constant monitoring by the user,” Drs. Hovorka and Thabit wrote.

The artificial pancreas could be approved by the FDA as early as next year. They have found that the system works, but clinical trials are testing the long-term safety and efficacy of these new devices.

For now, they are also trying to ensure that the closed-system will be able to deliver insulin quickly enough. They are also considering the vulnerability of the systems to cybersecurity threats.

According to the press release, the timeline to availability of the artificial pancreas in the United States depends on approval by the FDA, which is currently reviewing one proposed artificial pancreas.

[Image via Pixabay]