A draft guidance to help artificial pancreas researchers and makers as they create and submit their devices for FDA approval has been issued by the Agency. Artificial pancreases are currently being designed and created for the treatment of diabetes type 1.
The draft guidance provides flexible recommendations for the design and testing of devices so that they can still meet regulatory requirements for efficacy and safety. An example is a flexible choice of study endpoints, how many patients can be involved in the study, and how long the clinical trial can be.
Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said:
"The FDA is focused on improving the process for the study and approval of artificial pancreas systems, and developed this guidance to provide maximum flexibility to manufacturers seeking to bring this device to U.S. patients. We understand how this device could change the lives of millions of Americans with diabetes, and we want our safety and effectiveness review to give patients the confidence that the device works."
Type 1 DiabetesType 1 diabetes is an autoimmune disease - the patient's body has attacked and destroyed his/her own beta cells in the pancreas (beta cells produce insulin). An individual with diabetes type 1 cannot produce insulin. This type of diabetes starts when the patient is young, under the age of 40 years. 15% of all diabetes cases of are this type, the rest are type two.
A person with type 1 diabetes cannot survive without regularly taking exogenous insulin. In some cases, a pancreas transplant can restore their own insulin production.
Type 1 diabetes is not preventable; it is not the result of lifestyle, which is usually the case with type 2 diabetes. You cannot reverse diabetes type 1 with a change in lifestyle.
Diabetes type 1 patients have to monitor their blood sugar levels throughout the day using a glucose meter. They have to calculate how much insulin they need each time in order to bring their blood glucose levels down to normal. The insulin is administered using a syringe or insulin pump into subcutaneous tissue.
Artificial PancreasAn artificial pancreas consists of two medical devices:
- An insulin pump
- A CGM (continuous glucose monitor) - this receives data on glucose levels from a sensor that is implanted below the patient's skin
An artificial pancreas is not a cure for diabetes type 1. However, it can significantly reduce the incidence and severity or high or low blood sugar levels, leading to a better quality of life and a much lower risk of diabetes-related complications.
In order to get a clinical study moving as quickly as possible to an outpatient setting, the guidance recommends a 3-phase human trial progression. The guidance also offers suggestions on how sponsors could "leverage existing safety and effectiveness data for components that may make up an artificial pancreas system, as well as data gathered from clinical studies conducted outside of the U.S."
The sponsor would also be able to choose from, for example, the following two options:
- Whether their device provides good glycemic control alongside standard therapies
- Whether their device provides superior glycemic control compared to other therapies
In June 2010, the Agency issued a draft guidance which outlined its expectations regarding non-clinical testing and human trials for a first-generation artificial pancreas system called a Low Glucose Suspend System. The FDA explained that "Such a system helps eliminate, or reduce the severity of, a dangerous drop in blood glucose levels by temporarily suspending insulin delivery when glucose levels approach a low threshold."
In a communiqué yesterday, the FDA wrote:
"Today's guidance was informed by the comments on the Low Glucose Suspend System guidance document. It addresses future generation artificial pancreas devices such as a treat-to-range system that would adjust insulin dosing if a person's glucose level approaches a low or high threshold and a treat-to-target system that would set target glucose levels and try to achieve these levels at all times. This system would be fully automated and require no interaction from the user, except for calibration of the CGM system."
The FDA will soon publish a Federal Register notice inviting the public to comment on this draft guidance.
Written by Christian Nordqvist