Draft Guidance for Early Version of Artificial Pancreas System Released

The US Food and Drug Administration (FDA, Silver Spring, MD, USA) has issued a draft guidance that will help advance the development and approval of an artificial pancreas system to treat type 1 diabetes mellitus (DM) in the United States.

The FDA draft guidance document addresses an early version of an artificial pancreas system, known as a Low Glucose Suspend (LGS) system, which can help reduce or lessen the severity of hypoglycemia--a dangerous drop in glucose levels--by temporarily reducing or stopping the delivery of insulin. However, patients must still manage their blood glucose levels with a glucose meter and self-administer insulin, if necessary. The draft guidance provides recommendations for those planning to develop and submit an application for a LGS system intended for single patient use in the home environment.

The FDA is therefore seeking input from industry, researchers, the clinical community, and other stakeholders on the draft LGS guidance. Specifically, the agency is interested in the types of clinical studies that should be conducted and what their target outcomes should be to demonstrate safety and effectiveness, necessary requirements for FDA approval. The FDA is also working on a second draft guidance that will help manufacturers and researchers develop more autonomous artificial pancreas systems, which are expected to be issued by the end of 2011.

“Our goal is to provide a clear pathway for artificial pancreas development so that people with diabetes can benefit from innovative medical devices,” said Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health. “Getting a safe and effective artificial pancreas system to Americans with type 1 diabetes is an FDA priority.”

DM type 1 (formerly known as juvenile diabetes) results from autoimmune destruction of insulin-producing beta cells of the pancreas. The subsequent lack of insulin leads to increased blood and urine glucose. The classical symptoms are polyuria (frequent urination), polydipsia (increased thirst), polyphagia (increased hunger), and weight loss. Type 1 DM is generally fatal unless treated with insulin, with injection being the most common method of administration. Although the cause of type 1 diabetes is still not fully understood, it is believed to be of immunological origin; type 1 can be distinguished from type 2 diabetes via a C-peptide assay, which measures endogenous insulin production.

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