In the United States the Artificial Pancreas Project is well underway and picking up steam. Since 2006, the Juvenile Diabetes Research Foundation (JDRF) has launched a multi-year initiative to help accelerate the availability of an artificial pancreas to people with diabetes. Health spending associated with diabetes and pre-diabetes was about US$ 194 Billion in 2010, which is approximately 7% of total U.S. health spending.

With an artificial pancreas in development, the current diabetes treatment market in the US comprises three related but distinct submarkets that address different aspects of the condition. Products in the US market are currently comprised of blood glucose monitors, lancets & test strips, continuous blood glucose monitors, insulin, insulin pumps, syringes, and other insulin delivery devices & anti-diabetic drugs. Right now, the most significant growth in this market (U.S.) is in continuous blood glucose meters, insulin pumps, and anti-diabetic drugs.

The overall goal of the Artificial Pancreas Project is to accelerate the development, regulatory approval, and acceptance of continuous glucose monitoring and artificial pancreas technology in the shortest possible timeframe. The long term goal is for broad patient access and a thriving competitive market for these devices and products.

The epidemic of type-2 diabetes and its warning sign, pre-diabetes, is sweeping across the United States. It has been estimated that around 52% of the adult population will have diabetes or pre-diabetes by 2020. Yet shockingly, the vast majority, 90% of people with prediabetes and about a quarter of people with diabetes, are unaware of their conditions.

It is believed that this increasing epidemic will have major implications for people’s health and life expectancy. It will result in out-of-control U.S. healthcare costs, placing growing strain on the budgets of families, employers, states, and the federal government.

To date, artificial pancreas devices have been successfully tested in controlled inpatient or hospital settings demonstrating the potential for this technology to improve blood sugar control. Now the technology must be tested safely in real-world conditions. And clear and reasonable regulatory guidelines must be established to ensure that the upcoming studies advance the technology to reach patients as soon as possible.

Even with treatments available today, tight blood sugar control remains a challenge and daily struggle for those living with type 1 diabetes. In fact, the majority of people living with the disease are not achieving recommended target levels.

Dr. Aaron Kowalski, Assistant Vice President of Treatment Therapies at JDRF states:

“An artificial pancreas, essentially a device that would both measure sugar levels and dispense appropriate amounts of insulin to keep blood sugar levels in optimal range, would take much of the guesswork out of daily management of the disease. In the long-run, controlled sugar levels will help to lessen or avert the devastating complications from diabetes.”

Based on initial trials, improvements in blood sugar control were greatest for patients 25 years of age or older, whose HbA1c levels decreased (improved) during the study by an average of 0.53% compared with control patients. Improvements in secondary measurements were also significantly greater in patients, including the percentage of patients able to achieve an HbA1c level below 7%, or a 10% relative or 0.5% absolute drop in HbA1c. The improvement in HbA1c occurred without an increase in hypoglycemia (low blood sugar), which is the worry when attempting to tighten glucose control.

Basically, the eventual, ultimate goal of the JDRF Artificial Pancreas Project is speeding the development of automated diabetes management systems. This development and goal of an artificial pancreas has also been embraced by the U.S. Food and Drug Administration, which, along with JDRF and the National Institutes of Health, brought together scientists, regulators, industry and patients for scientific workshops on the subject in 2005 and 2008. The FDA has designated an artificial pancreas as one of its “critical path” initiatives for 2011.

Sources: The Juvenile Diabetes Research Foundation and RNCOA Industry Research Solutions

Written by Sy Kraft, B.A.