A Medical Device Daily

The Juvenile Diabetes Research Foundation (JDRF; New York) reported that it is funding researchers from around the world to assess new diabetes technologies, with first-year financing of more than $5.5 million.

The research announced includes:

• Continuous Glucose Sensor Human Clinical Trial, a multi-site clinical trial, will compare health outcomes — such as HbA1c levels and avoidance of hypoglycemia — of people who use continuous glucose sensors to those who do not, to quantify the benefits of these devices. The trial will enroll both children and adults with type 1 diabetes and will collect data to assess the economic costs and benefits of sensor use over the next 12 months.

• Artificial Pancreas Consortium, a multi-site research consortium will work collaboratively to research potential algorithms for a closed-loop system that links continuous glucose sensors and insulin pumps to automatically dispense insulin to patients with Type 1 diabetes.

The Continuous Glucose Sensor trial will invite nine research centers, each using the same clinical protocol, testing the effectiveness of sensors in various populations and different settings. The trial will investigate whether continuous glucose sensors have a direct impact on better glycemic control, reduced HbA1c levels and hypoglycemia and also will explore the impact of sensors on quality of life issues for the children using the devices and their parents.

The selected researchers include: Howard Wolpert, MD, of Joslin Diabetes Center (Boston); Lori Laffel, MD, of Joslin Diabetes Center (Boston); Jean Lawrence, ScD, of Kaiser Permanente Southern California (Pasadena); Tim Wysocki, PhD, of Nemours Children's Clinic (Jacksonville, Florida); Anne Peters, MD, of Roybal Community Health Center/Univ. Southern California (Los Angeles); Bruce Buckingham, MD, of Stanford University (Stanford, California); Peter Chase, MD, of the University of Colorado, Barbara Davis Center (Aurora); Eva Tsalkian of the University of Iowa Carver College of Medicine (Iowa City); Irl Hirsch, MD, of the University of Washington (Seattle); and William Tamborlane, MD, of Yale University (New Haven, Connecticut).

The Artificial Pancreas Consortium will aim to speed the process of linking continuous glucose sensors and insulin pumps, including the development of various computer algorithms to communicate between the two devices and investigate the safety and efficiency of the technology, such as whether insulin pumps can be shut off automatically during potentially severe hypoglycemic episodes. While the initial research will take place in hospital-based clinical settings, the goal of the initiative is to eventually test artificial pancreas systems in everyday life settings.

Researchers include: Roman Hovorka, PhD, of the Cambridge University (Cambridge, England); Lois Jovanovic, MD, of the Sansum Diabetes Research Institute (Santa Barbara, California); Bruce Buckingham, MD, of Stanford University; Peter Chase, MD, of the University of Colorado (Boulder); Boris Kovatchev, PhD, of the University of Virginia (Charlottesville); and Stuart Weinzimer, MD, of Yale University.

JDRF said it has made its Artificial Pancreas Project, launched last year, a priority because of research confirming that current diabetes technology is inadequate: some studies have found that even patients who aggressively manage their disease — measuring their blood glucose an average of nine times a day — spent less than 30% of the day in normal range.