An LGS system is a version of an insulin pump which suspends insulin delivery when a monitor indicates a person with diabetes has or is projected to have dangerously low glucose levels. These systems are the first step toward an artificial pancreas, a device that could transform the lives of individuals with type 1 diabetes.
“This lifesaving technology is already available in over 40 nations around the world, and unfortunately this proposed guidance by the FDA will only further delay access to this system in the United States,” said Jeffrey Brewer, President and CEO of JDRF. “We urge the FDA to resolve three core issues in the guidance to enable people with diabetes to have access to this lifesaving technology as soon as possible.”
JDRF’s three core issues are as follows:
- The proposed clinical study pathway is excessively burdensome, and would further delay patients’ access to the technology. Without changes, this guidance will require multiple clinical trials (inpatient and outpatient) involving a large number of subjects in order to show statistically significant differences in preventing hypoglycemia. This would be an excessive hurdle in order to make available to patients a simple but important feature which shuts off insulin when someone has or is near severe low blood sugar (hypoglycemia). Instead, the LGS systems should be approved based on data showing safety and equivalent glycemic control. Clinical effectiveness data among larger populations could be collected in post-market studies.
- There is a lack of clarity in the use of continuous glucose monitors (CGM) in LGS studies. JDRF is pleased the guidance allows the use of CGM data in evaluating the safety and effectiveness of LGS systems. The use of any other outcomes would be considered impractical by the diabetes research community. FDA must express a commitment to the use of CGM data, rather than indicating it may change its standard later after studies have begun.
- The proposed guidance requires that substitution of substantially equivalent components in the LGS system would be allowed only if additional separate clinical studies of the system for each component variation are conducted. This requirement would severely limit choice for patients and discourage the development of technologies serving a critical public health need. FDA needs to adopt more efficient means to allow sponsors of clinical investigations and holders of approved premarket approval (“PMA”) applications to utilize multiple versions of components or make modifications to their LGS and artificial pancreas systems.
“Millions of people are in desperate need of the LGS system to help manage this disease and prevent life-threatening complications. Nighttime is a particularly dangerous time for a person with diabetes, because an individual’s blood sugar level can drop while they are sleeping, unaware that their levels are too low and unable to do anything about it, leading to seizures, coma, or death,” Brewer stated.
Low glucose suspend systems were a focus of a July 20th hearing in the U.S. House of Representatives Energy and Commerce Committee, which included testimony from a mother of a young woman with type 1 diabetes who has been hospitalized many times from dangerous low blood sugars. A copy of that testimony can be found here.
JDRF is the worldwide leader for research to cure type 1 diabetes (T1D). It sets the global agenda for diabetes research, and is the largest charitable funder and advocate of diabetes science worldwide.
The mission of JDRF is to find a cure for diabetes and its complications through the support of research. T1D is an autoimmune disease that strikes children and adults suddenly, and can be fatal. Until a cure is found, people with T1D have to test their blood sugar and give themselves insulin injections multiple times or use a pump–each day, every day of their lives. And even with that intensive care, insulin is not a cure for diabetes, nor does it prevent its potential complications, which may include kidney failure, blindness, heart disease, stroke, and amputation.
Since its founding in 1970 by parents of children with T1D, JDRF has awarded more than $1.5 billion to diabetes research, including $107 million last year. More than 80 percent of JDRF’s expenditures directly support research and research-related education. For more information, please visit www.jdrf.org.