If you or your loved one has Type 1 diabetes, you may not remember the last time you had a good night’s sleep. One of the most frightening aspects of living with Type 1 diabetes is nocturnal hypoglycemia, or when low blood sugar occurs during sleep. The Barbara Davis Center (BDC) is enrolling patients now in a clinical trial of a closed-loop insulin pump for the U.S. market which aims to address hypoglycemia. This trial is the first step toward the development of an artificial pancreas (Bionic pancreas) for Type 1 diabetes management.
“This study leads an industry-wide effort to tackle the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react,” said Satish K. Garg, MD, professor of medicine and pediatrics at the BDC and principle investigator of the Automation to Simulate Pancreatic Insulin REsponse (ASPIRE) study at the BDC. “This is the world’s first and only insulin pump which can automatically shut-off the supply of basal insulin if the patient’s glucose levels drop too low, reducing the length and severity of hypoglycemia.” The previous completed in-clinic study confirmed efficacy of the system in exercise induced hypoglycemia.
ASPIRE is a multi-center, randomized, pivotal in-home study that will compare nocturnal hypoglycemic events in a treatment arm with the Low Glucose Suspend (LGS) -ON to a control arm that uses a device without the LGS feature in the homes of people with Type 1 diabetes. This is the second phase of the ASPIRE study, following the completion of the in-patient clinical study.
Though previous versions of insulin pumps have been available in the US for more than 25 years, LGS technology is not yet approved by the US Food and Drug Administration. This FDA-approved study is an important step in the process to bring LGS feature to the U.S. market.