In a step toward the development of an artificial pancreas, the FDA has approved Medtronic's ($MDT) IDE to conduct a pivotal in-home clinical trial protocol for the ASPIRE study of the MiniMed Paradigm system featuring low glucose suspend (LGS) automation. The ASPIRE study is the first in-home pivotal trial of a closed loop system for Type 1 diabetes management, the company notes in a release.
ASPIRE will compare hypoglycemic events in a treatment arm with the LGS ON to a control arm that has the LGS OFF. The device is designed to halt insulin delivery for two hours when a patient's blood sugar level gets too low, the Pioneer Press notes.
"FDA approval of the ASPIRE in-home study is an important milestone toward bringing Low Glucose Suspend technology to the U.S. market," said Dr. Francine Kaufman, CMO and VP of global clinical affairs for Medtronic's diabetes business. "It's also a critical step toward our ultimate goal--the development of an artificial pancreas. We believe this innovation has the potential to provide patients with added protection by lowering the risks associated with nocturnal hypoglycemia."
The Juvenile Diabetes Research Foundation also praised the FDA's actions. "JDRF and others have been urging FDA to create a more clear and reasonable path for low glucose suspend pumps in the United States," added Aaron Kowalski, assistant VP of treatment therapies at JDRF. "While long overdue, we commend Medtronic for their commitment and persistence to our patients in the United Stands and we are pleased that FDA has agreed to let this promising technology move forward into outpatient trials."
The company anticipates enrolling roughly 260 patients, said Amanda Shelton, a Medtronic spokeswoman, as quoted by the Pioneer Press. However, it would be "several years" before the technology would be commercially available in the U.S.--even with successful results, she added.
- check out Medtronic's release
- read more from the JDRF statement
- see the Pioneer Press story