Medtronic, Inc., the world’s largest medical technology company, recently announced that it received approval from the U.S. Food and Drug Administration for its Investigational Device Exemption (IDE) in conducting a pivotal clinical trial in the ASPIRE study, an investigation of the in-home efficacy of the Low Glucose Suspend feature of Medtronic’s MiniMed Paradigm insulin pump system. The FDA’s approval means that the ASPIRE study will be the first in-home pivotal trial of a closed loop system for treating Type 1 diabetes.
According to David Klonoff, Medical Director of the Diabetes Research Institute at Mills-Peninsula Health Services, the ASPIRE (Automation to Stimulate Pancreatic Insulin Response) study is leading the way in ensuring that hypoglycemia does not get out of control when patients are unable to respond to their low blood glucose conditions, such as when they’re asleep.
“This study leads an industry-wide effort to close the diabetes treatment loop by tackling the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react,” said Klonoff. “The new Low Glucose Suspend integrated system is designed to help improve patients’ ability to manage nocturnal hypoglycemia, which can be one of the most frightening aspects of living with Type 1 diabetes. Until now, we have never had a therapy designed to automatically intervene when blood glucose becomes severely low.”
Francine Kaufman, Chief Medical Officer and Vice President of Global Clinical Affairs at the diabetes division of Medtronic, said that the FDA’s approval is “an important milestone toward bringing Low Glucose Suspend technology to the U.S. market.
“It’s also a critical step toward our ultimate goal — the development of an artificial pancreas,” continued Kaufman. “We believe this innovation has the potential to provide patients with added protection by lowering the risks associated with nocturnal hypoglycemia.”
According to Kaufman, Medtronic worked closely with the FDA to ensure that approval for the study was reached as quickly as possible. “FDA review of the ASPIRE IDE application was conducted through an interactive review process that involved frequent communication with the FDA review team, allowing issues to be resolved quickly and avoiding any unnecessary delays during the review. We appreciate the valuable input provided by members of the FDA’s Artificial Pancreas Working Group,” said Kaufman.
The ASPIRE study is now in its second phase, with the first phase—an in-patient clinical study—now complete. ASPIRE is a randomized, pivotal in-home study spanning several investigational facilities. The study is intended to test the MiniMed Paradigm insulin pump developed by Medtronic, specifically the efficacy and safety of the equipment, which uses sensors to monitor blood glucose and deliver insulin when necessary. Medtronic has developed a blood glucose sensor called Enlite which will also be tested in the ASPIRE study.
Researchers will study data on hypoglycemic events from two groups of individuals: one with the Low Glucose Suspend feature switched on and the other with the feature switched off. The data will be provided by patients using the system at home to ensure that the results are accurate where the system will ultimately be used. The research team plans to demonstrate that the use of the Low Glucose Suspend feature is safe and will not result in glycemic deterioration; HbA1c levels will be used to determine the efficacy of the system. Additionally, the researchers intend to demonstrate that using the Low Glucose Suspend feature in-home will decrease nocturnal hypoglycemia when patients cannot respond to their own low blood sugar.