Medtronic (NYSE:MDT) today announced the results of its SMILE study that investigated the safety and effectiveness of its MiniMed 640G system with SmartGuard.
The study was conducted in adults who have type 1 diabetes and are more prone to severe hypoglycemia. The SMILE study tested the MiniMed 640G insulin pump with SmartGuide to prevent low glucose events in adults that have type 1 diabetes.
“This new data adds to the robust body of evidence of our insulin pump systems and demonstrates the clinical effectiveness of our SmartGuard technology – available both within the MiniMed 640G and the MiniMed 670G systems. Additionally, these results were achieved with a group of patients that are among the most challenging to treat successfully,” Dr. Robert Vigersky, chief medical officer of global medical and clinical affairs for the diabetes group at Medtronic, said in a press release. “Medtronic is committed to continuous technology innovation and expanding access to our therapies. These results further support our focus to deliver improved glycemic control while reducing the burden of people living with diabetes.”
In 16 centers in France, Italy, the U.K., the Netherlands and Canada, 153 adults participated in the study for a six month period. The results showed the effectiveness of the MiniMed 640G in reducing hypoglycemia compared to insulin pump therapy without continuous glucose monitoring in adults with a higher risk of severe hypoglycemia. It also showed improvement in the amount of time spent by people using the MiniMed 640G system with SmartGuard Suspend before low compared to people using insulin pump therapy without CGM.
“The study demonstrated the MiniMed 640G system with SmartGuard Suspend before low was associated with a significant reduction in both biochemical and severe hypoglycemia compared to insulin pump therapy. This reduction, including 84 percent fewer events of severe hypoglycemia, was achieved without increasing HbA1c levels. The clinical outcomes improvements were more pronounced during the night when hypoglycemic episodes are most problematic,” said Emanuele Bosi, from the Diabetes Research Institute, Vita Salute San Raffaele University & San Raffaele Hospital in Milan, Italy. “Another important conclusion is that patients using SmartGuard Suspend before low showed less fear of hypoglycemia and higher satisfaction with their treatment. Hypoglycemia unawareness and fear of hypoglycemia have a major impact on people with diabetes and their loved ones’ lives. These results confirm the confidence that I have in this advanced technology, and the improvement it provides to my patients in glycemic control and quality of life.”
