In news sure to cheer Type 1 diabetics and their families, a study published in Diabetes Technology & Therapeutics of Medtronic's ($MDT) MiniMed Paradigm system yielded positive results. The study is seen as a step in the development of artificial pancreas technology.
Medtronic's ASPIRE study met its efficacy endpoints in its in-clinic portion. In addition, investigators saw a 19% reduction in time spent below the low glucose threshold in patients using the MiniMed Paradigm system, which features low glucose suspend automation, versus those on conventional pump therapy.
"Achieving the endpoints of the in-clinic ASPIRE study is an important milestone toward FDA approval and bringing Low Glucose Suspend technology to the U.S. market," said Dr. Francine Kaufman, CMO and VP of global clinical affairs for the diabetes business of Medtronic. "We are excited about this first step and are committed to advancing the insulin delivery, sensor technology, and closed loop algorithms to commercialize an artificial pancreas."
The Paradigm system is commercially available in many countries, but limited to investigational use in the U.S. Many are pushing for the fast development of an artificial pancreas, as it could reduce dangerous high and low blood sugars in diabetics and lower the risk for future complications.
The FDA released draft guidance on the development and testing of the artificial pancreas last year. At the time, Reuters' Julie Steenhuysen noted that some people in the industry worried that the proposed guidelines would hamper development of a viable artificial pancreas system.
- check out the study abstract
- read Medtronic's release