Medtronic's auto-adjust insulin pump on cusp of FDA approval

Medtronic's ($MDT) robust results from a trial involving its new sensor-integrated insulin pump are now published in a major journal. The milestone could help finally trigger U.S. approval of the innovative device and also push the company toward its longer-term goal of developing a fully automated artificial pancreas.

As Reuters reports, details of the company's 247-patient ASPIRE In-Home study have been published in the New England Journal of Medicine, following a presentation of the major highlights in June at the American Diabetes Association meeting in Chicago. The MiniMed integrated system, using the company's Threshold Suspend feature, is the first of its kind before the FDA designed to detect dangerous levels of blood sugar and then automatically adjust or shut off to correct the problem, according to the story. Other companies including Becton Dickinson ($BDX), Johnson & Johnson ($JNJ) and Tandem are plowing ahead with similar products.

The next step, Medtronic executives hope, will be FDA approval later this year. This would cap years of clinical trials and regulatory back and forth, even as Medtronic has sold insulin pumps in more than 50 countries outside of the U.S. that automatically turn off to adjust for blood sugar levels, Reuters notes. Dr. Francine Kaufman, vice president of global medical affairs for Medtronic's diabetes business, explained to the news service that the company is nearly there. Medtronic already has an approvable letter for the next-generation insulin pump, she said, and now the company is working with the FDA to establish consensus on overall quality issues. Execs have previously said they expect an FDA approval in 2013. 

The ASPIRE study looked at 247 patients with Type 1 diabetes, half of which were outfitted with the company's MiniMed integrated system (continuous glucose monitoring with insulin infusion), at night. Those devices also featured Threshold Suspend, sensors that read blood glucose levels and taper off or end insulin infusion, depending on the patient's condition. The rest used a regular insulin pump. The company found that the combination device slashed nighttime hypoglycemia by nearly 32% and lowered the degree and duration of hypoglycemic events by 37.5%--all without serious adverse events.

A full artificial pancreas would go much further, Reuters notes, involving a more complex system that completely automates care and treatment of Type 1 diabetics.

- read the Reuters story
- here's the journal abstract