Medtronic announces ONSET trial results of sensor-enhanced CSII in children

Oct 23 2009

Medtronic, Inc. (NYSE: MDT) today announced study results from an oral presentation at the International Diabetes Federation’s World Diabetes Congress held in Montreal, Canada. This scientific convention highlights the latest developments in clinical research aimed at improving diabetes management and outcomes.

Improved Glycemic Control and Evidence for Beta Cell Preservation

In an oral presentation entitled, “The ONSET trial of sensor-enhanced CSII in children with new onset type 1 diabetes,” results of a prospective, randomized, multi-center trial were shared. The physician-initiated study, performed in five pediatric centers, assessed whether children (ages 1-16) newly diagnosed with type 1 diabetes could achieve improved glycemic control using an insulin pump augmented with Personal continuous glucose monitoring (CGM), known as the MiniMed Paradigm^® REAL-Time System, compared to a control group using a conventional insulin pump with self monitoring of blood glucose (SMBG).

“It is quite evident that children with type 1 diabetes can benefit from using insulin pump therapy with real-time continuous glucose monitoring at the onset of their disease,” said Thomas Danne, M.D., lead investigator and chief physician at the “Auf der Bult” Diabetes Center for Children and Adolescents in Hanover, Germany. “In fact, we noted evidence that reducing glycemic variability has an effect on the pancreas, preserving beta cell function, which likely will improve diabetes outcomes over the long-term in these children.”

A total of 160 patients in this Medtronic-supported study were randomized to use conventional insulin pump therapy with SMBG or an insulin pump with Personal CGM for 12 months. Key results highlighted during the oral presentation include:

• Insulin pump therapy at diabetes onset results in lower A1C values (average blood glucose) compared to historical controls (the use of insulin injections during the first 12 months after diagnosis), and improves psychological well being.
• The sub-group of patients using Personal CGM regularly (at least one glucose sensor per week) experienced significantly lower A1C values (0.5%,>
• There were significantly fewer episodes of severe hypoglycemia in patients using an insulin pump with Personal CGM compared to those using conventional insulin pumps.
• In patients using Personal CGM, more frequent glucose sensor use during the first year was associated with significantly less C-peptide loss, and C-peptide values at 12 months were significantly higher in adolescents (12-16 years). In addition, glycemic variability (calculated by mean amplitude glucose excursion, MAGE) was significantly lower compared to the group using a conventional insulin pump with SMBG.

The ONSET trial, conducted in Austria, France, Germany, and Poland, adds to the growing body of evidence that demonstrates using Personal CGM on a regular basis improves glycemic control.

The MiniMed Paradigm REAL-Time System is the world’s only system to integrate an insulin pump with Personal CGM. Patients using Personal CGM are able to view glucose sensor data and use this information to understand how diet, exercise, medications and lifestyle affect glucose levels. By viewing graphs and receiving alerts when glucose levels are becoming too high or too low, patients can make more informed therapy decisions to maintain near-normal glucose control.