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Medtronic Presents REAL Trend Study Results Of MiniMed Paradigm REAL-Time System At 69th Annual Scientific Sessions Of The ADA

Medtronic, Inc. announced results of a randomized, controlled trial to demonstrate the benefits of an insulin pump therapy augmented with real-time continuous glucose monitoring (Personal CGM) versus a conventional pump and self-monitoring of blood glucose in type 1 diabetes patients with poor metabolic control. Study findings showed that patients who used Personal CGM more than 70 percent of the time achieved nearly a full percentage point reduction in A1C (average blood glucose levels). The results were presented at the 69th Annual Scientific Sessions of the American Diabetes Association (ADA) in New Orleans.

“The REAL Trend study validates a growing body of clinical evidence that demonstrates the power of combining insulin pump therapy with Personal CGM,” said Chris O’Connell, president of the Diabetes business and senior vice president at Medtronic. “As the clinical evidence continues to build, we are seeing an impressive increase in CGM adoption globally.

The six-month, multicenter REAL Trend study was designed to determine whether patients with poorly controlled A1C (=8 percent) who used multiple daily injections could improve their metabolic control with the MiniMed Paradigm REAL-Time System (insulin pump augmented with Personal CGM) versus a conventional insulin pump and self-monitoring of blood glucose levels. The study enrolled 132 patients in France including 51 children age two and older.

“Diabetes is a complicated disease, and technologies like insulin pump therapy and Personal CGM can help patients best manage short- and long-term outcomes,” said Dr. Francine Kaufman, chief medical officer of the Diabetes Business at Medtronic. “This study reinforces the need for an integrated, management approach that uses multiple technologies to achieve significant results. Combining an insulin pump with Personal CGM and therapy management software are powerful tools for patients wanting to achieve optimal control.”

As evident in previous studies, sensor compliance drove increased improvement of glycemic control, reflected by lower A1C results without increased hypoglycemia in the REAL Trend study. Among the compliant patient population (n=91), investigators saw a significant difference in each treatment group and between groups from baseline to study end (p=0.004), including an A1C reduction of 0.96 percent among the group fitted with the MiniMed Paradigm REAL-Time System. The conventional insulin pump arm only saw a 0.55 percent reduction. In the full study population (n=135), A1C measurements decreased in each treatment group without reaching statistical significance between the two groups from baseline to study end (p=0.0087). This may be attributed to use of the CGM device less often than prescribed (70 percent of the time).

This study also reinforced the superiority of insulin pump therapy over multiple daily injections for poorly-controlled type 1 patients. Across study populations, A1C levels improved significantly after treatment was changed from multiple daily injections to a conventional insulin pump or an insulin pump augmented with personal CGM. Studies have shown that reducing A1C can result in reduced risk of long-term side effects associated with diabetes, including blindness and kidney disease.