Upstate participates in clinical trial of first-of-its-kind insulin pump

One of the most frightening aspects of living with type 1 diabetes is hypoglycemia, or low blood sugar, while the patient sleeps. Joslin Diabetes Center at Upstate Medical University is participating in a clinical trial to test the effectiveness of a first-of-its-kind insulin pump for the U.S. market that addresses hypoglycemia in patients with type 1 diabetes.

The trial – ASPIRE (Automation to Simulate Pancreatic Insulin REsponse)— funded by Medtronic Inc. will test the MiniMed Paradigm System featuring low glucose suspend (LGS) automation. ASPIRE will determine the safety and efficacy of LGS, an advanced feature for the MiniMed Paradigm insulin pump, which also integrates continuous glucose monitoring (CGM), or the continuous measurement of glucose levels.

“This study leads an industry-wide effort to tackle the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react,” said Ruth Weinstock, MD, PhD, professor of medicine and medical director of the Joslin Diabetes Center at Upstate. Dr. Weinstock serves as principal investigator for the ASPIRE study at Upstate. “This is the world’s first and only insulin pump that can automatically shut-off the supply of insulin if the patient’s glucose levels drop too low, reducing the duration and severity of hypoglycemia.”

MiniMed Paradigm System featuring LGS is already available in 50 countries outside the United States, but has not yet been approved by the U.S. Food and Drug Administration.  Previous generations of insulin pumps combined with CGM have been available in the United States since 2003, but this next generation of Medtronic’s MiniMed Paradigm System, with the addition of LGS automation, is a first-of-its-kind insulin pump that works by automatically suspending basal insulin delivery temporarily if glucose levels become too low as defined by the patient and or healthcare provider. The CGM-integrated system and LGS automation are the first key steps towards the creation of an artificial pancreas.

Hypoglycemia is a common occurrence and concern in type 1 diabetes management and can result in confusion, unresponsiveness and — in severe prolonged cases — even coma or death. One of the most frightening aspects of living with type 1 diabetes is nocturnal hypoglycemia, or when low blood sugar occurs during sleep.

Research has indicated that, on average, a person with type 1 diabetes will experience more than one hypoglycemic, or low blood glucose, event every two weeks. In addition, each year nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycemia.

ASPIRE is being conducted as a multi-center, randomized, pivotal in-home study. The study will determine the safety of the system and will compare nocturnal hypoglycemic events in a treatment arm with the LGS on to a control arm without the LGS feature in individuals with type 1 diabetes.

For more information, contact Patricia Conboy at 464-9007.

Caption: Ruth Weinstock, MD, PhD, right, and Clinical Research Coordinator Suzan Carusone, RN. Carusone is holding the MiniMed Paradigm insulin pump.

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