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Closed-loop system reduced hypoglycemia, improved glycemic control
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Patients with type 1 diabetes experienced significant improvements in overnight glucose control and nocturnal hypoglycemic events with use of an artificial pancreas, or closed-loop delivery system, compared with standard pump therapy, according to researchers.
“Several studies have promoted the use of insulin pumps, glucose sensors, or a combination of the two devices (sensor-augmented pump) to improve glucose control,” the researchers wrote. “However, the risk of hypoglycemia is still present with the use of all currently available therapies.”
Moshe Phillip, MD, of the Jesse Z. and Sara Lea Shafer Institute for Endocrinology and Diabetes, National Center for Childhood Diabetes, Schneider Children’s Medical Center of Israel, and Tel Aviv University, and colleagues conducted a multicenter, multinational, randomized, crossover trial to assess the short-term safety and efficacy of a closed-loop delivery system for the control of nocturnal glucose levels in patients aged 10 to 18 years with type 1 diabetes.
In what the researchers refer to as a “diabetes camp,” Phillip and colleagues conducted two overnight sessions in which 56 patients were randomly assigned to a closed-loop delivery system on the first night followed by a second night using a sensor-augmented insulin pump (control) on the second night or a reverse order of the therapies.
According to data, when the closed-loop delivery system was used, there were significantly fewer episodes of nighttime glucose levels <63 mg/dL (7 vs. 22; P=.003) vs. nights it was not used. There also were significantly shorter periods of time when glucose levels fell <60 mg/dL (P=.02), according to data.
The researchers wrote that median values for the individual mean overnight glucose levels were 126.4 mg/dL (interquartile range, 115.7 to 139.1) with the closed-loop delivery system and 140.4 mg/dL (interquartile range, 105.7 to 167.4) with the sensor-augmented pump.
The researchers concluded that these findings demonstrate the use of a closed-loop delivery system led to less hypoglycemia and improved glycemic control, with no adverse events.
Disclosure: The study was supported in part by Sanofi. Medtronic Diabetes supplied software to interface with the Paradigm Veo system. Intel Israel, Dell Israel and Yael Software and Systems donated laptops for the study. Many of the researchers report financial ties with Abbott Diabetes Care, Andromeda Biotech, Animas (Johnson & Johnson), AstraZeneca, Bayer, Bristol Myers-Squibb, CGM3 Ltd., D-medical Industries Ltd., Dell Israel, Dexcom, Diamyd Medical, Eli Lilly, Ferring Pharmaceuticals, GluSense, Insulet, Intel Israel, Macrogenics, MD-Logic, Medtronic Diabetes, Novo Nordisk, Pfizer, Roche, Sandoz, Sanofi, Spring, Unomedical, and Yael Software and Systems.
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