An artificial pancreas system proved more effective at controlling nocturnal glucose levels than a sensor-augmented insulin pump, in a study of children with Type 1 diabetes treated outside the hospital setting in a diabetes camp, report researchers.
During the study, conducted at three diabetes youth camps in Israel, Slovenia, and Germany, use of the MD-Logic Artificial Pancreas system resulted in less nocturnal hypoglycemia and tighter nocturnal glucose control than use of a sensor-augmented pump system, report Moshe Phillip (Schneider Children's Medical Center, Israel) and colleagues.
"Fully automated artificial-pancreas systems… link glucose sensors with insulin pumps through computerized control algorithms, which dictate insulin delivery in response to real-time sensor data," explains the team.
Although recent studies carried out in hospitals have shown that artificial pancreas systems can improve glucose control and reduce the risk for nocturnal hypoglycemia, the major challenge that lies ahead is successful implementation of such systems outside of the hospital setting, write Phillip et al in The New England Journal of Medicine.
"The setting of a diabetes camp was chosen for the study because it represents a transitional phase between a hospital research center and the child's home," explain Phillip et al. "The camp provides the elements of a real-life setting, in a place where healthcare needs can still be met by the research team."
In an intention-to-treat analysis of 54 children allocated to receive an artificial pancreas on the first night and a sensor-augmented insulin pump on the second night or vice versa, there were significant decreases in the number of hypoglycemic episodes (glucose level <63 mg/dL, as per European guidelines), during the night when the artificial pancreas was used compared with when the insulin pump was used, at seven versus 22.
Use of the artificial pancreas versus insulin pump also significantly decreased the time during which glucose levels were below 60 mg/dL, the definition of hypoglycemia according to the latest Food and Drug Administration draft guidelines.
In addition, the total overnight insulin doses were significantly higher during nights when the artificial pancreas was used than during nights when the insulin pump was used, although basal insulin doses were not significantly different.
Finally, significantly more adverse events, including day and nighttime hypoglycemia, headaches, dizziness, and reports of "feeling ill" occurred during nights when the insulin pump was used than during nights when the artificial pancreas was used. No serious adverse events were observed throughout the study.
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