Findings among kids with diabetes at a residential camp, outside of a controlled medical environment
The use of an artificial pancreas system yields less hypoglycemia and tighter control of nocturnal glucose levels in children, compared to a sensor-augmented pump system, according to a study published in the Feb. 28 issue of the New England Journal of Medicine.
Moshe Phillip, M.D., from the Schneider Children’s Medical Center of Israel in Petah Tikva, and colleagues conducted a multicenter crossover trial in which 56 patients with type 1 diabetes (ages 10 to 18 years) at a residential diabetes camp were randomized to receive treatment on consecutive nights with either an artificial pancreas or a sensor-augmented insulin pump (control). The order was randomly assigned.
On nights when the artificial pancreas was used the researchers observed significantly fewer episodes of nighttime glucose levels below 63 mg/dL (seven versus 22) and significantly shorter periods when glucose levels were below 60 mg/dL. With the artificial pancreas, median values for the individual mean overnight glucose levels were 126.4 mg/dL (interquartile range, 115.7 to 139.1), compared to 140.4 mg/dL (interquartile range, 105.7 to 167.4) with the sensor-augmented pump. No serious adverse events were reported.
”Patients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump,” the authors write.
The study was funded in part by the medical device and pharmaceutical industries.
Abstract
http://www.nejm.org/doi/full/10.1056/NEJMoa1206881
Original Article
Nocturnal Glucose Control with an Artificial Pancreas at a Diabetes Camp
Moshe Phillip, M.D., Tadej Battelino, M.D., Eran Atlas, M.Sc., Olga Kordonouri, M.D., Natasa Bratina, M.D., Shahar Miller, B.Sc., Torben Biester, M.D., Magdalena Avbelj Stefanija, M.D., Ido Muller, B.Sc., Revital Nimri, M.D., and Thomas Danne, M.D.
N Engl J Med 2013; 368:824-833 February 28 2013
Recent studies have shown that an artificial-pancreas system can improve glucose control and reduce nocturnal hypoglycemia. However, it is not known whether such results can be replicated in settings outside the hospital.
Methods
In this multicenter, multinational, randomized, crossover trial, we assessed the short-term safety and efficacy of an artificial pancreas system for control of nocturnal glucose levels in patients (10 to 18 years of age) with type 1 diabetes at a diabetes camp. In two consecutive overnight sessions, we randomly assigned 56 patients to receive treatment with an artificial pancreas on the first night and a sensor-augmented insulin pump (control) on the second night or to the reverse order of therapies on the first and second nights. Thus, all the patients received each treatment in a randomly assigned order. The primary end points were the number of hypoglycemic events (defined as a sensor glucose value of <63 mg per deciliter [3.5 mmol per liter] for at least 10 consecutive minutes), the time spent with glucose levels below 60 mg per deciliter (3.3 mmol per liter), and the mean overnight glucose level for individual patients.
Results
On nights when the artificial pancreas was used, versus nights when the sensor-augmented insulin pump was used, there were significantly fewer episodes of nighttime glucose levels below 63 mg per deciliter (7 vs. 22) and significantly shorter periods when glucose levels were below 60 mg per deciliter (P=0.003 and P=0.02, respectively, after adjustment for multiplicity). Median values for the individual mean overnight glucose levels were 126.4 mg per deciliter (interquartile range, 115.7 to 139.1 [7.0 mmol per liter; interquartile range, 6.4 to 7.7]) with the artificial pancreas and 140.4 mg per deciliter (interquartile range, 105.7 to 167.4 [7.8 mmol per liter; interquartile range, 5.9 to 9.3]) with the sensor-augmented pump. No serious adverse events were reported.
Conclusions
Patients at a diabetes camp who were treated with an artificial-pancreas system had less nocturnal hypoglycemia and tighter glucose control than when they were treated with a sensor-augmented insulin pump. ClinicalTrials.gov number, NCT01238406.
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