Issue: December 2015
October 12, 2015
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Extended home use of artificial pancreas safe, effective for adults with type 1 diabetes

Issue: December 2015
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Adults with type 1 diabetes using a closed-loop artificial pancreas system for 8 weeks maintained better overnight glucose control vs. adults who used sensor-augmented pump therapy alone, according to research in The Lancet Diabetes & Endocrinology.

In a crossover, randomized study conducted in France, Italy and the Netherlands assessing at-home use of a single-hormone artificial pancreas during the evening and overnight, researchers also found that incidents of overnight hypoglycemia were significantly reduced for adults assigned to the closed-loop control system.

“This study is the first in which glucose control was investigated over a prolonged period and not just overnight, and included the difficult post-dinner period,” Jort Kropff, MD, of the Academic Medical Center at University of Amsterdam, and colleagues wrote. “Although mean glucose concentration during the evening was not different between the closed-loop and [sensor-augmented pump] period, the use of closed-loop control significantly reduced the time spent below the target range in this period.”

Kropff and colleagues analyzed data from 32 adults with type 1 diabetes using insulin pump therapy (mean age, 47 years; 18 men; mean BMI, 25.1 kg/m²; mean HbA1c, 8.2%; mean duration of diabetes, 28.6 years) between April and December 2014. Three patients in the cohort were using continuous glucose monitoring (CGM) before the start of the study; patients with severe hypoglycemia or ketoacidosis in the past year were excluded.

During two 8-week study periods, adults were assigned an artificial pancreas system (Dexcom G4 Platinum CGM and Accu-Chek Spirit Combo insulin pump connected to a modified smartphone with a model predictive control algorithm) to be used from dinner until wake time, plus sensor-augmented pump therapy during the day, or assigned sensor-augmented pump therapy only, both in free-living conditions. All participants used both therapies; the order of the two sessions were randomly assigned. Participants had no restrictions on their daily activities.

Researchers found that participants spent more time in the target range while using the artificial pancreas than sensor-augmented pump therapy alone (66.7% vs. 58.1%; paired difference, 8.6%) through reductions of mean time spent in both hyperglycemia and hypoglycemia. There was a significantly greater decrease in HbA1c while participants used the artificial pancreas vs. sensor-augmented pump alone (–0.3% vs. –0.2%; paired difference, –0.2%).

There were no serious adverse events during the study period; mild to moderate adverse events were determined to be unrelated to the study.

In commentary accompanying the study, Laurent Legault, MD, FRCP, an endocrinologist at Montreal Children’s Hospital, said the study proves the artificial pancreas is safe and efficient for the in-home setting, and longer-term studies are needed.

“It remains to be seen if the use of this technology leads to substantial improvements in HbA1c concentrations over 3 months or more,” Legault said. “Studies to answer this question are presently underway.” – by Regina Schaffer

Disclosure: Kropff reports no relevant financial disclosures. Please see the full study for the other authors’ relevant financial disclosures. Legault reports no relevant financial disclosures.