medwireNews: Results of a randomized crossover trial suggest that a bihormonal artificial pancreas that can be used at home and is initialized only with body mass index provides improved glycemic control compared with usual care among adults with type 1 diabetes.
“Since meal announcements are optional and no carbohydrate counting is required, use of the bionic pancreas reduces the patient burden associated with management of diabetes,” write study authors Steven Russell (Massachusetts General Hospital, Boston, USA) and colleagues.
Such systems have “the potential to deliver substantially improved glycaemic management,” they add.
As reported in The Lancet, 20 adults with type 1 diabetes were assigned to undergo glycemic regulation with an artificial pancreas system and 19 to receive usual care with conventional or sensor-augmented insulin pump therapy for 11 days, after which they swapped to the alternative intervention for a further 11 days. The artificial pancreas algorithm used data from a continuous glucose monitor (CGM) to control subcutaneous delivery of insulin and glucagon, and the system initialized with participants’ body mass.
In the artificial pancreas period, the mean CGM glucose concentration and the time spent in hypoglycemia (mean CGM glucose concentration <3.3 mmol/L) were significantly lower compared with the usual care period, at 7.8 mmol/L versus 9.0 mmol/L and 0.6% versus 1.9%, respectively.
“This finding occurred despite participants taking fewer capillary plasma glucose measurements and triggering fewer insulin boluses during the bionic pancreas period,” note the authors.
During the artificial pancreas phase, all corrections were carried out automatically and participants initiated boluses by providing meal announcements, without the need for carbohydrate counting. This occurred a mean of 2.6 times per day, whereas boluses were self-administered a mean of 5.6 times per day during the comparator period.
No serious or unexpected adverse events occurred during treatment with the artificial pancreas. Participants experienced a higher degree of nausea during the artificial pancreas phase, with visual analog scale scores of 0.52 versus 0.05, even though “the absolute amount was low.”
Although the study was a “free-living home-use trial” of the artificial pancreas, the authors of an accompanying commentary note that the study conditions were “strictly supervised.” The “participants were remotely monitored […] and required to send a text message to the research team before driving,” they point out.
“[W]e now need definitive proof of clinical efficacy in real-life health-care settings,” believe Helen Murphy (University of East Anglia, Norwich, UK) and Zoe Stewart (University of Cambridge, UK).
The study authors agree: “A fully integrated device should be tested in much larger studies of longer duration to establish the long-term benefits and risks of automated glycaemic management with a bihormonal bionic pancreas.”
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