Dual-hormone artificial pancreas may help youth with nocturnal glucose

Last Updated: 2015-06-30

By Lorraine L. Janeczko

NEW YORK (Reuters Health) - A dual-hormone artificial pancreas may improve nocturnal glucose control in children and adolescents with type 1 diabetes, new research suggests.

"We undertook the first three-way comparison, in pediatric outpatient nocturnal camp settings, over multiple nights, between a dual-hormone artificial pancreas, a single-hormone artificial pancreas, and conventional pump therapy. The dual-hormone artificial pancreas reduced the time spent in nocturnal hypoglycemia compared to the single-hormone artificial pancreas and conventional insulin pump therapy," the study authors reported online June 9 in the Lancet Diabetes & Endocrinology.

"The dual-hormone artificial pancreas has more potential to reduce hypoglycemia compared to the single-hormone artificial pancreas, but it also necessitates an extra infusion set and additional costs. It is, therefore, important to determine the additional benefits that glucagon brings to the system, and this study is the first to try to answer this question in outpatient settings," wrote lead study author Dr. Ahmad Haidar, engineer and postdoctoral fellow at the Institute of Clinical Research at the University of Montreal, Quebec, Canada, in an email to Reuters Health.

Asked how far from market these dual-hormone devices are, worldwide, Dr. Haidar replied, "We still need 1) dual-chamber pumps; 2) more stable glucagon formulations that are compatible with infusion pumps; and 3) longer and larger clinical trials. We need longer and larger outpatient studies to see whether adding glucagon to the artificial pancreas results in reduction of severe hypoglycemia. It is still too early to say how these findings may potentially affect patient care."

Over roughly six weeks, Dr. Haidar and colleagues enrolled in their study 33 children aged 9 through 17 years, with a mean age of 13.3, who had type 1 diabetes and were attending a diabetes camp in Canada.

In their three-way crossover trial, they randomized the children to different sequences of the three treatments (single-hormone artificial pancreas, dual-hormone artificial pancreas, and conventional continuous subcutaneous insulin pump therapy). Each treatment was given for three consecutive nights, and the researchers determined the percentage of time between 11 pm and 7 am the participants spent with glucose concentrations under 4.0 mmol/L.

The time spent at glucose concentration under 4.0 mmol/L came to a median 0% on nights with the dual-hormone artificial pancreas, 3.1% on nights with the single-hormone artificial pancreas (p=0.032), and 3.4% on nights with conventional pump therapy (p=0.0048 compared to dual-hormone artificial pancreas; and p=0.32 compared to single-hormone artificial pancreas).

Overall, 15 hypoglycemic events (<3.1 mmol/L for 20 minutes measured by sensor and confirmed with capillary glucose <4.0 mmol/L) were recorded on nights with conventional pump therapy compared to four events found with the single-hormone system and no events with the dual-hormone system. The order in which the children were assigned to their groups did not affect the results.

Dr. Jessica Castle, assistant professor in the Department of Medicine at Oregon Health & Science University in Portland, wrote in an editorial accompanying the study, "Until a truly ultra-rapid insulin is available, an insulin-only system will be suboptimal, particularly in situations where insulin needs drop rapidly, such as during exercise."

In an email, Dr. Castle added, "I anticipate insulin-only artificial pancreas systems will be available on the commercial market in two years. Such systems will have a reduced, but still significant, risk of hypoglycemia. The commercial availability of a combined insulin and glucagon artificial pancreas system will likely take longer, but will even further reduce hypoglycemia and may be able to entirely eliminate severe hypoglycemia."

The Canadian Diabetes Association and Foundation J A De Seve funded this research. Four authors and Dr. Castle reported relationships with companies involved with diabetes products.

SOURCE: http://bit.ly/1RQQbfY and http://bit.ly/1FOpEsA

Lancet Diabetes Endocrinol 2015.