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Artificial pancreas systems improved glycemic control in type 1 diabetes
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Patients showed better glycemic control with single-hormone and dual-hormone artificial pancreas systems than with conventional insulin pump therapy, according to research published in The Lancet Diabetes & Endocrinology.
“The dual-hormone artificial pancreas is associated with an increased reduction of hypoglycemia compared to the single-hormone artificial pancreas,” Ahmad Haidar, PhD, of the Institut de Recherches Cliniques de Montreal, told Endocrine Today.
Ahmad Haider
The single-hormone artificial pancreas could be sufficient for overnight glycemic control without hypoglycemia, the researchers said.
“This is very important, given that overnight hypoglycemia is very frequent and a major source of stress and anxiety for the patients and their families,” Haidar said.
Haidar and colleagues conducted an unmasked, randomized crossover trial of single-hormone artificial pancreas (insulin alone), dual-hormone artificial pancreas (insulin and glucagon) and conventional insulin pump therapy in patients aged at least 12 years with type 1 diabetes. The researchers aimed to delineate the usefulness of glucagon in the artificial pancreas system.
Participants were randomly assigned to the three interventions in blocks and attended a research facility for three 24-hour study visits.
Insulin was delivered based on glucose sensor readings and a predictive dosing algorithm during visits with the single-hormone artificial pancreas; during dual-hormone artificial pancreas visits, glucagon also was delivered when glucose was low or falling. Patients received continuous subcutaneous insulin infusion during visits with conventional insulin pump therapy.
The researchers primarily looked at how long plasma glucose concentrations remained in the target range (4 mmol/L-10 mmol/L for 2 hours postprandially and 4 mmol/L-8 mmol/L otherwise). Hypoglycemic events were defined as either plasma glucose concentration <3.3 mmol/L with symptoms or <3 mmol/L regardless of symptoms.
Results were based on a modified intention-to-treat analysis, including data for all patients who completed at least two visits.
On average, the proportion of time patients spent in the plasma glucose target range over 24 hours was 62% with single-hormone artificial pancreas, 63% with dual-hormone artificial pancreas and 51% with conventional insulin pump therapy.
Time spent in target range differed 11% (P=.002) between single-hormone artificial pancreas and conventional insulin pump therapy and 12% (P=.00011) between dual-hormone artificial pancreas and conventional insulin pump therapy. No difference (P=.75) was observed between single-hormone and dual-hormone systems.
Patients with conventional insulin pump therapy demonstrated 52 hypoglycemic events (12 symptomatic) vs. 13 (five symptomatic) with the single-hormone artificial pancreas and nine with the dual-hormone artificial pancreas (0 symptomatic); nocturnal hypoglycemic events numbered 13 (0 symptomatic) with conventional insulin pump therapy and zero for single-hormone and dual-hormone artificial pancreas.
Haidar said the findings “will accelerate the development of the dual-hormone artificial pancreas, which many consider as the most promising therapy for type 1 diabetes.”
He noted that future studies should go beyond an inpatient setting and 24-hour time frame, highlighting research he has underway.
“We need to do longer outpatient studies,” Haidar said. “We actually just finalized two outpatient studies focusing on the night control (multiple nights), and we have a day and night (60 hours) study currently ongoing.” – by Allegra Tiver
For more information:
Ahmad Haidar, PhD, can be reached at the Institut de Recherches Cliniques de Montreal, 110 avenue des Pins Ouest, Montreal, QC, H2W 1R7, Canada; email: ahmad.haidar@mail.mcgill.ca.
Disclosure: Please see the study for a full list of researchers’ financial disclosures.
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