Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial
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posted on 2021-01-05, 00:01 authored by Helga Blauw, A. Joannet Onvlee, Michel Klaassen, Arianne C. van Bon, J. Hans DeVriesOBJECTIVE
<p>To demonstrate the performance and safety of a bihormonal (insulin and
glucagon) artificial pancreas in adults with type 1 diabetes.</p>
<p> </p>RESEARCH
DESIGN AND METHODS
<p>In this outpatient, randomized, crossover trial, two-week fully closed
loop glucose control (artificial pancreas therapy) was compared to two-week
open loop control (patient’s normal insulin pump therapy with a glucose sensor
if they had one). </p>
<p> </p>RESULTS
<p>Twenty three patients were included in the
analysis. Median (IQR) time in range (70-180 mg/dL [3.9-10 mmol/L]) was
significantly higher during closed loop (86.6% [84.9-88.5]) compared with open loop (53.9% [49.7-67.2]; p<0.0001).</p>
<p> </p>CONCLUSIONS
<p>Compared to insulin pump therapy, the bihormonal artificial pancreas provided
superior glucose control, without meal or exercise announcements, and was safe
in adults with type 1 diabetes.</p>
Funding
Inreda Diabetic supplied the artificial pancreas systems and funded the glucose sensors and glucagon. Dexcom supplied the CGM devices with glucose sensors. Roche supplied infusion sets, pump cartridges, and blood glucose meters with corresponding lancets and test cassettes. Inreda Diabetic was involved in study design and data analysis. Besides, no funder had any role in study design, data collection, data analysis, data interpretation, or writing of the manuscript. Dexcom read the manuscript before submission.
History
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