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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 05.01.2021, 00:01 by Helga Blauw, A. Joannet Onvlee, Michel Klaassen, Arianne C. van Bon, J. Hans DeVries
OBJECTIVE

To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas in adults with type 1 diabetes.

RESEARCH DESIGN AND METHODS

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).

RESULTS

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).

CONCLUSIONS

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.

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.

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