Fully Closed Loop Glucose Control With a Bihormonal Artificial Pancreas in Adults With Type 1 Diabetes: An Outpatient, Randomized, Crossover Trial
Abstract
OBJECTIVE To demonstrate the performance and safety of a bihormonal (insulin and glucagon) artificial pancreas (AP) in adults with type 1 diabetes.
RESEARCH DESIGN AND METHODS In this outpatient, randomized, crossover trial, 2-week fully closed loop glucose control (AP therapy) was compared with 2-week open loop control (patient’s normal insulin pump therapy with a glucose sensor if they had one).
RESULTS A total of 23 patients were included in the analysis. Time in range (70–180 mg/dL [3.9–10 mmol/L]) was significantly higher during closed loop (median 86.6% of time [interquartile range 84.9–88.5]) compared with open loop (53.9% [49.7–67.2]; P < 0.0001).
CONCLUSIONS Compared with insulin pump therapy, the bihormonal AP provided superior glucose control, without meal or exercise announcements, and was safe in adults with type 1 diabetes.
Footnotes
Clinical trial reg. no. NCT03858062, clinicaltrials.gov
This article contains supplementary material online at https://doi.org/10.2337/figshare.13283912.
- Received August 24, 2020.
- Accepted November 24, 2020.
- © 2021 by the American Diabetes Association
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at https://www.diabetesjournals.org/content/license.
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