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          Abstract

          Background: The t:slim X2™ insulin pump with Control-IQ ® technology from Tandem Diabetes Care is an advanced hybrid closed-loop system that was first commercialized in the United States in January 2020. Longitudinal glycemic outcomes associated with real-world use of this system have yet to be reported.

          Methods: A retrospective analysis of Control-IQ technology users who uploaded data to Tandem's t:connect ® web application as of February 11, 2021 was performed. Users age ≥6 years, with >2 weeks of continuous glucose monitoring (CGM) data pre- and >12 months post-Control-IQ technology initiation were included in the analysis.

          Results: In total 9451 users met the inclusion criteria, 83% had type 1 diabetes, and the rest had type 2 or other forms of diabetes. The mean age was 42.6 ± 20.8 years, and 52% were female. Median percent time in automation was 94.2% [interquartile range, IQR: 90.1%–96.4%] for the entire 12-month duration of observation, with no significant changes over time. Of these users, 9010 (96.8%) had ≥75% of their CGM data available, that is, sufficient data for reliable computation of CGM-based glycemic outcomes. At baseline, median percent time in range (70–180 mg/dL) was 63.6 (IQR: 49.9%–75.6%) and increased to 73.6% (IQR: 64.4%–81.8%) for the 12 months of Control-IQ technology use with no significant changes over time. Median percent time <70 mg/dL remained consistent at ∼1% (IQR: 0.5%–1.9%).

          Conclusion: In this real-world use analysis, Control-IQ technology retained, and to some extent exceeded, the results obtained in randomized controlled trials, showing glycemic improvements in a broad age range of people with different types of diabetes.

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          Most cited references24

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          International Consensus on Use of Continuous Glucose Monitoring

          Measurement of glycated hemoglobin (HbA1c) has been the traditional method for assessing glycemic control. However, it does not reflect intra- and interday glycemic excursions that may lead to acute events (such as hypoglycemia) or postprandial hyperglycemia, which have been linked to both microvascular and macrovascular complications. Continuous glucose monitoring (CGM), either from real-time use (rtCGM) or intermittently viewed (iCGM), addresses many of the limitations inherent in HbA1c testing and self-monitoring of blood glucose. Although both provide the means to move beyond the HbA1c measurement as the sole marker of glycemic control, standardized metrics for analyzing CGM data are lacking. Moreover, clear criteria for matching people with diabetes to the most appropriate glucose monitoring methodologies, as well as standardized advice about how best to use the new information they provide, have yet to be established. In February 2017, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address these issues. This article summarizes the ATTD consensus recommendations and represents the current understanding of how CGM results can affect outcomes.
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            Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes

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              Violin Plots: A Box Plot-Density Trace Synergism

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                Author and article information

                Journal
                Diabetes Technol Ther
                Diabetes Technol Ther
                dia
                Diabetes Technology & Therapeutics
                Mary Ann Liebert, Inc., publishers (140 Huguenot Street, 3rd FloorNew Rochelle, NY 10801USA )
                1520-9156
                1557-8593
                September 2021
                01 September 2021
                01 September 2021
                : 23
                : 9
                : 601-608
                Affiliations
                [1]Center for Diabetes Technology, University of Virginia, Charlottesville, Virginia, USA.
                Author notes
                [*]Address correspondence to: Marc Breton, PhD, Center for Diabetes Technology, University of Virginia, 560 Ray C Hunt Drive, Charlottesville, VA 22903, USA mb6nt@ 123456virginia.edu
                Author information
                https://orcid.org/0000-0001-7645-2693
                Article
                10.1089/dia.2021.0097
                10.1089/dia.2021.0097
                8501470
                33784196
                9f136841-be59-421b-858b-223f3ac637c8
                © Marc D. Breton and Boris P. Kovatchev, 2021; Published by Mary Ann Liebert, Inc.

                This Open Access article is distributed under the terms of the Creative Commons License [CC-BY] ( http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited.

                History
                Page count
                Figures: 6, Tables: 2, References: 26, Pages: 8
                Categories
                Original Articles

                continuous glucose monitoring,automated insulin dosing,closed-loop control,time in range

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