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One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology.

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.

SUBMITTER: Breton MD

PROVIDER: S-EPMC8501470 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:AimTo evaluate the effect of a one-year use of an advanced hybrid closed-loop (AHCL) system on the quality of life, level of anxiety, and level of self-efficacy in adults with type 1 diabetes (T1D) previously treated with multiple daily injections (MDI) and naïve to advanced diabetes technology.MethodsA total of 18 participants of a previously published 3-month randomized trial (10 men, 8 women; age 40.9 ± 7.6 years) who were switched directly from MDI/BMG to AHCL completed 12 months of MiniMed 780G™system use (a 3-month randomized trial followed by a 9-month follow-up phase). At month 6 of the study, patients were switched from the sensor GS3 (Continuous Glucose Monitoring) system, powered by Guardian™ Sensor 3) to GS4. Quality of life was assessed using the Polish validated version of the 'QoL-Q Diabetes' questionnaire. The level of anxiety was evaluated with the use of the State-Trait Anxiety Inventory (STAI). Self-efficacy was assessed with the General Self-Efficacy Scale (GSES). Results were obtained at baseline and at the end of the study.ResultsSignificant increase in QoL was reported in the global score (p=0.02, Cohen d=0.61) and in as many as 11 out of 23 analyzed areas of life: being physically active (p=0.02, Cohen d = 0.71); feeling well (p<.01, Cohen d = 0.73); feeling in control of my body (p<.01, Cohen d = 0.72); looking good (p<.01, Cohen d = 1.07); working (p<.01, Cohen d = 1.12); sleeping (p=0.01, Cohen d = 0.66); eating as I would like (p<.01, Cohen d = 0.79); looking after or being useful to others (p= 0.02, Cohen d = 0.65); being active with pets/animals (p<.01, Cohen d = 0.95); being spontaneous (p=0.02, Cohen d = 0.67); and doing "normal" things (p=0.02, Cohen d = 0.67). Both state (p=0.04, Cohen d = 0.56) and trait (p=0.02, Cohen d = 0.60) anxiety decreased while the general self-efficacy increased (p=0.03, Cohen d = 0.76). No participant stopped the use of the pump.ConclusionAdult patients with T1D previously treated with MDI and naïve to modern technologies experienced significant improvement in their psychological well-being after transitioning to the AHCL system after 12 months of treatment.

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One Year Real-World Use of the Control-IQ Advanced Hybrid Closed-Loop Technology.

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