Transitioning of people with T1D from Multiple Daily Injections (MDI) and Self-Monitoring of Blood Glucose (BGM) directly to MiniMed™ 780G Advanced Hybrid Closed Loop (AHCL) system: a two-center, randomized controlled study

Abstract

<p> </p> <p>Objective: The aim of this study was to evaluate the outcomes of transitioning to the MiniMed™ 780G advanced hybrid closed-loop (AHCL) system in adult individuals with type 1 diabetes (T1DM) naïve to CSII and CGM technologies. </p> <p>Research Design and Methods: The trial was a two-center, randomized controlled, parallel group study evaluating individuals with T1DM aged 26-60 years managed with Multiple Daily Injection (MDI) and self-monitoring of blood glucose (BGM), with an HbA1c <10%. </p> <p>Results: 41 participants were recruited and randomized to either the AHCL (20) or the MDI+BGM (21) group. 37 participants (age 40.3±8.0 years; duration of diabetes 17.3 ± 12.1 years; BMI 25.1±3.1 kg/m2; HbA1c 7.2% ± 1.0) completed the study. Time spent in target (TIR) increased from 69.3±12.3% at baseline to 85.0±6.3% at 3 months in the AHCL group, while remaining unchanged in the control group: treatment effect 21.5% [95% CI 15.7, 27.3%]; p < 0.001. The Time Below Range (<70 mg/dl; TBR) decreased from 8.7%±7.3 to 2.1%±1.7 in the AHCL group and remained unchanged in the MDI+BGM group (treatment effect -4.4% [95% CI -7.4, -2.1%]; P < 0.001). Participants from the AHCL group also had significant improvements in HbA1c levels (treatment effect -0.6% [95% CI -0.9, -0.2]; p=0.005) and in the quality of life in specific subscales, compared to the MDI+BGM group.</p> <p>Conclusions: People with T1DM naïve to CSII and CGM technologies initiating AHCL significantly and safely improved their glycemic control, as well as their quality of life and psychological well-being.</p>