Efficacy and safety of sensor-augmented pump therapy (SAPT) with predictive low-glucose management in patients diagnosed with type 1 diabetes mellitus previously treated with SAPT and low glucose suspend

Background: Sensor-augmented insulin pump therapy (SAPT) with low-glucose suspend (LGS) is an effective and safe alternative for treating patients with type 1 diabetes mellitus (T1DM). New predictive low-glucose management (PLGM) systems decrease the severity and duration of hypoglycemic events. However, evidence of benefits in patients previously treated with SAPT-LGS is limited. Methods: A prospective before-after study was conducted in patients with T1DM treated with SAPT-LGS, who were switched to the Minimed^® 640G system with SmartGuard^® to assess the impact on A1c levels, severe hypoglycemia (SH), hypoglycemia unawareness (HU), and area under the curve (AUC) <70 mg/dL after three months of follow-up. Results: Fifty-five patients with T1DM with a mean age of 37.9 (IQR 6, 79) years and a mean baseline A1c level of 7.52 ± 1.11% were enrolled. After three months under PLGM, A1c levels significantly decreased to 7.18 ± 0.91% (p = 0.004). SH rate decreased from 2.47 (CI 0.44, 4.90) to 0.87 (CI 0.22, 1.52) events/patient-year (Incidence rate ratio 0.353, 95% CI 0.178, 0.637), AUC <70 mg/dL decreased from 0.59 ± 0.76 to 0.35 ± 0.65 mg/dL x minute (p = 0.030). HU determined by Clarke questionnaire resolved in 23 out of 30 patients (p = 0.002). Conclusions: This study suggests that SAPT with PLGM decreases the frequency of SH, HU, exposure to glucose levels below 70 mg/dL, and A1c levels. Based on these results, this therapy should be considered in T1DM patients previously treated with SAPT-LGS with persistent SH and HU. Further clinical trials comparing the efficacy and safety of these features are required.