Prevention of Hypoglycemia by Using Low Glucose Suspend Function in Sensor-Augmented Pump Therapy

Background: Severe hypoglycemic episodes are a barrier for achieving optimal glycemic control. Sensor-augmented pump (SAP) therapy with insulin in combination with a novel mechanism of automatic insulin shutoff (low glucose suspend [LGS]) can be used to prevent and reduce hypoglycemia. In a prospective study, we investigated the effect of the LGS algorithm on the frequency of hypoglycemia in children and adolescents with type 1 diabetes under real-life conditions. Methods: Twenty-one patients with type 1 diabetes (10.8 +/- 3.8 years old, duration of diabetes 5.9 +/- 3.0 years, pump therapy for 3.7 +/- 1.7 years, glycated hemoglobin level 7.8 +/- 1.1%) from three pediatric centers used the Paradigm (R) Veo (TM) system (Medtronic Minimed, Northridge, CA) during two subseqent time periods: SAP without LGS for 2 weeks and then SAP with LGS enabled for 6 weeks. The primary objective was to assess the frequency of hypoglycemic episodes when using the LGS feature with an insulin delivery shutoff of a maximum of 2 h at a sensor glucose level below 70 mg/dL (3.9 mmol/L). Results: In total, 1,298 LGS alerts occurred (853 shorter than 5 min). Forty-two percent of LGS activations (>5 min) lasted less than 30 min, whereas 24% had a duration of 2 h. The number of hypoglycemic excursions (average/day) was reduced during SAP + LGS (<70 mg/L, 1.27 +/- 0.75 vs. 0.95 +/- 0.49, P = 0.010; <= 40 mg/dL, 0.28 +/- 0.18 vs. 0.13 +/- 0.14, P = 0.005) as was the time spent in hypoglycemia (average minutes/day, 101 +/- 68 vs. 58 +/- 33, P = 0.002) without significant difference in the mean glucose level (145 +/- 23 vs. 148 +/- 19 mg/dL). No episodes of severe hyperglycemia or diabetic ketoacidosis were observed following LGS activation. Conclusions: The present investigation provides evidence that SAP with LGS reduces the frequency of hypoglycemia without compromising safety.