Efficacy and safety of short-term sensor-augmented insulin-pump therapy for poorly controlled patients with type 1 diabetes mellitus

Abstract

Objective To evaluate the efficacy and safety of short-term sensor-augmented insulin-pump (SAP) therapy for poorly controlled patients with type 1 diabetes mellitus (T1DM). Methods Sixty T1DM patients with glycosylated hemoglobin (HbA1c)>9.0% were randomly assigned to 2 groups treated with SAP or multiple daily insulin injection (MDI) for 6 days, then all patients converted to MDI therapy. Results Compared with MDI group and before therapy, the mean blood glucose concentration (MBG), SD of blood glucose, mean amplitude of glycemic excursion (MAGE) and 24-h area under curve at 10.0 (AUC10.0) levels in SAP group significantly decreased after 6-day therapy (compared with MDI group: t=1.761, P=0.028, t=2.569, P=0.037, t=2.712, P=0.020, t=2.985, P=0.014, compared with before therapy: t=3.128, P=0.006, t=2.689, P=0.024, t=2.966, P=0.013, t=3.076, P=0.009); while there was no difference in 24-h area under curve at 3.9 (AUC3.9) between groups (P>0.05). After 1 month follow-up HbA1c levels decreased in SAP group (t=2.344, P=0.023) and were significantly lower than those in MDI group (t=1.844, P=0.035). There was no difference in daily insulin dosage, fasting C peptide (FCP) and postprandial 2 h C peptide (2 hCP) between two groups (P>0.05). Age (t=2.125, P=0.012) and SAP therapy (t=3.376, P=0.009) were independently correlated with the HbA1c after 1 month. Conclusion Short-term SAP therapy is effective and safe for poorly controlled T1DM patients with rapid glucose lowering and glycemic excursions reduction. Key words: Diabetes mellitus, type 1; Insulin infusion systems; Continuous glucose monitoring; Treatment outcome