BACKGROUND: The purpose of this study was to understand the effect of sensor-augmented insulin pump (SAP) use on hypoglycemia and blood glucose (BG) fluctuations. SUBJECTS AND METHODS: Sixty patients with type 2 diabetes mellitus were randomly assigned to three groups of treatment with SAP, continuous subcutaneous insulin infusion (CSII), or multiple daily injection (MDI) therapy for 6 days. Parameters of glycemic control that were determined included mean BG concentration (MBG), SD of BG (SDBG), mean amplitude of glycemic excursions (MAGE), absolute means of daily differences (MODD), 24-h area under the curve at 10 h (AUC10), 24-h area under the curve at 3.9 h (AUC3.9), and Low Blood Glucose Index (LBGI). RESULTS: No significant differences were observed among the three groups in terms of MBG, SDBG, MAGE, or MODD at the beginning of treatment. The MBG, SDBG, MAGE, MODD, and total AUC10 of the SAP group improved over the 4 days of the intervention compared with the CSII and MDI groups; however, no significant differences were observed among the three groups in terms of total AUC3.9 and LBGI. CONCLUSIONS: Compared with CSII and MDI therapy, SAP therapy was able to rapidly lower mean BG and reduce BG level fluctuations with no increased risks of hypoglycemia.
RCT Entities:
BACKGROUND: The purpose of this study was to understand the effect of sensor-augmented insulin pump (SAP) use on hypoglycemia and blood glucose (BG) fluctuations. SUBJECTS AND METHODS: Sixty patients with type 2 diabetes mellitus were randomly assigned to three groups of treatment with SAP, continuous subcutaneous insulin infusion (CSII), or multiple daily injection (MDI) therapy for 6 days. Parameters of glycemic control that were determined included mean BG concentration (MBG), SD of BG (SDBG), mean amplitude of glycemic excursions (MAGE), absolute means of daily differences (MODD), 24-h area under the curve at 10 h (AUC10), 24-h area under the curve at 3.9 h (AUC3.9), and Low Blood Glucose Index (LBGI). RESULTS: No significant differences were observed among the three groups in terms of MBG, SDBG, MAGE, or MODD at the beginning of treatment. The MBG, SDBG, MAGE, MODD, and total AUC10 of the SAP group improved over the 4 days of the intervention compared with the CSII and MDI groups; however, no significant differences were observed among the three groups in terms of total AUC3.9 and LBGI. CONCLUSIONS: Compared with CSII and MDI therapy, SAP therapy was able to rapidly lower mean BG and reduce BG level fluctuations with no increased risks of hypoglycemia.
Authors: Mark P Christiansen; Satish K Garg; Ronald Brazg; Bruce W Bode; Timothy S Bailey; Robert H Slover; Ashley Sullivan; Suiying Huang; John Shin; Scott W Lee; Francine R Kaufman Journal: Diabetes Technol Ther Date: 2017-07-12 Impact factor: 6.118