The Impact of Insulin Pump Therapy on Glycemic Profiles in Patients with Type 2 Diabetes: Data from the OpT2mise Study

摘要

Background: The OpT2mise randomized trial was designed to compare the effects of continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDI) on glucose profiles in patients with type 2 diabetes. Research Design and Methods: Patients with glycated hemoglobin (HbA(1c)) levels of 8% (64mmol/mol) and 12% (108mmol/mol) despite insulin doses of 0.7-1.8U/kg/day via MDI were randomized to CSII (n=168) or continued MDI (n=163). Changes in glucose profiles were evaluated using continuous glucose monitoring data collected over 6-day periods before and 6 months after randomization. Results: After 6 months, reductions in HbA(1c) levels were significantly greater with CSII (-1.11.2% [-12.0 +/- 13.1mmol/mol]) than with MDI (-0.4 +/- 1.1% [-4.4 +/- 12.0mmol/mol]) (P<0.001). Similarly, compared with patients receiving MDI, those receiving CSII showed significantly greater reductions in 24-h mean sensor glucose (SG) (treatment difference, -17.1mg/dL; P=0.0023), less exposure to SG >180mg/dL (-12.4%; P=0.0004) and SG >250mg/dL (-5.5%; P=0.0153), and more time in the SG range of 70-180mg/dL (12.3%; P=0.0002), with no differences in exposure to SG<70mg/dL or in glucose variability. Changes in postprandial (4-h) glucose area under the curve >180mg/dL were significantly greater with CSII than with MDI after breakfast (-775.9 +/- 1,441.2mg/dL/min vs. -160.7 +/- 1,074.1mg/dL/min; P=0.0015) and after dinner (-731.4 +/- 1,580.7mg/dL/min vs. -71.1 +/- 1,083.5mg/dL/min; P=0.0014). Conclusions: In patients with suboptimally controlled type 2 diabetes, CSII significantly improves selected glucometrics, compared with MDI, without increasing the risk of hypoglycemia.