Abstract

Objective: Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) and multiple daily injections (MDI) with insulin glargine (glargine) as basal insulin and mealtime insulin lispro (lispro) have not been prospectively compared in people naïve to either regimen in a multicenter study. We aimed to help close that deficiency.

Research Design and Methods: People with type 1 diabetes on NPH-based insulin therapy were randomized to CSII or glargine-based MDI (both otherwise using lispro) and followed for 24 weeks in an equivalence design. Fifty people were correctly randomized and 43 completed the study.

Results: Total insulin requirement (mean±standard deviation [SD]) at endpoint was 36.2±11.5 U/day on CSII and 42.6±15.5 U/day on MDI. Mean A1C fell similarly in the two groups (CSII −0.7±0.7% [±SD], MDI −0.6±0.8%) with a baseline-adjusted difference of −0.1% (95% CI: −0.5, 0.3). Similarly, fasting blood glucose and other pre-prandial, post-prandial and night-time self-monitored plasma glucose (PG) levels did not differ between the regimens, nor did measures of PG variability. On CSII, 1152 hypoglycemia events were recorded by 23 of 28 participants (82%), and 1022 in the MDI group by 27 of 29 patients (93%; all hypoglycemia differences non-significant). Treatment satisfaction score increased more with CSII, however, the change in score was similar for the groups. Costs were around 3.9 times higher for CSII.

Conclusion: In unselected people with type 1 diabetes naïve to CSII or insulin glargine, glycemic control is no better with the more expensive CSII therapy compared to glargine-based MDI therapy.