Abstract

Objective: To compare the improvements in glycemic control associated with transitioning to insulin pump therapy in patients using continuous glucose monitoring versus standard blood glucose self-monitoring.

Research design and methods: The RealTrend study was a 6-month, randomized, parallel-group, two-arm, open-label study of 132 adults and children with uncontrolled type 1 diabetes (HbA1c ≥ 8%) being treated with multiple daily injections (MDI). One group was fitted with the Medtronic Minimed Paradigm REAL-Time system (PRT group), an insulin pump with integrated continuous subcutaneous glucose monitoring (CGM) capability, with instructions to wear CGM sensors at least 70% of the time. Conventional insulin pump therapy was initiated in the other group (CSII group). Outcome measures included HbA1c and glycemic variability.

Results: A total of 115 patients completed the study. Between baseline and trial end, HbA1c improved significantly in both groups (PRT group, −0.81 ± 1.09%, P < 0.001; CSII group −0.57 ± 0.94%, P < 0.001), with no significant difference between groups. When considering the 91 patients who were fully protocol-compliant (including CGM sensor wear ≥ 70% of the time), HbA1c improvement was significantly greater in the PRT group (P = 0.004) (PRT group −0.96 ± 0.93%, P < 0.001; CSII group −0.55 ± 0.93%, P < 0.001). Hyperglycemia parameters decreased in line with improvements in HbA1c with no impact on hypoglycemia.

Conclusions: CGM-enabled insulin pump therapy improves glycemia more than conventional pump therapy during the first 6 months of pump use in patients who wear CGM sensors at least 70% of the time.