Incremental value of continuous glucose monitoring when starting pump therapy in patients with poorly controlled type 1 diabetes: the RealTrend study

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 (A1C >or=8%) being treated with multiple daily injections. 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 (continuous subcutaneous insulin infusion [CSII] group). Outcome measures included A1C and glycemic variability.

Results: A total of 115 patients completed the study. Between baseline and trial end, A1C 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 the 91 patients who were fully protocol-compliant (including CGM sensor wear >or=70% of the time) were considered, A1C 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 A1C 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.

Trial registration: ClinicalTrials.gov NCT00441129.

Figure 1

Change in A1C during the study period. A: A1C levels in the intention-to-treat population measured at screening and visits 3, 5, and 6 in the FAS population (n = 115). ΔA1C intergroup visit 3–to–visit 6 ratio: 0.24%, P = 0.08; ΔA1C intergroup screening–to–visit 6 ratio: 0.57%, P = 0.006. B: A1C levels in the per protocol population (compliant patients, n = 91), ΔA1C intergroup visit 3–to–visit 6 ratio: 0.41%, P = 0.004; ΔA1C intergroup screening–to–visit 6 ratio: 0.68%, P < 0.001. All values are means ± SD.