Abstract
Objective: Use of real-time continuous glucose monitoring (rtCGM) has been shown to improve glycemic control in patients with type 2 diabetes (T2D) who are treated with intensive insulin therapy. However, most T2D patients are denied coverage for rtCGM due to failure to meet payer eligibility requirements: treatment with ≥3 insulin injections (or pump) and history of 4 × /day blood glucose testing. We investigated the relevance of these criteria to successful rtCGM use. Methods: This 6-month, prospective, interventional, single-arm study assessed the clinical effects of use rtCGM in patients with T2D treated with basal insulin only or noninsulin therapy. Primary outcomes were changes in HbA1c, average glucose, glycemic variability (% coefficient of variation), and percent of time in range (%TIR), below range (%TBR) and above range (%TAR). Results: Thirty-eight patients were included in the analysis (10.1% ± 1.8% HbA1c, 54.7 ± 10.2 years, 35.6 ± 6.4 body mass index). At 6 months, we observed reductions in HbA1c (-3.0% ± 1.3%, P < 0.001) and average glucose (-23.6 ± 38.8, P < 0.001). %TIR increased 15.2 ± 22.3, from 57.0 ± 29.9 to 72.2 ± 23.6, P < 0.001, with all patients maintaining %TBR targets (<4% at 70 mg/dL, <1% at <54 mg/dL). No changes in glycemic variability were observed. The greatest improvements in %TIR and %TAR were seen in patients treated with ≤1 medication. Conclusions: rtCGM use was associated with significant glycemic improvements in T2D patients treated with basal insulin only or noninsulin therapy. Given the growing body of evidence supporting rtCGM use in this population, insurance eligibility criteria should be modified to expand rtCGM use by T2D patients treated with less intensive therapies.