Introduction: Self-Monitoring of Blood Glucose (SMBG) uses capillary blood glucose to measure glycemia in diabetic patients. Recently FDA-approved Flash Continuous Glucose Monitoring (F-CGM) reveals glucose levels when scanned by the reading device. The Centers for Medicare and Medicaid Services (CMS) have announced to reimburse F-CGM at the same level as CGM devices.

Aim: This analysis’ objective was to quantify the CMS budget impact (BI) of F-CGM reimbursement in patients with type 2 diabetes (T2DM) on intensified insulin therapy (IIT), and compare it to the BI of conventional SMBG via cost-related break-even metrics. These were chosen because - in the absence of RCT-based, primary endpoint-driven clinical superiority evidence of F-CGM over SMBG for this population (REPLACE study) - they are well-suited to inform budget allocation decisions.

Methods: An economic model was developed in Excel. CMS reimbursement/patient co-insurance levels for SMBG and F-CGM were used; data on morbidity, treatment and usage patterns were sourced from the literature and official websites. Different scenarios were simulated to elicit break-even points between F-CGM and SMBG.

Results: The annual cost of SMBG with 3.7 tests per day (see REPLACE) is $180 per patient, compared to $2,156 incurred per F-CGM patient, representing a cost difference of $1,976/year or $5.41/day. This implies a budget break-even ratio of 1:12 patients (F-CGM:SMBG). Both technologies would break even at a consumption of 44 test strips per day. A year’s SMBG budget would last only 30 days if spent on F-CGM.

Conclusion: With diabetes budgets under pressure, thoughtful spending policies are needed. It is recommended to analyze in detail which T2DM subgroups will benefit most from F-CGM, focusing reimbursement to the latter. SMBG, being an established technology, represents - at current reimbursement levels - an attractive spending option to budget holders.


M. Stueve: Employee; Self; JnJ GmbH Life Scan. Y.F. Zoellner: Research Support; Self; J&J Medical GmbH, LifeScan.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at