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The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past six years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.

Background: In this study, we evaluated the analytical performance of the second-generation factory-calibrated FreeStyle Libre Flash Glucose Monitoring (FreeStyle Libre 2) System compared to plasma venous blood glucose reference, Yellow Springs Instrument 2300 (YSI). Methods: The study enrolled participants aged four and above with type 1 or type 2 diabetes at seven sites in the United States. Adult participants (18+ years) participated in three in-clinic sessions and pediatric participants (4-17 years) participated in up to two in-clinic sessions stratified to provide data for days 1, 2, 3, 7, 8, 9, 12, 13, or 14 of sensor wear. Participants aged 11+ underwent supervised glycemic manipulation during in-clinic sessions to achieve glucose levels across the measurement range of the System. Performance evaluation included accuracy measures such as the proportion of continuous glucose monitoring (CGM) values that were within ±20% or ±20 mg/dL of reference glucose values, and bias measures such as the mean absolute relative difference (MARD) between CGM and reference values. Results: Data from the 144 adults and 129 pediatric participants were analyzed. Percent of sensor results within ±20%/20 mg/dL of YSI reference were 93.2% and 92.1%, and MARD was 9.2% and 9.7% for the adults and pediatric participants, respectively. The System performed well in the hypoglycemic range, with 94.3% of the results for the adult population and 96.1% of the data for pediatric population being within 15 mg/dL of the YSI reference. The time lag was 2.4 ± 4.6 minutes for adults and 2.1 ± 5.0 minutes for pediatrics. Conclusions: The System demonstrated improved analytical accuracy performance across the dynamic range during the 14-day sensor wear period as compared to the previous-generation device. NCT#: NCT03607448 and NCT03820050