INTRODUCTION
T2D, T1D, diabetes, DKA, hypoglycaemia
DIABETIC KETOACIDOSIS, TYPE 1 DIABETES, DIABETES, TYPE 2 DIABETES, HYPOGLYCAEMIA
Prior to the introduction of continuous glucose monitoring (CGM) systems, patients with type 1 diabetes (T1D) and type 2 diabetes (T2D) relied on self‐monitored blood glucose (SMBG) data to make therapy adjustments. While studies showed that SMBG improved glycaemic control, glucose management was still limited by the frequency of fingerstick measurements.Early CGM systems such as the Dexcom G4 were approved for adjunctive use, meaning that confirmatory SMBG measurements were still required to make insulin dosing decisions. Advancements to CGM accuracy and performance led to an expanded indication for the Dexcom G5, and in 2016, the US Food and Drug Administration (FDA) approved G5 data for non‐adjunctive use. The 2017 REPLACE‐BG study further demonstrated that using CGM data in place of SMBG testing as the basis for diabetes treatment decisions was safe for adults with T1D.The Dexcom G6 system is approved for non‐adjunctive use in several jurisdictions for patients ages 2 years and older with insulin‐treated T1D or T2D. Previous studies have evaluated the sensor's accuracy,Here, we report results from the Assessing Non‐adjunctive CGM Safety at Home and In New Markets (ANSHIN) study that evaluated the impact of non‐adjunctive use of this CGM system on glycaemic control in adults with intensive insulin therapy (IIT)‐managed diabetes. We assessed the change in HbA1c and CGM‐measured outcomes in participants who switched from SMBG testing to non‐adjunctive CGM use. The main safety endpoints were severe hypoglycaemia (SH) and diabetic ketoacidosis (DKA).