Early randomized controlled trials (RCTs) showed a strong inverse relationship between A1C and severe hypoglycemia (SH) risk, which could potentially limit therapy intensification and resulted in some guidelines suggesting increased A1C goals in at-risk patients. Subsequently, RCTs demonstrated that real-time continuous glucose monitoring (CGM) alters this relationship and attenuates SH risk associated with low A1C values ≥6.5%. The glucose management indicator (GMI) reflects average CGM glucose and correlates with A1C. This analysis uses real-world evidence to explore the relationship between GMI and hypoglycemia exposure. Data were from an anonymized convenience sample of 151,315 U.S.-based Dexcom G6 CGM app users with good device adherence evidenced by having uploaded ≥80% of possible CGM values in 3Q 2019. Hypoglycemia exposure was reported as the percentage of glucose values <70 or <54 mg/dL (level 1 or level 2 hypoglycemia, respectively). The Figure shows hypoglycemia and the number of users in six GMI categories. Although there are small, incremental increases in hypoglycemia until GMI is <6.5%, time spent in level 1 and level 2 hypoglycemia remains below the consensus goals of <4% and <1% for users with GMI values ≥6.5%. On average, CGM users with GMI values ≥6.5% have acceptably low rates of hypoglycemia, obviating the need to relax GMI goals as a strategy to reduce the risk of SH.
T.C. Walker: Employee; Self; Dexcom, Inc. J. Welsh: Employee; Self; CSL Behring. G.J. Norman: Employee; Self; Dexcom, Inc. A. Parker: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Dexcom, Inc. D.A. Price: Employee; Self; Dexcom, Inc.