Relationship Between Sensor-Detected Hypoglycemia and Patient-Reported Hypoglycemia in People With Type 1 and Insulin-Treated Type 2 Diabetes: The Hypo-METRICS Study.

ABSTRACT

OBJECTIVE: Use of continuous glucose monitoring (CGM) has led to greater detection of hypoglycemia; the clinical significance of this is not fully understood. The Hypoglycaemia-Measurement, Thresholds and Impacts (Hypo-METRICS) study was designed to investigate the rates and duration of sensor-detected hypoglycemia (SDH) and their relationship with person-reported hypoglycemia (PRH) in people living with type 1 diabetes (T1D) and insulin-treated type 2 diabetes (T2D) with prior experience of hypoglycemia. RESEARCH DESIGN AND METHODS: We recruited 276 participants with T1D and 321 with T2D who wore a blinded CGM and recorded PRH in the Hypo-METRICS app over 10 weeks. Rates of SDH <70 mg/dL, SDH <54 mg/dL, and PRH were expressed as median episodes per week. Episodes of SDH were matched to episodes of PRH that occurred within 1 h. RESULTS: Median [interquartile range] rates of hypoglycemia were significantly higher in T1D versus T2D; for SDH <70 mg/dL (6.5 [3.8-10.4] vs. 2.1 [0.8-4.0]), SDH <54 mg/dL (1.2 [0.4-2.5] vs. 0.2 [0.0-0.5]), and PRH (3.9 [2.4-5.9] vs. 1.1 [0.5-2.0]). Overall, 65% of SDH <70 mg/dL was not associated with PRH, and 43% of PRH had no associated SDH. The median proportion of SDH associated with PRH in T1D was higher for SDH <70 mg/dL (40% vs. 22%) and SDH <54 mg/dL (47% vs. 25%) than in T2D. CONCLUSIONS: The novel findings are that at least half of CGM hypoglycemia is asymptomatic, even below 54 mg/dL, and many reported symptomatic hypoglycemia episodes happen above 70 mg/dL. In the clinical and research setting, these episodes cannot be used interchangeably, and both need to be recorded and addressed.