Real‐time continuous glucose monitoring immediately after severe hypoglycaemia requiring emergency medical services: A randomised controlled trial

Abstract

AbstractAimsSevere hypoglycaemia requiring emergency medical services remains prevalent despite advances in all aspects of diabetes self‐management. Real‐time continuous glucose monitoring (RTCGM) technologies can reduce the risk of severe hypoglycaemia for adults with type 1 diabetes, but the impact of these devices has not been assessed in the acute phase after an episode of severe hypoglycaemia.MethodsWe recruited and randomised 35 adults with type 1 diabetes in the acute period after an episode of severe hypoglycaemia requiring emergency medical services and randomised participants to RTCGM with alerts and alarms, or usual care with self‐monitored blood glucose for 12 weeks with intermittent blinded CGM. The primary outcome was the difference between groups in percentage time spent in hypoglycaemia (≤3.0 mmol/L, 55 mg/dL).ResultsThirty participants completed the study (median (IQR) age, duration of diabetes, and BMI was 43 (36–56) years, 26 (19–37) years, and 24.9 (21.9–29.0) kg/m2, respectively). Sufficient CGM data was available for 15 participants in RT‐CGM group and 8 in SMBG group for the primary outcome analysis. The RTCGM group had a significantly larger reduction in exposure to glucose below 3.0 mmol/L (RTCGM −0.16 [−1.23 to 0.01] vs. SMBG 1.58 [0.41 to 3.48], p = 0.03) and episodes of nocturnal hypoglycaemia (RT‐CGM −0.03 [−0.15 to 0.02] vs. SMBG 0.05 [−0.03 to 0.40], p = 0.02). Episodes of severe hypoglycaemia were significantly lower in the RTCGM group (RTCGM 0.0 vs. SMBG 4.0, p 0.04).ConclusionsRTCGM implemented acutely after an episode of severe hypoglycaemia is feasible and clinically effective with important implications for hypoglycaemia management pathways and self‐monitoring cost effectiveness.