In type 1 diabetes (T1D) patients prone to hypoglycemia, a significant decrease in TBR ^<54 (time spent with glucose values below 54 mg/dL) can be achieved with the help of the Eversense CGM (continuous glucose monitoring) system.

• In this randomized (2:1), prospective, national, multicenter study, glucose control outcomes of the implantable Eversense real-time CGM system vs self-monitoring of blood glucose or intermittently scanned CGM were assessed in patients with type 1 or type 2 diabetes (T2D).

• Patients with T1D or T2D with a glycated hemoglobin (HbA1c) level > 8% (64 mmol/mol) (Cohort 1; n=149) or T1D with a time spent with glucose values below 70 mg/dL (3.8 mmol/l) (TBR ^<70 ) for >1.5 h/d during the previous 28 days (Cohort 2; n=90) were included.

• Outcomes of interest (primary outcomes) included HbA1c change at D180 (Cohort 1) or change in time spent with glucose values below 54 mg/dL (TBR ^<54 ) during the period of Day (D)90 to D120 (Cohort 2).

• Adjusted mean difference (enabled − control) in HbA1c at D180 in Cohort 1 was noted to be −0.1% (95% confidence interval [CI] −0.4; 0.1).

• There was no significant difference in time with values in the range 70 to 180 mg/dL or time with values above range (>180 mg/dL).

• In Cohort 2, mean adjusted difference in TBR ^<54 was noted to be −1.6% (95% CI −3.1; −0.1) during D90 to D120 and remained at −2.6% (95% CI −4.5; −0.6) during D150 to D180 (prespecified secondary outcome).

• Results showed the safety of the CGM system.