Reduction of clinically important low glucose excursions with a long‐term implantable continuous glucose monitoring ( CGM ) system in adults with type 1 diabetes prone to hypoglycemia. France Adoption randomized clinical trial

International audienceAim: This trial assessed the outcomes on glucose control of the implantable Eversense real-time continuous glucose monitoring (CGM) system compared to self-monitoring of blood glucose or intermittently scanned CGM in patients with type 1 or type 2 diabetes (T1D or T2D).Patients and methods: This was a randomized (2:1), prospective, national, multicenter study. All participants, aged >18, on multiple daily insulin injections or insulin pump had a sensor inserted, activated only in the enabled group. Included patients had T1D or T2D with an HbA1c level >8% (cohort 1) or T1D with a time below range 1.5 hour/day during the previous 28 days (cohort 2). The primary outcomes were the HbA1c change at D180 (cohort 1) or the change in TBR180 ) was observed. In cohort 2, the mean adjusted difference in TBR<54 was -1.6% [-3.1; -0.1], p=0.039 during D90-D120 and remained at -2.6%, [-4.5; -0.6], p=0.011 during D150-D180 (pre-specified secondary outcome). There was no safety issue.Conclusion: This study shows that the Eversense CGM system can significantly decrease TBR