Reduction of clinically important low glucose excursions with a long-term implantable continuous glucose monitoring system in adults with type 1 diabetes prone to hypoglycaemia: the France Adoption Randomized Clinical Trial

Abstract

Aim: To assess the glucose control outcomes 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 (T1D) or type 2 diabetes (T2D). Patients and Methods: This was a randomized (2:1), prospective, national, multicentre study. All participants, aged >18 years and on multiple daily insulin injections or insulin pump treatment, had a sensor inserted, which was activated only in the “enabled” group. Included patients had T1D or T2D with a glycated haemoglobin (HbA1c) level > 8% (64 mmol/mol) (Cohort 1) 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). The primary outcomes were 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). A covariance model (analyses of covariance) was used for endpoint analyses. Results: Overall, 149 patients were included in Cohort 1 and 90 in Cohort 2. In Cohort 1, the adjusted mean difference (enabled − control) in HbA1c at D180 was −0.1% (95% confidence interval [CI] −0.4; 0.1; P = 0.341). No significant difference in time with values in the range 70 to 180 mg/dL or time with values above range (>180 mg/dL) was observed. In Cohort 2, the mean adjusted difference in TBR<54 was −1.6% (95% CI −3.1; −0.1; P = 0.039) during D90 to D120 and remained at −2.6% (95% CI −4.5; −0.6; P = 0.011) during D150 to D180 (prespecified secondary outcome). The CGM system was found to be safe. Conclusion: This study shows that the Eversense CGM system can significantly decrease TBR<54 in patients with T1D prone to hypoglycaemia.