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 À control) in HbA1c at D180 was À0.1% (95% confidence interval [CI] À0.4; 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 À1.6% (95% CI À3.1; À0.1; P = 0.039) during D90 to D120 and remained at À2.6% (95% CI À4.5; À0.6; 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.

Impact on diabetes control and patient-reported outcomes of a newer implantable continuous glucose monitoring system (Eversense® CGM System): a single-centre retro- and prospective observational study

“…However, a recently published randomised and prospective study [18] with the Eversense ® XL CGM System in nearly 150 patients with an HbA 1c of >8% compared the effect of the system between patients with implanted and activated sensors (enabled group) and implanted but inactivated sensors (control group). After 6 months, the HbA 1c was 0.1% lower in the enabled group, supporting our findings.…”

Current and future therapies to treat impaired awareness of hypoglycemia

“…In a larger population (N = 90 subjects) T1D subjects who spent greater than 1.5 h/day in hypoglycemia were given the Eversense © (Ascensia Diabetes Care, United States) CGM to determine if it decreased the time spent in hypoglycemia. Researchers found that after 3–4 months subjects decreased their TBR, which was associated with increased TIR and was sustained after 5–6 months ( Renard et al, 2022 ); however, hypoglycemia awareness status was not assessed in the trial. Decreased TBR could improve awareness; however, this study found ( Renard et al, 2022 ) no improvement in HbA1c after 6-month indicating that glycemic control was still not attained.…”

“…Researchers found that after 3–4 months subjects decreased their TBR, which was associated with increased TIR and was sustained after 5–6 months ( Renard et al, 2022 ); however, hypoglycemia awareness status was not assessed in the trial. Decreased TBR could improve awareness; however, this study found ( Renard et al, 2022 ) no improvement in HbA1c after 6-month indicating that glycemic control was still not attained.…”

Glycemia control using remote technologies

“…Реальное клиническое использование системы Eversense в течение 180 дней было связано со значительным улучшением показателей HbA1c у взрослых с СД 1-го типа [42]. Рандомизированное клиническое исследование среди взрослых с СД 1-го типа, склонных к гипогликемии, во Франции показало, что система Eversense может значительно снизить TBR (<3 ммоль/л) у пациентов с СД 1, склонных к гипогликемии [43].…”