Clinical use of a 180‐day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes

Abstract

AimsThis real‐world study evaluated the changes in glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics associated with use of the implantable 180‐day Eversense CGM System (Eversense) in patients with type 1 diabetes.Materials and methodsThis was a prospective, multicentre, observational study among adult participants aged ≥18 years with type 1 diabetes across seven diabetes‐care centres in Italy who had Eversense inserted for the first time. HbA1c was measured at baseline and at 180 days. Changes in time in range [TIR (glucose 70–180 mg/dL)], time above range [TAR (glucose >180 mg/dL)], time below range [TBR (glucose <70 mg/dL)] and glycaemic variability were also assessed. Data were also analysed by previous CGM use and by mode of insulin delivery.ResultsOne‐hundred patients were enrolled (mean age 36 ± 12 years, mean baseline HbA1c 7.4 ± 0.92% [57 ± 10 mmol/mol]). Fifty‐six per cent of patients were users of the continuous subcutaneous insulin infusion pump and 45% were previous users of CGM. HbA1c significantly decreased in patients after 180 days of sensor wear (−0.43% ± 0.69%, 5 ± 8 mmol/mol, P < 0.0001). As expected, CGM‐naïve patients achieved the greatest reduction in HbA1c (−0.74% ± 0.48%, 8 ± 5 mmol/mol). TIR significantly increased and TAR and mean daily sensor glucose significantly decreased while TBR did not change after 180 days of sensor wear.ConclusionsReal‐world clinical use of the Eversense CGM System for 180 days was associated with significant improvements in HbA1c and CGM metrics among adults with type 1 diabetes. The study is registered on clinicaltrials.gov (NCT04160156).

The Optimal “Time in Range” and “Time below Range” are Difficult to Coordinate in Patients with Type 1 Diabetes

“…Indeed, the TBR (< 70) of patients with type 2 diabetes in our study was very high at 5.6%, but most patients did not feel hypoglycemic. This would explain the higher-thanexpected HbA1c for a TIR of 70% (7.6%) than the 6.9% measured in a previous study (Irace et al 2020). In this regard, the accuracy of readings below the hypoglycemic range was not confirmed in our study given that the FreeStyle Libre Pro does not utilize blood glucose for calibration.…”

“…This was inconsistent with the HbA1c level corresponding to a 70% TIR, indicating the difficulty in achieving a 70% TIR without hypoglycemia in patients with type 1 diabetes in this study. This might be due to higher GV, standard deviation, % coefficient of variation, mean amplitude of glycemic excursion, and average daily risk range in the type 1 diabetes group in this study, which highlighted the difficulty and importance of targeting GV in type 1 diabetes if the recommended targets are to be achieved safely (Irace et al 2020;Rodbard 2020). Indeed, our data demonstrated that dissociations between the desired TIR and TBR were observed more frequently in patients with type 1 diabetes who had % coefficients of variation > 36%.…”

Lessons learned from the continuous glucose monitoring metrics in pediatric patients with type 1 diabetes under COVID-19 lockdown

“…We stratified the study population to 3 groups according to delta-TIR: improved TIR (delta-TIR > 3%), stable TIR (−3% ≤ delta-TIR ≤ 3%) and worse TIR (delta-TIR < -3%). This stratification was based on charts that translate a change in TIR to a clinically significant change in HbA1c [18,19]. Although the difference in TIR is a useful research tool for comparative analysis, consensus regarding a clinically significant difference is lacking [15].…”

Evaluation of Accuracy and Safety of the Next-Generation Up to 180-Day Long-Term Implantable Eversense Continuous Glucose Monitoring System: The PROMISE Study

“…As a result, the PROMISE study provided further evidence of the safety of the Eversense 180 CGM System, which has been demonstrated in other clinical studies [7][8][9] and real-world evaluation. 10,19,20 Many of the AEs associated with the Eversense 180 CGM system, including with SBA sensors, are common to all CGM systems. However, due to the unique requirement for a minor office-based procedure to insert and remove the sensor, the insertion/removal procedure-related AEs in the PROMISE study, including with the SBA sensor, were minor and similar to that observed in the 90-day US pivotal studies 8,9 and in studies evaluating the present EU Eversense system.…”