Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study.

The implanted Eversense Continuous Glucose Monitoring (CGM) System transitioned from 90- to 180- to 365-day durations marketed today. This report summarizes the 365-day clinical study. ENHANCE was a prospective, multicenter study evaluating the accuracy and safety of the Eversense 365 CGM system through 1 year in adults with diabetes.

Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems.

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations and their rate of change (RoC) that are used to evaluate CGM performance, impairs comparability. For this article, several experts in the field of CGM performance testing have collaborated to propose characteristics of the distribution of comparator measurements that should be collected during CGM performance testing.

Accuracy of the Third Generation of a 14-Day Continuous Glucose Monitoring System.

Introduction: We have evaluated the performance of the FreeStyle Libre® 3 continuous glucose monitoring system (FSL3) compared to (1) the venous plasma reference for participants aged ≥ 6 years and (2) the fingerstick capillary blood glucose (BG) reference for pediatric participants aged 4 and 5 years. The analytical performance of the third-generation factory-calibrated FSL3 CGM system was compared to the plasma venous blood glucose reference using the YSI 2300 STAT PLUS Glucose and Lactate Analyzer (the YSI reference) and the self-monitoring blood glucose (SMBG) reference for participants aged ≥ 6 years and participants aged 4 and 5 years, respectively.

Methods: A total of 108 participants aged ≥ 4 years with type 1 or type 2 diabetes from four sites in the USA were enrolled in the study.

Improved Glycemia with Hybrid Closed-Loop Versus Continuous Subcutaneous Insulin Infusion Therapy: Results from a Randomized Controlled Trial.

To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop (HCL) in comparison with continuous subcutaneous insulin infusion (CSII) therapy for 6 months in persons with type 1 diabetes (T1D). Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to 6 months of HCL intervention (n = 151, mean age of 39.9 ± 19.

Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial.

Standard insulin infusion sets (IISs) are to be replaced every 2 to 3 days to avoid complications and diabetic ketosis due to set failure. This pivotal trial evaluated the safety and performance of a new extended-wear infusion set (EIS) when used for 7 days by adults with type 1 diabetes (T1D). This single-arm, nonrandomized trial enrolled adults (18-80 years of age) with T1D, who used their own MiniMed™ 670G system with insulin lispro or insulin aspart and the EIS for up to 7 days, across 12 consecutive wears.