Dataset Information

Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator.

ABSTRACT: BACKGROUND:This study assessed the accuracy of a factory-calibrated 10-day real-time continuous glucose monitoring (CGM) system (G6), which includes an automated sensor applicator. METHODS:Seventy-six participants with insulin-treated diabetes were enrolled at four U.S. sites as part of a larger study of G6 system performance. In-clinic visits for frequent comparative blood glucose measurements using a reference instrument (YSI) were conducted on days 1, 4-5, 7, and/or 10 of system use. Accuracy evaluation included the proportion of CGM values that were within ±20% of YSI reference value for glucose levels >100?mg/dL and ±20?mg/dL for YSI glucose levels ?100?mg/dL (%20/20), the analogous %15/15 and %30/30, and the mean absolute relative difference (MARD) between temporally matched CGM and YSI values. Participants calibrated the systems once daily. Raw sensor data were reprocessed using assigned sensor codes and a factory-calibration algorithm. RESULTS:Reprocessed data from 62 participants (25 adults and 37 children and adolescents of ages 6-17 years; 3532 YSI-CGM pairs) were analyzed. The G6 system's overall %20/20 was 93.9% (adults, 92.5%; children and adolescents, 96.2%), its %15/15 was 83.3% (adults, 78.3%; children and adolescents, 91.1%), and its MARD was 9.0% (adults, 9.8%; children and adolescents, 7.7%). Overall day-1 %20/20 accuracy was 92.2%, %15/15 was 81.5%, and MARD was 9.3%. Accuracy was maintained across 10 days of use and various glucose concentration ranges in both adults and children and adolescents. CONCLUSIONS:The G6 system utilizing an automated sensor applicator provides accurate glucose readings in adults and children and adolescents throughout the 10-day sensor life.

SUBMITTER: Shah VN

PROVIDER: S-EPMC6422005 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

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Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator.

Shah Viral N VN Laffel Lori M LM Wadwa R Paul RP Garg Satish K SK

Diabetes technology & therapeutics 20180601 6

<h4>Background</h4>This study assessed the accuracy of a factory-calibrated 10-day real-time continuous glucose monitoring (CGM) system (G6), which includes an automated sensor applicator.<h4>Methods</h4>Seventy-six participants with insulin-treated diabetes were enrolled at four U.S. sites as part of a larger study of G6 system performance. In-clinic visits for frequent comparative blood glucose measurements using a reference instrument (YSI) were conducted on days 1, 4-5, 7, and/or 10 of syste ...[more]

PMID: 29923775

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Project description:BACKGROUND:Frequent use of continuous glucose monitoring (CGM) systems is associated with improved glycemic outcomes in persons with diabetes, but the need for calibrations and sensor insertions are often barriers to adoption. In this study, we evaluated the performance of G6, a sixth-generation, factory-calibrated CGM system specified for 10-day wear. METHODS:The study enrolled participants of ages 6 years and up with type 1 diabetes or insulin-treated type 2 diabetes at 11 sites in the United States. Participation involved one sensor wear period of up to 10 days. Adults wore the system on the abdomen; youth of ages 6-17 years could choose to wear it on the abdomen or upper buttocks. Clinic sessions for frequent comparison with reference blood glucose measurements took place on days 1, 4-5, 7, and/or 10. Participants of ages 13 years and up underwent purposeful supervised glucose manipulation during in-clinic sessions. During the study, participants calibrated the systems once daily. However, analysis was performed on glucose values that were derived from reprocessed raw sensor data, independently of self-monitored blood glucose values used for calibration. Reprocessing used assigned sensor codes and a factory-calibration algorithm. Performance evaluation included the proportion of CGM values that were within ±20% of reference glucose values >100 mg/dL or within ±20 mg/dL of reference glucose values ≤100 mg/dL (%20/20), the analogous %15/15, and the mean absolute relative difference (MARD, expressed as a percentage) between temporally matched CGM and reference values. RESULTS:Data from 262 study participants (21,569 matched CGM reference pairs) were analyzed. The overall %15/15, %20/20, and MARD were 82.4%, 92.3%, and 10.0%, respectively. Matched pairs from 134 adults and 128 youth of ages 6-17 years were similar with respect to %20/20 (92.4% and 91.9%) and MARD (9.9% and 10.1%). Overall %20/20 values on days 1 and 10 of sensor wear were 88.6% and 90.6%, respectively. The system's "Urgent Low Soon" (predictive of hypoglycemia within 20 min) hypoglycemia alert was correctly provided 84% of the time within 30 min before impending biochemical hypoglycemia (<70 mg/dL). The 10-day sensor survival rate was 87%. CONCLUSION:The new factory-calibrated G6 real-time CGM system provides accurate readings for 10 days and removes several clinical barriers to broader CGM adoption.

Dataset Information

Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator.

Publications

Performance of a Factory-Calibrated Real-Time Continuous Glucose Monitoring System Utilizing an Automated Sensor Applicator.

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