Accuracy of the SEVEN continuous glucose monitoring system: comparison with frequently sampled venous glucose measurements.

Publisher: Sage Country of Publication: United States NLM ID: 101306166 Publication Model: Electronic Cited Medium: Internet ISSN: 1932-2968 (Electronic) Linking ISSN: 19322968 NLM ISO Abbreviation: J Diabetes Sci Technol Subsets: MEDLINE

Publication: 2014- : Thousand Oaks, CA : Sage
Original Publication: Foster City, CA : Diabetes Technology Society

Diagnostic Equipment*; Blood Glucose/*metabolism ; Blood Glucose Self-Monitoring/*instrumentation ; Diabetes Mellitus, Type 1/*diagnosis ; Diabetes Mellitus, Type 2/*diagnosis; Adolescent ; Adult ; Aged ; Blood Glucose Self-Monitoring/standards ; Blood Specimen Collection ; Calibration ; Catheterization, Peripheral ; Diabetes Mellitus, Type 1/blood ; Diabetes Mellitus, Type 1/drug therapy ; Diabetes Mellitus, Type 2/blood ; Diabetes Mellitus, Type 2/drug therapy ; Dietary Carbohydrates/administration & dosage ; Dietary Carbohydrates/metabolism ; Equipment Design ; Female ; Humans ; Hypoglycemic Agents/administration & dosage ; Insulin/administration & dosage ; Male ; Middle Aged ; Predictive Value of Tests ; Prospective Studies ; Reproducibility of Results ; Time Factors ; United States ; Young Adult

Background: The purpose of this study was to compare the accuracy of measurements obtained from the DexCom SEVEN system with Yellow Springs Instrument (YSI) laboratory measurements of venous blood glucose.
Methods: Seventy-two subjects with insulin-requiring diabetes, aged 18-71, were enrolled in a multicenter, prospective single-arm study. All participants wore the SEVEN continuous glucose monitoring (CGM) system for one, 7-day wear period. Calibration with capillary finger stick measurements was performed 2 hours after sensor insertion and once every 12 hours thereafter. A subset of subjects (28) wore two systems simultaneously to assess precision. All subjects participated in one, 10-hour in-clinic session on day 1, 4, or 7 of the study to compare CGM measurements against a laboratory method (YSI analyzer) using venous measurements taken once every 20 minutes. Carbohydrate consumption and insulin dosing were adjusted in order to obtain a broad range of glucose values.
Results: Comparison of CGM measurements with the laboratory reference method (n = 2318) gave mean and median absolute relative differences (ARDs) of 16.7 and 13.2%, respectively. The percentage was 70.4% in the clinically accurate Clarke error grid A zone and 27.5% in the benign error B zone. Performance of the SEVEN system was consistent over time with mean and median ARD lowest on day 7 as compared to YSI (13.3 and 10.2%, respectively). Average sensor time lag was 5 minutes.
Conclusions: Measurements of the DexCom SEVEN system were found to be consistent and accurate compared with venous measurements made using a laboratory reference method over 7 days of wear.
(2009 Diabetes Technology Society.)

Comment on: J Diabetes Sci Technol. 2009 Sep 01;3(5):1155-7. (PMID: 20144430)
Comment on: J Diabetes Sci Technol. 2009 Sep;3(5):1155-7. (PMID: 20144430)

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0 (Blood Glucose)
0 (Dietary Carbohydrates)
0 (Hypoglycemic Agents)
0 (Insulin)

Date Created: 20100211 Date Completed: 20100602 Latest Revision: 20240408

20240408

PMC2769895

10.1177/193229680900300519

20144429