Abstract
Background: This study evaluated the accuracy and performance of a fourth-generation subcutaneous glucose sensor (Guardian™ Sensor 3) in the abdomen and arm.Methods: Eighty-eight subjects (14–75 years of age, mean ± standard deviation [SD] of 42.0 ± 19.1 years) with type 1 or type 2 diabetes participated in the study. Subjects wore two sensors in the abdomen that were paired with either a MiniMed™ 640G insulin pump, or an iPhone® or iPod® touch® running a glucose monitoring mobile application (Guardian Connect system) and a third sensor in the arm, which was connected to a glucose sensor recorder (GSR). Subjects were also asked to undergo in-clinic visits of 12–14 h on study days 1, 3, and 7 for frequent blood glucose sample testing using a Yellow Springs Instrument (YSI) reference.Results: The overall mean absolute relative difference (MARD ± SD) between abdomen sensor glucose (SG) and YSI reference values was 9.6% ± 9.0% and 9.4% ± 9.8% for the MiniMed 640G insulin pump and Guardian Connect system, respectively; and 8.7% ± 8.0% between arm SG and YSI reference values. The percentage of SG values within 20% agreement of the YSI reference value (for YSI >80 mg/dL) was 90.7% with the MiniMed 640G insulin pump, 91.8% with the Guardian Connect system, and 93.1% for GSR-connected arm sensors. Mean functional sensor life, when calibrating 3–4 times/day, was 145.9 ± 39.3 h for sensors paired with the MiniMed 640G insulin pump, 146.1 ± 41.6 h for sensors paired with the Guardian Connect system, and 147.6 ± 40.4 h for sensors connected to the GSR. Responses to survey questions regarding sensor comfort and ease of use were favorable.Conclusions: The Guardian Sensor 3 glucose sensor, whether located in abdomen or the arm, provided accurate glucose readings when compared with the YSI reference and demonstrated functional life commensurate with the intended 7-day use.ClinicalTrials.gov: NCT02246582
Highlights
Continuous glucose monitoring (CGM), relative to intermittent self-monitored blood glucose (SMBG) values, has afforded significant improvements in the management of diabetes mellitus
Exclusion criteria included hypoglycemic seizure, loss of consciousness, or an episode of diabetic ketoacidosis (DKA) within 6 months of the screening visit; a history of central nervous system or seizure disorder; cardiac disorder resulting in syncope; myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances, or thromboembolic disease; a hematocrit lower than the normal reference range; a history of adrenal insufficiency; the inability to tolerate tape adhesive in the area of sensor placement; any unresolved adverse skin condition in the area of sensor or device placement; or active participation in an investigational study where treatment was received within 2 weeks of the screening visit
Important end-user benefits of real-time CGM (RT-CGM), when compared with point-intime SMBG, have included the means to visualize current and trending glucose values that approximate blood glucose, and the ability to respond to those values in real-time
Summary
Continuous glucose monitoring (CGM), relative to intermittent self-monitored blood glucose (SMBG) values, has afforded significant improvements in the management of diabetes mellitus. Results: The overall mean absolute relative difference (MARD – SD) between abdomen sensor glucose (SG) and YSI reference values was 9.6% – 9.0% and 9.4% – 9.8% for the MiniMed 640G insulin pump and Guardian Connect system, respectively; and 8.7% – 8.0% between arm SG and YSI reference values. The percentage of SG values within 20% agreement of the YSI reference value (for YSI >80 mg/dL) was 90.7% with the MiniMed 640G insulin pump, 91.8% with the Guardian Connect system, and 93.1% for GSR-connected arm sensors. Conclusions: The Guardian Sensor 3 glucose sensor, whether located in abdomen or the arm, provided accurate glucose readings when compared with the YSI reference and demonstrated functional life commensurate with the intended 7-day use
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