Retrospective Analysis of Continuous Glucose Monitoring Data With the Surveillance Error Grid Supports Nonadjunctive Dosing Decisions

Welsh, John; Walker, Tomas C.; Price, David A.

doi:10.1177/1932296817694180

Cited by 2 publications

(1 citation statement)

References 23 publications

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“…5 We conducted a clinical trial to evaluate the safety, accuracy, reliability, and risks of an investigational CGM sensor calibrated once per day over the course of 10 days.…”

Section: Introductionmentioning

confidence: 99%

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor

Hughes

Welsh

Bhavaraju

et al. 2017

Diabetes Technology & Therapeutics

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Background: Users of continuous glucose monitoring (CGM) systems are concerned with the frequency of inserting and calibrating new sensors, with sensor accuracy and reliability throughout the sensor's functional life, and with the risks associated with inaccurate sensor readings. Methods: A sensor for our next-generation CGM system was tested for accuracy by comparison with selfmonitored blood glucose (SMBG) values throughout 10 days of wear. Fifty subjects (49 with type 1 diabetes, 1 with type 2 diabetes, 20 male, mean -standard deviation [SD] age 32.5 -18.7 years) enrolled. Subjects wore one sensor each, calibrated it once per day, and obtained multiple daily SMBG values for comparison. A total of 2739 paired CGM-SMBG values were analyzed to arrive at standard accuracy statistics and plotted on the surveillance error grid (SEG) to estimate the risk of SMBG-CGM discrepancies. Results: The overall mean and median absolute relative difference (ARD) values were 9.6% and 7.2%, respectively. The median ARD values ranged from 8.9% on Day 1 to 6.5% on Day 10. SEG analysis categorized 2727 points (99.6%) as ''no'' or ''slight'' risk and 12 points (0.4%) as ''moderate'' or ''great'' risk. Thirty-nine (79.6%) of the 49 systems worked through the end of Day 10. Sensors and adhesives were well tolerated, with minimal erythema and induration. Conclusions: This new CGM system's accuracy throughout its 10-day functional life, the convenience associated with once-daily calibrations, and the high proportion of measurements in the ''no risk'' zone of the SEG support its nonadjunctive use in diabetes management and closed-loop insulin delivery systems.

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“…5 We conducted a clinical trial to evaluate the safety, accuracy, reliability, and risks of an investigational CGM sensor calibrated once per day over the course of 10 days.…”

Section: Introductionmentioning

confidence: 99%

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor

Hughes

Welsh

Bhavaraju

et al. 2017

Diabetes Technology & Therapeutics

Self Cite

View full text Add to dashboard Cite

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Comparison of venous, capillary and interstitial blood glucose data measured during hyperbaric oxygen treatment from patients with diabetes mellitus

et al. 2021

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Introduction: Patients undergoing hyperbaric oxygen treatments (HBOT) have been shown to experience a reduction in blood glucose (BG) levels during a treatment. This necessitates frequent assessment of BG levels. Continuous glucose monitoring (CGM) may represent an alternative to the current finger prick monitoring method in-chamber, however, continuous sensor glucose (SG) data has not been validated in situ. The aim was to determine the validity of continuous SG and intermittent BG monitoring with serum BG levels in diabetic patients during HBOT. Methods: Measurements were obtained (finger prick [capillary sample], CGM [interstitial fluid], and serum [venous sample]) at baseline, and at 30, 60, 90 and 120 minutes during the hyperbaric treatment. Data were analysed by calculating intraclass correlation coefficients (ICC) and using mixed effects linear regression. Results: The ICC results (n = 10 patients) between the three methods indicated very high and statistically significant absolute agreement at baseline (pre-dive) (ICC = 0.90, 95% CI 0.74-0.97), at 30 minutes (ICC = 0.85, 95% CI 0.61−0.96), 60 minutes (ICC = 0.86, 95% CI 0.58−0.96), 90 minutes (ICC = 0.87, 96% CI 0.63−0.96) and 120 minutes (ICC = 0.90, 95% CI 0.70-0.97). Capillary glucose and CGM SG readings were each within 1 mmol·L-1 on average of the serum glucose reading, with multi-level linear regression finding the average difference between the CGM SG and capillary glucose methods of BG sampling was not statistically significant (P = 0.81). Conclusions: The CGM SG data were comparable with glucose readings from capillary monitoring. Both CGM and capillary data were consistent with serum values.

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Retrospective Analysis of Continuous Glucose Monitoring Data With the Surveillance Error Grid Supports Nonadjunctive Dosing Decisions

Cited by 2 publications

References 23 publications

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor

Stability, Accuracy, and Risk Assessment of a Novel Subcutaneous Glucose Sensor

Comparison of venous, capillary and interstitial blood glucose data measured during hyperbaric oxygen treatment from patients with diabetes mellitus

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