Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes

Welsh, John; Zhang, Xiaohe; Puhr, Sarah; Johnson, Terri; Walker, Tomas C.; Balo, Andrew; Price, David A.

doi:10.1177/1932296818798816

Cited by 27 publications

(23 citation statements)

References 13 publications

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“…During the observation period, sensor technology advanced considerably. Dexcom released the G6 system, which is the first CGM not requiring calibrations, resistant to acetaminophen interference, and approved for nonadjunctive use (17,18). Given these benefits over the Guardian 3, we assessed Dexcom G6 use among participants at the end of the trial.…”

Section: Methodsmentioning

confidence: 99%

One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System

et al. 2019

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In September 2016, the U.S. Food and Drug Administration approved the Medtronic 670G "hybrid" closed-loop system. In Auto Mode, this system automatically controls basal insulin delivery based on continuous glucose monitoring data but requires users to enter carbohydrates and blood glucose for boluses. To track real-world experience with this first commercial closed-loop device, we prospectively followed pediatric and adult patients starting the 670G system. RESEARCH DESIGN AND METHODS This was a 1-year prospective observational study of patients with type 1 diabetes starting the 670G system between May 2017 and May 2018 in clinic. RESULTS Of the total of 84 patients who received 670G and consented, 5 never returned for follow-up, with 79 (aged 9-61 years) providing data at 1 week and 3, 6, 9, and/or 12 months after Auto Mode initiation. For the 86% (68 out of 79) with 1-week data, 99% (67 out of 68) successfully started. By 3 months, at least 28% (22 out of 79) had stopped using Auto Mode; at 6 months, 34% (27 out of 79); at 9 months, 35% (28 out of 79); and by 12 months, 33% (26 out of 79). The primary reason for continuing Auto Mode was desire for increased time in range. Reasons for discontinuation included sensor issues in 62% (16 out of 26), problems obtaining supplies in 12% (3 out of 26), hypoglycemia fear in 12% (3 out of 26), multiple daily injection preference in 8% (2 out of 26), and sports in 8% (2 out of 26). At all visits, there was a significant correlation between hemoglobin A 1c (HbA 1c) and Auto Mode utilization. CONCLUSIONS While Auto Mode utilization correlates with improved glycemic control, a focus on usability and human factors is necessary to ensure use of Auto Mode. Alarms and sensor calibration are a major patient concern, which future technology should alleviate.

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Section: Methodsmentioning

confidence: 99%

One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System

et al. 2019

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“…Several pediatric studies have investigated the accuracy of modern sensor systems in individuals with T1D 6 . They have shown encouraging results for both user‐ and factory‐calibrated real‐time continuous glucose monitoring systems such as the Guardian Sensor 3, 6 the Dexcom G6 16,17 and for the intermittently scanned continuous glucose monitoring (isCGM) system FreeStyle Libre 18 . To the best of our knowledge, no study so far has compared the three sensor systems that are approved in pediatric diabetes care in parallel under real‐world conditions in a standardized way in children with type 1 diabetes (T1D).…”

Section: Introductionmentioning

confidence: 99%

Performance of three different continuous glucose monitoring systems in children with type 1 diabetes during a diabetes summer camp

et al. 2020

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The aim of this study was to assess accuracy of the three most commonly used continuous glucose monitoring (CGM) systems in almost real‐life situation during a diabetes camp in children with type 1 diabetes (T1D) aged 9–14 years. Data was gathered during a 2‐week summer camp under physicians' supervision. Out of 38 participating children with T1D (aged: 11.0 [9.9; 12.1] years; 57% girls, mean HbA1c 7.2 [6.9; 7.7] %,) 37 wore a CGM system (either Abbott FreeStyle Libre (FSL), Dexcom G6 (DEX) or Medtronic Enlite (ENL)) throughout the camp. All concomitantly available data pairs of capillary glucose measurements and sensor values were used for the analysis. Mean absolute relative difference (MARD) was calculated and Parkes Error Grid analyses were done for all three systems used. In total 2079 data pairs were available for analysis. The overall MARDs of CGM systems used at the camp was FSL: 13.3% (6.7;21.6). DEX: 10.3% (5.8; 16.7) and ENL 8.5% (3.6; 15.6). During eu‐, hypo‐ and hyperglycemia MARDs were lowest in ENL. Highest MARDs were seen in hypoglycemia, where all three systems exhibited MARDs above 15%. Overnight MARDs of all systems was higher than during daytime. All sensors performed worst in hypoglycemia. Performance of the adequately calibrated Medtronic system outperformed the factory‐calibrated sensors. For clinical practice, it is important to adequately train children with T1D and families in the correct procedures for sensors that require calibrations.

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“…To characterize the accuracy of a CGM, the sensor glucose values are compared with plasma glucose levels, measured directly from a venous blood sample, and the mean percent difference between the CGM glucose value and plasma blood glucose is calculated, referred to as the mean absolute relative difference, or MARD. The newest CGM systems have MARDs between 8% and 12% (Christiansen et al, 2017;Slover et al, 2018;Wadwa et al, 2018;Welsh et al, 2019). Dexcom G4, which is an older generation CGM, has the highest MARD of commercial CGMs in use today, at 17% (Lafell et al, 2016).…”

Section: Overview Of Cgmmentioning

confidence: 99%

Use of Technology in Managing Diabetes in Youth, Part 1: Continuous Glucose Monitoring: Information and Tips for the School Nurse

Berget¹,

Wykoff

2020

NASN School Nurse

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Glucose monitoring is an essential component of type 1 diabetes (T1D) treatment. Continuous glucose monitoring (CGM) systems measure glucose levels every few minutes and provide valuable trend information about the direction and speed glucose levels are changing. Use of CGM is increasing rapidly in youth with T1D and consistent use of CGM is associated with improved glycemic control. School nurses are a vital part of the care team for a student with T1D, and therefore, must be comfortable using CGM to support their students at school. This is the first article in a three-part series on the use of technology in managing diabetes in youth. The purpose of this article is to describe CGM devices, including calibration requirements and interpretation of trend arrows and provide tips for school nurses in incorporating CGM into the student’s individualized healthcare plan. Part 2 in this series will focus on insulin pumps and Part 3 will focus on special considerations and problem solving when using diabetes technology in the school setting.

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Performance of a Factory-Calibrated, Real-Time Continuous Glucose Monitoring System in Pediatric Participants With Type 1 Diabetes

Abstract: The accuracy of the G6 CGM system in pediatrics may encourage consistent use of the system and contribute to improved glycemic outcomes in this population.

Cited by 27 publications

References 13 publications

One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System

One Year Clinical Experience of the First Commercial Hybrid Closed-Loop System

Performance of three different continuous glucose monitoring systems in children with type 1 diabetes during a diabetes summer camp

Use of Technology in Managing Diabetes in Youth, Part 1: Continuous Glucose Monitoring: Information and Tips for the School Nurse

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