A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes

Ji, Linong; Guo, Xiaokui; Guo, Lixin; Ren, Qian; Ye, Nan; Zhang, Jie

doi:10.1177/1932296816662884

Cited by 54 publications

(56 citation statements)

References 18 publications

(22 reference statements)

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“…To our knowledge, no scientific studies have been published previously evaluating the feasibility of factory calibration besides the ones leading to FreeStyle Libre. [9][10][11][12][13] All calibration-related studies and publications were focused on understanding and improving the standard BG-based fingerstick calibration [14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30] or overcoming transient effects, such as lag and signal artifacts [31][32][33][34][35] that can impact calibration. This demonstrates the novelty of this alternative approach and also possibly the superiority of the chemistry used in FreeStyle Libre over other sensor systems.…”

Section: Implementation Of Factory Calibration For Freestyle Librementioning

confidence: 99%

Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology

Hoss

Budiman

2017

Diabetes Technology & Therapeutics

115

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The use of commercially available continuous glucose monitors for diabetes management requires sensor calibrations, which until recently are exclusively performed by the patient. A new development is the implementation of factory calibration for subcutaneous glucose sensors, which eliminates the need for user calibrations and the associated blood glucose tests. Factory calibration means that the calibration process is part of the sensor manufacturing process and performed under controlled laboratory conditions. The ability to move from a user calibration to factory calibration is based on several technical requirements related to sensor stability and the robustness of the sensor manufacturing process. The main advantages of factory calibration over the conventional user calibration are: (a) more convenience for the user, since no more fingersticks are required for calibration and (b) elimination of use errors related to the execution of the calibration process, which can lead to sensor inaccuracies. The FreeStyle Libre TM and FreeStyle Libre Pro TM flash continuous glucose monitoring systems are the first commercially available sensor systems using factory-calibrated sensors. For these sensor systems, no user calibrations are required throughout the sensor wear duration.

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Section: Implementation Of Factory Calibration For Freestyle Librementioning

confidence: 99%

Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology

Hoss

Budiman

2017

Diabetes Technology & Therapeutics

115

View full text Add to dashboard Cite

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“…There is enough literature available highlighting the accuracy and safety of flash glucose monitoring personal use as a stand-alone system, just like CGMs. 4,[26][27][28][29][30][31] Future developments in flash glucose monitoring may include the availability of ''adjustable and predictable'' alerts and alarms and data made available on a mobile phone (so that patients do not need to carry another device). 32 Early versions of FreeStyle Libre link are available in Europe through an application on Android phones.…”

mentioning

confidence: 99%

Flash Glucose Monitoring: The Future Is Here

Garg

Aktürk

2017

Diabetes Technology & Therapeutics

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“…As the FGM Libre system has only been available for a short time, the number of scientific papers assessing the quality and reliability of laboratory measurements, traditional glucometers or comparing FGM Libre with systems existing for a long time is not too large. However, several independent studies conducted in different patients (with type 1 diabetes and type 2 diabetes, in adults and children) confirmed that the measurements by scanning are reliable and are within the limits of permissible error (on the Clarke Error Grid) and MARD indexes amounted to a dozen or so percent, that is they remained at a similar level as in the case of CGM systems which have been available for years [8][9][10][11]. The accuracy of measurement is not affected by age, body mass index (BMI), the method of insulin administration or HbA 1 c [4,6].…”

Section: Discussionmentioning

confidence: 84%

The usefulness of the FlashStyle Libre system in glycemic control in children with type 1 diabetes during summer camp

Deja

Kłeczek

Chumięcki³

et al. 2018

Pediatr Endocrino Diabetes Metab

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Type 1 diabetes requires the patient to be very involved in the treatment process, especially in terms of proper self-control. The new method of non-invasive glycemic control by scanning is an attractive alternative for patients requiring multiple measurements due to the high dynamics of glycemic changes. The aim of the study was to evaluate the usefulness of Flash FreeStyle Libre in glycemic control in children during summer camp on the basis of the participants' completed questionnaire and on the basis of the assessment o the suitability of the system performed by medical staff based on a comparative analysis: glycemia by sensor and glucometer. Material and Methods. A study using the new Flash FreeStyle Libre glycemic control system was conducted at a seaside summer camp for children with diabetes at the seaside. The study included 75 children (32 boys and 43 girls), in mean 13.4 (SD 4.6) years old, with an average duration of diabetes of 6.5 (SD 4.5) years and mean HbA 1 c of 7.81% (SD 2.05). All camp participants were provided with Libre sensors, however, routine glucose control measurements with therapeutic decisions was made using traditional glucose meters. On the last day of the camp, after the removal of the sensors, a satisfaction survey was conducted to assess with a new self-monitoring method and a comparative analysis of the glucose results from the sensor with the personal glucose meters -MARD, MAD, and clinical errors on the Clarke Error Grid were calculated. Results. In the Libre user's survey, wearing comfort and ease of installation were described as very good / good by 86% and 94% of the respondends, respectively. Ease of reading blood glucose by scan was positively evaluated by 92% of the respondents, 95% of the subjects did not report any side effects. The sensor remained intact for 14 days in 46 children (62%), which value was the basis for the statistical calculations. Comparative analysis of glucose results obtained from Libre measurements performed with glucose meters (3143 measurements) showed a relatively good MARD index -18.22% on average, with a large individual variation (6.36-29.51%). Clarke Error Grid showed that 75.2% (2309) of the results were in Zone A (Acceptable Errors) and 95.81% (3012) in Zone A and B (Non-Negative Errors). Conclusion. Libre user's satisfaction survey revealed that most of the respondents rated the cooperation with Flash FreeStyle Libre positively. The relatively good results of Libre in comparison with glucose meters have confirmed the usefulness of this method of monitoring glucose in summer camps for children with diabetes.

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A Multicenter Evaluation of the Performance and Usability of a Novel Glucose Monitoring System in Chinese Adults With Diabetes

Abstract: The system works well for people with diabetes in China, and it is easy to wear and use.

Cited by 54 publications

References 18 publications

Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology

Factory-Calibrated Continuous Glucose Sensors: The Science Behind the Technology

Flash Glucose Monitoring: The Future Is Here

The usefulness of the FlashStyle Libre system in glycemic control in children with type 1 diabetes during summer camp

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