Journal articles on the topic 'CGM sensor'
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1
Heo, Yun Jung, and Seong-Hyok Kim. "Toward Long-Term Implantable Glucose Biosensors for Clinical Use." Applied Sciences 9, no. 10 (May 27, 2019): 2158. http://dx.doi.org/10.3390/app9102158.
Abstract:
Continuous glucose monitoring (CGM) sensors have led a paradigm shift to painless, continuous, zero-finger pricking measurement in blood glucose monitoring. Recent electrochemical CGM sensors have reached two-week lifespans and no calibration with clinically acceptable accuracy. The system with the recent CGM sensors is identified as an “integrated glucose monitoring system,” which can replace finger-pricking glucose-testing for diabetes treatment decisions. Although such innovation has brought CGM technology closer to realizing the artificial pancreas, discomfort and infection problems have arisen from short lifespans and open wounds. A fully implantable sensor with a longer-term lifespan (90 days) is considered as an alternative CGM sensor with high comfort and low running cost. However, it still has barriers, including surgery for applying and replacing and frequent calibration. If technical refinement is conducted (e.g., stability and reproducibility of sensor fabrication), fully implantable, long-term CGM sensors can open the new era of continuous glucose monitoring.
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Vettoretti, Martina, Cristina Battocchio, Giovanni Sparacino, and Andrea Facchinetti. "Development of an Error Model for a Factory-Calibrated Continuous Glucose Monitoring Sensor with 10-Day Lifetime." Sensors 19, no. 23 (December 3, 2019): 5320. http://dx.doi.org/10.3390/s19235320.
Abstract:
Factory-calibrated continuous glucose monitoring (FC-CGM) sensors are new devices used in type 1 diabetes (T1D) therapy to measure the glucose concentration almost continuously for 10–14 days without requiring any in vivo calibration. Understanding and modelling CGM errors is important when designing new tools for T1D therapy. Available literature CGM error models are not suitable to describe the FC-CGM sensor error, since their domain of validity is limited to 12-h time windows, i.e., the time between two consecutive in vivo calibrations. The aim of this paper is to develop a model of the error of FC-CGM sensors. The dataset used contains 79 FC-CGM traces collected by the Dexcom G6 sensor. The model is designed to dissect the error into its three main components: effect of plasma-interstitium kinetics, calibration error, and random measurement noise. The main novelties are the model extension to cover the entire sensor lifetime and the use of a new single-step identification procedure. The final error model, which combines a first-order linear dynamic model to describe plasma-interstitium kinetics, a second-order polynomial model to describe calibration error, and an autoregressive model to describe measurement noise, proved to be suitable to describe FC-CGM sensor errors, in particular improving the estimation of the physiological time-delay.
3
Barnard, Katharine D., Jort Kropff, Pratik Choudhary, Sankalpa Neupane, Stephen C. Bain, Christoph Kapitza, Thomas Forst, Manuela Link, Colleen Mdingi, and J. Hans DeVries. "Acceptability of Implantable Continuous Glucose Monitoring Sensor." Journal of Diabetes Science and Technology 12, no. 3 (October 8, 2017): 634–38. http://dx.doi.org/10.1177/1932296817735123.
Abstract:
Background: Real-time continuous glucose monitoring is associated with significant benefits for diabetes management. Implantable sensors could overcome some challenges reportedly associated with device visibility, psychosocial functioning and sensor durability. Methods: A psychosocial assessment was conducted to determine acceptability and impact of an implantable continuous glucose monitoring (CGM) sensor as part of the PRECISE trial. Questionnaires were administered to participants comprising the Diabetes Distress Scale, the CGM impact scale, and bespoke device satisfaction. Results: Fifty-one participants across the United Kingdom (n = 10) and Germany (n = 41) completed the questionnaires. Of these, 90% had T1D, 50% followed an insulin pump therapy regimen, and 45% of the participants were previous CGM users. CGM Impact Scale results show 86% (n = 44) of participants reported feeling better (14% neutral) about their diabetes control with 90% CGM naïve participants and 81% previous CGM users reporting increased confidence about their diabetes management. Furthermore, 73% (n = 37) felt more safe (27% neutral) while sleeping and 78% (n = 39) more confident (22% neutral) about avoiding serious hypoglycemia. Responses correspond with an average improvement in HbA1c from 7.51 to 7.05 ( P < .0001) over the 90 days use of the CGM. Overall, the system was rated highly on ease of use, convenience and comfort. 84% would choose to be inserted again with 93% of CGM naïve participants (86% previous CGM users) reporting minimized burden of diabetes. Conclusions: Implantable CGM devices are acceptable to users and are evaluated favorably. The considerable majority of participants (93% of first time users and 77% previous CGM users) would like to continue using the system to help manage their diabetes more effectively.
4
Vettoretti, Martina, Giacomo Cappon, Giada Acciaroli, Andrea Facchinetti, and Giovanni Sparacino. "Continuous Glucose Monitoring: Current Use in Diabetes Management and Possible Future Applications." Journal of Diabetes Science and Technology 12, no. 5 (May 22, 2018): 1064–71. http://dx.doi.org/10.1177/1932296818774078.
Abstract:
The recent announcement of the production of new low-cost continuous glucose monitoring (CGM) sensors, the approval of marketed CGM sensors for making treatment decisions, and new reimbursement criteria have the potential to revolutionize CGM use. After briefly summarizing current CGM applications, we discuss how, in our opinion, these changes are expected to extend CGM utilization beyond diabetes patients, for example, to subjects with prediabetes or even healthy individuals. We also elaborate on how the integration of CGM data with other relevant information, for example, health records and other medical device/wearable sensor data, will contribute to creating a digital data ecosystem that will improve our understanding of the etiology and complications of diabetes and will facilitate the development of data analytics for personalized diabetes management and prevention.
5
Ray, Partha Pratim. "Continuous glucose monitoring: a systematic review of sensor systems and prospects." Sensor Review 38, no. 4 (September 17, 2018): 420–37. http://dx.doi.org/10.1108/sr-12-2017-0268.
Abstract:
Purpose Continuous glucose monitoring (CGM) is a notable invention introduced in the biomedical industry. It provides valuable information about intermittent capillary blood glucose that is normally unattainable by regular clinical blood sample tests. CGM includes several progressive facilities such as instantaneous and real-time display of blood glucose level, “24/7” coverage, continuous motion of alerts for actual or impending hypo- and hyperglycemia and the ability to characterize glycemic variability. CGM allows users and physicians to visualize and diagnose more accurate and precise rate of change of glucose by capacitating small, comfortable, user-friendly sensor devices. Sometimes, this vital information is shared to the personal message box over Internet. In short, CGM is capable to inform, educate, motivate and alert (IEMA) people with diabetes. Despite the huge expectation with CGM, the available solutions have not attracted much attention among people. The huge potential of CGM in future diabetic study relies on the successful implication of the CGM. This paper aims at disseminating of state-of-the-art knowledge about existing work around the CGM. Design/methodology/approach This paper presents a comprehensive systematic review on the recent developments in CGM development techniques that have been reported in credible sources, namely PubMed, IEEE Xplore, Science Direct, Springer Link, Scopus and Google Scholar. Detailed analysis and systematic comparison are provided to highlight the achievement and future direction of CGM deployment. Findings Several key challenges are also portrayed for suitable opportunistic orientation. CGM solutions from four leading manufacturers such as Tandem, Dexcom, Abbott and Medtronic are compared based on the following factors including accuracy (% MARD); sensor lifetime, calibration requirement, smart device, compatibility and remote monitoring. Qualitative and quantitative analyses are performed. Originality/value This work can be a valuable source of reference and guidance for future research in this field.
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Guillot, Florian H., Peter G. Jacobs, Leah M. Wilson, Joseph El Youssef, Virginia B. Gabo, Deborah L. Branigan, Nichole S. Tyler, Katrina Ramsey, Michael C. Riddell, and Jessica R. Castle. "Accuracy of the Dexcom G6 Glucose Sensor during Aerobic, Resistance, and Interval Exercise in Adults with Type 1 Diabetes." Biosensors 10, no. 10 (September 29, 2020): 138. http://dx.doi.org/10.3390/bios10100138.
Abstract:
The accuracy of continuous glucose monitoring (CGM) sensors may be significantly impacted by exercise. We evaluated the impact of three different types of exercise on the accuracy of the Dexcom G6 sensor. Twenty-four adults with type 1 diabetes on multiple daily injections wore a G6 sensor. Participants were randomized to aerobic, resistance, or high intensity interval training (HIIT) exercise. Each participant completed two in-clinic 30-min exercise sessions. The sensors were applied on average 5.3 days prior to the in-clinic visits (range 0.6–9.9). Capillary blood glucose (CBG) measurements with a Contour Next meter were performed before and after exercise as well as every 10 min during exercise. No CGM calibrations were performed. The median absolute relative difference (MARD) and median relative difference (MRD) of the CGM as compared with the reference CBG did not differ significantly from the start of exercise to the end exercise across all exercise types (ranges for aerobic MARD: 8.9 to 13.9% and MRD: −6.4 to 0.5%, resistance MARD: 7.7 to 14.5% and MRD: −8.3 to −2.9%, HIIT MARD: 12.1 to 16.8% and MRD: −14.3 to −9.1%). The accuracy of the no-calibration Dexcom G6 CGM was not significantly impacted by aerobic, resistance, or HIIT exercise.
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Park, Kyong Chan, and Hwan Jun Choi. "Impaction of a continuous glucose monitoring sensor." Archives of Plastic Surgery 48, no. 4 (July 15, 2021): 392–94. http://dx.doi.org/10.5999/aps.2021.00178.
Abstract:
A 33-year-old man presented to the plastic surgery department for foreign body removal 1 month after the insertion of a continuous glucose monitoring (CGM) sensor (Dexcom G5) in the left upper arm. The patient had used the CGM system for 5 years, and the insertion was done in the usual manner. The entire sensor wire was visible on simple radiography and ultrasonography. In the operating room, and the sensor wire was identified in the intermuscular septum and removed. No foreign body reaction or inflammatory signs were found around the CGM, and the extracted wire measured 2.5 cm. Thus, it was assumed that the whole sensor wire was detached from the transmitter, not fractured. No remnant foreign body was observed on follow-up simple radiography.
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Moreno-Fernandez, Jesus, Francisco Javier Gómez, Maria Ángeles Gálvez Moreno, and Justo P. Castaño. "Clinical Efficacy of Two Different Methods to Initiate Sensor-Augmented Insulin Pumps: A Randomized Controlled Trial." Journal of Diabetes Research 2016 (2016): 1–6. http://dx.doi.org/10.1155/2016/4171789.
Abstract:
Aim. To analyze clinical effect of a novel approach to initiate sensor-augmented insulin pumps in type 1 diabetes mellitus (T1DM) patients through early real-time continuous glucose monitoring (RT-CGM) initiation.Methods. A 26-week pilot study with T1DM subjects randomized (1 : 1) to start RT-CGM three weeks before continuous subcutaneous insulin infusion (CGM pre-CSII) or adding RT-CGM three weeks after continuous subcutaneous insulin infusion (CGM post-CSII).Results. Twenty-two patients were enrolled with a mean age of 36.6 yr. (range 19–59 yr.) and T1DM duration of16.8±10.6 yr. Higher adherence in CGM pre-CSII patients was confirmed at study end (84.6±11.1% versus64.0±25.4%;P=0.01). The two intervention groups had similarHbA1creduction at study end of −0.6% (P=0.9). Hypoglycemic event frequency reduction was observed from baseline to study end only in CGM pre-CSII group (mean difference in change, −6.3%; 95% confidence interval, −12.0 to −0.5;P=0.04). Moreover, no severe hypoglycemia was detected among CGM pre-CSII subjects during the study follow-up (0.0±0.0events versus0.63±1.0events;P=0.03). CGM pre-CSII patients showed better satisfaction than CGM post-CSII patients at the end of the study (27.3±9.3versus32.9±7.2;P=0.04).Conclusions. CGM pre-CSII is a novel approach to improve glycemic control and satisfaction in type 1 diabetes sensor-augmented pump treated patients.
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Yin, Ruixue, Jizhong Xin, Dasheng Yang, Yang Gao, Hongbo Zhang, Zhiqin Qian, and Wenjun Zhang. "High-Linearity Hydrogel-Based Capacitive Sensor Based on Con A–Sugar Affinity and Low-Melting-Point Metal." Polymers 14, no. 20 (October 13, 2022): 4302. http://dx.doi.org/10.3390/polym14204302.
Abstract:
Continuous glucose monitoring (CGM) plays an important role in the treatment of diabetes. Affinity sensing based on the principle of reversible binding to glucose does not produce intermediates, and the specificity of concanavalin A (Con A) to glucose molecules helps to improve the anti-interference performance and long-term stability of CGM sensors. However, these affinity glucose sensors have some limitations in their linearity with a large detection range, and stable attachment of hydrogels to sensor electrodes is also challenging. In this study, a capacitive glucose sensor with high linearity and a wide detection range was proposed based on a glucose-responsive DexG–Con A hydrogel and a serpentine coplanar electrode made from a low-melting-point metal. The results show that within the glucose concentration range of 0–20 mM, the sensor can achieve high linearity (R2 = 0.94), with a sensitivity of 33.3 pF mM−1, and even with the larger glucose concentration range of 0–30 mM the sensor can achieve good linearity (R2 = 0.84). The sensor also shows resistance to disturbances of small molecules, good reversibility, and long-term stability. Due to its low cost, wide detection range, high linearity, good sensitivity, and biocompatibility, the sensor is expected to be used in the field of continuous monitoring of blood glucose.
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Shah, Viral N., Stephanie N. DuBose, Zoey Li, Roy W. Beck, Anne L. Peters, Ruth S. Weinstock, Davida Kruger, et al. "Continuous Glucose Monitoring Profiles in Healthy Nondiabetic Participants: A Multicenter Prospective Study." Journal of Clinical Endocrinology & Metabolism 104, no. 10 (April 25, 2019): 4356–64. http://dx.doi.org/10.1210/jc.2018-02763.
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Abstract Context Use of continuous glucose monitoring (CGM) is increasing for insulin-requiring patients with diabetes. Although data on glycemic profiles of healthy, nondiabetic individuals exist for older sensors, assessment of glycemic metrics with new-generation CGM devices is lacking. Objective To establish reference sensor glucose ranges in healthy, nondiabetic individuals across different age groups using a current generation CGM sensor. Design Multicenter, prospective study. Setting Twelve centers within the T1D Exchange Clinic Network. Patients or Participants Nonpregnant, healthy, nondiabetic children and adults (age ≥6 years) with nonobese body mass index. Intervention Each participant wore a blinded Dexcom G6 CGM, with once-daily calibration, for up to 10 days. Main Outcome Measures CGM metrics of mean glucose, hyperglycemia, hypoglycemia, and glycemic variability. Results A total of 153 participants (age 7 to 80 years) were included in the analyses. Mean average glucose was 98 to 99 mg/dL (5.4 to 5.5 mmol/L) for all age groups except those over 60 years, in whom mean average glucose was 104 mg/dL (5.8 mmol/L). The median time between 70 to 140 mg/dL (3.9 to 7.8 mmol/L) was 96% (interquartile range, 93 to 98). Mean within-individual coefficient of variation was 17 ± 3%. Median time spent with glucose levels >140 mg/dL was 2.1% (30 min/d), and median time spent with glucose levels <70 mg/dL (3.9 mmol/L) was 1.1% (15 min/d). Conclusion By assessing across age groups in a healthy, nondiabetic population, normative sensor glucose data have been derived and will be useful as a benchmark for future research studies.
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Lee, Kyuhan, Shakthi Gunasinghe, Alyson Chapman, Lynne A. Findlow, Jody Hyland, Sheetal Ohol, Andrea Urwin, et al. "Real-World Outcomes of Glucose Sensor Use in Type 1 Diabetes—Findings from a Large UK Centre." Biosensors 11, no. 11 (November 15, 2021): 457. http://dx.doi.org/10.3390/bios11110457.
Abstract:
Flash glucose monitoring (FGM) and real-time continuous glucose monitoring (RT-CGM) are increasingly used in clinical practice, with improvements in HbA1c and time in range (TIR) reported in clinical studies. We aimed to evaluate the impact of FGM and RT-CGM use on glycaemic outcomes in adults with type 1 diabetes (T1DM) under routine clinical care. We performed a retrospective data analysis from electronic outpatient records and proprietary web-based glucose monitoring platforms. We measured HbA1c (pre-sensor vs. on-sensor data) and sensor-based outcomes from the previous three months as per the international consensus on RT-CGM reporting guidelines. Amongst the 789 adults with T1DM, HbA1c level decreased from 61.0 (54.0, 71.0) mmol/mol to 57 (49, 65.8) mmol/mol in 561 people using FGM, and from 60.0 (50.0, 70.0) mmol/mol to 58.8 (50.3, 66.8) mmol/mol in 198 using RT-CGM (p < 0.001 for both). We found that 23% of FGM users and 32% of RT-CGM users achieved a time-in-range (TIR) (3.9 to 10 mmol/L) of >70%. For time-below-range (TBR) < 4 mmol/L, 70% of RT-CGM users and 58% of FGM users met international recommendations of <4%. Our data add to the growing body of evidence supporting the use of FGM and RT-CGM in T1DM.
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Evans, Keira, Christine Richardson, Alanna Landry, Janice Muileboom, Lynne Cormack, and Margaret L. Lawson. "Experience With the Enlite Sensor in a Multicenter Pediatric Study." Diabetes Educator 41, no. 1 (December 15, 2014): 31–37. http://dx.doi.org/10.1177/0145721714560589.
Abstract:
Purpose The purpose of this article is to outline the experience of certified diabetes educators (CDEs) using the Enlite continuous glucose monitoring sensor system in a pediatric multicenter randomized controlled trial. Continuous glucose monitoring (CGM) is becoming popular as a tool for educators and families to improve glycemic control. CGM can be a valuable educational tool to demonstrate to the user the impact of insulin dosing and effects of physical activity, food intake, and other life events such as work, illness, and stress on their glycemic control. The authors will share education tips and practical applications for diabetes educators to facilitate education and sustained use of Enlite glucose sensors in children and adolescents using insulin pump therapy. Conclusions The Enlite glucose sensor is a comfortable and user-friendly device. Improvements to both the insertion device and the Enlite glucose sensor have resulted in improved level of comfort on insertion and with ongoing wear, which may translate into greater adherence and effectiveness.
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Schmelzeisen-Redeker, Günther. "Analysis of “Simple Post-Processing of Continuous Glucose Monitoring Measurements Improves Endpoints in Clinical Trials”." Journal of Diabetes Science and Technology 14, no. 6 (June 13, 2019): 1079–80. http://dx.doi.org/10.1177/1932296819856571.
Abstract:
Jensen et al used continuous glucose monitoring (CGM) data of the Dexcom G4 Platinum (DG4P) sensor obtained in a clinical efficacy and safety study of Novo Nordisk’s new insulin Fiasp® to calculate the CGM time delay versus plasma glucose (PG) and self-measured blood glucose (SMBG) measurements (9-10 min). Shifting the CGM signal by 9 min backward in time versus PG and SMBG data improved the analytical accuracy of the DG4P sensor and the reliability of clinical research endpoint (hypoglycemia, postprandial glucose increments) detection. Since this method takes advantage of post-processing of CGM data, it is particularly suited for the optimization of data processing in clinical studies. In contrast, real-time corrections of time delays need predictive algorithms.
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Takeishi, Soichi, and Tatsuo Inoue. "Comparison Between Glycemic Variability Values Calculated From Professional-CGM and Glycemic Variability Values Calculated From Personal-CGM." Journal of the Endocrine Society 5, Supplement_1 (May 1, 2021): A330. http://dx.doi.org/10.1210/jendso/bvab048.674.
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Abstract It is important whether the differences between glycemic variability (GV) values calculated from professional CGM and GV values calculated from personal CGM are acceptable when using professional CGM data and personal CGM data together in studies. This is a prospective study. 41 inpatients with type 2 diabetes wore professional CGM (iPro2) and personal CGM (GUARDIAN CONNECT) in parallel for 6 days (CGM attachment: day 1). Each CGM were calibrated 22 times from day 2 to day 5, on the same timing in all patients (n of calibration = 902). Four 24 h GV from day 2 to day 5 per patient were evaluated (n of 24 h GV = 164) on each CGM. There were no significant differences between the standard deviation on professional CGM and that on personal CGM (32.2 mg/dL vs 32.8 mg/dL, p = 0.21). For time in range (70–180 mg/dL) [TIR 70–180], mean glucose levels and coefficient of variation (CV), the values were numerically almost equal between GV on professional CGM and that on personal CGM. However, for TIR 70–180 and CV, the GV on professional CGM was statistically significantly lower than that on personal CGM (70.8 % vs 72.5 %, p = 0.002, 20.6 % vs 21.3 %, p = 0.04); and for mean glucose levels, the GV on professional CGM was statistically significantly higher than that on personal CGM (157.7 mg/dL vs 155.2 mg/dL, p < 0.001). For mean absolute glucose (MAG) and glycemic variability percentage (GVP), the GV on professional CGM was significantly lower than that on personal CGM (25.3 mg/dL/h vs 41.0 mg/dL/h, p < 0.001, 14.4 % vs 31.1 %, p < 0.001). The calibrations, whose blood glucose levels (BG) were higher than ‘sensor glucose levels just before the BG’ (SGjb), were more than those, whose BG were lower than SGjb (482 times vs 420 times). The mean absolute relative differences on professional CGM were significantly lower than those on personal CGM (5.0 % vs 6.3 %, p < 0.001). The study patients correlated to distributions of ‘ratio of CV on personal CGM to CV on professional CGM on the same day’ (correlation ratio: η 2 = 0.48, p < 0.001). The results of TIR 70–180 and mean glucose levels may have been caused by the fact that the calibration BG were high dissociated from SGjb and algorithm of professional CGM is easier to allow the dissociation than that of personal CGM. The results of CV may have been caused by the individual differences in sensor accuracy between professional CGM and personal CGM. The results of MAG and GVP may have been caused by the fact that personal CGM can reveal detailed glycemic variability which cannot be revealed by professional CGM, due to real time calibration. According to purpose of studies, it should be determined whether using professional CGM data and personal CGM data together is acceptable.
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Maia, Frederico F. R., and Levimar R. Araújo. "Acurácia, efeitos na terapia insulínica e controle glicêmico e complicações do sistema de monitorização contínua da glicose em pacientes com diabetes mellitus tipo 1." Arquivos Brasileiros de Endocrinologia & Metabologia 49, no. 4 (August 2005): 563–68. http://dx.doi.org/10.1590/s0004-27302005000400015.
Abstract:
Para avaliar a acurácia, segurança e complicações do sistema de monitorização contínua da glicose (CGMS) em pacientes com diabetes mellitus tipo 1 (DM1), estudamos retrospectivamente 30 pacientes (25,8 ± 12,2 anos) sob monitorização contínua da glicose (CGM) (Medtronic; Northridge, CA) por 72hs. Foram analisados: glicemia capilar (GC) média e pelo sensor durante a CGM, coeficiente de correlação (%), mediana da diferença percentual absoluta (MAD%), número de leituras, excursões glicêmicas (sensor CGMS vs. GC), presença de complicações (trauma, infecção, desconexão), abandono e conduta após CGMS. Os níveis de A1c foram determinados 1 mês antes e 3 meses após o CGMS. A GC média durante a utilização do CGMS foi de 186,5 ± 43,3mg/dl vs. 179,7 ± 48,1mg/dl detectada pelo sensor, com correlação significativa (p= 0,001). O número de leituras pelo sensor CGMS foi de 772,4 ± 254,1 (VR > 680), com duração média de 68,7 ± 19,8hs de exame. O coeficiente de correlação foi de 0,86 ± 0,21 (VR > 0,79). Quanto à MAD%, observou-se valor de 13,9 ± 4,7% (VR < 28%). O CGMS mostrou-se estatisticamente mais eficaz na detecção de excursões glicêmicas em relação à GC (p= 0,009). Observou-se redução significante da A1c três meses após o CGMS nesse grupo de pacientes (p= 0,018). Não houve complicações durante a CGM em 96,7% dos exames. Não houve registro de trauma, infecção local ou sangramento em nenhum caso. A CGM promoveu mudança de conduta terapêutica em 100% dos pacientes. A CGM mostrou-se método seguro, bem tolerado, com alta acurácia nos valores glicêmicos detectados, sendo método de alta eficácia, com baixo índice de complicações e abandono, devendo sua prática ser cada vez mais estimulada em nosso meio.
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Hochfellner, Daniel A., Amra Simic, Marlene T. Taucher, Lea S. Sailer, Julia Kopanz, Tina Pöttler, and Julia K. Mader. "Accuracy Assessment of the GlucoMen® Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study." Biosensors 12, no. 2 (February 9, 2022): 106. http://dx.doi.org/10.3390/bios12020106.
Abstract:
The aim of this study was to evaluate the accuracy and usability of a novel continuous glucose monitoring (CGM) system designed for needle-free insertion and reduced environmental impact. We assessed the sensor performance of two GlucoMen® Day CGM systems worn simultaneously by eight participants with type 1 diabetes. Self-monitoring of blood glucose (SMBG) was performed regularly over 14 days at home. Participants underwent two standardized, 5-h meal challenges at the research center with frequent plasma glucose (PG) measurements using a laboratory reference (YSI) instrument. When comparing CGM to PG, the overall mean absolute relative difference (MARD) was 9.7 [2.6–14.6]%. The overall MARD for CGM vs. SMBG was 13.1 [3.5–18.6]%. The consensus error grid (CEG) analysis showed 98% of both CGM/PG and CGM/SMBG pairs in the clinically acceptable zones A and B. The analysis confirmed that GlucoMen® Day CGM meets the clinical requirements for state-of-the-art CGM. In addition, the needle-free insertion technology is well tolerated by users and reduces medical waste compared to conventional CGM systems.
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Barnett, Anne, Varsha Chiruvella, Ghada Elshimy, Jenny Grimm, and Sara Healy. "PSUN229 Transitions of Care and Readmissions in Patients with Diabetes Receiving CGM at Hospital Discharge." Journal of the Endocrine Society 6, Supplement_1 (November 1, 2022): A384—A385. http://dx.doi.org/10.1210/jendso/bvac150.800.
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Abstract Background Use of inpatient continuous glucose monitoring (CGM) has increased during the COVID-19 pandemic. The objective of this study was to evaluate outpatient follow-up patterns and readmission rates for patients discharged from the hospital with CGM. Research Design and Methods We retrospectively identified patients with diabetes (DM) aged >18 years who were admitted between 3/27/20 and 5/13/21 and received Freestyle Libre or Freestyle Libre 2 14-day sensor at the time of discharge from the hospital. The sensor was placed in the hospital by our diabetic educator. Only the first admission was included. The medical record was reviewed to determine attendance at outpatient follow-up visit, CGM downloading and prescribing at that visit, and readmission within 30 days. Results 87 patient charts were analyzed (31% type 1 DM, 66% type 2 DM, 3% other). The most common reasons for CGM placement were patients new to insulin (40%), DKA (34%), new diabetes diagnosis (30%), or HHS (5%). Follow-up information was not available for 25 patients (29%). The remaining 62 patients had scheduled follow-up within our system. 42 of those patients (68%) attended their follow-up appointment while 14 patients (33%) attended follow-up in an endocrine clinic. Among the 42 patients who attended follow-up, 8 patients (19%) had CGM data downloaded and 18 patients (43%) were prescribed CGM. Of the patients who attended endocrine follow-up, 50% had CGM downloads, compared to only 4% of patients seen in non-endocrine clinics (p = 0.001). Similarly, 79% of patients with endocrine follow-up were prescribed CGM sensors, while 25% of patients seen in non-endocrine clinics received a CGM prescription (p = 0.001). For patients newly diagnosed with DM and available follow-up data, 89% (N=16) attended their appointment. Overall, 16% of patients were readmitted within 30 days. Of the patients readmitted, only 17% attended outpatient follow-up and none had CGM downloaded or prescribed. Backward binary logistic regression was used to assess the relationship between outcomes (follow-up attendance and readmission) and variables (including diagnosis and follow-up location) in the 62 patients with follow-up data. In the final models, a new diagnosis of DM was associated with follow-up attendance, and type 1 DM and follow-up nonattendance were associated with 30-day readmission. Results were verified using exact logistic regression. Conclusions Downloading and prescribing of CGM after hospital discharge occurred in less than half of patients, but occurred more frequently in endocrine clinics. A specialized transition of care clinic may benefit patients discharged with CGM. Follow-up attendance among readmitted patients was poor. Patients with a new diagnosis of DM had good follow-up attendance and may be good candidates for CGM at hospital discharge, which can be examined in future prospective studies. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m.
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Kim, Nicole, Kevin Pham, Allen Shek, Jeremy Lim, Xiaohan Liu, and Sachin A. Shah. "Differences in glucose level between right arm and left arm using continuous glucose monitors." DIGITAL HEALTH 6 (January 2020): 205520762097034. http://dx.doi.org/10.1177/2055207620970342.
Abstract:
Background Continuous glucose monitoring (CGM) measures interstitial glucose levels through a sensor with a thin filament inserted under the skin. It is customary for patients to rotate sensor application sites between arms to minimize skin irritation. However, there is limited data regarding the degree of inter-arm differences with CGM technology. Methods Self-proclaimed right-handed (n = 5) and left-handed (n = 5) participants, regardless of concurrent comorbidities, were enrolled for CGM. Participants wore a FreeStyle Libre Pro sensor on each arm for a maximum of 14 days. Muscle mass and body fat analysis was conducted using a multi-frequency segmental body composition analyzer. Glucose levels from both arms were time-matched with the first 12 hours eliminated from analysis. Mean glucose and time in target range were compared between readings from the right and left arm. Results A total of 9830 paired glucose levels were included for analysis. In all participants (n = 10), mean glucose on the right arm was 89.1 mg/dL (SD, 19.9) and 85.3 mg/dL (SD, 19.3) on the left arm (P < 0.001). Glucose was out of target range (70-180 mg/dL) for 12.7% of the time in the right arm compared to 18.5% in the left arm (P < 0.001). Conclusions In a group of 10 nondiabetic and diabetic adults, there was a statistically significant difference in CGM readings between the right and left arms. Time in target range may differ based on arm selection when using a CGM. Arm dominance did not explain the inter-arm glucose level discordance.
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Asarani, Nurul A. Mohd, Andrew N. Reynolds, Sara E. Boucher, Martin de Bock, and Benjamin J. Wheeler. "Cutaneous Complications With Continuous or Flash Glucose Monitoring Use: Systematic Review of Trials and Observational Studies." Journal of Diabetes Science and Technology 14, no. 2 (August 27, 2019): 328–37. http://dx.doi.org/10.1177/1932296819870849.
Abstract:
Background: Continuous glucose monitoring (CGM)/flash glucose monitoring (FGM) use in diabetes management is increasing. Cutaneous complications associated with these devices were reported. We conducted a systematic review to provide an overview of cutaneous complications with CGM/FGM use. Methods: We identified observational studies and intervention trials that report on cutaneous complications with CGM/FGM use up to January 14, 2019. Studies were identified through Medline, Embase, and PubMed, or with hand searching of the previous publications. Screening was duplicated and data extracted to consider four main themes: incidence rate and severity, participant perspectives of cutaneous complications, potential solutions, and future directions in diabetic technology relevant to reducing cutaneous complications. Results: A total of 54 eligible studies were identified. The overall event rate of cutaneous complications reported from 19 trials was one event per eight weeks of sensor wear-time of which 1.5% were considered severe. The most common cutaneous complications were wear-related erythema, itching, and induration. Although skin irritations were the most common cause of CGM/FGM discontinuation, most users experienced less pain or discomfort with CGM/FGM than capillary blood glucose testing. Future technological advances may reduce, but not eliminate cutaneous complications. Conclusion: The incidence rate of reported cutaneous complications with CGM/FGM use from the available literature is low, with one event per eight weeks of sensor wear-time. Reported complication severity was also low, leading to low rates of CGM/FGM discontinuation. However, there appear to be discrepancies between reporting in trial and observational data. Greater constancy in reporting is necessary to understand the frequency of this issue.
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Muñoz Fabra, Elena, José-Luis Díez, Jorge Bondia, and Alejandro José Laguna Sanz. "A Comprehensive Review of Continuous Glucose Monitoring Accuracy during Exercise Periods." Sensors 21, no. 2 (January 12, 2021): 479. http://dx.doi.org/10.3390/s21020479.
Abstract:
Continuous Glucose Monitoring (CGM) has been a springboard of new diabetes management technologies such as integrated sensor-pump systems, the artificial pancreas, and more recently, smart pens. It also allows patients to make better informed decisions compared to a few measurements per day from a glucometer. However, CGM accuracy is reportedly affected during exercise periods, which can impact the effectiveness of CGM-based treatments. In this review, several studies that used CGM during exercise periods are scrutinized. An extensive literature review of clinical trials including exercise and CGM in type 1 diabetes was conducted. The gathered data were critically analysed, especially the Mean Absolute Relative Difference (MARD), as the main metric of glucose accuracy. Most papers did not provide accuracy metrics that differentiated between exercise and rest (non-exercise) periods, which hindered comparative data analysis. Nevertheless, the statistic results confirmed that CGM during exercise periods is less accurate.
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Kersten, C. J. B. A., A. A. M. Zandbergen, M. J. Fokkert, R. J. Slingerland, and H. M. den Hertog. "Continuous glucose monitoring in acute ischemic stroke patients treated with endovascular therapy: A pilot study to assess feasibility and accuracy." PLOS ONE 18, no. 2 (February 9, 2023): e0280153. http://dx.doi.org/10.1371/journal.pone.0280153.
Abstract:
Introduction Hyperglycemia is common in acute ischemic stroke and is associated with larger infarct volume and unfavorable functional outcome, also in patients who undergo reperfusion therapy. Hyperglycemia during reperfusion may be a therapeutic target. However, previous randomized trials on the effect of glucose lowering in the acute phase of ischemic stroke failed to demonstrate effects on clinical outcome. Inaccurate glucose measurements and not focussing on patients who undergo reperfusion therapy are possible explanations. Our aim was to study the feasibility and accuracy of continuous glucose monitoring (CGM) in patients with acute ischemic stroke undergoing endovascular treatment (EVT). Methods All consecutive patients with ischemic stroke and large vessel occlusion (LVO) of the anterior circulation who were eligible for endovascular therapy within 24 hours of symptom onset and presenting at the emergency department of Isala Hospital Zwolle, the Netherlands, were enrolled in this study. CGM was performed using a Freestyle Libre Flash 2 device (FSL-CGM, Abbot Diabetes Care, Alameda, California, USA) which was implanted on arrival at the emergency department. Feasibility was defined as the number of patients who could be registered for 24 hours and delay in door-to-groin time because of sensor implantation. Accuracy of CGM versus capillary and venous based plasma glucose values was determined with the Parkes error grid analysis. Results Twenty-three patients were included of whom 20 completed 24 hours monitoring (87%). One patient did not give permission to use the data; one sensor broke during implantation and one meter was broken after a sensor was shot in so no measurements could be recorded. There was no significant delay in treatment due to implantation of the sensor and no adverse events. One hundred percent of CGM data are in zones A and B of the Parkes error grid analysis so data out of the sensor can be interpreted as accurate. Conclusion In this study, we showed that continuous glucose monitoring in patients with acute ischemic stroke due to large vessel occlusion of the anterior circulation in patients who were treated with endovascular therapy is feasible, safe and accurate.
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Wang, Meng, Lakshmi G. Singh, and Elias K. Spanakis. "Advancing the Use of CGM Devices in a Non-ICU Setting." Journal of Diabetes Science and Technology 13, no. 4 (January 13, 2019): 674–81. http://dx.doi.org/10.1177/1932296818821094.
Abstract:
Improvements in glycemic control using continuous glucose monitoring (CGM) systems have been demonstrated in the outpatient setting. Among hospitalized patients the use of CGM is largely investigational, particularly in the non-ICU setting. Although there is no commercially available closed-loop system, it has recently been evaluated in the non–critical care setting. Both CGMs and closed-loop systems may lead to improved glycemic control, decreased length of stay, reduced risk of adverse events related to severe hypoglycemia or hyperglycemia. Limitations of inpatient use of CGM and closed-loop systems include lack of FDA approvals, inexperience with this technology, and costs related to supplies. Significant investment may be necessary for hospital staff training and for development of infrastructure to support inpatient use. Additional limitations for CGM systems includes potential inaccuracy of interstitial glucose measurements due to medication interferences, sensor lag, or sensor drift. Limitations for closed-loop systems also includes need for routine monitoring to detect infusion site issues as well as monitoring to ensure adequate insulin supply in reservoir to avoid abrupt cessation of insulin infusion leading to severe hyperglycemia. Hospital staff must be familiar with trouble-shooting and conversion to alternative mode of insulin delivery in the event of insulin pump malfunction. Given these complexities, implementation of closed-loop systems may require involvement of an endocrinology team, limiting widespread adoption. This article reviews current state of CGM and closed-loop system use in the non-ICU setting, available literature, advantages and limitations, as well as suggestions for future CGM design, specifically for the inpatient setting.
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Jamiołkowska, Milena, Izabela Jamiołkowska, Włodzimierz Łuczyński, Joanna Tołwińska, Artur Bossowski, and Barbara Głowińska Olszewska. "Impact of Real-Time Continuous Glucose Monitoring Use on Glucose Variability and Endothelial Function in Adolescents with Type 1 Diabetes: New Technology—New Possibility to Decrease Cardiovascular Risk?" Journal of Diabetes Research 2016 (2016): 1–8. http://dx.doi.org/10.1155/2016/4385312.
Abstract:
Children with type 1 diabetes (T1DM) are the high-risk group of accelerated atherosclerosis. Real-time continuous glucose monitoring (RT-CGM) provides possibilities for the detection of glycaemic variability, newly recognized cardiovascular risk factor. The aim of the study was to assess the usefulness of RT-CGM as an educational tool to find and reduce glycaemic variability in order to improve endothelial function in T1DM adolescents. Forty patients aged 14.6 years were recruited. The study was based on one-month CGM sensors use. Parameters of glycaemic variability were analyzed during first and last sensor use, together with brachial artery flow-mediated dilatation (FMD) to assess endothelial function. In the whole group, FMD improvement was found (10.9% to 16.6%,p<0.005), together with decrease in all studied glycaemic variability parameters. In patients with HbA1c improvement compared to the group without HbA1c improvement, we found greater increase of FMD (12% to 19%,p<0.005versus 8.2% to 11.3%,p=0.080) and greater improvement of glucose variability. RT-CGM can be considered as an additional tool that offers T1DM adolescents the quick reaction to decrease glycaemic variability in short time observation. Whether such approach might influence improvement in endothelial function and reduction of the risk of future cardiovascular disease remains to be elucidated.
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Joseph, Jeffrey I. "Review of the Long-Term Implantable Senseonics Continuous Glucose Monitoring System and Other Continuous Glucose Monitoring Systems." Journal of Diabetes Science and Technology 15, no. 1 (April 29, 2020): 167–73. http://dx.doi.org/10.1177/1932296820911919.
Abstract:
The article published by Kevin Cowart in this issue of the Journal of Diabetes Science and Technology (JDST) is a detailed overview of the clinical trial data and analysis used to demonstrate the safety and effectiveness of the Eversense continuous glucose monitoring (CGM) System for regulatory approval and clinical acceptance. The article describes the published study results for safety, accuracy, reliability, ease of insertion/removal, adverse events, and ease of diabetes patient-use for controlling their glucose levels short and long term. The author nicely compares Eversense CGM System safety and performance with the short-term subcutaneous tissue CGM systems being commercialized by Dexcom, Medtronic Diabetes, and Abbott Diabetes. This comparison may help the clinician define which type of patient with diabetes might benefit the most from the long-term implantable CGM system. The majority of studied patients describe a positive experience managing their diabetes with the Eversense CGM System and request implantation of a new sensor 90 or 180 days later.
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North, Robert, Christine Pospisil, Ryan J. Clukey, and Christopher G. Parkin. "Impact of Human Factors Testing on Medical Device Design: Validation of an Automated CGM Sensor Applicator." Journal of Diabetes Science and Technology 13, no. 5 (February 14, 2019): 949–53. http://dx.doi.org/10.1177/1932296819831071.
Abstract:
Improving user engagement with continuous glucose monitoring (CGM) is considered a major requirement for achieving optimal treatment efficacy. Human factors testing is needed to ensure that CGM product designs and requisite training simplify the user experience and enhance usability and patient safety. Dexcom, Inc, recently introduced a novel, “one-button” automatic sensor applicator (ASA) for use with the Dexcom G6 (rtCGM) system. The device was developed utilizing all phases of the human factors testing process. We recruited eight certified diabetes educators from independent health care institutions to conduct a comparative ease-of-use analysis to confirm the usability of the ASA. Participants judged the instructions and device to be easier to use than the previous sensor applicator.
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Zheng, Mingyue, Anamica Patel, Adeel Khoja, Yunting Luo, Wei Lin, Qian He, Xuan Zhao, Juan Wang, Shenqiao Yang, and Peng Hu. "Barriers and facilitators of diabetes management by continuous glucose monitoring systems among adults with type 2 diabetes: a protocol of qualitative systematic review." BMJ Open 11, no. 10 (October 2021): e046050. http://dx.doi.org/10.1136/bmjopen-2020-046050.
Abstract:
IntroductionStudies suggest that continuous glucose monitors (CGMs) play an important role in the management of diabetes. Although general acceptance has been reported by patients with type 2 diabetes towards the use of CGMs, potential barriers exist like pain due to sensor insertion, accidental removal of the device or adhesive strip, impacts of daily activities, skin reactions to sensor adhesive, etc. This systematic review of qualitative studies aims to explore the perspectives, experiences and narratives of patients and caregivers about CGM use, and its barriers and facilitators.Methods and analysisThis review will include qualitative studies and cross-sectional and longitudinal cohort studies using open-ended questions, published in English by 30 October 2021. The following electronic databases will be searched: Cochrane Library, PubMed, EMBASE, CINAHL, PsycINFO and Scopus. A search of grey literature will be conducted via an online search of Google Scholar, WorldCat, ClinicalTrials.gov and OpenGrey A combined search strategy using medical subject headings (MeSH), controlled vocabulary and ‘free-text’ terms will be appropriately revised to suit each database. Primary outcomes will include patient and caregiver perspectives on diabetes management regarding glucose control; living with CGM (quality of life, experience of wearing a CGM); psychological aspects (anxiety, depression, emotional burden); barriers (technical issues, financial issues) to use of CGM and thoughts (interpretation, understanding) on the CGM report. A qualitative meta-synthesis will be conducted employing a systematic literature search of existing literature, quality assessment using study-specific tools and an aggregative thematic synthesis by a multidisciplinary team.Ethics and disseminationEthical approval is not required since this is a systematic review. The results will help improve clinical implementation of CGMs on part of both patients and caregivers.PROSPERO registration numberCRD42020152211.
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Liao, Yue, Christopher J. Miller, Diana L. Urbauer, Therese B. Bevers, Ernest Hawk, Karen M. Basen-Engquist, and Susan M. Schembre. "Abstract A17: An innovative physical activity intervention in overweight and obese adults using continuous glucose monitor." Cancer Epidemiology, Biomarkers & Prevention 29, no. 9_Supplement (September 1, 2020): A17. http://dx.doi.org/10.1158/1538-7755.modpop19-a17.
Abstract:
Abstract Introduction: Regular physical activity (PA) lowers the risk of endometrial, breast, and colorectal cancer. However, nearly half of American adults are not sufficiently active. The physical inactivity rate is even higher among the overweight and obese population, which, in combination with the unfavorable effect of excess body weight, puts this population at a greater risk for cancer. Advancements in wearable sensor technology provide opportunities for personalized approaches to increase motivation to be active. The current pilot study used continuous glucose monitors (CGM) to demonstrate the immediate, physiologic benefits of PA. Methods: Insufficiently active (<150 mins of moderate intensity PA per week) overweight and obese (body mass index >= 25 kg/m2) adults (18-65 years old) without diabetes are being recruited to participate in this pilot intervention. Upon enrollment, participants go through a one-on-one PA education session that includes a discussion about the health benefits of recommended PA levels, demonstration of the acute effect of PA on daily glucose patterns using a web-based glucose simulator, calculation of personal heart rate zones for moderate intensity PA, and development of an exercise plan. After the education session, participants are given a Fitbit Alta HR wristband and are instructed to wear it over the next 10 days. Participants are also given a Freestyle Libre CGM, which consists of a sensor and a reader. The sensor is inserted into the back of the upper arm to collect interstitial glucose data every 15 minutes for 10 days after activation. The reader displays current glucose readings and a graph of the 8 previous hours of glucose data upon scanning the sensor. Participants are instructed to scan the sensor at least 4 times a day and are encouraged to achieve at least 150 minutes of moderate-intensity PA each week. At the end of the self-monitoring period, participants return their Fitbit and have their CGM sensor removed. Results: Thus far, 10 of 20 participants have enrolled in and completed the study. These participants have been 100% female, 70% obese, and 20% Hispanic with a mean age of 41.5 (SD = 8.6) years old. On average, participants scanned their sensor 6 times each day and wore the Fitbit for all 10 days. On average, participants highly rated each component of the education session (on a 5-point scale) for improving their PA knowledge (mean = 4.4), increasing their PA motivation (mean = 4.4), and providing personally relevant information (mean = 4.6). Participants also reported a very positive experience wearing the CGM, with mean ratings (on a 5-point scale) of 4.8 for usability, 4.6 for convenience, 4.9 for value, 4.9 for relevance, and 4.7 for motivating. Conclusion: These preliminary data suggest that using a CGM to motivate PA among nondiabetic adults is feasible and acceptable. Future research will be conducted to examine the effect a CGM-based PA intervention has on changing PA behavior. Citation Format: Yue Liao, Christopher J. Miller, Diana L. Urbauer, Therese B. Bevers, Ernest Hawk, Karen M. Basen-Engquist, Susan M. Schembre. An innovative physical activity intervention in overweight and obese adults using continuous glucose monitor [abstract]. In: Proceedings of the AACR Special Conference on Modernizing Population Sciences in the Digital Age; 2019 Feb 19-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(9 Suppl):Abstract nr A17.
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Porcel-Chacón, Rocio, Cristina Antúnez-Fernández, Maria Mora Loro, Ana-Belen Ariza-Jimenez, Leopoldo Tapia Ceballos, Jose Manuel Jimenez Hinojosa, Juan Pedro Lopez-Siguero, and Isabel Leiva Gea. "Good Metabolic Control in Children with Type 1 Diabetes Mellitus: Does Glycated Hemoglobin Correlate with Interstitial Glucose Monitoring Using FreeStyle Libre?" Journal of Clinical Medicine 10, no. 21 (October 24, 2021): 4913. http://dx.doi.org/10.3390/jcm10214913.
Abstract:
Background: Good metabolic control of Type 1 diabetes (T1D) leads to a reduction in complications. The only validated parameter for establishing the degree of control is glycated hemoglobin (HbA1c). We examined the relationship between HbA1c and a continuous glucose monitoring (CGM) system. Materials and methods: A cohort prospective study with 191 pediatric patients with T1D was conducted. Time in range (TIR), time below range (TBR), coefficient of variation (CV), number of capillary blood glucose tests, and HbA1c before sensor insertion and at one year of use were collected. Results: Patients were classified into five groups according to HbA1c at one year of using CGM. They performed fewer capillary blood glucose test at one year using CGM (−6 +/− 2, p < 0.0001). We found statistically significant differences in TIR between categories. Although groups with HbA1c < 6.5% and HbA1c 6.5–7% had the highest TIR (62.214 and 50.462%), their values were highly below optimal control according to CGM consensus. Groups with TBR < 5% were those with HbA1c between 6.5% and 8%. Conclusions: In our study, groups classified as well-controlled by guidelines were not consistent with good control according to the CGM consensus criteria. HbA1c should not be considered as the only parameter for metabolic control. CGM parameters allow individualized targets.
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McAuley, Sybil A., Steven Trawley, Sara Vogrin, Glenn M. Ward, Spiros Fourlanos, Charlotte A. Grills, Melissa H. Lee, et al. "Closed-Loop Insulin Delivery Versus Sensor-Augmented Pump Therapy in Older Adults With Type 1 Diabetes (ORACL): A Randomized, Crossover Trial." Diabetes Care 45, no. 2 (November 29, 2021): 381–90. http://dx.doi.org/10.2337/dc21-1667.
Abstract:
OBJECTIVE To assess the efficacy and safety of closed-loop insulin delivery compared with sensor-augmented pump therapy among older adults with type 1 diabetes. RESEARCH DESIGN AND METHODS This open-label, randomized (1:1), crossover trial compared 4 months of closed-loop versus sensor-augmented pump therapy. Eligible adults were aged ≥60 years, with type 1 diabetes (duration ≥10 years), using an insulin pump. The primary outcome was continuous glucose monitoring (CGM) time in range (TIR; 3.9–10.0 mmol/L). RESULTS There were 30 participants (mean age 67 [SD 5] years), with median type 1 diabetes duration of 38 years (interquartile range [IQR] 20–47), randomized (n = 15 to each sequence); all completed the trial. The mean TIR was 75.2% (SD 6.3) during the closed-loop stage and 69.0% (9.1) during the sensor-augmented pump stage (difference of 6.2 percentage points [95% CI 4.4 to 8.0]; P < 0.0001). All prespecified CGM metrics favored closed loop over the sensor-augmented pump; benefits were greatest overnight. Closed loop reduced CGM time <3.9 mmol/L during 24 h/day by 0.5 percentage points (95% CI 0.3 to 1.1; P = 0.0005) and overnight by 0.8 percentage points (0.4 to 1.1; P < 0.0001) compared with sensor-augmented pump. There was no significant difference in HbA1c between closed-loop versus sensor-augmented pump stages (7.3% [IQR, 7.1–7.5] (56 mmol/mol [54–59]) vs. 7.5% [7.1–7.9] (59 mmol/mol [54–62]), respectively; P = 0.13). Three severe hypoglycemia events occurred during the closed-loop stage and two occurred during the sensor-augmented pump stage; no hypoglycemic events required hospitalization. One episode of diabetic ketoacidosis occurred during the sensor-augmented pump stage; no serious adverse events occurred during the closed-loop stage. CONCLUSIONS Closed-loop therapy is an effective treatment option for older adults with long-duration type 1 diabetes, and no safety issues were identified. These older adults had higher TIR accompanied by less time below range during closed loop than during sensor-augmented pump therapy. Of particular clinical importance, closed loop reduced the time spent in hypoglycemic range overnight.
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Facchinetti, A., G. Sparacino, and C. Cobelli. "An Online Self-Tunable Method to Denoise CGM Sensor Data." IEEE Transactions on Biomedical Engineering 57, no. 3 (March 2010): 634–41. http://dx.doi.org/10.1109/tbme.2009.2033264.
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Ahmed, Hanan Badeea, and Ali Serener. "Effects of External Factors in CGM Sensor Glucose Concentration Prediction." Procedia Computer Science 102 (2016): 623–29. http://dx.doi.org/10.1016/j.procs.2016.09.452.
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Roux de Bézieux, Hector, James Bullard, Orville Kolterman, Michael Souza, and Fanny Perraudeau. "Medical Food Assessment Using a Smartphone App With Continuous Glucose Monitoring Sensors: Proof-of-Concept Study." JMIR Formative Research 5, no. 3 (March 4, 2021): e20175. http://dx.doi.org/10.2196/20175.
Abstract:
Background Novel wearable biosensors, ubiquitous smartphone ownership, and telemedicine are converging to enable new paradigms of clinical research. A new generation of continuous glucose monitoring (CGM) devices provides access to clinical-grade measurement of interstitial glucose levels. Adoption of these sensors has become widespread for the management of type 1 diabetes and is accelerating in type 2 diabetes. In parallel, individuals are adopting health-related smartphone-based apps to monitor and manage care. Objective We conducted a proof-of-concept study to investigate the potential of collecting robust, annotated, real-time clinical study measures of glucose levels without clinic visits. Methods Self-administered meal-tolerance tests were conducted to assess the impact of a proprietary synbiotic medical food on glucose control in a 6-week, double-blind, placebo-controlled, 2×2 cross-over pilot study (n=6). The primary endpoint was incremental glucose measured using Abbott Freestyle Libre CGM devices associated with a smartphone app that provided a visual diet log. Results All subjects completed the study and mastered CGM device usage. Over 40 days, 3000 data points on average per subject were collected across three sensors. No adverse events were recorded, and subjects reported general satisfaction with sensor management, the study product, and the smartphone app, with an average self-reported satisfaction score of 8.25/10. Despite a lack of sufficient power to achieve statistical significance, we demonstrated that we can detect meaningful changes in the postprandial glucose response in real-world settings, pointing to the merits of larger studies in the future. Conclusions We have shown that CGM devices can provide a comprehensive picture of glucose control without clinic visits. CGM device usage in conjunction with our custom smartphone app can lower the participation burden for subjects while reducing study costs, and allows for robust integration of multiple valuable data types with glucose levels remotely. Trial Registration ClinicalTrials.gov NCT04424888; http://clinicaltrials.gov/ct2/show/NCT04424888.
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Velychko, V. I., D. O. Lahoda, G. Yu Amirova, Ya I. Bazhora, O. O. Shapovalov, O. A. Shpak, and O. M. Sydor. "Peculiarities of using personal continuous glucose monitoring in children and adolescents." CHILD`S HEALTH 17, no. 6 (November 5, 2022): 263–68. http://dx.doi.org/10.22141/2224-0551.17.6.2022.1527.
Abstract:
Recent data from the International Diabetes Federation indicated that at least 500,000 children aged 14 to 18 years worldwide have type 1 diabetes mellitus (T1DM). Currently, there is no cure for T1DM, so the goal of therapy is to achieve and maintain optimal glucose levels, in particular, using insulin therapy, physical activity, and diet. Studies of more than 20,000 children with T1DM have shown the benefits of self-monitoring of glucose levels for episodic glycemic control and long-term reduction of glycated hemoglobin (HbA1c). The purpose of our study was to investigate the specifics of using personal continuous glucose monitoring (CGM) in adolescents. Materials and methods. According to the design, the study included 22 patients (12 adolescents and 10 children) aged 8 to 16 years who were diagnosed with T1DM. Questionnaires offered included the Pediatric Quality of Life Inventory, the PedsQL Diabetes Module, the Hypoglycemia Fear Survey-II, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ). Results. Before the installation of personal CGM systems, patients had average indicators of emotional, social and role functioning. It was noted that these indicators significantly increased in response to the use of personal CGM (p < 0.05 each), while the parameter of physical functioning did not change significantly (р > 0.05). We did not find a significant correlation between the level of HbA1c and the total score on the DTSQ (ρ = 0.13; p > 0.05). This indicates that satisfaction with treatment is not necessarily related to glycemic control. It was found that children who previously used personal CGM were more compliant with further use of personal CGM (p < 0.05). Among the most frequent drawbacks related to the use of personal CGM, children and their parents mentioned: discomfort from the sensor (62.19 %), the need for calibration, i.e. measuring the glucose level using a portable glucometer (58.61 %), stigmatization of the child who wears the sensor by the surrounding society (47.83 %). Conclusions. In our opinion, the use of personal CGM is appropriate and can be recommended for patients with a newly diagnosed T1DM and with a history of the disease in order to optimize therapy, improve the patient’s awareness of disease control, and increase compliance both in terms of communication with the doctor and general treatment.
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Houlder, Shaelyn, and Jane Yardley. "Continuous Glucose Monitoring and Exercise in Type 1 Diabetes: Past, Present and Future." Biosensors 8, no. 3 (August 3, 2018): 73. http://dx.doi.org/10.3390/bios8030073.
Abstract:
Prior to the widespread use of continuous glucose monitoring (CGM), knowledge of the effects of exercise in type 1 diabetes (T1D) was limited to the exercise period, with few studies having the budget or capacity to monitor participants overnight. Recently, CGM has become a staple of many exercise studies, allowing researchers to observe the otherwise elusive late post-exercise period. We performed a strategic search using PubMed and Academic Search Complete. Studies were included if they involved adults with T1D performing exercise or physical activity, had a sample size greater than 5, and involved the use of CGM. Upon completion of the search protocol, 26 articles were reviewed for inclusion. While outcomes have been variable, CGM use in exercise studies has allowed the assessment of post-exercise (especially nocturnal) trends for different exercise modalities in individuals with T1D. Sensor accuracy is currently considered adequate for exercise, which has been crucial to developing closed-loop and artificial pancreas systems. Until these systems are perfected, CGM continues to provide information about late post-exercise responses, to assist T1D patients in managing their glucose, and to be useful as a tool for teaching individuals with T1D about exercise.
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Bomholt, Tobias, Bo Feldt-Rasmussen, Rizwan Butt, Rikke Borg, Mir Hassan Sarwary, Thomas Elung-Jensen, Thomas Almdal, et al. "Hemoglobin A1c and Fructosamine Evaluated in Patients with Type 2 Diabetes Receiving Peritoneal Dialysis Using Long-Term Continuous Glucose Monitoring." Nephron 146, no. 2 (November 3, 2021): 146–52. http://dx.doi.org/10.1159/000519493.
Abstract:
<b><i>Introduction:</i></b> Shortened erythrocyte life span and erythropoietin-stimulating agents may affect hemoglobin A<sub>1c</sub> (HbA<sub>1c</sub>) levels in patients receiving peritoneal dialysis (PD). We compared HbA<sub>1c</sub> with interstitial glucose measured by continuous glucose monitoring (CGM) in patients with type 2 diabetes receiving PD. <b><i>Methods:</i></b> Fourteen days of CGM (Ipro2, Medtronic) were performed in 23 patients with type 2 diabetes receiving PD and in 23 controls with type 2 diabetes and an estimated glomerular filtration rate over 60 mL/min/1.73 m<sup>2</sup>. Patients were matched on gender and age (±5 years). HbA<sub>1c</sub> (mmol/mol), its derived estimate of mean plasma glucose (eMPG<sub>A1c</sub>) (mmol/L), and fructosamine (µmol/L) were measured at the end of the CGM period and compared with the mean sensor glucose (mmol/L) from CGM. <b><i>Results:</i></b> In the PD group, mean sensor glucose was 0.98 (95% confidence interval (CI): 0.43–1.54) mmol/L higher than the eMPG<sub>A1c</sub> compared with the control group (<i>p</i> = 0.002) where glucose levels were nearly identical (−0.05 (95% CI: −0.35–0.25) mmol/L). A significant association was found between fructosamine and mean sensor glucose using linear regression with no difference between slopes (<i>p</i> = 0.89) or y-intercepts (<i>p</i> = 0.28). <b><i>Discussion/Conclusion:</i></b> HbA<sub>1c</sub> underestimates mean plasma glucose levels in patients with type 2 diabetes receiving PD. However, the clinical significance of this finding is undetermined. Fructosamine seems to more accurately reflect glycemic status. CGM or fructosamine could complement HbA<sub>1c</sub> to increase the accuracy of glycemic monitoring in the PD population.
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Pleus, Stefan, Lutz Heinemann, and Guido Freckmann. "Blood Glucose Monitoring Data Should Be Reported in Detail When Studies About Efficacy of Continuous Glucose Monitoring Systems Are Published." Journal of Diabetes Science and Technology 12, no. 5 (January 11, 2018): 1061–63. http://dx.doi.org/10.1177/1932296817753629.
Abstract:
Recently, two clinical trials about a “sensor-based flash glucose monitoring system” and its efficacy in reducing time in hypoglycemia were published. Interestingly, patients spent more time at low glucose concentrations in these studies than in other studies related to the efficacy of real-time continuous glucose monitoring (rtCGM). Although it is possible that the study populations differed from those in other studies, another potential explanation is that the CGM system used in these two studies had a negative glucose measurement bias. Such a negative bias was reported in recent literature, suggesting that the CGM system may inaccurately indicate hypoglycemia. Reporting blood glucose monitoring data would help to interpret the CGM data at least in the context of time spent in various glucose ranges as a parameter with which quality of diabetes therapy is measured.
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Sharma, Sanjiv, Ahmed El-Laboudi, Monika Reddy, Narvada Jugnee, Sujan Sivasubramaniyam, Mohamed El Sharkawy, Pantelis Georgiou, Desmond Johnston, Nick Oliver, and Anthony E. G. Cass. "A pilot study in humans of microneedle sensor arrays for continuous glucose monitoring." Analytical Methods 10, no. 18 (2018): 2088–95. http://dx.doi.org/10.1039/c8ay00264a.
Abstract:
Although subcutaneously implanted continuous glucose monitoring (CGM) devices have been shown to support diabetes self-management, their uptake remains low due to high costs and poor accuracy and precision arising from their invasiveness.
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Price, Catherine E., Joseph Anthony Aloi, Saskia Anzola, Jessica Fanelli, Susan Vishneski, Christopher Woody, and Scott B. Segal. "LBODP061 A Pilot Trial Of Continuous Glucose Monitoring Technology In The Perioperative Period." Journal of the Endocrine Society 6, Supplement_1 (November 1, 2022): A277. http://dx.doi.org/10.1210/jendso/bvac150.571.
Abstract:
Abstract Objective To evaluate use of continuous glucose monitoring (CGM) technology in the perioperative setting by comparing CGM with concurrent point of care fingerstick blood glucose (BG) or arterial BG values, as indicated, in patients with hyperglycemia and/or diabetes mellitus undergoing surgery. To assess if grounding device correlated with loss of CGM signal as a prior study of CGM in the perioperative period noted intermittent signal loss during operative time. Methods A prospective cohort analysis of 94 participants with hyperglycemia and/or diabetes mellitus undergoing surgery of 3 hours duration was conducted using Dexcom G6 and/or Freestyle Libre 2. 0 CGM. CGMs were placed preoperatively and compared to standard of care BG checks in the perioperative setting. Correction insulin was administered based on fingerstick glucoses. Of those consented, 18 were excluded resulting in 76 enrolled subjects. Results Preliminary data for use of CGM in perioperative period analyzed 50 participants with Freestyle Libre 2. 0 CGM, 20 participants with Dexcom G6 CGM, and 6 participants with both devices worn simultaneously. Lost sensor data occurred for 3 participants wearing Dexcom G6 CGM and 10 participants wearing Freestyle Libre 2. 0 CGM, which affected 2 of the participants wearing both devices simultaneously. The absolute difference of Dexcom G6 CGM glucose readings compared to BG readings was 29.17 mg/dL (SD = 22.15). The absolute difference of Freestyle Libre 2. 0 CGM glucose readings compared to BG readings was 26.94 mg/dL (SD = 24.16). There was not a significant difference in averages of absolute change in glucose when comparing Dexcom G6 CGM to Freestyle Libre 2. 0 CGM when utilized simultaneously. Grounding devices utilized Megadyne grounding pad for use of bipolar cautery, monopolar cautery, and surgeries with da Vinci robot. Of the 13 participants with lost data, 3 patients had bipolar cautery reported as being used at least once and 10 participants with lost data utilized monopolar cautery. None of the 6 participants with surgery utilizing da Vinci robot had loss of CGM data. Conclusion Both Dexcom G6 and Freestyle Libre 2. 0 CGMs were able to be utilized in the perioperative setting and generally functioned well. Use of CGM provided more glycemic data and better characterized glycemic trends than individual BG readings. It is anticipated that this technology could improve prevention of hypoglycemic events and better glycemic control in the perioperative setting. Use of CGMs in the perioperative setting is a novel area of application that warrants further evaluation of this technology. Presentation: No date and time listed
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Baines, Carol, Don Vicendese, David Cooper, William McGuiness, and Charne Miller. "Comparison of venous, capillary and interstitial blood glucose data measured during hyperbaric oxygen treatment from patients with diabetes mellitus." Diving and Hyperbaric Medicine Journal 51, no. 3 (September 30, 2021): 240–47. http://dx.doi.org/10.28920/dhm51.3.240-247.
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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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Nallicheri, Armaan, Katherine M. Mahoney, Hanna A. Gutow, Natalie Bellini, and Diana Isaacs. "Review of Automated Insulin Delivery Systems for Type 1 Diabetes and Associated Time in Range Outcomes." Endocrinology 18, no. 1 (2022): 27. http://dx.doi.org/10.17925/ee.2022.18.1.27.
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Automated insulin delivery (AID) systems play an important role in the management of type 1 diabetes mellitus (T1DM). These systems include three components: a continuous glucose monitor (CGM), an insulin pump and an algorithm that adjusts the pump based on the CGM sensor glucose readings. They are not fully automated and still require the user to administer bolus insulin doses for food. Some AID systems have automatic correction boluses, while others only have automatic basal or background insulin adjustments. As CGM has become more accurate and the technology has evolved, AID systems have demonstrated improved glycaemic outcomes. The clinical evaluation of AID systems in randomized controlled trials and real-world studies have shown their utility in helping glycaemic management. In this review, we compare AID systems that are commercially available in the US and summarize the literature, with a special focus on time in range in T1DM. The review also discusses new AID systems on the horizon and explores considerations for personalized care.
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Shapiro, Alan R. "Nonadjunctive Use of Continuous Glucose Monitors for Insulin Dosing: Is It Safe?" Journal of Diabetes Science and Technology 11, no. 4 (March 1, 2017): 833–38. http://dx.doi.org/10.1177/1932296816688303.
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With the increasing accuracy of continuous glucose monitors (CGM) have come calls for the Food and Drug Administration (FDA) to label these devices as safe for nonadjunctive dosing of insulin. However, there is evidence that these devices are subject to sporadic, unpredictable, large errors. A text analysis of reports to the FDA MAUDE database since 2015 reveals over 25 000 complaints of CGM sensor inaccuracy, with instances directly leading to serious outcomes. These new data were not considered at a recent FDA Advisory Panel meeting that voted to approve Dexcom G5 relabeling for nonadjunctive use. Social media is another source of surveillance data providing evidence of large CGM inaccuracies in real-world use. We need to improve safety procedures, not remove them. CGMs offer unique information and alerts for managing diabetes, but the issue is not whether they are better than other approaches to monitoring glucose, but how they can be best used in conjunction with devices that offer the confirmatory readings needed for patient safety.
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Gubitosi-Klug, Rose A., Barbara H. Braffett, Ionut Bebu, Mary L. Johnson, Kaleigh Farrell, David Kenny, Victoria R. Trapani, et al. "Continuous Glucose Monitoring in Adults With Type 1 Diabetes With 35 Years Duration From the DCCT/EDIC Study." Diabetes Care 45, no. 3 (January 25, 2022): 659–65. http://dx.doi.org/10.2337/dc21-0629.
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OBJECTIVE We evaluated blinded continuous glucose monitoring (CGM) profiles in a subset of adults with type 1 diabetes from the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) study to characterize the frequency of glycemic excursions and contributing factors. RESEARCH DESIGN AND METHODS CGM-derived metrics were compared for daytime and nighttime periods using blinded CGM for a minimum of 6.5 days (average 11.9 days) and correlated with HbA1c levels, routine use of diabetes devices, and other characteristics in 765 participants. RESULTS Participants were 58.9 ± 6.5 years of age with diabetes duration 36.8 ± 4.9 years and HbA1c 7.8 ± 1.2%; 58% used insulin pumps, and 27% used personal, unblinded CGM. Compared with daytime, nighttime mean sensor glucose was lower, percent time in range 70–180 mg/dL (TIR) was similar, and hypoglycemia was more common. Over the entire recording period, only 9% of the 765 participants achieved >70% TIR and only 28% achieved <1% of observations of <54 mg/dL. Indeed, participants with the highest percentage of hypoglycemia had the lowest HbA1c levels. However, use of insulin pumps and CGM decreased the percent time at <54 mg/dL. CONCLUSIONS In adults with long-standing type 1 diabetes, short-term blinded CGM profiles revealed frequent clinically significant hypoglycemia (<54 mg/dL) during the night and more time in hyperglycemia during the day. The small subset of participants using routine CGM and insulin pumps had fewer hypoglycemic and hyperglycemic excursions and lower HbA1c levels. Thus, strategies to lower meal-stimulated hyperglycemia during the day and prevent hypoglycemia at night are relevant clinical goals in older patients with type 1 diabetes.
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Pleus, Stefan, Ulrike Kamecke, Delia Waldenmaier, Manuela Link, Eva Zschornack, Nina Jendrike, Cornelia Haug, and Guido Freckmann. "Time in Specific Glucose Ranges, Glucose Management Indicator, and Glycemic Variability: Impact of Continuous Glucose Monitoring (CGM) System Model and Sensor on CGM Metrics." Journal of Diabetes Science and Technology, June 8, 2020, 193229682093182. http://dx.doi.org/10.1177/1932296820931825.
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Background: International consensus recommends a set of continuous glucose monitoring (CGM) metrics to assess quality of diabetes therapy. The impact of individual CGM sensors on these metrics has not been thoroughly studied yet. This post hoc analysis aimed at comparing time in specific glucose ranges, coefficient of variation (CV) of glucose concentrations, and glucose management indicator (GMI) between different CGM systems and different sensors of the same system. Method: A total of 20 subjects each wore two Dexcom G5 (G5) sensors and two FreeStyle Libre (FL) sensors for 14 days in parallel. Times in ranges, GMI, and CV were calculated for each 14-day sensor experiment, with up to four sensor experiments per subject. Pairwise differences between different sensors of the same CGM system as well as between sensors of different CGM system were calculated for these metrics. Results: Pairwise differences between sensors of the same model showed larger differences and larger variability for FL than for G5, with some subjects showing considerable differences between the two sensors. When pairwise differences between sensors of different CGM models were calculated, substantial differences were found in some subjects (75th percentiles of differences of time spent <70 mg/dL: 5.0%, time spent >180 mg/dL: 9.2%, and GMI: 0.42%). Conclusion: Relevant differences in CGM metrics between different models of CGM systems, and between different sensors of the same model, worn by the same study subjects were found. Such differences should be taken into consideration when these metrics are used in the treatment of diabetes.
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Lee, Inyoung, Tsugawa Wakako, Kazunori Ikebukuro, and Koji Sode. "In Vitro Continuous 3 Months Operation of Direct Electron Transfer Type Open Circuit Potential Based Glucose Sensor: Heralding the Next CGM Sensor~." Journal of Diabetes Science and Technology, April 25, 2022, 193229682210924. http://dx.doi.org/10.1177/19322968221092449.
Abstract:
Background: While continuous glucose monitoring (CGM) systems allow precise and real-time blood glucose control, current electrochemicalbased CGM technologies inherently harbor enzyme instability issues. The direct electron transfer (DET) type open circuit potential (OCP) based enzyme sensing principle can minimize the catalytic turnover of the enzyme reaction, thereby providing longer-term operational stability in future CGM glucose sensors. Method: DET-type OCP based glucose sensors were constructed using gold disk electrodes with glucose dehydrogenase capable of DET which was immobilized using a self-assembled monolayer (SAM). The single enzyme layer prepared on the gold electrode was operated in the presence of glucose, using in vitro buffer solution, continuously for over 3 months with the OCP sensor signal monitored every 10 seconds at 25°C. Results: The DET-type OCP glucose sensor was continuously operated for more than 3 months without a significant decrease of the sensor signal and sensitivity (slope). These results suggest that the DET-type OCP glucose sensor is far more stable than the sensor constructed based on the amperometric principle. The long-term stability of DET-type OCP glucose sensor is attributed to the enzyme’s minimized catalytic reaction during the operation, thereby extending the lifetime of enzyme. Conclusion: The DET-type OCP glucose sensor can be continuously operated for more than 3 months at 25 °C, in vitro without significant decreases in sensor signal and sensitivity. While the further investigation will be required for in vivo validation, the DET-type OCP glucose sensor is ideal for next generation CGM’s, especially in long duration implantable use cases.
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Thomson, Lynn, Daniela Elleri, Simon Bond, James Howlett, David B. Dunger, and Kathryn Beardsall. "Targeting glucose control in preterm infants: pilot studies of continuous glucose monitoring." Archives of Disease in Childhood - Fetal and Neonatal Edition, September 19, 2018, fetalneonatal—2018–314814. http://dx.doi.org/10.1136/archdischild-2018-314814.
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ObjectiveHyperglycaemia is common in very preterm infants and is associated with adverse outcomes. Preventing hyperglycaemia without increasing the risk of hypoglycaemia is difficult. Real time tracking with continuous glucose monitors (CGM) may improve glucose control. We assessed the feasibility and safety of CGM to target glucose control in preterm infants, to inform a randomised controlled trial (RCT).DesignWe performed a single centre study in very preterm infants during the first week of life. Accuracy was assessed by comparison of CGM with blood glucose levels (n=20 infants). In a separate pilot study of efficacy (n=20), real-time CGM combined with a paper guideline to target glucose control (2.6–10 mmol/L) was compared with standard neonatal care (masked CGM). Questionnaires were used to assess staff acceptability.ResultsNo concerns were raised about infection or skin integrity at sensor site. The sensor performed well compared with point-of-care blood glucose measurements, mean bias of −0.27 (95% CI −0.35 to −0.19). Per cent time in target range (sensor glucose 2.6–10 mmol/L) was greater with CGM than POC (77% vs 59%, respectively) and per cent time sensor glucose >10 mmol/L was less with CGM than POC (24% vs 40%, respectively). The CGM also detected clinically unsuspected episodes of hypoglycaemia. Staff reported that the use of the CGM positively improved clinical care.ConclusionsThis study suggests that CGM has sufficient accuracy and utility in preterm infants to warrant formal testing in a RCT.
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Didyuk, Olesya, Nicolas Econom, Angelica Guardia, Kelsey Livingston, and Ulrike Klueh. "Continuous Glucose Monitoring Devices: Past, Present, and Future Focus on the History and Evolution of Technological Innovation." Journal of Diabetes Science and Technology, January 13, 2020, 193229681989939. http://dx.doi.org/10.1177/1932296819899394.
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The concept of implantable glucose sensors has been promulgated for more than 40 years. It is now accepted that continuous glucose monitoring (CGM) increases quality of life by allowing informed diabetes management decisions as a result of more optimized glucose control. The focus of this article is to provide a brief overview of the CGM market history, emerging technologies, and the foreseeable challenges for the next CGM generations as well as proposing possible solutions in an effort to advance the next generation of implantable sensor.
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Wright, Jordan J., Alexander J. Williams, Sally B. Friedman, Rita G. Weaver, Jonathan M. Williams, Elizabeth Hodge, Michael Fowler, and Shichun Bao. "Accuracy of Continuous Glucose Monitors for Inpatient Diabetes Management." Journal of Diabetes Science and Technology, February 7, 2022, 193229682210765. http://dx.doi.org/10.1177/19322968221076562.
Abstract:
Introduction: In hospitalized patients, continuous glucose monitoring (CGM) may improve glycemic control, prevent hypoglycemic events, and reduce staff workload compared with point-of-care (POC) capillary glucose monitoring. Methods: To evaluate CGM accuracy and safety of use in the inpatient setting, two versions of CGM sensors were placed on 43 and 34 adult patients with diabetes admitted to non-intensive care unit (ICU) medical wards, respectively. CGM accuracy relative to POC and safety of use were measured by calculating mean absolute relative difference (MARD) and by Clarke Error Grid (CEG) analysis. Results: CGM version 2 had improved accuracy compared with CGM version 1 with MARD 17.7 compared with 21.4%. CGM accuracy did not change with POC value or with time of sensor wear. On CEG, 98.8% of paired values fell within acceptable zones A and B. Conclusion: Despite reduced accuracy compared with the outpatient setting, both versions of CGMs had acceptable safety profiles in the inpatient setting.
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Matievich, William, Namvar Kiaie, and Timothy C. Dunn. "Safety and Functional Integrity of CGM Sensors When Used During Radiologic Procedures Under High Exposure Conditions." Journal of Diabetes Science and Technology, June 30, 2022, 193229682211062. http://dx.doi.org/10.1177/19322968221106206.
Abstract:
Background: We investigated wearable components of the Abbott Diabetes Care FreeStyle Libre® (continuous glucose monitoring [CGM 1), FreeStyle Libre® 2 (CGM 2), and FreeStyle Libre® 3 (CGM 3) systems in simulated diagnostic radiologic procedures. Methods: Sensors were loaded with simulated glucose data and exposed to X-ray scanning, computed tomography (CT), and magnetic resonance imaging (MRI) to simulate radiotherapeutic procedures. The exposure settings were representative of maximum in clinical settings. After the simulations, bench tests were used to assess data integrity and responsiveness of sensors to various concentrations of aqueous glucose. Results: All sensors passed all acceptance criteria following each session of X-ray, CT, and MRI exposures. During the 3 T MRI simulation, the displacement forces for the CGM 1, CGM 2, and CGM 3 sensors were 0.132, 0.109, and 0.063 N, respectively, which are more than 100× smaller than the force of 15.97 N required to dislodge the sensor from the body. Data stored in the sensors prior to the exposures remained intact. Conclusion: The sensors maintained functionality following a series of high exposure conditions in both X-ray and CT scanning systems, and the sensors were easily visible and identifiable when scanned using clinically relevant scanning parameters. Therefore, patients can continue to wear and use their sensors during and after imaging. The nonclinical MRI testing demonstrated that the sensors can be worn under the specified MRI conditions.
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Kölle, Julia, Manuel Eichenlaub, Jochen Mende, Manuela Link, Beatrice Vetter, Elvis Safary, Stefan Pleus, Cornelia Haug, and Guido Freckmann. "Performance Assessment of Three Continuous Glucose Monitoring Systems in Adults With Type 1 Diabetes." Journal of Diabetes Science and Technology, February 22, 2023, 193229682311596. http://dx.doi.org/10.1177/19322968231159657.
Abstract:
Background: FIND, the global alliance for diagnostics, identified the nonmarket-approved continuous glucose monitoring (CGM) system, FiberSense system (FBS), as a potential device for use in low- and middle-income countries. Together with two market-approved, factory-calibrated CGM systems, namely, the FreeStyle Libre 2 (FL2) and the GlucoRx AiDEX (ADX), the FBS was subjected to a clinical performance evaluation. Methods: Thirty adult participants with type 1 diabetes were enrolled. The study was mainly conducted at home, with three in-clinic sessions conducted over the study period of 28 days. Comparator measurements were collected from capillary samples, using a high-quality blood glucose monitoring system. Results: Data from 31, 70, and 78 sensors of FBS, FL2, and ADX, respectively, were included in the performance analysis. The mean absolute relative differences between CGM and comparator data for FBS, FL2, and ADX were 14.7%, 9.2%, and 21.9%, and relative biases were −2.1%, −2.5%, and −18.5%, respectively. Analysis of individual sensor accuracy revealed low, moderate, and high sensor-to-sensor variability for FBS, FL2, and ADX, respectively. Sensor survival probabilities until the end of sensor life were 47.2% for FBS (28 days), 71.3% for FL2 (14 days), and 48.4% for ADX (14 days). Conclusions: The results of FBS were encouraging enough to conduct further performance and usability evaluations in a low- and middle-income country. The results of FL2 mainly agreed with existing studies, whereas ADX showed substantial deviations from previously reported results.
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Hidefjäll, Patrik, and Lars Berg. "Patient Controlled, Off-label Use of Continuous Glucose Monitoring: Real-World Medical Costs and Effects of Patient Controlled Sensor Augmented Pump Therapy in Adult Patients Type 1 Diabetes." Journal of Diabetes Science and Technology, June 9, 2020, 193229682092090. http://dx.doi.org/10.1177/1932296820920909.
Abstract:
Background: Continuous glucose monitoring (CGM) has shown promise to reduce glycated hemoglobin (HbA1c) levels, but its cost-effectiveness is seen as uncertain by reimbursement agencies. The aim of this study was to explore the impact of real-world, off-label, patient controlled CGM use in combination with continuous subcutaneous insulin infusion (CSII) on costs and effects in patients with type 1 diabetes in a Swedish clinic. Methods: A real-world, retrospective study with questionnaire on CGM use by adult patients with type 1 diabetes on CSII (Animas Vibe) were offered sensor augmented pump therapy (SAPT) (Dexcom G4) as part of hospital innovation funding program. Direct medical costs, HbA1c, and complications following switch from CSII with self-monitoring of blood glucose (SMBG) to SAPT were calculated. Results: Questionnaire data showed that CGM sensors were on average used 92% of the time for 22 days. One hundred and thirty-nine (95%) of 146 respondents used each sensor for longer than one week. Data analysis showed a statistically significant HbA1c decrease of 0.56% (6.1 mmol/mol) after change to SAPT. In patients using the sensor 100%, the decrease was 0.89% (9.8 mmol/mol). The analysis showed that SAPT led to higher costs (5500 USD/year) than CSII + SMBG (3680 USD/year), with incremental costs being 1815 USD per year to achieve an HbA1c decrease of 0.56% (6.1 mmol/mol). The incidence of all complications declined after switch to SAPT. Conclusion: The primary data analysis showed a decrease in HbA1c values following switch to SAPT, corresponding to previous cost-effectiveness studies, but at substantially lower costs due to longer sensor off-label use.