Estimating plasma glucose with the FreeStyle Libre Pro continuous glucose monitor during oral glucose tolerance tests in youth without diabetes.
Ontology highlight
ABSTRACT:
SUBMITTER: Ghane N
PROVIDER: S-EPMC6821586 | biostudies-literature | 2019 Dec
REPOSITORIES: biostudies-literature
Publications
Estimating plasma glucose with the FreeStyle Libre Pro continuous glucose monitor during oral glucose tolerance tests in youth without diabetes.
Ghane Nejla N Broadney Miranda M MM Davis Elisabeth K EK Trenschel Robert W RW Collins Shavonne M SM Brady Sheila M SM Yanovski Jack A JA
Pediatric diabetes 20190829 8
Few studies have assessed the accuracy of the FreeStyle Libre Pro (FLP) continuous glucose monitor for estimating plasma glucose (PG) in non-diabetic children.<h4>Objective</h4>Determine the accuracy of FLP compared to PG during OGTT in healthy children.<h4>Subjects</h4>Children (7-11.99 years) with healthy weight and overweight/obesity (n = 33; 52% male).<h4>Methods</h4>Participants wore the FLP before and during a 2-hour OGTT; PG was measured at 30 minutes intervals. Potential systematic- and ...[more]
Similar Datasets
Project description:AIM:Many countries require individuals with diabetes to adhere to standards regarding blood glucose testing in order to be granted or retain a driving licence. Currently, interstitial glucose results may not be used. The aim of this study was to determine whether interstitial glucose measurements using flash glucose-sensing technology can provide additional information to augment safe driving. METHODS:Sensor data from two European studies (NCT02232698 and NCT02082184) of the FreeStyle Libre Glucose Monitoring System™ in insulin-treated Type 1 and Type 2 diabetes, 241 and 224 participants respectively, were used to determine the frequency of a low interstitial sensor glucose result (< 3.9 mmol/l) up to 4 h subsequent to a daytime (07:00-21:00 h) capillary blood glucose result ? 5 mmol/l. RESULTS:Within 4 h of a capillary blood glucose result ? 5 mmol/l a sensor glucose result of < 3.9 mmol/l occurred on 22.0% of occasions (2573 of 11 706 blood glucose readings) for those with Type 1 diabetes, and 8.4% of occasions (699/8352) for those with Type 2 diabetes; 13.8% (1610/11 628) and 4.4% (365/8203) within 2 h, and 10.0% (1160/11 601) and 3.1% (254/8152) within 1.5 h. Analysis of sensor glucose results 5-7 mmol/l demonstrated the glucose trend arrow descending on 14.7% (1163/7894, Type 1 diabetes) and 9.4% (305/3233, Type 2 diabetes) of occasions. CONCLUSIONS:Sensor-based glucose information with directional arrows has the potential to support assessment of safe glucose levels associated with driving and offers distinct advantages over blood glucose testing for individuals with Type 1 and Type 2 diabetes to concord with driving safety standards.
| S-EPMC5887912 | biostudies-literature
Project description:BackgroundIn Sweden, FreeStyle Libre a flash glucose monitoring system came onto the market in 2014 as a complement to self-monitoring of blood glucose. The aim of this study was to evaluate the accuracy and treatment experience of the FreeStyle Libre system.MethodsFifty-eight adults with type 1 diabetes used FreeStyle Libre for 10-14 days and measured capillary blood glucose levels with the HemoCue blood glucose measurement system at least six times a day simultaneously.ResultsFor the entire study period, the mean absolute relative difference (MARD) was 13.2% (95% confidence interval [CI] 12.0%-14.4%). MARD was 13.6% (95% CI 12.1%-15.4%) during week 1 and 12.7% (95% CI 11.5%-13.9%) during week 2. The mean absolute difference (MAD) for the whole study period was 19.8 mg/dL (1.1 mmol/L) (95% CI 17.8-21.8 mg/dL), including 20.5 mg/dL (1.14 mmol/L) during week 1 and 19.0 mg/dL (1.05 mmol/L) during week 2. The overall correlation coefficient was 0.96. For glucose values <72, 72-180, and >180 mg/dL (<4, 4-10, and >10 mmol/L), the MARD was 20.3% (95% CI 17.7%-23.1%), 14.7% (95% CI 13.4%-16%), and 9.6% (95% CI 8.5%-10.8%), respectively, and respective MAD values were 12.3, 17.8, and 23.6 mg/dL (0.69, 0.99, and 1.31 mmol/L). Using the 10-item visual analog scale, patients rated their experience with FreeStyle Libre as generally positive, with mean values ranging from 8.22 to 9.8.ConclusionsFreeStyle Libre had a similar overall MARD as continuous blood glucose monitoring systems in earlier studies when studied in similar at-home conditions. The overall patient satisfaction was high.
| S-EPMC5359691 | biostudies-literature
Project description:ObjectiveWe compared the performance of the FreeStyle Libre Pro continuous glucose monitoring (CGM) and point-of-care capillary glucose testing (POC) among insulin-treated hospitalized patients with type 2 diabetes (T2D).Research design and methodsThis was a prospective study in adult patients with T2D admitted to general medicine and surgery wards. Patients were monitored with POC before meals and bedtime and with CGM during the hospital stay. Study end points included differences between POC and CGM in mean daily blood glucose (BG), hypoglycemia <70 and <54 mg/dL, and nocturnal hypoglycemia. We also calculated the mean absolute relative difference (MARD), ±15%/15 mg/dL, ±20%/20 mg/dL, and ±30%/30 mg/dL and error grid analysis between matched glucose pairs.ResultsMean daily glucose was significantly higher by POC (188.9 ± 37.3 vs. 176.1 ± 46.9 mg/dL) with an estimated mean difference of 12.8 mg/dL (95% CI 8.3-17.2 mg/dL), and proportions of patients with glucose readings <70 mg/dL (14% vs. 56%) and <54 mg/dL (4.1% vs. 36%) detected by POC BG were significantly lower compared with CGM (all P < 0.001). Nocturnal and prolonged CGM hypoglycemia <54 mg/dL were 26% and 12%, respectively. The overall MARD was 14.8%, ranging between 11.4% and 16.7% for glucose values between 70 and 250 mg/dL and higher for 51-69 mg/dL (MARD 28.0%). The percentages of glucose readings within ±15%/15 mg/dL, ±20%/20 mg/dL, and ±30%/30 mg/dL were 62%, 76%, and 91%, respectively. Error grid analysis showed 98.8% of glucose pairs within zones A and B.ConclusionsCompared with POC, FreeStyle Libre CGM showed lower mean daily glucose and higher detection of hypoglycemic events, particularly nocturnal and prolonged hypoglycemia in hospitalized patients with T2D. CGM's accuracy was lower in the hypoglycemic range.
| S-EPMC7809713 | biostudies-literature
Project description:AimsTo identify factors predicting HbA1c reduction in patients with diabetes mellitus (DM) using FreeStyle Libre Flash Glucose Monitoring (FSL-FGM).MethodsData from a 12-month prospective nation-wide FSL registry were used and analysed with multivariable regression. For the present study we included patients with hypoglycaemia unawareness or unexpected hypoglycaemias (n = 566) and persons who did not reach acceptable glycaemic control (HbA1c > 70 mmol/mol (8.5%)) (n = 294). People with other indications for use, such as sensation loss of the fingers or individuals already using FSL-FGM or rtCGM, were excluded (37%).ResultsEight hundred and sixty persons (55% male with a mean age of 46.7 (±16.4) years) were included. Baseline HbA1c was 65.1 (±14.5) mmol/mol (8.1 ± 1.3%), 75% of the patients had type 1 DM and 37% had microvascular complications. Data concerning HbA1c was present for 482 (56.0%) at 6 months and 423 (49.2%) persons at 12 months. A significant reduction in HbA1c (≥5 mmol/mol (0.5%)) was present in 187 (22%) persons. For these persons, median HbA1c reduction was -9.0 [-13.0, -4.0] mmol/mol (-0.82 [-1.19, -0.37]%) at 6 months and -9.0 [-15.0, -7.0] mmol/mol (-0.82 [-1.37, -0.64]%) at 12 months. In multivariable regression analysis with age, gender and SF-12 physical and mental component scores as covariates, only baseline HbA1c was significant: -0.319 (SE 0.025; p < 0.001; R2 = 0.240 for the model). In exploratory analysis among subgroups with different indications for FSL-FGM use (hypoglycaemia unawareness or persistently high HbA1c) and persons with a significant HbA1c decrease over the study period, baseline HbA1c remained the only significant predictor.ConclusionsAmong the variables we analysed in the present study, only high HbA1c at baseline predicts significant HbA1c reduction during FSL-CGM use.
| S-EPMC7578738 | biostudies-literature
Project description:In patients with diabetes mellitus (DM), adequate glucose control is of major importance. When treatment schemes become more complicated, proper self-management through intermittent self-measurement of blood glucose (SMBG), among others, becomes crucial in achieving this goal. In the last decade, continuous glucose monitoring (CGM) has been on the rise, providing not only intermittent information but also information on continuous glucose trends. The FreeStyle Libre (FSL) Flash CGM system is a CGM system mainly used for patients with DM and is designed based on the same techniques as early CGMs. Compared with earlier CGMs, the FSL is factory calibrated, has no automated readings or direct alarms, and is cheaper to use. Although less accurate compared with the gold standard for SMBG, users report high satisfaction because it is easy to use and can help users monitor glucose trends. The Flash Monitor Register in the Netherlands (FLARE-NL) study aims to assess the effects of FSL Flash CGM use in daily practice. The study has a before-after design, with each participant being his or her own control. Users will be followed for at least 1 year. The endpoints include changes in HbA1c, frequency and severity of hypoglycemias, and quality of life. In addition, the effects of its use on work absenteeism rate, diabetes-related hospital admission rate, and daily functioning (including sports performance) will be studied. Furthermore, cost-benefit analysis based on the combination of registered information within the health insurance data will be investigated. Ultimately, the data gathered in this study will help increase the knowledge and skills of the use of the Flash CGM in daily practice and assess the financial impact on the use of the Flash CGM within the Dutch healthcare system.
| S-EPMC6875221 | biostudies-literature
Project description:BACKGROUND:The diagnosis of hyperglycaemia in sub-Saharan Africa (SSA) is challenging. Blood glucose levels obtained during oral glucose tolerance test (OGTT) may not reflect home glycaemic profiles. We compare OGTT results with home glycaemic profiles obtained using the FreeStyle Libre continuous glucose monitoring device (FSL-CGM). METHODS:Twenty-eight women (20 with gestational diabetes [GDM], 8 controls) were recruited following OGTT between 24 and 28?weeks of gestation. All women wore the FSL-CGM device for 48-96?h at home in early third trimester, and recorded a meal diary. OGTT was repeated on the final day of FSL-CGM recording. OGTT results were compared with ambulatory glycaemic variables, and repeat OGTT was undertaken whilst wearing FSL-CGM to determine accuracy of the device. RESULTS:FSL-CGM results were available for 27/28 women with mean data capture 92.8%. There were significant differences in the ambulatory fasting, post-prandial peaks, and mean glucose between controls in whom both primary and secondary OGTT was normal (n?=?6) and those with two abnormal OGTTs or "true" GDM (n?=?7). There was no difference in ambulatory mean glucose between these controls and the 13 women who had an abnormal primary OGTT and normal repeat OGTT. These participants had significantly lower body mass index (BMI) than the true GDM group (29.0 Vs 36.3?kg/m2, p-value 0.014). Paired OGTT/FSL-CGM readings revealed a Mean Absolute difference (MAD) -0.58?mmol/L and Mean Absolute Relative Difference (MARD) -11.9%. Bland-Altman plot suggests FSL-CGM underestimated blood glucose by approximately 0.78?mmol/L. CONCLUSION:Diagnosis of GDM on a single OGTT identifies a proportion of women who do not have a significantly higher home glucose levels than controls. This raises questions about factors which may affect the reproducibility of OGTT in this population, including food insecurity and atypical phenotypes of diabetes. More investigation is needed to understand the suitability of the OGTT as a diagnostic test in sub-Saharan Africa.
| S-EPMC7574406 | biostudies-literature
Project description:ObjectivesHome blood glucose monitoring using a portable blood glucose meter is important in the management of feline diabetes mellitus, but taking blood samples may be stressful for owners and cats. A flash glucose monitoring system measuring interstitial glucose, such as the FreeStyle Libre, overcomes some of these drawbacks. The aim of this study was to evaluate the practical use and analytical and clinical accuracy of the FreeStyle Libre in 41 client-owned diabetic cats.MethodsIn this prospective study, interstitial glucose concentrations were measured with the FreeStyle Libre and compared with blood glucose concentrations measured with a portable blood glucose meter (AlphaTRAK) on days 1, 7 or 8 and 14 after application of the device. Cat behaviour during application, location, skin reaction at the attachment site and owner satisfaction were assessed. Accuracy was determined by fulfilment of ISO 15197:2013 criteria, including Bland-Altman plotting and error grid analysis.ResultsPlacing the device was easy, with 70% of cats showing no reaction. Most sensors were placed on the thoracic wall. Skin reactions at the attachment site were not present or mild in almost all cats. Owners were very satisfied with the use of the FreeStyle Libre. Median functional life of the sensor was 10 days (range 1-14). Good correlation was found between interstitial and blood glucose measurements (rho[r] = 0.88, P <0.0001). Fifty-three percent of interstitial glucose concentrations were within a maximum deviation of 15% from blood glucose concentrations and 92.7% were within the safe risk zones 0 and 1 of the surveillance error grid.Conclusions and relevanceThe flash glucose monitoring system was easy to use and owners of diabetic cats were satisfied with its use. Although the device did not completely fulfil ISO requirements, it is sufficiently accurate for glucose monitoring in diabetic cats.
| S-EPMC9315169 | biostudies-literature
Project description:BackgroundWith the development of continuous glucose monitoring systems (CGMS), detailed glycemic data are now available for analysis. Yet analysis of this data-rich information can be formidable. The power of CGMS-derived data lies in its characterization of glycemic variability. In contrast, many standard glycemic measures like hemoglobin A1c (HbA1c) and self-monitored blood glucose inadequately describe glycemic variability and run the risk of bias toward overreporting hyperglycemia. Methods that adjust for this bias are often overlooked in clinical research due to difficulty of computation and lack of accessible analysis tools.MethodsIn response, we have developed a new R package rGV, which calculates a suite of 16 glycemic variability metrics when provided a single individual's CGM data. rGV is versatile and robust; it is capable of handling data of many formats from many sensor types. We also created a companion R Shiny web app that provides these glycemic variability analysis tools without prior knowledge of R coding. We analyzed the statistical reliability of all the glycemic variability metrics included in rGV and illustrate the clinical utility of rGV by analyzing CGM data from three studies.ResultsIn subjects without diabetes, greater glycemic variability was associated with higher HbA1c values. In patients with type 2 diabetes mellitus (T2DM), we found that high glucose is the primary driver of glycemic variability. In patients with type 1 diabetes (T1DM), we found that naltrexone use may potentially reduce glycemic variability.ConclusionsWe present a new R package and accompanying web app to facilitate quick and easy computation of a suite of glycemic variability metrics.
| S-EPMC9631526 | biostudies-literature
Project description:The first-generation FreeStyle Navigator® Continuous Glucose Monitoring System (FreeStyle Navigator CGM) requires a 10 h warm-up period to avoid inaccurate glucose readings caused by sensor insertion trauma and wound-healing processes. The performance of a second-generation FreeStyle Navigator CGM that begins reporting glucose 1 h after sensor insertion is described.Second-generation FreeStyle Navigator CGM performance was evaluated in an in-clinic study using the YSI Model 2300 STATPlus Glucose Analyzer as reference with 47 subjects with type 1 diabetes. The reference readings were taken at 15 min intervals, and the study was designed to emphasize the first 10 h of use.The second-generation FreeStyle Navigator CGM exhibited continuous glucose error grid analysis ratings of 93.7% "clinically accurate," 3.6% "benign errors," and 2.8% "clinical errors" and a mean and median absolute relative difference of 14.5% and 10.7%, respectively. The second-generation algorithm detected signal instability in the first 10 h of use and suspended the reporting of 14.1% of first day continuous glucose readings. The clinical accuracy of the second-generation FreeStyle Navigator CGM was similar for the first 10 h versus subsequent hours, with 92.6% and 94.2% "clinically accurate" readings, respectively.The warm-up period for the second-generation FreeStyle Navigator CGM was reduced from 10 to 1 h, with minimal interruption of glucose reporting and without sacrificing clinical performance.
| S-EPMC3045239 | biostudies-literature
Project description:IntroductionOptimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG.MethodsThis open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%-11%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected.AnalysisEfficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed.EthicsThe study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants.Trial registration numberNCT03815006.Protocol version4.0 dated 29 June 2020.
| S-EPMC8280849 | biostudies-literature