scholarly journals The Accuracy and Precision of the Continuously Stored Data from Flash Glucose Monitoring System in Type 2 Diabetes Patients during Standard Meal Tolerance Test

2020 ◽  
Vol 2020 ◽  
pp. 1-6 ◽  
Author(s):  
Rengna Yan ◽  
Huiqin Li ◽  
Xiaocen Kong ◽  
Xiaofang Zhai ◽  
Maoyuan Chen ◽  
...  

Background. The purpose of this study was to investigate the accuracy of the continuously stored data from the Abbott FreeStyle Libre flash glucose monitoring (FGM) system in Chinese diabetes patients during standard meal tests when glucose concentrations were rapidly changing. Subjects and Methods. Interstitial glucose levels were monitored for 14 days in 26 insulin-treated patients with type 2 diabetes using the FGM system. Standard meal tests were conducted to induce large glucose swings. Venous blood glucose (VBG) was tested at 0, 30, 60, and 120 min after standard meal tests in one middle day of the first and second weeks, respectively. The corresponding sensor glucose values were obtained from interpolating continuously stored data points. Assessment of accuracy was according to recent consensus recommendations with median absolute relative difference (MARD) and Clarke and Parkes error grid analysis (CEG and PEG). Results. Among 208 paired sensor-reference values, 100% were falling within zones A and B of the Clarke and Parkes error grid analysis. The overall MARD was 10.7% (SD, 7.8%). Weighted least squares regression analysis resulted in high agreement between the FGM sensor glucose and VBG readings. The overall MTT results showed that FGM was lower than actual VBG, with MAD of 22.1 mg/dL (1.2 mmol/L). At VBG rates of change of -1 to 0, 0 to 1, 1 to 2, and 2 to 3 mg/dl/min, MARD results were 11.4% (SD, 8.7%), 9.4% (SD, 6.5%), 9.9% (SD, 7.5%), and 9.5% (SD, 7.7%). At rapidly changing VBG concentrations (>3 mg/dl/min), MARD increased to 19.0%, which was significantly higher than slow changing BG groups. Conclusions. Continuously stored interstitial glucose measurements with the FGM system were found to be acceptable to evaluate VBG in terms of clinical decision during standard meal tests. The continuously stored data from the FGM system appeared to underestimate venous glucose and performed less well during rapid glucose changes.

2019 ◽  
Vol 14 (6) ◽  
pp. 1088-1094 ◽  
Author(s):  
Takahiro Yajima ◽  
Hiroshi Takahashi ◽  
Keigo Yasuda

Background: The accuracy of flash glucose monitoring (FGM, FreeStyle Libre Pro [FSL-Pro]) remains unclear in patients with type 2 diabetes mellitus (T2DM) undergoing hemodialysis. Methods: We assessed 13 patients with T2DM undergoing hemodialysis. They simultaneously underwent FGM, continuous glucose monitoring (CGM, iPro2), and self-monitoring blood glucose (SMBG). Results: Parkes error grid analysis against SMBG showed that 49.0% and 51.0% of interstitial fluid glucose (ISFG) levels measured using FGM and 93.3% and 6.7% of those measured using CGM fell into zones A and B, respectively. Mean absolute relative difference (MARD) against SMBG for FGM was significantly higher than that for CGM (19.5% ± 13.2% vs 8.1% ± 7.6%, P < .0001). Parkes error grid analysis of 2496 paired ISFG levels between FGM and CGM showed that 53.6%, 46.2%, and 0.2% of the plots fell into zones A, B, and C, respectively. Mean ISFG levels were lower with FGM than with CGM (143.7 ± 67.2 mg/dL vs 164.6 ± 58.5 mg/dL; P < .0001). Mean absolute relative difference of ISFG levels between FGM and CGM was 19.2% ± 13.8%. Among three groups classified according to CGM ISFG levels (hypoglycemia, <70 mg/dL; euglycemia, 70-180 mg/dL; and hyperglycemia, >180 mg/dL), the MARDs for hypoglycemia (31.9% ± 25.0%) and euglycemia (22.8% ± 14.6%) were significantly higher than MARD for hyperglycemia (13.0% ± 8.5%) ( P < .0001 in both). Conclusions: Flash glucose monitoring may be clinically acceptable. Average ISFG levels were lower with FGM than with CGM, and MARDs were higher for hypoglycemia and euglycemia in patients with T2DM undergoing hemodialysis.


2019 ◽  
Vol 16 (4) ◽  
pp. 385-395 ◽  
Author(s):  
Ramzi A Ajjan ◽  
Neil Jackson ◽  
Scott A Thomson

Aim: Analyse the effects of professional flash glucose monitoring system (FreeStyle Libre Pro™) on glycaemic control in insulin-treated type 2 diabetes. Methods: Primary (n = 17) and secondary care centres (n = 5) randomised 148 type 2 diabetes patients into three groups: (A) self-monitoring of blood glucose (n = 52), (B) self-monitoring of blood glucose and two Libre Pro sensor wears (n = 46) or (C) self-monitoring of blood glucose and four sensor wears (n = 50). Primary endpoint was time in range (glucose 3.9–10 mmol/L) within group C comparing baseline with days 172–187. Predefined secondary endpoints included HbA1c, hypoglycaemia and quality of life measures analysed within and between groups (clinicaltrials.gov, NCT02434315). Results: In group C, time in range in the first 14 days (baseline) and days 172–187 was similar at 15.0 ± 5.0 and 14.1 ± 4.7 h/day (mean ± SD), respectively, (p = 0.1589). In contrast, HbA1c reduced from baseline to study end within group C by 4.9 ± 8.8 mmol/mol (0.44% ± 0.81%; p = 0.0003). HbA1c was also lower in group C compared with A at study end by 5.4 ± 1.79 mmol/mol (0.48% ± 0.16%; p = 0.0041, adjusted mean ± SE), without increased time in hypoglycaemia ( p = 0.1795). Treatment satisfaction scores improved in group C compared with A ( p = 0.0225) and no device-related serious adverse events were reported. Conclusions: Libre Pro can improve HbA1c and treatment satisfaction without increasing hypoglycaemic exposure in insulin-treated type 2 diabetes individuals managed in primary/secondary care centres.


Author(s):  
Rodolfo J. Galindo ◽  
Alexandra L. Migdal ◽  
Georgia M. Davis ◽  
Maria A. Urrutia ◽  
Bonnie Albury ◽  
...  

<b>Background:</b> We compared the performance of the FreeStyle Libre Pro continuous glucose monitoring (CGM) and point-of-care glucose testing among insulin-treated hospitalized patients with type 2 diabetes (T2D). <p> </p> <p><b>Methods:</b> Prospective study in general medicine and surgery adult patients with T2D. Patient were monitored with POC before meals and bedtime, and with CGM during the hospital stay. Major endpoints included differences between POC and CGM in mean daily blood glucose, hypoglycemia < 70 and < 54 mg/dl, and nocturnal hypoglycemia. We also calculated the mean absolute relative difference (MARD), and ±15%/15mg/dl, ±20%/20mg/dl, ± 30%/30mg/dl, and Error Grid analysis between matched glucose pairs. </p> <p> </p> <p><b>Results</b>: Mean daily glucose was significantly higher by POC testing (188.9±37.3 vs. 176.1±46.9 mg/dl), and proportions of patients with glucoses < 70 mg/dl (14% vs 56%) and < 54 mg/dl (4.1% vs 36%) detected by POC BG were significantly lower compared to CGM, all p<0.001. Nocturnal and prolonged CGM hypoglycemia < 54 mg/dl was 26% and 12%, respectively. The overall MARD was 14.8%, ranging between 11.4 to 16.7% for glucoses between 70 and 250 mg/dl, and lower for 51- 69 mg/dL (MARD= 28.0%). The percentage of glucoses within the ±15%/15mg/dl, ±20%/20mg/dl, and ±30%/30mg/dl were 62%, 76%, and 91%, respectively. Error Grid analysis showed 98.0% of glucose pairs within Zones A and B. </p> <p><b> </b></p> <p><b>Conclusions</b>: Compared to POC testing, 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 hypoglycemic range. </p>


Nephron ◽  
2021 ◽  
pp. 1-7
Author(s):  
Tobias Bomholt ◽  
Bo Feldt-Rasmussen ◽  
Rizwan Butt ◽  
Rikke Borg ◽  
Mir Hassan Sarwary ◽  
...  

<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.


2020 ◽  
Author(s):  
Rodolfo J. Galindo ◽  
Alexandra L. Migdal ◽  
Georgia M. Davis ◽  
Maria A. Urrutia ◽  
Bonnie Albury ◽  
...  

<b>Background:</b> We compared the performance of the FreeStyle Libre Pro continuous glucose monitoring (CGM) and point-of-care glucose testing among insulin-treated hospitalized patients with type 2 diabetes (T2D). <p> </p> <p><b>Methods:</b> Prospective study in general medicine and surgery adult patients with T2D. Patient were monitored with POC before meals and bedtime, and with CGM during the hospital stay. Major endpoints included differences between POC and CGM in mean daily blood glucose, hypoglycemia < 70 and < 54 mg/dl, and nocturnal hypoglycemia. We also calculated the mean absolute relative difference (MARD), and ±15%/15mg/dl, ±20%/20mg/dl, ± 30%/30mg/dl, and Error Grid analysis between matched glucose pairs. </p> <p> </p> <p><b>Results</b>: Mean daily glucose was significantly higher by POC testing (188.9±37.3 vs. 176.1±46.9 mg/dl), and proportions of patients with glucoses < 70 mg/dl (14% vs 56%) and < 54 mg/dl (4.1% vs 36%) detected by POC BG were significantly lower compared to CGM, all p<0.001. Nocturnal and prolonged CGM hypoglycemia < 54 mg/dl was 26% and 12%, respectively. The overall MARD was 14.8%, ranging between 11.4 to 16.7% for glucoses between 70 and 250 mg/dl, and lower for 51- 69 mg/dL (MARD= 28.0%). The percentage of glucoses within the ±15%/15mg/dl, ±20%/20mg/dl, and ±30%/30mg/dl were 62%, 76%, and 91%, respectively. Error Grid analysis showed 98.0% of glucose pairs within Zones A and B. </p> <p><b> </b></p> <p><b>Conclusions</b>: Compared to POC testing, 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 hypoglycemic range. </p>


2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Marcio Krakauer ◽  
Jose Fernando Botero ◽  
Fernando J. Lavalle-González ◽  
Adrian Proietti ◽  
Douglas Eugenio Barbieri

Abstract Background Continuous glucose monitoring systems are increasingly being adopted as an alternative to self-monitoring of blood glucose (SMBG) by persons with diabetes mellitus receiving insulin therapy. Main body The FreeStyle Libre flash glucose monitoring system (Abbott Diabetes Care, Witney, United Kingdom) consists of a factory-calibrated sensor worn on the back of the arm which measures glucose levels in the interstitial fluid every minute and stores the reading automatically every 15 min. Swiping the reader device over the sensor retrieves stored data and displays current interstitial glucose levels, a glucose trend arrow, and a graph of glucose readings over the preceding 8 h. In patients with type 2 diabetes (T2D) receiving insulin therapy, pivotal efficacy data were provided by the 6-month REPLACE randomized controlled trial (RCT) and 6-month extension study. Compared to SMBG, the flash system significantly reduced the time spent in hypoglycemia and frequency of hypoglycemic events, although no significant change was observed in glycosylated hemoglobin (HbA1c) levels. Subsequent RCTs and real-world chart review studies have since shown that flash glucose monitoring significantly reduces HbA1c from baseline. Real-world studies in both type 1 diabetes or T2D populations also showed that flash glucose monitoring improved glycemic control. Higher (versus lower) scanning frequency was associated with significantly greater reductions in HbA1c and significant improvements in other measures such as time spent in hypoglycemia, time spent in hyperglycemia, and time in range. Additional benefits associated with flash glucose monitoring versus SMBG include reductions in acute diabetes events, all-cause hospitalizations and hospitalized ketoacidosis episodes; improved well-being and decreased disease burden; and greater treatment satisfaction. Conclusion T2D patients who use flash glucose monitoring might expect to achieve significant improvement in HbA1c and glycemic parameters and several associated benefits.


Sign in / Sign up

Export Citation Format

Share Document