scholarly journals Implantable and transcutaneous continuous glucose monitoring system: a randomized cross over trial comparing accuracy, efficacy and acceptance

Author(s):  
F. Boscari ◽  
M. Vettoretti ◽  
F. Cavallin ◽  
A. M. L. Amato ◽  
A. Uliana ◽  
...  

Abstract Aim To compare accuracy, efficacy and acceptance of implantable and transcutaneous continuous glucose monitoring (CGM) systems. Methods In a randomized crossover trial we compared 12 weeks with Eversense implantable sensor (EVS) and 12 weeks with Dexcom G5 transcutaneous sensor (DG5) in terms of accuracy, evaluated as Mean Absolute Relative Difference (MARD) vs capillary glucose (SMBG), time of CGM use, adverse events, efficacy (as HbA1c, time in range, time above and below range) and psychological outcomes evaluated with Diabetes Treatment Satisfaction Questionnaire (DTSQ), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Fear Survey (HFS2), Diabetes Distress Scale (DDS). Results 16 subjects (13 males, 48.8 ± 10.1 years, HbA1c 55.8 ± 7.9 mmol/mol, mean ± SD) completed the study. DG5 was used more than EVS [percentage of use 95.7 ± 3.6% vs 93.5 ± 4.3% (p = 0.02)]. MARD was better with EVS (12.2 ± 11.5% vs. 13.1 ± 14.7%, p< 0.001). No differences were found in HbA1c. While using EVS time spent in range increased and time spent in hyperglycemia decreased, but these data were not confirmed by analysis of retrofitted data based on SMBG values. EVS reduced perceived distress, without significant changes in other psychological outcomes. Conclusions CGM features may affect glycemic control and device acceptance.

2020 ◽  
Vol 4 (9) ◽  
Author(s):  
Robin L Gal ◽  
Nathan J Cohen ◽  
Davida Kruger ◽  
Roy W Beck ◽  
Richard M Bergenstal ◽  
...  

Abstract The purpose of this study was to evaluate feasibility of initiating continuous glucose monitoring (CGM) through telehealth as a means of expanding access. Adults with type 1 diabetes (N = 27) or type 2 diabetes using insulin (N = 7) and interest in starting CGM selected a CGM system (Dexcom G6 or Abbott FreeStyle Libre), which they received by mail. CGM was initiated with a certified diabetes care and education specialist providing instruction via videoconference or phone. The primary outcome was days per week of CGM use during the last 4 weeks. Hemoglobin A1c (HbA1c) was measured at baseline and 12 weeks. Participant self-reported outcome measures were also evaluated. All 34 participants (mean age, 46 ± 18 years; 53% female, 85% white) were using CGM at 12 weeks, with 94% using CGM at least 6 days per week during weeks 9 to 12. Mean HbA1c decreased from 8.3 ± 1.6 at baseline to 7.2 ± 1.3 at 12 weeks (P &lt; .001) and mean time in range (70-180 mg/dL, 3.9-10.0 mmol/L) increased from an estimated 48% ± 18% to 59% ± 20% (P &lt; .001), an increase of approximately 2.7 hours/day. Substantial benefits of CGM to quality of life were observed, with reduced diabetes distress, increased satisfaction with glucose monitoring, and fewer perceived technology barriers to management. Remote CGM initiation was successful in achieving sustained use and improving glycemic control after 12 weeks as well as improving quality-of-life indicators. If widely implemented, this telehealth approach could substantially increase the adoption of CGM and potentially improve glycemic control for people with diabetes using insulin.


2017 ◽  
Vol 12 (3) ◽  
pp. 634-638 ◽  
Author(s):  
Katharine D. Barnard ◽  
Jort Kropff ◽  
Pratik Choudhary ◽  
Sankalpa Neupane ◽  
Stephen C. Bain ◽  
...  

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.


Diabetes ◽  
2018 ◽  
Vol 67 (Supplement 1) ◽  
pp. 1179-P ◽  
Author(s):  
THOMAS DANNE ◽  
BERTRAND CARIOU ◽  
JOHN B. BUSE ◽  
SATISH K. GARG ◽  
JULIO ROSENSTOCK ◽  
...  

2021 ◽  
pp. 193229682110275
Author(s):  
Wannita Tingsarat ◽  
Patinut Buranasupkajorn ◽  
Weerapan Khovidhunkit ◽  
Patchaya Boonchaya-anant ◽  
Nitchakarn Laichuthai

Objective: To assess the accuracy of continuous glucose monitoring (CGM) in medical intensive care unit (MICU) patients. Methods: A Medtronic Enlite® sensor accuracy was assessed versus capillary blood glucose (CBG) and plasma glucose (PG) using the mean absolute relative difference (MARD), surveillance error grid (SEG) analysis and modified Bland-Altman plots. Results: Using CBG as a reference, MARD was 6.6%. Overall, 99.7% of the CGM readings were within the “no risk” zone. No significant differences in accuracy were seen within vasopressor subgroups. Using PG as the reference, MARD was 8.8%. The surveillance error grid analysis showed 95.2% of glucose readings were within the “no risk” zone. There were no device-related adverse events. Conclusion: The CGM sensor showed acceptable accuracy in MICU patients, regardless of vasopressor use.


2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Fumi Uemura ◽  
Yosuke Okada ◽  
Keiichi Torimoto ◽  
Yoshiya Tanaka

AbstractTime in range (TIR) is an index of glycemic control obtained from continuous glucose monitoring (CGM). The aim was to compare the glycemic variability of treatment with sulfonylureas (SUs) in type 2 diabetes mellitus (T2DM) with well-controlled glucose level (TIR > 70%). The study subjects were 123 patients selected T2DM who underwent CGM more than 24 h on admission without changing treatment. The primary endpoint was the difference in glycemic variability, while the secondary endpoint was the difference in time below range < 54 mg/dL; TBR < 54, between the SU (n = 63) and non-SU (n = 60) groups. The standard deviation, percentage coefficient of variation (%CV), and maximum glucose level were higher in the SU group than in the non-SU group, and TBR < 54 was longer in the high-dose SU patients. SU treatment was identified as a significant factor that affected %CV (β: 2.678, p = 0.034). High-dose SU use contributed to prolonged TBR < 54 (β: 0.487, p = 0.028). Our study identified enlarged glycemic variability in sulfonylurea-treated well-controlled T2DM patients and high-dose SU use was associated with TBR < 54. The results highlight the need for careful adjustment of the SU dose, irrespective of glycated hemoglobin level or TIR value.


2009 ◽  
Vol 53 (4) ◽  
pp. 425-428
Author(s):  
Gustavo A. Augusto ◽  
André G. P. Sousa ◽  
Marcela N. A. Perazo ◽  
Maria L. C. Correa-Giannella ◽  
Marcia Nery ◽  
...  

INTRODUCTION: Continuous glucose monitoring system is a valuable instrument to measure glycemic control, which uses a retrospective calibration based upon 3 to 4 capillary glucose meter values inserted by the patient each day. OBJECTIVE: We evaluated the interference of calibration during the dawn period in the system accuracy. METHODS: The monitoring data were retrospectively divided into two groups: with (Group A) or without (Group B) the dawn period calibration (between 1:00 and 5:00 AM). Accuracy of the method was expressed by relative absolute difference. RESULTS: Thirty-four continuous glucose monitoring data were evaluated comprising a total of 112 nights. A total of 289 paired readings were analyzed - 195 in Group A and 94 in Group B. We did not find a difference in relative absolute difference (RAD%) in any analyzed period of day by adding dawn calibration. CONCLUSIONS: These data suggest that dawn calibration does not alter accuracy of method.


2018 ◽  
Vol 15 (3) ◽  
pp. 175-184 ◽  
Author(s):  
Ramzi A Ajjan ◽  
Michael H Cummings ◽  
Peter Jennings ◽  
Lalantha Leelarathna ◽  
Gerry Rayman ◽  
...  

Continuous glucose monitoring and flash glucose monitoring technologies measure glucose in the interstitial fluid and are increasingly used in diabetes care. Their accuracy, key to effective glycaemic management, is usually measured using the mean absolute relative difference of the interstitial fluid sensor compared to reference blood glucose readings. However, mean absolute relative difference is not standardised and has limitations. This review aims to provide a consensus opinion on assessing accuracy of interstitial fluid glucose sensing technologies. Mean absolute relative difference is influenced by glucose distribution and rate of change; hence, we express caution on the reliability of comparing mean absolute relative difference data from different study systems and conditions. We also review the pitfalls associated with mean absolute relative difference at different glucose levels and explore additional ways of assessing accuracy of interstitial fluid devices. Importantly, much data indicate that current practice of assessing accuracy of different systems based on individualised mean absolute relative difference results has limitations, which have potential clinical implications. Healthcare professionals must understand the factors that influence mean absolute relative difference as a metric for accuracy and look at additional assessments, such as consensus error grid analysis, when evaluating continuous glucose monitoring and flash glucose monitoring systems in diabetes care. This in turn will ensure that management decisions based on interstitial fluid sensor data are both effective and safe.


Sign in / Sign up

Export Citation Format

Share Document