E-POSTER DISCUSSION
Session Type
E-POSTER DISCUSSION
Chair(s)
  • Frans Pouwer, Denmark
Channel
Station 5 (E-Poster Area)
Date
21.02.2020, Friday
Session Time
10:05 - 10:25

THE GLYCEMIC OUTCOMES OF THE EVERSENSE CGM SYSTEM IN AN EXPANDED COHORT OF 582 REAL-WORLD US COMMERCIAL USERS

Session Name
E-POSTER DISCUSSION 11
Session Type
E-POSTER DISCUSSION
Date
21.02.2020, Friday
Session Time
10:05 - 10:25
Channel
Station 5 (E-Poster Area)
Lecture Time
10:05 - 10:10
Presenter
  • Katherine S. Tweden, United States of America
Authors
  • Samanwoy Ghosh-dastidar, United States of America
  • Patricia Sanchez, United States of America
  • Katherine S. Tweden, United States of America
  • Francine Kaufman, United States of America

Abstract

Background and Aims

The first long term implantable Eversense CGM system was approved for US commercialization in 2018. Accuracy and safety have been demonstrated in multiple clinical trials and real-world studies. The first US real-world data publication reported on 205 users with a 90-day sensor wear cycle. Using the same analytic methodology, a larger user base of 582 was subsequently analyzed.

Methods

De‐identified sensor glucose (SG) data from the Eversense data management system were analyzed for the first 582 patients who reached a 90‐day wear period and compared to the first 205 patients previously reported. Mean SG, variability measures (SD, CV), GMI, and glucometrics were computed. Median transmitter wear time was assessed.

Results

The makeup of the 582 cohort was similar to the 205 cohort with ~1/3 naïve CGM users and ~80-85% T1D. Glucometric data were similar between the larger cohort and the original population (Table). The mean SG was 162 and 161 mg/dL, CV was .35, GMI was 7.18% and 7.16%, and time in range was 62 and 63% in the 205 and 582 user groups, respectively. Mean percent SG <70mg/dL approached the targeted value of <4% (4.2 and 4.0%). Median transmitter wear time was 84 and 85%.

Conclusions

These data show that the promising glycemic outcomes and system usage obtained in the first 205 users was sustained in a larger cohort of US commercial Eversense CGM system users and likely represents the real-world population outcomes to be expected when using the system as a tool for diabetes management.expanded cohort.png

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GLUCOSE MANAGEMENT INDICATOR (GMI) BASED ON SENSOR DATA AND LABORATORY HBA1C IN PEOPLE WITH TYPE 1 DIABETES FROM THE DPV DATABASE: DIFFERENCES BY SENSOR TYPE

Session Name
E-POSTER DISCUSSION 11
Session Type
E-POSTER DISCUSSION
Date
21.02.2020, Friday
Session Time
10:05 - 10:25
Channel
Station 5 (E-Poster Area)
Lecture Time
10:10 - 10:15
Presenter
  • Reinhard W. Holl, Germany
Authors
  • Julia M. Hermann, Germany
  • Simone Von sengbusch, Germany
  • Markus Freff, Germany
  • Uwe Ermer, Germany
  • Pia Schlumberger, Germany
  • Kerstin Placzek, Germany
  • Thomas Danne, Germany
  • Elke Hammer, Germany
  • Reinhard W. Holl, Germany

Abstract

Background and Aims

The Glucose Management Indicator (GMI) was developed using data from real-time continuous glucose monitoring (rtCGM). We aimed to compare GMI and laboratory HbA1c using both rtCGM and intermittent scanning CGM (iscCGM) profiles collected during routine care in people with type 1 diabetes (T1D).

Methods

We analyzed 132,361 CGM days from N=1,973 individuals with T1D duration ≥1 year from the German/Austrian DPV Registry. As measurement ranges of CGM devices differ, we truncated glucose values to the same range (40-400 mg/dl). GMI was calculated from a median number of 77 [IQR: 46-89] days/individual as GMI (%) = 3.31+0.02392*[mean glucose, mg/dL]. Differences between GMI and laboratory HbA1c were illustrated using boxplots for rtCGM vs. iscCGM stratified by glucose variability (coefficient of variation [CV] </≥36%), normal weight vs. overweight, and HbA1c </≥7.5%.

Results

Mean GMI and HbA1c were similar in rtCGM users (n=405, 7.6±0.7% vs. 7.6±1.1%), whereas iscCGM users (n=1,568) had higher mean GMI than HbA1c (7.9±0.9% vs. 7.6±1.2%). Overall and stratified by glucose variability or weight, differences between GMI and laboratory HbA1c were almost symmetrically distributed around 0 in rtCGM users, whereas GMI was higher than HbA1c in almost three fourth of all iscCGM users. For both sensor types, most individuals with HbA1c <7.5% had higher GMI than HbA1c, whereas three fourth of the individuals with HbA1c ≥7.5% and rtCGM had lower GMI than HbA1c (Figure).

figure_differencesa1c_gmi_overall+cv+bmi+a1c_2019-10-14.jpg

Conclusions

As measurement ranges, distributions of glucose values, and calibration methods differ between CGM sensors, it may be necessary to use formulas specific for sensor type to calculate GMI.

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A NOVEL CERUMEN GLUCOSE SELF-SAMPLING DEVICE

Session Name
E-POSTER DISCUSSION 11
Session Type
E-POSTER DISCUSSION
Date
21.02.2020, Friday
Session Time
10:05 - 10:25
Channel
Station 5 (E-Poster Area)
Lecture Time
10:15 - 10:20
Presenter
  • Andres Herane-vives, United Kingdom
Authors
  • Andres Herane-vives, United Kingdom

Abstract

Background and Aims

Background: Cerumen glucose may have the potential to improve the diagnosis of diabetes. Currently, cerumen extraction has to be exclusively performed by clinicians. Its extraction is not advisable for healthy ears, although it is a common practice through the use of “cotton buds”. Then, a novel cerumen sampling device should be safe, reliable, comfortable and usable by a patient.

Methods

Methods: Both external ears were cleaned on two occasions, one month apart, in 37 controls. A clinical method was used for cleaning both ears during a baseline visit. During a follow-up visit, one month later, a right cerumen sample was obtained using the novel self-sampling external ear device, and a left ear sample, using the clinical method. Both follow-up samples represented the same retrospective period of cerumen secretion. Vector of Sample Relative Dispersion (VRSD) analysis was performed for comparing the reliability between both extraction methods. Potential side-effects and novel device user experience were recorded.

Results

Results: The weight of the baseline samples were not significantly different between ear sides (both p>0.05). The self-extraction method removed 8 times more earwax than the clinical method (p<0.01). Although no VRSD was significant, left ear cerumen samples (baseline and follow-up) showed the largest variability between them (p=0.15). No side effects were reported by any method in any visit. Participants considered that the self-sampling external ear device was safer, more effective, and as comfortable as the use of “cotton buds”.

Conclusions

Conclusion: The novel device may constitute a reliable, economical, comfortable and effective option for measuring glucose level.

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IMPROVING HBA1C CONTROL IN PEOPLE WITH TYPE 1 OR TYPE 2 DIABETES USING FLASH GLUCOSE MONITORING: A RETROSPECTIVE OBSERVATIONAL ANALYSIS IN 2 GERMAN CENTRES

Session Name
E-POSTER DISCUSSION 11
Session Type
E-POSTER DISCUSSION
Date
21.02.2020, Friday
Session Time
10:05 - 10:25
Channel
Station 5 (E-Poster Area)
Lecture Time
10:20 - 10:25
Presenter
  • Alexander Seibold, Germany
Authors
  • Gerhard Klausmann, Germany
  • Ludger Rose, Germany
  • Alexander Seibold, Germany

Abstract

Background and Aims

To evaluate change in HbA1c in patients with Type 1 (T1D) or Type 2 diabetes (T2D) following initiation of the FreeStyle Libre® flash continuous glucose monitoring system.

Methods

A retrospective observational study was undertaken on adults with T1D (n=131) or T2D on insulin (n=176), who were started on the FreeStyle Libre system. Chart review included patients with HbA1c recorded prior to initiation and at 3- month intervals thereafter.

Results

Mean HbA1c decreased significantly at 3 months after initiation of the FreeStyle Libre system in T1D (mean change -0.75±0.15% (-8.2±1.6 mmol/mol); p<0.001) and in T2D (mean change -0.52±0.11% (-5.7±1.2 mmol/mol); p<0.001). Reduction was maintained for 12 months. Change in HbA1c from 3 months to 12 months was not significant in either T1D or T2D. Subgroup analysis showed significant improvements in patients with mean baseline HbA1c >7.5 % (>58 mmol/mol). Patients with a baseline HbA1c >7.5 % (> 58 mmol/mol) showed a reduction of -1.36±0.34% (-14.9±3.7 mmol/mol) in T1D and a reduction of -1.16±0.38% (-12.7±4.2 mmol/mol) in T2D at 12 months (p<0.001). Linear regression confirms that baseline HbA1c is negatively correlated with change in HbA1c, both in T1D (p<0.001) and in T2D (p<0.001) (Fig 1).

fig1_attd2020.png

Conclusions

People with T1D or T2D on insulin show a reduction in HbA1c by 3 months following initiation of the FreeStyle Libre system. Fall in HbA1c at 3 months is negatively correlated with starting HbA1c and is maintained over 12 months. The most significant benefit seen in patients with a starting HbA1c >7.5% (>58 mmol/mol).

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