Accuracy and Acceptability of the 6-Day Enlite Continuous Subcutaneous Glucose Sensor

Bailey, Timothy S.; Ahmann, Andrew J.; Brazg, Ronald; Christiansen, Mark P.; Garg, Satish K.; Watkins, Elaine; Welsh, John; Lee, Scott W.

doi:10.1089/dia.2013.0222

Cited by 85 publications

(83 citation statements)

References 7 publications

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“…78% within 0 to <1 mg/dl/min and only 5% ≥2 mg/dl/min). 3 The PARD of the 2 systems differed moderately between the rate-of-change categories. This indicates that the rate-of-change dependence of the 2 sensors of the same system is similar.…”

Section: Discussionmentioning

confidence: 95%

“…Bailey and colleagues recently presented MARD results for another CGM system. 3 While they also investigated the rate-of-change dependence of MARD, their results are hardly comparable since their distribution of absolute rate of change was very different (approx. 78% within 0 to <1 mg/dl/min and only 5% ≥2 mg/dl/min).…”

Section: Discussionmentioning

confidence: 99%

“…4,6,8,[17][18][19][20] Detailed information about accuracy at specific BG rates of change are even scarcer. 3,4,18 For the results presented here, data obtained in a clinical study 8,20 were analyzed in a post hoc evaluation to investigate the rate-of-change dependence of 2 CGM systems.…”

mentioning

confidence: 99%

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Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Pleus

Schoemaker

Morgenstern

et al. 2015

J Diabetes Sci Technol

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Introduction: The accuracy of continuous glucose monitoring (CGM) systems is often assessed with respect to blood glucose (BG) readings. CGM readings are affected by a physiological and a technical time delay when compared to BG readings. In this analysis, the dependence of CGM performance parameters on the BG rate of change was investigated for 2 CGM systems. Methods: Data from a previously published study were retrospectively analyzed. An established CGM system (Dexcom G4, Dexcom, San Diego, CA; system A) and a prototype system (Roche Diagnostics GmbH, Mannheim, Germany; system B) with 2 sensors each were worn by 10 subjects in parallel. Glucose swings were induced to achieve rapidly changing BG concentrations. Mean absolute relative differences (MARD) were calculated in different BG rate-of-change categories. In addition, sensor-to-sensor precision was assessed. Results: At BG rates of change of –1 mg/dl/min to 0 mg/dl/min and 0 mg/dl/min to +1 mg/dl/min, MARD results were 12.6% and 11.3% for system A and 8.2% and 10.0% for system B. At rapidly changing BG concentrations (<–3 mg/dl/min and ≥+3 mg/dl/min), higher MARD results were found for both systems, but system B was less affected (system A: 24.9% and 29.6%, system B: 10.6% and 16.3%). The impact of rate of change on sensor-to-sensor precision was less pronounced. Conclusions: Both systems were affected by rapidly changing BG concentrations to some degree, although system B was mostly unaffected by decreasing BG concentrations. It would seem that technological advancements in CGM systems might allow for a more precise tracking of BG concentrations even at rapidly changing BG concentrations.

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Section: Discussionmentioning

confidence: 95%

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Pleus

Schoemaker

Morgenstern

et al. 2015

J Diabetes Sci Technol

View full text Add to dashboard Cite

show abstract

“…20 Nevertheless, the accuracy of CGM is increasing and may be approaching a physiological limit for subcutaneous glucose monitoring. [21][22][23][24][25][26][27] CGM data and information CGM generates data streams that are both voluminous and complex. From an analytical point of view, these data are time series-sequences of BG readings that are equally spaced in time (e.g., every 5 min).…”

Section: Introductionmentioning

confidence: 99%

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Kovatchev

Patek

Ortiz

et al. 2015

Diabetes Technology & Therapeutics

191

154

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Background: The level of continuous glucose monitoring (CGM) accuracy needed for insulin dosing using sensor values (i.e., the level of accuracy permitting non-adjunct CGM use) is a topic of ongoing debate. Assessment of this level in clinical experiments is virtually impossible because the magnitude of CGM errors cannot be manipulated and related prospectively to clinical outcomes. Materials and Methods: A combination of archival data (parallel CGM, insulin pump, self-monitoring of blood glucose [SMBG] records, and meals for 56 pump users with type 1 diabetes) and in silico experiments was used to ''replay'' real-life treatment scenarios and relate sensor error to glycemic outcomes. Nominal blood glucose (BG) traces were extracted using a mathematical model, yielding 2,082 BG segments each initiated by insulin bolus and confirmed by SMBG. These segments were replayed at seven sensor accuracy levels (mean absolute relative differences [MARDs] of 3-22%) testing six scenarios: insulin dosing using sensor values, threshold, and predictive alarms, each without or with considering CGM trend arrows. Results: In all six scenarios, the occurrence of hypoglycemia (frequency of BG levels £ 50 mg/dL and BG levels £ 39 mg/dL) increased with sensor error, displaying an abrupt slope change at MARD = 10%. Similarly, hyperglycemia (frequency of BG levels ‡ 250 mg/dL and BG levels ‡ 400 mg/dL) increased and displayed an abrupt slope change at MARD = 10%. When added to insulin dosing decisions, information from CGM trend arrows, threshold, and predictive alarms resulted in improvement in average glycemia by 1.86, 8.17, and 8.88 mg/dL, respectively. Conclusions: Using CGM for insulin dosing decisions is feasible below a certain level of sensor error, estimated in silico at MARD = 10%. In our experiments, further accuracy improvement did not contribute substantively to better glycemic outcomes.

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“…As with other sensors, 11 the sensor used by Duo requires a warm-up phase, and its performance improves with time. Insulin delivery may also change over the course of an infusion set's functional life, with faster absorption occurring later.…”

Section: Discussionmentioning

confidence: 99%

Performance and Acceptability of a Combined Device for Insulin Infusion and Glucose Sensing in the Home Setting

Nørgaard

Shin

Welsh

et al. 2015

J Diabetes Sci Technol

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For many patients who require insulin, continuous subcutaneous insulin infusion (CSII) offers significant advantages compared to multiple daily injections (MDI). In part because CSII can more closely match the endogenous insulin profile of normal pancreatic β cells, it offers reduced rates of severe hypoglycemia, better metabolic control, and improved quality of life compared to MDI. 1Pumps are often used in conjunction with continuous glucose monitoring (CGM) systems that provide real-time data on glucose concentrations in the interstitial fluid; the CGM data can be displayed on the pump itself, or on a separate device. As shown in the STAR 3 study 2 and in the Eurythmics study, 3 sensor-augmented pump (SAP) therapy offers rapid, significant, and durable improvements in metabolic control compared to MDI therapy. A significant "dose effect" of CGM use was noted in STAR 3, with increasing frequencies of sensor use being associated with greater reductions in A1C levels at 1 year. The incremental advantage of CGM was more recently demonstrated in the INTERPRET study, in which factors associated with A1C reductions included more frequent sensor use. The use of sensor-augmented insulin pump (SAP) therapy is increasing. Currently, glucose sensors and insulin infusion cannulas are inserted separately. A new device, MiniMed Duo, combines sensing and infusion capabilities on the same platform and is intended to simplify device insertion and site management. We evaluated the device's performance with respect to insulin delivery and glucose sensing, and its acceptability with patients.

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Accuracy and Acceptability of the 6-Day Enlite Continuous Subcutaneous Glucose Sensor

Abstract: The Enlite sensor provided accurate data at different glucose concentrations and rates of change. Subjects found the sensor comfortable and easy to use.

Cited by 85 publications

References 7 publications

Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Rate-of-Change Dependence of the Performance of Two CGM Systems During Induced Glucose Swings

Assessing Sensor Accuracy for Non-Adjunct Use of Continuous Glucose Monitoring

Performance and Acceptability of a Combined Device for Insulin Infusion and Glucose Sensing in the Home Setting

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