Safety and accuracy of a new long‐term subconjunctival glucose sensor

Hasslacher, Christoph; Auffarth, Gerd U.; Platten, I; Rabsilber, Tanja M.; Smith, Beate; Kulozik, Felix; Knuth, Monika; Nikolaus, Katharina Sibylle; Müller, Achim

doi:10.1111/j.1753-0407.2012.00192.x

Cited by 8 publications

(13 citation statements)

References 15 publications

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“…8 Mean values for age and duration of diabetes were 52.3 ± 8.9 and 16.3 ± 4.0 years, respectively. Metabolic control was stable, and Hba1c values ranged from 6.4% to 8.3% (46.45 to 67.21 mmol/mol).…”

Section: Methodsmentioning

confidence: 99%

“…BG measurement procedure are described in detail elsewhere 8 and can be briefly summarized as follows: glucose excursions at levels ranging between 50 and 300 mg/dl were induced by administration of a carbohydrate-rich meal and/ or injection of an appropriate dose of insulin. Capillary blood (20 µl) was taken from the fingertip using lancets at 10-minute intervals and immediately hemolyzed for laboratory glucose determination.…”

Section: Methodsmentioning

confidence: 99%

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Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Hasslacher

Kulozik

Platten

2014

J Diabetes Sci Technol

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Glucose monitoring systems (GMS) are routinely used by patients with diabetes to monitor glycemic control and modify treatment as needed. In this respect, the analytical performance of GMS is of course of crucial importance. The accuracy of GMS is usually assessed according to the Guidelines of the International Organization for Standardization (ISO). A new standard has recently been published with more stringent criteria than in the previous edition.1,2 Minimum acceptable system accuracy requirements for GMS now specify that ≥95% of the glucose meter results may not differ more than ±15 mg/dl from the reference method at glucose concentrations < 100 mg/dl (previously < 75 mg/dl) and ±15% (previously ±20%) at glucose concentrations ≥ 100 mg/dl.1 Furthermore, concerning prevalence and range of outliers, it is now specified that >99% of measured glucose values must fall in zones A and B of the consensus error grid.During the consultation process of the new criteria it has been suggested that the analytical performance of GMS is highly dependent on its intended use.3-6 For example, insulin-dependent patients under intensified glycemic control require highly accurate devices for adequate insulin dosing, whereas patients with Type 2 diabetes who are treated with medication with no or little risk of hypoglycemia could use less accurate GMS. It has, therefore, been suggested that the analytical accuracy of GMS should be tested not only in relation to BG level ranges below and above 100 mg/dL but also in relation to different glycemic ranges, as already previously proposed for continuous glucose monitoring systems. The aim of the present study was to analyze test results from 27 GMS obtained in a clinical setting, with regard to (1) analytical accuracy according to the new ISO accuracy limits as well as after stratification into 5 different BG level ranges and (2) frequency and extent of outliers. AbstractWe investigated the analytical accuracy of 27 glucose monitoring systems (GMS) in a clinical setting, using the new ISO accuracy limits. In addition to measuring accuracy at blood glucose (BG) levels < 100 mg/dl and > 100 mg/dl, we also analyzed devices performance with respect to these criteria at 5 specific BG level ranges, making it possible to further differentiate between devices with regard to overall performance. Carbohydrate meals and insulin injections were used to induce an increase or decrease in BG levels in 37 insulin-dependent patients. Capillary blood samples were collected at 10-minute intervals, and BG levels determined simultaneously using GMS and a laboratory-based method. Results obtained via both methods were analyzed according to the new ISO criteria. Only 12 of 27 devices tested met overall requirements of the new ISO accuracy limits. When accuracy was assessed at BG levels < 100 mg/dl and > 100 mg/dl, criteria were met by 14 and 13 devices, respectively. A more detailed analysis involving 5 different BG level ranges revealed that 13 (48.1%) devices met the required criteria at BG levels between...

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Hasslacher

Kulozik

Platten

2014

J Diabetes Sci Technol

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“…In this application, the sensor chemistry exhibited a duration of action of more than 4 months. 31,32 Therefore, a lifetime of the FiberSense CGM system of even longer than 14 days seems possible.…”

Section: Discussionmentioning

confidence: 99%

First Clinical Evaluation of a New Percutaneous Optical Fiber Glucose Sensor for Continuous Glucose Monitoring in Diabetes

Müller

Knuth

Nikolaus

et al. 2013

J Diabetes Sci Technol

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“…Postoperatively, most patients showed a small subconjunctival hemorrhage, which disappeared within 7-14 days, as reported previously. 27 All patients reported a "foreign body feeling," which lasted approximately 5-10 days after implantation and was attributed to the suture. Both uncoated and surface-coated OMIs were well tolerated by the patients.…”

Section: Safety Evaluation Of the Clinical Studymentioning

confidence: 99%

“…First clinical evaluations of the subconjunctival glucose measurement system have already proven a high correlation between the sensor data and corresponding BG values, 26 but the performance of the system decreased with longer implantation times. 27 This is most likely caused by fibrotic encapsulation of the OMI due to the foreign body response (FBR) initiated after implantation. Foreign body response is a common cause of failure of implanted medical devices, especially implanted glucose sensors.…”

Section: Introductionmentioning

confidence: 99%

Blood Glucose Self-Monitoring with a Long-Term Subconjunctival Glucose Sensor

Müller

Knuth

Nikolaus

et al. 2013

J Diabetes Sci Technol

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Safety and accuracy of a new long‐term subconjunctival glucose sensor

Abstract: he present study demonstrates good tolerability and measurement performance of the biosensor. The reasons for an increase in the lag time are still unknown; local reactions may be involved.

Cited by 8 publications

References 15 publications

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

Analytical Performance of Glucose Monitoring Systems at Different Blood Glucose Ranges and Analysis of Outliers in a Clinical Setting

First Clinical Evaluation of a New Percutaneous Optical Fiber Glucose Sensor for Continuous Glucose Monitoring in Diabetes

Blood Glucose Self-Monitoring with a Long-Term Subconjunctival Glucose Sensor

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