The Precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors

Ramljak, Sanja; Musholt, Petra B.; Schipper, Christina; Flacke, Frank; Sieber, Jochen; Borchert, Margret; Forst, Thomas; Pfützner, Andreas

doi:10.1517/17530059.2013.839984

Cited by 12 publications

(6 citation statements)

References 7 publications

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“…The use of the Diabetes Manager App with the iBGStar ® facilitated electronic communication between participants and providers. The precision of iBGStar ® was shown previously in an in vitro diagnostic device study [ 16 ]. Diabetes Manager App allowed participants to upload and review SMBG data on an iPhone.…”

Section: Discussionmentioning

confidence: 77%

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management

et al. 2017

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IntroductionThe role of mobile technology in patient-reported outcomes (PRO) and glycemic control in adults with type 1 diabetes (T1D) needs further evaluation.MethodsThe single-center, prospective, 6-month, open-label, investigator-initiated study randomized 100 subjects with T1D in a 1:1 fashion to a control group using self-monitoring of blood glucose (SMBG) with Accu-Chek Nano® and an intervention group using SMBG with iPhone plus glucose meter (iBGStar®). The primary endpoint was the change in PRO (hypoglycemia fear score, behavior and worry subscores). Secondary outcomes were the improvement in glycemic variability indices and the reduction in A1c values.ResultsBaseline demographics and glycosylated hemoglobin (A1c) values were similar in the two groups. There was a significant decrease in A1c value at 6 months in iBGStar® group compared to the control group (−0.16 vs. −0.51, p = 0.04). The total insulin dose increased significantly in the iBGStar® group at 3 months but did not change at 6 months. The hypoglycemia fear scale (PRO) improved in both groups at 6 months (−1.4 ± 10.0 vs. −3.9 ± 12.5, p = 0.32).ConclusionThe use of iBGStar® resulted in better glycemic control and improvement in some PRO (hypoglycemia fear and behavior scores) compared to the control group at 6 months with no increased risk of hypoglycemia.Clinical trial registration ClinicalTrials.gov: NCT01825382.FundingSanofi.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-017-0272-5) contains supplementary material, which is available to authorized users.

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Section: Discussionmentioning

confidence: 77%

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management

et al. 2017

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“…Confidence in our CSF-1 assay was supported by the CSF-1 interassay variability (8.5%) and intra-assay variability (7.2% for serum and 5.1% for urine). 15 Moreover, we found little variability in CSF-1 levels using serum and urine specimens that we froze and thawed four times (Supplemental Figure 1B). The difference (mean6SD) of the change of CSF-1 levels was 2.760.5 pg/ml in serum and 6.760.6 pg/ml in urine.…”

Section: Serum and Urine Csf-1 Levels Are Notably Elevated In Patientmentioning

confidence: 86%

“…We calculated the intra-assay variability and interassay variability as defined elsewhere. 15 We calculated the PPV and NPV using the serum CSF-1 levels that were tracked in individual patients in Figures 4 and 5. For each patient, the laboratory results nearest to the predefined time points 60 and 120 days before flare were used for this calculation.…”

Section: Statistical Analysesmentioning

confidence: 99%

Colony-Stimulating Factor-1

Menke¹,

Amann

Cavagna

et al. 2015

Journal of the American Society of Nephrology

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A noninvasive means to predict the onset and recurrence of lupus nephritis (LN) before overt renal injury is needed to optimize and individualize treatment. Colony-stimulating factor-1 (CSF-1) is expressed by kidney tubules at the onset of LN, increases with disease progression, and spills into the circulation in lupus-prone mice. We tested the hypothesis that amplified expression of CSF-1 detected in the serum or urine correlates with intrarenal CSF-1 expression and histopathology (increased macrophage accumulation, activity indices) and clinical kidney disease activity and predicts the onset and recurrence of nephritis in patients with systemic lupus erythematosus (SLE). We found increased serum or urine CSF-1 levels in patients with cutaneous, serositis, and musculoskeletal disease; however, the increase in CSF-1 levels was far greater in LN. Moreover, an elevation in serum or urine CSF-1 levels correlated with increasing intrarenal CSF-1 expression and histopathology. By longitudinally tracking patients, we found that elevated serum CSF-1 heralded the initial onset of disease, and a rise in serum or urine CSF-1 predicted recurrences of LN before clinical evidence of glomerular dysfunction and conventional serologic measures, even in patients with other manifestations of SLE. These findings indicate that serial monitoring for a rise in serum or urine CSF-1 levels in patients with SLE reflects kidney histopathology and may predict renal disease activity and the onset and recurrence of LN more accurately than conventional laboratory measures. 26: 379-389, 201526: 379-389, . doi: 10.1681 Lupus nephritis (LN) is the main cause of morbidity and mortality for patients with systemic lupus erythematosus (SLE). 1 Despite current treatment, ESRD is frequent in patients with LN (up to 26%). 2 Moreover, relapses or flares of LN are common (27%-66%) and contribute to mortality. 3,4 Current methods for diagnosing LN in patients with SLE include proteinuria, active sediment, and a decrease in GFR with confirmation by a renal biopsy. 5 Clearly, identification of a biomarker that heralds LN before structural renal damage and the loss of renal function would provide a window to treat early and obviate renal tissue injury. J Am Soc NephrolColony-stimulating factor-1 (CSF-1) is largely responsible for Mø development, survival, proliferation, and activation. 6 We hypothesize that amplified expression of CSF-1 in serum or urine reflects the magnitude of intrarenal CSF-1 and histopathology, correlates with LN clinical disease activity, and heralds the onset and recurrence of LN.

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“…This study focused on measurement accuracy only, so that other aspects of ISO 15197 were not analysed. However, data on precision and haematocrit interference were published recently for the SMBG system tested in this study [10,11].…”

Section: Discussionmentioning

confidence: 99%

System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems

Freckmann

Schmid

Pleus

et al. 2014

Clinical Chemistry and Laboratory Medicine (CCLM)

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The Precision study: examining the inter- and intra-assay variability of replicate measurements of BGStar, iBGStar and 12 other blood glucose monitors

Abstract: BGStar and iBGStar were proven to have very good inter-assay and high intra-assay precision, demonstrating low scattering of replicate measurements with both clinical samples and control solutions.

Cited by 12 publications

References 7 publications

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management

Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar® in Type 1 Diabetes Management

Colony-Stimulating Factor-1

System accuracy evaluation of systems for point-of-care testing of blood glucose: a comparison of a patient-use system with six professional-use systems

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