False Negative Detection Rates Research Articles

Sentinel node mapping in the prostate cancer

SummaryAim: Sentinel node (SN) biopsy is becoming a standard procedure in the management of several malignancies. Several groups have evaluated the feasibility and value of this procedure in prostate cancer patients. In the current meta-analysis, we comprehensively and quantitatively summarized the results of these studies. Methods: Several databases including Medline, SCOPUS, Google Scholar, Ovid, Springer, and Science direct were systematically searched for the relevant studies regarding SL biopsy in the prostate cancer (“prostate” AND “sentinel” as search keywords). The outcomes of interest were sensitivity and detection rate of the procedure. Results: For detection rate and sensitivity 21 and 16 studies met the criteria of inclusion respectively. Pooled detection rate was 93.8% (95% CI 89–96.6%). Cochrane Q value was 216.077 (I2 = 89.81% and p < 0.001). Pooled sensitivity was 94% (95% CI 91–96%). Cochrane Q value was 14.12 (I2 = 0.0 and p = 0.516). Conclusion: SL biopsy can prevent unnecessary pelvic lymph node dissection in prostate cancer patients. This procedure is feasible with low false negative rate and high detection rate.

Abstract P1-01-17: Comparative Analysis of Metastatic Tumor Cells within the Sentinel Lymph Nodes of Breast Cancer Patients Utilizing a Novel Approach

Abstract Background and Objective: The intrinsic high false negative rate associated with intraoperative analysis of SLN may result in a second surgical procedure for the patient. We attempt to improve the intraoperative and the pathologic and molecular evaluation of SLN by utilizing novel immunobead methods for detection and assessment of tumor cell expression of Her2, CD44 and Muc1. Methods: During the operation of breast cancer patients, gived sentinel lymph node biopsy firstly, and the SLN will each be divided in four quadrants, and two quadrants (B,C) will be brought to the pathologist for routine intraoperative analysis and further immunhistochemical (H&E and CK) examination often 2 mm thick sections of each quadrant. The other (A,D) quadrants will be immediately mechanically disaggregated and filtered in order to remove stromal elements and cellular debris. The resulting cell suspension will be incubated with 4.5 µm magnetic beads coated with MOC31 antibody, and simultaneously with different nonmagnetic, fluorescent microparticles coated with either anti-Her2, anti-CD44, or anti-Muc1 by flow-cytometry. Results: 62 cases from 2009.1 to 2009.9 in our hospital has been studied, and results as follows: 1. Immunomagnetic evaluation of alive tumor cells in SLNs is rapidly and easily performed using the MOC-31 antibody that binds to the vast majority of breast cancer cells. The novel technologies will demonstrate higher detection sensitivity (96%) and lower false negative rate (4.0%). 2. For the intraoperative frozen HE staining, the sensitivity was 68%, false negative rate was 32%; and for CK-IHC, the sensitivity was 76.0%, and the false negative rate was 24%. 3.To compare to standard intraoperative procedures and histopathologic techniques of analyzing the SLN to that of the novel approach, it could get higher sensitivity (96%vs 68%,P=0.023;96%vs76%,P=0.049), lower false negative rate (4%vs32% ,P=0.023;4%vs24%,P=0.049) and higher micrometastasis detection rate. 4.Expession of Her2,CD44 and Muc1 in SLN is 32.5%±2.2%,83.4± 4.1% and 86.6%±3.4%, and each has positively correlated with the expression of that in primary tumor (P<0.5). Conclusion: Our novel approach that utilizing immunobead detection of metastatic breast cancer cells, and simultaneously characterize the isolated cells for membrane markers coated with antibodies targeting Her2, Muc1 or CD44 by flow-cytometry, has rapid speed and high accuracy. Compared to traditional HE and CK-IHC, it has higher sensitivity and lower false negative rate, and could be used more widely and easily. Expression of CD44, Her2 and Muc1 in sentinel lymph nodes were positively correlated with the expression of those in primary tumor. It is suggested that the three biomarkers above could predict metastasis of sentinel lymph nodes, and maybe direct treatment after operation. Citation Information: Cancer Res 2010;70(24 Suppl):Abstract nr P1-01-17.

Re-evaluating the performance of the nonlinear prediction error for the detection of deterministic dynamics

The nonlinear prediction error in combination with appropriately generated surrogate data is widely used as a discriminating statistic for weak nonlinearity. In this paper two of the most widely used formulations of this particular measure are evaluated using data from exemplary nonlinear and linear systems. It is found that both methods, contrary to expectation and accepted utility, give rise to substantial false positive and false negative detection rates in purely linear and nonlinear systems respectively. These findings suggest that the nonlinear prediction error should be used with considerable caution. The implications of these findings for the search for nonlinearity in the human electroencephalogram are briefly discussed.

Sentinel Lymph Node Biopsy in Breast Cancer: An Analysis of the Maximum Number of Nodes Requiring Excision

Sentinel lymph node biopsy (SNB) is now the standard of care in assessment of patients with clinically staged T1-2, N0 breast cancers. This study investigates whether there is a maximum number of sentinel lymph nodes (SLN) that need to be excised without compromising the false-negative (FN) rate of this procedure. Data were prospectively collected for 319 patients undergoing SNB between February 2001 and December 2006 at our institution. This data were analysed, both in terms of the order of SLN retrieval and relative isotope counts of the SLNs, in order to determine the maximum number of SLNs that need to be retrieved without increasing the FN rate. Furthermore, we investigated the relationship between SLN blue dye concentration and the presence of SLN metastases. The SLN identification rate was 97% with no false-negative cases amongst patients undergoing simultaneous axillary clearance historically during technique validation. In patients with SLN metastases, excision of the first 4 SLNs encountered results in the identification of a metastatic SLN in all cases. Although the majority (86%) of SNB metastases are in the hottest node, the SLN containing the metastasis is in the first 4 hottest nodes in 99% of patients with nodal metastases. The remaining 1% of SLN metastases were identified by blue dye. There was no statistically significant association between the SLN blue dye concentration and the presence of SLN metastases. A policy to remove a maximum of four blue and/or hot SLNs along with any palpably abnormal lymph nodes does not result in an increased false-negative rate of detection of SLN metastases.

Evaluation of preoperative lymphoscintigraphy and sentinel node procedure in vulvar cancer

Objective To assess the value of preoperative lymphoscintigraphy, and to evaluate the validity and feasibility of the sentinel node (SN) procedure in vulvar carcinoma. Study design Retrospective clinical and histopathological review of 77 patients with invasive squamous cell carcinoma in vulva who were treated at Karolinska University Hospital Stockholm, Sweden, from 2000 to 2007. The patients underwent SN mapping preoperatively with radioactive tracer and blue dye ( n = 60) or only blue dye ( n = 17). The SN was removed separately followed by complete inguinofemoral lymphadenectomy. Results The relation between SNs detected on the scintigram and those found during surgery showed good agreement using weighted kappa. The detection rate of SN was 98% for radioisotope plus blue dye, and 94% for blue dye alone. Two cases of false negative SN (false negative rate 2.7%) were found, both with large midline tumors. Conclusion Preoperative scintigram is a valuable help to identify and localize the SNs and gives the best estimate of the accurate number but cannot determine if unilateral or bilateral groins should be explored in cases of midline tumors. Our results are in favor of using radioisotope and blue dye to identify the SNs. This study support previous reports that the method is not recommended for tumors larger than 40 mm to optimize detection of SN and minimize the false negative detection rate.

Acoustic Radiation Force Impulse Imaging of Human Prostates Ex Vivo

It has been challenging for clinicians using current imaging modalities to visualize internal structures and detect lesions inside human prostates. Lack of contrast among prostatic tissues and high false positive or negative detection rates of prostate lesions have limited the use of current imaging modalities in the diagnosis of prostate cancer. In this study, acoustic radiation force impulse (ARFI) imaging is introduced to visualize the anatomical and abnormal structures in freshly excised human prostates. A modified Siemens Antares ultrasound scanner (Siemens Medical Solutions USA Inc., Malvern, PA) and a Siemens VF10-5 linear array were used to acquire ARFI images. The transducer was attached to a three-dimensional (3-D) translation stage, which was programmed to automate volumetric data acquisition. A depth dependent gain (DDG) method was developed and applied to 3-D ARFI datasets to compensate for the displacement gradients associated with spatially varying radiation force magnitudes as a function of depth. Nine human prostate specimens were collected and imaged immediately after surgical excision. Prostate anatomical structures such as seminal vesicles, ejaculatory ducts, peripheral zone, central zone, transition zone and verumontanum were visualized with high spatial resolution and in good agreement with McNeal's zonal anatomy. The characteristic appearance of prostate pathologies, such as prostate cancerous lesions, benign prostatic hyperplasia, calcified tissues and atrophy were identified in ARFI images based upon correlation with the corresponding histologic slides. This study demonstrates that ARFI imaging can be used to visualize internal structures and detecting suspicious lesions in the prostate and appears promising for image guidance of prostate biopsy. (E-mail: liang.zhai@duke.edu)

A Reference Standard-Based Quality Assurance Program for Radiology

The authors have developed a comprehensive radiology quality assurance (QA) program that evaluates radiology interpretations and procedures by comparing them with reference standards. Performance metrics are calculated and then compared with benchmarks or goals on the basis of published multicenter data and meta-analyses. Additional workload for physicians is kept to a minimum by having trained allied health staff members perform the comparisons of radiology reports with the reference standards. The performance metrics tracked by the QA program include the accuracy of CT colonography for detecting polyps, the false-negative rate for mammographic detection of breast cancer, the accuracy of CT angiography detection of coronary artery stenosis, the accuracy of meniscal tear detection on MRI, the accuracy of carotid artery stenosis detection on MR angiography, the accuracy of parathyroid adenoma detection by parathyroid scintigraphy, the success rate for obtaining cortical tissue on ultrasound-guided core biopsies of pelvic renal transplants, and the technical success rate for peripheral arterial angioplasty procedures. In contrast with peer-review programs, this reference standard-based QA program minimizes the possibilities of reviewer bias and erroneous second reviewer interpretations. The more objective assessment of performance afforded by the QA program will provide data that can easily be used for education and management conferences, research projects, and multicenter evaluations. Additionally, such performance data could be used by radiology departments to demonstrate their value over nonradiology competitors to referring clinicians, hospitals, patients, and third-party payers.

Sentinel lymph node biopsy in papillary thyroid cancer: Comparison study of blue dye method and combined radioisotope and blue dye method in papillary thyroid cancer

Aim Occult lymph node metastasis is common in differentiated thyroid cancer (DTC). However, the role of lymph node dissection in the treatment of DTC remains controversial. The authors investigated the usefulness of methylene blue dye only method and combined radioisotope and methylene blue dye method for detecting SLN and compared the values of these two methods in patients with DTC. Methods From February to May 2008, 97 patients with DTC underwent sentinel lymph node biopsy (SLNB). The methylene blue dye method (dye only method) was used in 54 of the 97 patients, and radioisotope and methylene blue dye method (combined method) in 43 patients. Results The SLNs were identified in 89 patients, and the sensitivity and specificity of SLNB in the 97 patients were 85% and 100% respectively. For the dye only method, sensitivity, specificity, and the false negative rate (FNR) were 79%, 100%, and 21%; and for the combined method (43 patients) the corresponding figures were, 91%, 100%, and 9%, respectively. Six patients with SLN metastasis in the lateral neck underwent additional modified radical neck dissection (MRND). Conclusions SLNB was found to be feasible, repeatable, and accurate in evaluating the lymph node status in patient with DTC. The present study indicates that the combined method could reduce false negative rate and increase detection rates of sentinel lymph node metastases, especially in lateral neck, compared to the dye only method.

Validación y uso de la técnica del linfonodo centinela axilar con colorante exclusivo en pacientes con cáncer de mama

The use of a dye and radiocolloid to detect sentinel lymph nodes in breast cancer increases the detection rates. However the use of either method alone does not modify the false negative rate. Therefore there is no formal contraindication for the exclusive use of dye to detect nodes.To report a prospective analysis of the exclusive blue dye technique for sentinel node biopsy in patients with early breast cancer.We analyzed the first 100 women with pathologically proven breast cancer who met the inclusion criteria. Patent blue dye was used as colorant. In the first 25 cases sentinel node was identified using radiocolloid and blue dye an then an axillary dissection performed. In the next 25 women, blue dye was used exclusively for detection and an axillary dissection was performed. In the next 50 cases, blue dye was used and only isolated sentinel node biopsy was performed.In 92 of the 100 women a sentinel node was successfully detected. In the first 50 women, the false negative rate of sentinel lymph node detection was 6.9%. No complications occurred. During follow-up, lasting three to 29 months, no axillary relapse was observed.Sentinel node biopsy in patients with early breast cancer using exclusively blue dye is feasible and safe.

Exclusive use of blue dye to detect sentinel lymph nodes in breast cancer

The use of a dye and radiocolloid to detect sentinel lymph nodes in breast cancer increases the detection rates. However the use of either method alone does not modify the false negative rate. Therefore there is no formal contraindication for the exclusive use of dye to detect nodes. To report a prospective analysis of the exclusive blue dye technique for sentinel node biopsy in patients with early breast cancer. We analyzed the first 100 women with pathologically proven breast cancer who met the inclusion criteria. Patent blue dye was used as colorant. In the first 25 cases sentinel node was identified using radiocolloid and blue dye an then an axillary dissection performed. In the next 25 women, blue dye was used exclusively for detection and an axillary dissection was performed. In the next 50 cases, blue dye was used and only isolated sentinel node biopsy was performed. In 92 of the 100 women a sentinel node was successfully detected. In the first 50 women, the false negative rate of sentinel lymph node detection was 6.9%. No complications occurred. During follow-up, lasting three to 29 months, no axillary relapse was observed. Sentinel node biopsy in patients with early breast cancer using exclusively blue dye is feasible and safe.

Automated cell analysis in 2D and 3D: A comparative study

Optical projection tomographic microscopy is a technique that allows 3D analysis of individual cells. Theoretically, 3D morphometry would more accurately capture cellular features than 2D morphometry. To evaluate this thesis, classifiers based on 3D reconstructions of cell nuclei were compared with 2D images from the same nuclei. Human adenocarcinoma and normal lung epithelium cells were used. Testing demonstrated a three-fold reduction in the false negative rate for adenocarcinoma detection in 3D versus 2D at the same high specificity. We conclude that 3D imaging will potentially expand the horizon for automated cell analysis with broad applications in the biological sciences.

Diagnosis of Trichophyton rubrum from Onychomycotic Nail Samples Using Polymerase Chain Reaction and Calcofluor White Microscopy

A high rate of false-negative dermatophyte detection is observed when the most common laboratory methods are used. These methods include microscopic observation of potassium hydroxide-digested nail clippings and culture methods using agar-based media supplemented with cycloheximide, chloramphenicol, and gentamicin to isolate dermatophytes. Microscopic detection methods that use calcofluor white staining or periodic acid-Schiff staining may also be substituted for and have previously been reported to be more sensitive than potassium hydroxide-digested nail clippings. Trichophyton rubrum infections were detected directly from nails in a double-round polymerase chain reaction assay that uses actin gene-based primers. This method was compared with detection of fungal hyphae by using calcofluor white fluorescence microscopy of nail samples collected from 83 patients with onychomycosis who were undergoing antifungal drug therapy. Twenty-six of 83 samples (31.3%) were found to be positive by calcofluor white fluorescence microscopy, and 21 of 83 samples (25.3%) yielded positive results for T rubrum when actin gene-based primers in a double-round polymerase chain reaction assay were used. When calcofluor white fluorescence microscopy and polymerase chain reaction assay were used, the combined detection was 46.9% compared with 31.3% when calcofluor microscopy and culture of nail samples on Sabouraud's dextrose agar supplemented with cycloheximide, chloramphenicol, and gentamicin were used. These results suggest that the use of a direct DNA protocol is an alternative method for detecting Trichophyton infections. When this protocol is used, the presence of T rubrum DNA is directly detected. However, the viability of the dermatophyte is not addressed, and further methods need to be developed for the detection of viable T rubrum directly from nail samples.

A comparison of CDKN2A mutation detection within the Melanoma Genetics Consortium (GenoMEL)

CDKN2A is the major melanoma susceptibility gene so far identified, but only 40% of three or more case families have identified mutations. A comparison of mutation detection rates was carried out by “blind” exchange of samples across GenoMEL, the Melanoma Genetics Consortium, to establish the false negative detection rates. Denaturing high performance liquid chromatography (DHPLC) screening results from 451 samples were compared to screening data from nine research groups in which the initial mutation screen had been done predominantly by sequencing. Three samples with mutations identified at the local centres were not detected by the DHPLC screen. No additional mutations were detected by DHPLC. Mutation detection across groups within GenoMEL is carried out to a consistently high standard. The relatively low rate of CDKN2A mutation detection is not due to failure to detect mutations and implies the existence of other high penetrance melanoma susceptibility genes.

Detection of trace Al in model biological tissue with laser-induced breakdown spectroscopy

Laser-induced breakdown spectroscopy (LIBS), which is an excellent tool for trace elemental analysis, was studied as a method of detecting sub-part-per-10(6) (ppm) concentrations of aluminum in surrogates of human tissue. Tissue was modeled using a 2% agarose gelatin doped with an Al(2)O(3) nanoparticle suspension. A calibration curve created with standard reference samples of known Al concentrations was used to determine the limit of detection, which was less than 1 ppm. Rates of false negative and false positive detection results for a much more realistic sampling methodology were also studied, suggesting that LIBS could be a candidate for the real-time in vivo detection of metal contamination in human soft tissue.

The Use of Periareolar Intradermal Tc-99m Tin Colloid and Peritumoral Intraparenchymal Isosulfan Blue Dye Injections for Determination of the Sentinel Lymph Node

The purpose of the present study was to evaluate the use of lymphoscintigraphy, blue dye, and gamma probe detection methods for determination of the sentinel lymph node (SLN) using both periareolar intradermal injection of Tc-99m tin colloid and peritumoral intraparenchymal injection of isosulfan blue dye. One hundred patients with T1-2 breast cancer and clinically negative nodes were enrolled in the present study. The study was composed of 2 groups. Backup axillary lymph node dissection (ALND) was mandatory in group 1 (20 patients) regardless of their lymph node status. In group 2 (80 patients), complete ALND was performed when intraoperative frozen section analysis of SLN revealed metastases. Otherwise, only SLN biopsy was performed without ALND. One day before surgery, Tc-99m tin colloid was injected at 4 periareolar sites intradermally. Lymphoscintigraphy was performed 1 to 2 hours after injection of the radiocolloid. Twenty minutes before surgery, isosulfan blue dye was injected into parenchyma surrounding the tumor or the biopsy cavity. The detection rates of SLN and false-negative rate of lymphoscintigraphy, blue dye, and gamma probe detection were 85%, 95% 100%, and 0% in group 1, 91%, 87%, and 95% in group 2, respectively. Detection rate by the combination of blue dye and radio tracer was 98%. According to the results of our study, we conclude that perioareolar intradermal injection of Tc-99m tin colloid combined with peritumoral intraparenchymal injection of blue dye is an accurate and easy method of locating the sentinel node with very high detection rates. It is recommended that the combination of all methods such as lymphoscintigraphy, blue dye, and gamma probe application will increase the success rate of SLN detection in patients with breast cancer.

Direct and Simultaneous Identification of Mycobacterium tuberculosis complex (MTBC) and Mycobacterium tuberculosis (MTB) by Rapid Multiplex nested PCR-ICT assay

The Mycobacterium tuberculosis (MTB) shows different virulence and host infection range from other members of the M. tuberculosis complex (MTBC). Differential identification of MTB from MTBC is thus important in certain occasions. The currently commercially available molecular assays which use either IS 6110 or 16S rDNA fragment as identification targets are mainly designed for identifying MTBC but not for MTB. Comparative genomic DNA analysis has provided valuable information on regions of difference (RD) present in MTB but not in other members of the MTBC. RD9 region is further suggested to be a potential target for differential identification of MTB from MTBC. In this study, using IS 6110 and Rv 3618 (belong to RD9) as the specific identification targets for MTBC and MTB, respectively, we developed and tested a multiplex nested PCR-ICT (immuno-chromatography test) assay for simultaneously and directly detecting not only MTBC but also MTB from 1500 clinical sputum specimens. The results were compared with traditional culture and biochemical identification results together with patients' clinical assessments. This assay showed a 95.5% sensitivity, 97.9% specificity, 2.1% false positive rate and 4.5% false negative rate towards detection of MTBC, and a 93.0% sensitivity, 99.8% specificity, 0.2% false positive rate and 7.0% false negative rate for detection of MTB. This detection system shows great potential in clinical application.

Direct monitoring of toxic compounds in air using a portable mass spectrometer

A portable tandem mass spectrometer, capable of performing atmospheric pressure chemical ionization (APCI) using a direct atmospheric inlet, is applied to the real-time monitoring of toxic compounds in air. Analytes of interest include dimethyl methylphosphonate, arsine, benzene, toluene, pyridine and vinyl acetate. The detection, identification and quantification of organic and inorganic compounds in air is demonstrated using short analysis times (<5 seconds) with detection limits in the low ppb (v/v) levels and linear dynamic ranges of several orders of magnitude. Highly specific detection and identification is achieved, even when the analyte is a trace component in a complex mixture including such interferents as fuels, lubricants, and cleaners. The effects of environmental conditions, including temperature and humidity, are delineated. Receiver operating characteristic (ROC) curves are presented to show the trade-off between false positive and false negative detection rates. Tandem mass spectrometry based both on collision-induced dissociation and on selective atmospheric pressure ion/molecule reactions is also used to increase selectivity and sensitivity.

Reply: Remarks on sentinel node biopsy in head and neck cancer

Reply: Remarks on sentinel node biopsy in head and neck cancer

Integration of animal linkage and BAC contig maps using overgo hybridization

The alignment of genome linkage maps, defined primarily by segregation of sequence-tagged site (STS) markers, with BAC contig physical maps and full genome sequences requires high throughput mechanisms to identify BAC clones that contain specific STS. A powerful technique for this purpose is multi-dimensional hybridization of “overgo” probes. The probes are chosen from available STS sequence data by selecting unique probe sequences that have a common melting temperature. We have hybridized sets of 216 overgo probes in subset pools of 36 overgos at a time to filter-spotted chicken BAC clone arrays. A four-dimensional pooling strategy, including one degree of redundancy, has been employed. This requires 24 hybridizations to completely assign BACs for all 216 probes. Results to date are consistent with about a 10% failure rate in overgo probe design and a 15–20% false negative detection rate within a group of 216 markers. Three complete rounds of overgo hybridization, each to sets of about 39,000 BACs (either BamHI or EcoRI partial digest inserts) generated a total of 1853 BAC alignments for 517 mapped chicken genome STS markers. These data are publicly available, and they have been used in the assembly of a first generation BAC contig map of the chicken genome.

Watching your glucose with the GlucoWatch.

283 THE INTRODUCTION of home glucose monitoring in the 1980s represented a major advance in diabetes care. It allowed patients with diabetes to graduate from inconvenient, inaccurate and messy urine testing to precise glucose measurements at specific points in time. However, it must be remembered that there are 1,440 minutes in a day and even those patients who are testing much more than the national average, which is less than two times per day, are only seeing their blood sugars a fraction of the time. Most people with diabetes and especially those with type 1 diabetes have a very difficult time keeping their blood sugars on an even level and furthermore, many do not realize the wide fluctuations that are occurring on a day to day basis. The nonphysiologic combination of subcutaneous insulin coupled with different activities, meals, stresses and other variables that affect blood sugar control all contribute to the difficulties experienced in diabetes management. The GlucoWatch represents a tremendous advance in diabetes management, as it is the first real time glucose sensing device where the person living with diabetes can see the results almost immediately and alter behavior accordingly. The GlucoWatch is a superb device to discover patterns and detect trends in home glucose values throughout the day. Although it is not meant to replace traditional home glucose monitoring, it will enlighten patients with diabetes and their caregivers to what happens to their blood sugars during the day and night in response to different meal times and amounts, varied activities and stress. Every time I wore the GlucoWatch as part of a clinical trial, I learned something new about my diabetes despite having lived with this disease for over thirty years. Shortly after I wore the GlucoWatch for the first time, I made changes in the basal rate on my insulin pump during the nighttime because of asymptomatic hypoglycemia. I also discovered that I have fairly severe gastroparesis, which now definitely explains many of the very high blood sugars that I would get several hours after eating a large meal. For individuals with hypoglycemia unawareness, the GlucoWatch represents a potentially life saving safety blanket. Alarms can be set individually for low blood sugar detection, and due to the potential inaccuracies of the GlucoWatch, as well as the other meters on the market, in the low and high glucose ranges, one can set the low alarm at a higher rate in order to reduce the false negative detection rate. For those diabetic mothers with young children at home and individuals who must be on the highways as part of their daily existence, the GlucoWatch represents a previously unavailable level of security that will help them avoid injuring themselves or others. The high glucose alarm will also allow people with diabetes to be notified when their blood sugars are rising above the desirable range. Recent data indicates that Americans are in the postprandial state approximately 11 hours a day, and this number is probably greater for people with diabetes. If an individual with diabetes has access to frequent blood glucose results and has the knowledge to act on these results, then supplementing themselves with extra