Performance of the CONTOUR® TS Blood Glucose Monitoring System

Background

Self-monitoring of blood glucose (SMBG) remains an important component of diabetes management, engendering a need for affordable blood glucose (BG) meters that are accurate, precise, and convenient. The CONTOUR^® TS is a BG meter that endeavors to meet this need. It uses glucose dehydrogenase/flavin dinucleotide chemistry, automatic test strip calibration, and autocompensation for hematocrit along with the ease of use that has come to be expected of a modern meter. The objective of this clinical trial was to determine whether the CONTOUR TS system met these criteria.

Methods

The system was evaluated at a single clinical site with 106 subjects with type 1 or type 2 diabetes. Blood glucose values ranged from 60 to 333 mg/dl over all subjects. Both lay users and health care professionals (HCPs) tested the meters, with test strips from three different lots. Results were compared to a reference analyzer of verified precision and accuracy. Forty-nine of the subjects also participated in a home study of the meter. Lay users learned to use the system without assistance and were surveyed on its use at the end of the study.

Results

When used with capillary blood, both subjects and HCPs obtained results that exceeded the International Organization for Standardization 15197:2003 criteria, (i.e., ≥95% of values fell within 20% or 15 mg/dl of the laboratory value for BG levels greater than or less than 75 mg/dl, respectively). Specifically, lay users achieved 97.9% and HCPs 98.6%. When used with venous blood, 99.8% of measurements were within the criteria. All measurements for both capillary and venous blood fell into zones A or B of the Parkes error grid, deemed clinically accurate. Hematocrit was found to have no influence on BG measurements. A large majority of the subjects found the system easy to learn and to use.

Conclusions

The CONTOUR TS BG meter system gave accurate and reproducible results with both capillary and venous blood; subjects learned to use the meter system by following the user guide and quick reference guide.     

Feasibility, Performance, and Acceptability of the Wisebag™ for Potential Monitoring of Daily Gel Applicator Use in Durban, South Africa

The Wisebag?, a lunchbag-style container with an electronic events-monitoring system, was designed as a real-time indirect objective measure of microbicide gel use. Due to cost, alternative functionalities (i.e. use of offline and dummy versions) were explored. We conducted a three-arm, double-blinded pilot study among 50 HIV-negative women in Durban, South Africa to assess participant adherence and Wisebag acceptability and performance. Participants were randomized 2:2:1 to Wisebag with online (events transmitted via cellular signal in real-time), offline (events stored in device memory) or inactive “dummy” devices. Participants were instructed to open the Wisebag daily for 2 weeks, retrieve a study sticker and affix it on a diary card. All participants completed the study. At exit, 94 % did not know which device they had received, nor could they differentiate the Wisebag types when presented with the three options. Five offline devices failed (no data recorded). Per Wisebag events, 26 % of women were perfectly adherent compared to 48 % by self-report and 46 % per diary card. Of reported non-adherence, 92 % did not open the Wisebag (travelling or forgot) and 22 % opened Wisebag >1×/day (curiosity). Participants liked and were comfortable carrying Wisebag. Successful blinding will allow inclusion of offline and/or dummy Wisebags in future study designs. Perfect adherence by opening events was significantly lower than by self-report, highlighting the importance of objective measures of adherence in clinical trials. Additional studies to validate Wisebag data with actual products, with and without SMS and online functionality, in different populations and settings, and in comparison to biomarkers are warranted.     

Performance and acute procedural outcomes of the EnSite Precision™ cardiac mapping system for electrophysiology mapping and ablation procedures: results from the EnSite Precision™ observational study

Journal of Interventional Cardiac Electrophysiology - The EnSite Precision? cardiac mapping system (Abbott) is a catheter navigation and mapping system capable of displaying the...     

STARR with CONTOUR® TRANSTAR™ device for obstructed defecation syndrome: one-year real-world outcomes of the European TRANSTAR registry

Purpose

Stapled transanal rectal resection (STARR) in patients with obstructive defecation syndrome (ODS) is limited by the capacity of the circular stapler used. This prospective cohort study was conducted to assess real-world clinical outcomes of STARR with the new CONTOUR® TRANSTAR? device, shortly named TRANSTAR, at 12 months postoperatively.

Methods

From January 2009 to January 2011, consecutive patients who underwent TRANSTAR in 22 European colorectal centers were enrolled in the study. Functional outcomes and quality of life were assessed by the changes in a number of scoring systems (Knowles-Eccersley-Scott-Symptom (KESS) score, ODS score, St. Mark’s score, Euro Quality of Life-5 Dimension (EQ-5D) score, and Patient Assessment of Constipation—Quality of Life (PAC-QoL) score), at 12 months as compared to baseline. All complications were recorded and analyzed.

Results

A total of 100 patients (98 % female), mean age 60 years, were entered in the study. Statistically significant improvements were seen in the KESS (median 18 vs. 6; p?<?0.01), ODS (median 15 vs. 4; p?<?0.01), and PAC-Qol scores (median 2.10 vs. 0.86; p?<?0.01). St. Mark’s and EQ-5D scores improved nonsignificantly. Complications were reported in 11 % of patients, including bleeding (5 %), staple line complications (3 %), urinary retention (2 %), and persistent pain (1 %). No major complications or mortality occurred.

Conclusion

TRANSTAR facilitated a tailored, real circumferential full-thickness rectal resection, leading to improved patient functional and quality of life outcomes at 12 months postoperatively. It represents a safe and effective treatment for ODS in local clinical practice, although the sustainability of real-world results needs to be proven in the long-term follow-up.     

The Use of the Point of Care Helena ICHOR/Plateletworks® and the Accumetrics Ultegra® RPFA for Assessment of Platelet Function with GPIIb-IIIa Antagonists

Objective: To evaluate a newly modified rapid platelet function analysis system (ICHOR/ Plateletworks®) and to compare the results obtained with those of traditional light transmission aggregometry (LTA), and the Ultegra/RPFA® system. Background: Anti-platelet therapy is standard of care for patients as an adjunct to percutaneous coronary intervention (PCI) or for medical management of non-ST elevation acute coronary syndromes (NSTE ACS). Recent clinical trial results suggest that the three currently approved platelet GPIIb-IIIa receptor antagonists, eptifibatide, tirofiban and abciximab, may vary in extent of inhibition of platelet aggregation (IPA) at the approved doses. Thus, pharmacodynamic evaluations of these agents to determine the extent of platelet function inhibition, especially during the periprocedural time of a cardiac intervention, are necessary. A rapid measurement method as a surrogate for LTA, the current gold standard, would be ideal in order to have the option for dose monitoring or adjustment prior to or during an intervention. The Helena ICHOR/ Plateletworks® may be useful for point of care testing. Methods: Blood samples collected in D-Phe-Pro-Arg-chloromethyl ketone dihydrochloride (PPACK) anticoagulant were treated with increasing concentrations of eptifibatide, tirofiban or abciximab. LTA was carried out in conjunction with the ICHOR/Plateletworks®, using a modified method, and Accumetrics Ultegra® with RPFA cartridges. Results: This study demonstrated that platelet inhibition measured by the ICHOR/Plateletworks® mirrored the level of IPA obtained with LTA. In contrast, the Ultegra® system had less correlation when compared to LTA at inhibition levels < 90%. Conclusions: Based on these data, the ICHOR/ Plateletworks® utilized under modified guidelines may serve as a surrogate for LTA when rapid measurements are necessary.Abbreviated Abstract A rapid platelet function measurement method as a surrogate for light transmission aggregometry (LTA), the current gold standard, is ideal in order to have the option for GPIIb-IIIa antagonist dose monitoring or adjustment prior to or during a coronary intervention. A newly modified rapid platelet function analysis system (ICHOR/Plateletworks® was evaluated and compared to the results obtained with traditional light transmission aggregometry (LTA), and the Ultegra/RPFA® system. Blood samples collected in D-Phe-Pro-Arg-chloromethyl ketone dihydrochloride (PPACK) anticoagulant were treated with increasing concentrations of eptifibatide, tirofiban or abciximab. LTA was carried out in conjunction with the ICHOR/Plateletworks®, using a modified method, and Accumetrics Ultegra® with RPFA cartridges. Based on these data, the ICHOR/Plateletworks® utilized under modified guidelines may serve as a surrogate for LTA when rapid measurements are necessary.Supported in part by Helena Laboratories, Inc. and the University of Tennessee Health Science Center Vascular Biology Center of ExcellenceThis revised version was published online in May 2005 with a corrected cover date.     

Analysis of the Performance of the CONTOUR? TS Blood Glucose Monitoring System: When Regulatory Performance Criteria Are Met,Should We Have Confidence to Use A Medical Device with All Patients?

The article entitled, Performance of the CONTOUR^® TS Blood Glucose Monitoring System, by Frank and colleagues in this issue of Journal of Diabetes Science and Technology, demonstrates that the CONTOUR^® TS glucose meter exceeds current regulatory expectations for glucose meter performance. However, the appropriateness of current regulatory expectations, such as International Organization for Standardization (ISO) 15197:2003, is being reevaluated because of increasing concern regarding the reliability of glucose meters in ambulatory and hospitalized environments. Between 2004 and 2008, 12,673 serious adverse events with glucose meters that met the ISO 15197 expectations were reported in the Food and Drug Administration–Manufacturer and User Facility Device Experience surveillance database. Should different glucose meter performance criteria be applied to ambulatory versus critical care patients?     

Comparison of the proportion of patients potentially treated with an anti-osteoporotic drug using the current criteria of the Belgian national social security and the new suggested FRAX® criteria

To assess the number of anti-osteoporosis treatments that would be reimbursed by the Belgian social security if either FRAX^® or the current criteria were used to determine access to reimbursement. This is a retrospective study based on data from 1,000 women randomly selected from an outpatient hospital specialized in bone metabolism in Belgium. Proportions of potentially refunded treatments between FRAX^® and current criteria were compared. Out of the 1,000 women files, 890 have sufficient information to assess FRAX^®. In Belgium, current criteria include a bone mineral density (BMD) T score below ?2.5 at the lumbar spine, the femoral neck or the total hip and/or at least a prevalent vertebral fracture. Using these criteria, 167 women (18.8 %) would have access to reimbursement. Using the criteria based on the validated Belgian FRAX^® tool, only 116 women (13.0 %) would have access to reimbursement, meaning that access to reimbursement based on FRAX^® criteria would reduce by 30 % the anti-osteoporosis drug expenses covered by the national social security. Interestingly, only 65 women out of the 116 (56.0 %) selected with the FRAX^® criteria were also selected with the current criteria of the national social security. A substantial proportion of individuals that would potentially receive a reimbursement for their treatment using the FRAX^® criteria do not have access to any refund for their treatment with the current criteria. Since patients identified with the FRAX^® tool are those with the highest risk profile for future fractures, reappraisals of treatment reimbursement guidelines are expected in Belgium.     

Analysis: New Point-of-Care Blood Glucose Monitoring System for the Hospital Demonstrates Satisfactory Analytical Accuracy Using Blood from Critically Ill Patients—An Important Step toward Improved Blood Glucose Control in the Hospital

Patients managed in the intensive care units (ICUs) and general wards of the hospital experience a high incidence of hyperglycemia, hypoglycemia, and glycemic variability, despite significant hospital resources devoted to glucose control. Optimized glucose meters and monitoring systems are required to improve the safety and efficacy of insulin delivery and glucose control in the hospital. Safe insulin dosing requires timely and accurate glucose measurements, especially during dynamic changes in nutrition, insulin sensitivity, and physiological stress. In the current issue of Journal of Diabetes Science and Technology, Mitsios and coauthors describe the analytical accuracy of the new Accu-Check^® Inform II blood glucose (BG) monitoring system commercialized by F. Hofmann-La Roche Ltd. The point-of-care glucose meter achieved the desired degree of accuracy and precision, as defined by Clinical and Laboratory Standards Institute POCT12-A3 guidelines when evaluated using venous blood from 600 critically ill patients from multiple ICUs at two medical centers. Venous whole blood samples were used to obtain glucose meter results in duplicate. The remaining blood sample was centrifuged to obtain plasma for central hospital laboratory testing using the hexokinase method within 5 min of meter testing. A total of 98.8% of the 1200 Accu-Check Inform II meter’s glucose values were within ±12.5% (±12 mg/dl) of the mean laboratory glucose value, and 99.8% were within ±20% (±20 mg/dl), thus meeting the Clinical and Laboratory Standards Institute criteria. Future studies are required to evaluate the clinical performance of the new BG monitoring system in the intended-use patient populations and critical care environments, using arterial, peripheral venous, central venous, and capillary blood samples.     

Accuracy performance of the Medtronic NexSensor™ for 6 days in an inpatient setting using abdomen and buttocks insertion sites

Background

Users of continuous glucose monitoring are concerned with product accuracy and choice of insertion site. The Medtronic NexSensor™ was evaluated for accuracy during 6 days of wear when inserted in the abdomen and buttocks areas.

Methods

Adults (ages 18–75) with type 1 diabetes wore two sensors simultaneously for 6 days, one each inserted in the abdomen and buttocks. Subjects underwent a frequent blood sampling study for 12 hours, during which time reference blood glucose values were obtained every 15 minutes and compared to sensor values.

Results

Sixty-three subjects were enrolled, and 61 subjects completed the study. The mean agreement rate between sensor and blood glucose values was 75.5% [95% confidence interval (CI), 69.5, 81.4] at the abdomen site, 73.8% (95% CI, 68.8, 78.8) at the buttocks site, and 75.6% (95% CI, 70.8, 80.4) when sensor and reference data were combined between sites. Over 90% of paired sensor-reference values on Clarke error grids were within the A and B ranges. The mean absolute relative differences were 17.1% at the abdomen site, 16.5% at the buttocks site, and 16.8% when sites were combined.

Conclusion

The NexSensor was accurate for inpatient, frequent-sample testing for 6 days when inserted into the abdomen and buttocks. The results of this study also provide evidence that both the abdomen and buttocks are suitable as sensor insertion sites.     

Enhanced 911/Global Position System Wizard: A Telemedicine Application for the Prevention of Severe Hypoglycemia—Monitor,Alert, and Locate

Intensive insulin therapy has an inherent risk of hypoglycemia that can lead to loss of consciousness, cardiac arrhythmia, seizure, and death (“dead-in-bed syndrome”). This risk of hypoglycemia is a major concern for patients, families, and physicians. The need for an automated system that can alert in the event of severe hypoglycemia is evident. In engineering systems, where there is a risk of malfunction of the primary control system, alert and safety mechanisms are implemented in layers of protection. This concept has been adopted in the proposed system that integrates a hypoglycemia prediction algorithm with a global position system (GPS) locator and short message service such that the current glucose value with the rate of change (ROC) and the location of the subject can be communicated to a predefined list. Furthermore, if the system is linked to the insulin pump, it can suspend the pump or decrease the basal insulin infusion rate to prevent the pending event. The system was evaluated on clinical datasets of glucose tracings from the DexCom Seven® system. Glucose tracings were analyzed for hypoglycemia events and then a text message was broadcast to a predefined list of people who were notified with the glucose value, ROC, GPS coordinates, and a Google map of the location. In addition to providing a safety layer to a future artificial pancreas, this system also can be easily implemented in current continuous glucose monitors to help provide information and alerts to people with diabetes.     

Gerontechnologies for Older Patients with Heart Failure: What is the Role of Smartphones,Tablets, and Remote Monitoring Devices in Improving Symptom Monitoring and Self-Care Management?

Older adults with heart failure have multiple chronic conditions and a large number and range of symptoms. A fundamental component of heart failure self-care management is regular symptom monitoring. Symptom monitoring can be facilitated by cost-effective, easily accessible technologies that are integrated into patients’ lives. Technologies that are tailored to older adults by incorporating gerontological design principles are called gerontechnologies. Gerontechnology is an interdisciplinary academic and professional field that combines gerontology and technology with the goals of improving prevention, care, and enhancing the quality of life for older adults. The purpose of this article is to discuss the role of gerontechnologies, specifically the use of mobile applications available on smartphones and tablets as well as remote monitoring systems, for outpatient disease management among older adults with heart failure. While largely unproven, these rapidly developing technologies have great potential to improve outcomes among older persons.     

Wireless Capsule Motility: Comparison of the SmartPill<Superscript>?</Superscript> GI Monitoring System with Scintigraphy for Measuring Whole Gut Transit

Introduction

Assessment of whole gut transit, by radio-opaque markers or scintigraphy, is used to evaluate patients with constipation for slow gastrointestinal transit. Wireless capsule motility, using the SmartPill^® GI monitoring system, samples and transmits intraluminal pH, pressure, and temperature data from a capsule at regular intervals as it traverses through the gastrointestinal tract; from these, gastric emptying and whole gastrointestinal tract transit can be assessed. The objective of this study was to compare the SmartPill^® with whole gut transit scintigraphy to determine whether the SmartPill system could serve as a test for measurement of whole gut motility and transit.

Methods

Ten healthy, asymptomatic subjects underwent simultaneous whole gut scintigraphy and SmartPill^® assessment of whole gut transit.

Results

All subjects completed the study per protocol and experienced natural passage of the pill. Capsule residence time in the stomach correlated very strongly with percent gastric retention of the Tc-99 radiolabel at 120 min (r = 0.95) and at 240 min (r = 0.73). Small bowel contraction-min^?1 measured by the SmartPill correlated with small bowel transit % (r = 0.69; P = 0.05) and with isotopic colonic geometric center at 24 h after ingestion (r = 0.70, P = 0.024). Capsule transit time correlated with scintigraphic assessment of whole gut transit.

Conclusions

SmartPill^® capsule assessment of gastric emptying and whole gut transit compares favorably with that of scintigraphy. Wireless capsule motility shows promise as a useful diagnostic test to evaluate patients for GI transit disorders and to study the effect of prokinetic agents on GI transit.

     

An evaluation of the SPIFE® 3000 semi-automated gel electrophoresis system for the identification of hemoglobin variants and comparison of relative electrophoretic mobilities with manual gel electrophoresis methods

Laboratory identification of hemoglobin (Hb) variants can involve multiple techniques. The use of semi-automated instruments that perform gel electrophoresis and staining, such as the SPIFE^® 3000 electrophoresis system, can greatly reduce the labor required for these commonly used techniques. We performed a comparison of the method involved in SPIFE^® 3000 system with those of manual gel electrophoresis. A total of 22 540 samples were analyzed using the SPIFE^® 3000, and compared with mobilities on cellulose acetate and citrate agar gels using standard manual methods. The results were compared using relative electrophoretic mobilities (REM). Of the 191 Hb variants identified, only 13 had REM that differed from manual electrophoresis when analyzed using the SPIFE^® 3000 system. One variant (Hb O-Indonesia) showed different mobility on both acid and alkaline gels, two (Hb E, Hb Sunshine Seth) on alkaline gel only, and 10 (Hbs N-Baltimore, N-Seattle, O-Arab, Shelby, Summer Hill, Tak, Hasharon, M-Iwate, Q-Iran, and Setif) on acid gels only. The SPIFE^® 3000 semi-automated electrophoresis system produces similar results when compared with those of standard manual electrophoresis methods.     

Patient Perceptions of Different Lancing Sites for Self-Monitoring of Blood Glucose: A Comparison of Fingertip Site with Palm Site Using the OneTouch? Ultra? Blood Glucose Monitoring System

Background

Alternate-site testing (AST) for self-monitoring of blood glucose leads to improved glycemic control for treatment of diabetes mellitus. The aim of this randomized, open-label, two-period, crossover study was to compare the comfort of two different lancing sites, fingertip and palm sites, for AST in diabetes patients.

Methods

Patients injected insulin four times a day. Self-monitoring of blood glucose was carried out more than thrice daily with fingertip measurements for at least three months using apparatuses except the OneTouch^®Ultra^®Blood Glucose Monitoring System (OneTouch) before examination. The comfort of two lancing sites using OneTouch were compared. In two randomized groups that used one fingertip lancing site for one week followed by the alternate lancing site for another week, patients completed 11-item questionnaires assessing usability of the site before and after each week. Each item was scored on a visual analogue scale from –100 (most negative) to +100 (most positive).

Results

Most patients desired to continue AST, which was insignificantly different between the two lancing sites (fingertip and palm AST) in 43 diabetes patients aged 57.3 ± 13.8 years, body mass index of 23.1 ± 2.5 kg/m², diabetes duration of 19.6 ± 9.7 years, and hemoglobin A1c of 7.4 ± 1.1%. However, patients were less (p < .01) satisfied with using the palm lancing site as compared to the fingertip lancing site because of difficulties in inserting the needle, drawing blood samples, and applying enough blood into the test strip.

Conclusions

These results suggest that patients desire to use the palm for AST, but more technological advances in AST of a palm site is required to reduce patient discomfort.     

Patterns of Protective Factors in an Intervention for the Prevention of Suicide and Alcohol Abuse with Yup’ik Alaska Native Youth

Background: Community-based participatory research (CBPR) with American Indian and Alaska Native communities creates distinct interventions, complicating cross-setting comparisons. Objective: The objective of this study is to develop a method for quantifying intervention exposure in CBPR interventions that differ in their forms across communities, permitting multi-site evaluation. Methods: Attendance data from 195 youth from three Yup’ik communities were coded for the specific protective factor exposure of each youth, based on information from the intervention manual. The coded attendance data were then submitted to latent class analysis to obtain participation patterns. Results: Five patterns of exposure to protective factors were obtained: Internal, External, Limits, Community/family, and Low Protection. Patterns differed significantly by community and youth age. Conclusion: Standardizing interventions by the functions an intervention serves (protective factors promoted) instead of their forms or components (specific activities) can assist in refining CBPR interventions and evaluating effects in culturally distinct settings.     

Testing the feasibility and acceptability of an online ‘Fatigue and Activity Management Education for Work (FAME-W) programme’ for individuals with inflammatory arthritis

Introduction

Fatigue and Activity Management Education for Work (FAME-W) is a four-week, occupational therapy led programme focussing on fatigue management strategies. FAME-W was designed to be delivered in person; however, due to COVID-19 pandemic it was modified to be an online group-based self-management intervention. The purpose of this study was to test the feasibility and acceptability of the online delivery format of FAME-W.

Methods

This was a mixed methods study. Participants were randomly allocated to intervention or control group. Participants in the intervention group received a four-week online FAME-W. The control group participants received a FAME-W handbook. Participants were required to complete questionnaires on work presenteeism, fatigue, mood, Health Related Quality of Life and pain at baseline, and 3 months post-intervention. Participants in the intervention group attended a focus group immediately following the completion of the programme and the control group participated in individual interviews.

Results

Seven of ten individuals recruited participated in the study. Majority of participants had Rheumatoid Arthritis and were working full-time. The mean age of intervention participants was 53 ± 10.4 and 56.5 ± 3.7 for the controls. All participants in the intervention group had 100% attendance, completed all study measures and activities. Participants had positive comments about the programme format, content, and delivery. Improvements were observed in most measures at follow up.

Conclusion

Results suggest that an online programme to improve work ability was feasible and acceptable to individuals with inflammatory arthritis. The online delivery format was favoured over attending a centre-based programme. The findings support a definitive intervention trial of online FAME-W.     

Quality of care for people with dementia in residential care settings and the “Vážka” Quality Certification System of the Czech Alzheimer Society

IntroductionPeople with dementia are one of the most vulnerable groups of residents of long-term care institutions. The Czech Alzheimer Society (CALS) aims to improve the situation of people with dementia and their families using various methods, including the improvement of quality of care.ObjectiveTo present the development of the “Vážka” Quality Certification System developed by CALS through first-hand experience.MethodsCALS organised workshops and focus groups to discuss the main issues in dementia care quality, worked to define criteria and their classification, and developed the “Vážka” Certification System. CALS also evaluated these criteria in practice through a pilot evaluation project and established standards that were achievable within the system of dementia care in the Czech Republic. The main characteristics of the process of assessment and certification are: partnership and mutual discussion, evaluation of relational care, respect for the dignity of people with dementia and those who care for them, and the level of collaboration with families.ResultsThirty-two facilities have been successfully certified. Among these feature 25 residential services, 5 day care centres, 1 weekday centre and 1 healthcare department.ConclusionThe criteria within “Vážka” are meaningful and valid. They change slightly with any increasing quality of care but they need not be radically changed or updated. After its first years of experience, it is possible to say that the system is able to confirm good practice in care for people with dementia in actual conditions and distinguish it from care which is not acceptable.