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Objective To demonstrate the clinical value of OneTouch (OT) Verio Flex glucose meter used in combination with a Spanish-language version of the OT Reveal mobile application (app) to support diabetes care and improve glycemic control in an underserved Hispanic population with type 2 diabetes. Research Design and Methods Test subjects (n = 81) used the meter and app for 12 weeks, while a randomized control group (n = 39) used their own glucose meters without connection to an app. Thereafter, test subjects continued the same regimen for an additional 12 weeks to determine the durability of effect, and control subjects crossed over to use the new meter and app. Results Test subjects experienced a mean reduction in A1C of 1.0% after 12 weeks (P Conclusion Use of the OT meter and a Spanish-language version of its diabetes management app in an underserved population helped participants achieve a sustained improvement in glycemic control. The tools were well received by the subjects and may have important utility in other low-numeracy, low-literacy populations.

Background We examined whether dynamic color range indicator (DCRI) and blood sugar mentor (BSM) features in a new blood glucose meter could improve interpretation of results and encourage patient action. Methods One hundred and thirty three people with type 2 (T2D) ( n = 73) or type 1 diabetes (T1D) ( n = 60) evaluated information first without and then with DCRI or BSM guidance using interactive exercises. Results Subjects improved their ability to categorize results into low, in range, or high glycemic ranges by 29% (T2D) and 22% (T1D) (each P Conclusions Use of DCRI and BSM in this meter may help patients improve their diabetes management decisions.

The OneTouch Verio Reflect blood glucose monitor (BGM) has market clearance in several countries based in part on fulfilling the lay user and system accuracy criteria described in ISO15197:2015. However, the Food and Drug Administration (FDA) does not recognize the accuracy criteria in ISO15197 as a basis for gaining regulatory clearance for these devices. The current study evaluates the BGM using the accuracy guidelines issued by the agency for self-monitoring blood glucose test systems for over-the-counter use. Glucose results were accurate vs comparator over a wide glucose range and met lay user and glucose accuracy criteria at extreme glucose values as described in the FDA guidance. Clinicaltrials.gov NCT03851549

Background: Accurate self-monitoring of blood glucose (SMBG) is a key component of effective self-management of glycemic control. Methods: The OneTouch Verio Reflect and OneTouch Ultra Plus Reflect BG monitoring systems were evaluated for accuracy in a clinical setting. Subjects also used the meters for a one-week trial period and reported their level of satisfaction with meter features. Results: Both systems were accurate over a wide glucose range and met lay user and system accuracy BG standards described in ISO15197:2015. Subjects felt that the features of a meter with a dynamic color range indicator and personalized guidance, insight, and encouragement could provide significant benefits to them in the management of their diabetes. Conclusions: Both meter systems were accurate over a wide glucose range and the features of the meter and messages were well received by patients in a short take-home trial. Clinical trial registration: Clinicaltrials.gov NCT0351542

In 2020, the European Commission up-classified metal cobalt as Class 1B Carcinogen (presumed to have carcinogenic potential) based primarily on data from rodent inhalation carcinogenicity studies. This up-classification requires an assessment under the Medical Device Regulations of cobalt cancer risk from medical devices. We performed a systematic review and meta-analysis to evaluate site-specific cancer risks with cobalt exposure from either total joint replacement (TJR) or occupational exposure (OC). Results were stratified by exposure type (OC or TJR), exposure level (metal-on-metal (MoM) or non-MoM), follow-up duration (latency period:5, 5-10 or10 years), and cancer incidence or mortality (detection bias assessment). From 30 studies (653,104 subjects, average 14.5 years follow-up), the association between TJR/OC and cancer risk was null for 22 of 27 cancer sites, negative for 3 sites, and positive for prostate cancer and myeloma. Significant heterogeneity and large estimate ranges were observed for many cancer sites. No significant increase in estimates was observed by exposure level or follow-up duration. The current evidence, including weak associations, heterogeneity across studies and no increased association with exposure level or follow-up duration, is insufficient to conclude that there exists an increased risk for people exposed to cobalt in TJR/OC of developing site-specific cancers.

In 2020, the European Commission up-classified pure cobalt metal to a Category 1B hazard, based primarily on data from rodent inhalation carcinogenicity studies of metallic cobalt. The European Commission review did not evaluate cobalt-containing alloys in medical devices, which have very different properties vs. pure cobalt metal and did not include a systematic epidemiologic review. We performed a systematic review and meta-analysis of published, peer-reviewed epidemiologic studies evaluating the association between overall cancer risk and exposure to orthopedic implants containing cobalt alloys or cobalt particulates in occupational settings. Study-specific estimates were pooled using random-effects models. Analyses included 20 papers on orthopedic implants and 10 occupational cohort papers (~1 million individuals). The meta-analysis summary estimates (95% confidence intervals) for overall cancer risk were 1.00 (0.96–1.04) overall and 0.97 (0.94–1.00) among high-quality studies. Results were also similar in analyses stratified by type of exposure/data sources (occupational cohort, implant registry or database), comparators (general or implant population), cancer incidence or mortality, follow-up duration (latency period), and study precision. In conclusion, meta-analysis found no association between exposure to orthopedic implants containing cobalt alloys or cobalt particulates in occupational settings and overall cancer risk, including an analysis of studies directly comparing metal-on-metal vs. non-metal-on-metal implants.

People with diabetes face numerous challenges to effective self-management of blood glucose (BG) including access to diabetes education and support. This study explores how a coaching program structured around the AADE7 Self-Care Behaviors™ and evidence-based behavior change strategies optimized for remote interaction between the coach and participant can improve glycemic control. Certified Diabetes Educator coaches used a care management platform, Welkin Health, that displays BG test results from integration with the OneTouch Reveal diabetes mobile app. Welkin supports communication methods with patients including email, SMS and telephone communication. The software platform also uses logic to prioritize patients who need attention so the coach can better manage their relationship with the participant. Adult participants with type 2 diabetes and HbA1c ≥8.0% received an AccuBase A1c mail-in test kit at baseline and weeks 12 and 24 to measure their HbA1c levels. Each participant used a OneTouch Verio Flex glucose meter connected by Bluetooth to OneTouch Reveal app. After 12 weeks (n=67), mean HbA1c declined by 0.85% from 9.19% to 8.34% (p0.5%. After 24 weeks, mean change in HbA1c was still 0.78% less than baseline (p0.5%. The decline in HbA1c occurred without any increase in hypoglycemic events. There was a 14.1% increase in % of results in range (p In conclusion, live coaching using the Welkin Patient Relationship Management technology in conjunction with the OneTouch Reveal diabetes app resulted in significant improvement in glycemic control in participants with type 2 diabetes who were in relatively poor control. Disclosure L.B. Katz: Employee; Self; LifeScan, Inc. K.D. Neland: Research Support; Self; LifeScan, Inc. D.J. Rolando: None. D.M. Shearer: None.

People with diabetes (PWD) who need to take mealtime insulin to help control their blood sugar often have difficulty correctly calculating their dose due to consideration of many factors such as current blood glucose, carbohydrate consumption, active insulin duration, insulin-to-carb ratio, and insulin sensitivity. The Insulin Mentor, a bolus calculator tool in the OneTouch Reveal diabetes management app, uses an algorithm to automate many of these calculations and contains a link to a food diary to help estimate carbohydrate intake. In the current study, healthcare professionals and PWD from United States and Germany responded favorably to simulations of this calculator tool and compared it positively with other apps on the market. The Insulin Mentor may simplify the difficult process of correctly calculating mealtime insulin doses for PWD.

Background: The ability of patients to improve glycemic control depends partly on their ability to interpret and act on blood glucose results. We investigated whether switching people with diabetes to blood glucose meters (BGMs) featuring a color range indicator (CRI) could improve glycemic control compared to remaining on their current BGM without color. Methods: 163 adults with type 1 (T1D) or type 2 diabetes (T2D) and a hemoglobin A1c (A1c) of 7.5-11% were randomized to: One Touch Verio™ (Verio), OneTouch Verio Flex™ (Flex), or controls remaining on their current BGM. Diabetes nurses had standard conversations about diabetes management with all subjects at baseline. No changes in medication, insulin dosing, or SMBG frequency were recommended. Results: After 12 weeks, subjects who switched to Verio or Flex meters with CRI (n = 108) had a mean change in A1c 0.36% lower than controls (n = 55) ( P = .017). A1c reductions were greatest in T1D subjects (n = 45), with a decrease of 0.50% ( P = .004). T1D subjects using Verio meters (n = 25) contributed a 0.59% reduction compared to controls ( P < .008), whereas T1D subjects using Flex meters (n = 20) had a clinical meaningful reduction in A1c of 0.40% without reaching statistical significance ( P > .05). Verio and Flex users reported taking more action and easier understanding of diabetes management compared to previous BGMs. Conclusions: This study demonstrated that switching patients to BGMs featuring a CRI resulted in improvements in glycemic control compared to subjects using currently marketed BGMs that do not use a CRI. Registration: Clinicaltrials.gov NCT02929654 https://clinicaltrials.gov/ct2/show/NCT02929654

In 2017, the European Union (EU) Committee for Risk Assessment (RAC) recommended the classification of metallic cobalt (Co) as Category 1B with respect to its carcinogenic and reproductive hazard potential and Category 2 for mutagenicity but did not evaluate the relevance of these classifications for patients exposed to Co-containing alloys (CoCA) used in medical devices. CoCA are inherently different materials from Co metal from a toxicological perspective and thus require a separate assessment. CoCA are biocompatible materials with a unique combination of properties including strength, durability, and a long history of safe use that make them uniquely suited for use in a wide-range of medical devices. Assessments were performed on relevant preclinical and clinical carcinogenicity and reproductive toxicity data for Co and CoCA to meet the requirements under the EU Medical Device Regulation triggered by the ECHA re-classification (adopted in October 2019 under the 14th Adaptation to Technical Progress to CLP) and to address their relevance to patient safety. The objective of this review is to present an integrated overview of these assessments, a benefit-risk assessment and an examination of potential alternative materials. The data support the conclusion that the exposure to CoCA in medical devices via clinically relevant routes does not represent a hazard for carcinogenicity or reproductive toxicity. Additionally, the risk for the adverse effects that are known to occur with elevated Co concentrations (e.g., cardiomyopathy) are very low for CoCA implant devices (infrequent reports often reflecting a unique catastrophic failure event out of millions of patients) and negligible for CoCA non-implant devices (not measurable/no case reports). In conclusion, the favorable benefit-risk profile also in relation to possible alternatives presented herein strongly support continued use of CoCA in medical devices.

Cobalt (Co) is an essential element with human exposure occurring from the diet, supplement ingestion, occupational sources, and medical devices. The European Chemical Agency (ECHA) recently voted to classify Co metal as a Reproductive Hazard Category 1B; presumed human reproductive toxicant due to adverse testicular effects in male rodents. A weight of evidence evaluation of the preclinical reproductive and developmental toxicity studies and available clinical data was performed to critically evaluate the relevance of this proposed classification for Co in medical devices. Reproductive responses to Co are limited to the male testes and sperm function following high systemic exposure in rodents, only at Co concentrations/doses that result in overt toxicity (i.e., above the maximum tolerable dose (MTD)). The potential mechanisms of Co reproductive/developmental toxicity, including its indirect mode of action in the testes and relevance to humans, are discussed. The available preclinical and clincial evidence suggests that it would be more appropriate to classify Co as a Reproductive Hazard Category 2 compound: suspected human reproductive toxicant and, in the case of Co-containing medical devices, it should not be considered a reproductive hazard.

Cobalt (Co) alloys have been used for over seven decades in a wide range of medical devices, including, but not limited to, hip and knee implants, surgical tools, and vascular stents, due to their favorable biocompatibility, durability, and mechanical properties. A recent regulatory hazard classification review by the European Chemicals Agency (ECHA) resulted in the classification of metallic Co as a Class 1B Carcinogen (presumed to have carcinogenic potential for humans), primarily based on inhalation rodent carcinogenicity studies with pure metallic Co. The ECHA review did not specifically consider the carcinogenicity hazard potential of forms or routes of Co that are relevant for medical devices. The purpose of this review is to present a comprehensive assessment of the available in vivo preclinical data on the carcinogenic hazard potential of exposure to Co-containing alloys (CoCA) in medical devices by relevant routes. In vivo data were reviewed from 33 preclinical studies that examined the impact of Co exposure on local and systemic tumor incidence in rats, mice, guinea pigs, and hamsters. Across these studies, there was no significant increase of local or systemic tumors in studies relevant for medical devices. Taken together, the relevant in vivo data led to the conclusion that CoCA in medical devices are not a carcinogenic hazard in available in vivo models. While specific patient and implant factors cannot be fully replicated using in vivo models, the available in vivo preclinical data support that CoCA in medical devices are unlikely a carcinogenic hazard to patients.

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. The OneTouch VerioFlex(™) (OTVF) blood glucose monitoring system (BGMS) was evaluated for accuracy in a clinical setting. Patients also used OTVF for a 1-wk trial period and reported their level of satisfaction with meter features. In a separate study, healthcare professionals used an on-line simulator of the BGMS and answered questions about its potential utility to their patients. OTVF was accurate over a wide glucose range and met lay user and system accuracy blood glucose standards described in ISO15197:2013 as well as the accuracy requirements to fulfill US FDA expectations for 510(k) clearance of BGMS. Patients and healthcare professionals felt the features of OTVF, which has the capability to connect wirelessly to mobile devices and interact wirelessly with diabetes management software, could provide significant benefits to them or their patients.

Background: Anecdotal blood glucose assessments conducted by health care professionals (HCPs) in the field have highlighted differences in results when methodology used is not according to best practices for measuring blood glucose. This study assessed the impact on accuracy of blood glucose measurements when methodology deviates from the recommended study design and recommended reference instrument. Methods: Adults with type 1 or type 2 diabetes provided capillary and venous blood samples for accuracy assessments using OneTouch® Verio® (Verio) and OneTouch® Ultra 2® (Ultra) blood glucose meters (BGM) and two different reference instruments. Results: Increases in mean bias were observed when comparing capillary to venous samples tested on the BGMs and the recommended reference instrument. Mean bias was even greater when a hospital blood glucose analyzer was used to measure venous plasma glucose. Increases in mean bias observed for Ultra BGM when testing venous blood on the meter compared to the recommended reference instrument was likely due to the interfering effects of low oxygen levels in the venous blood sample. Conversely, Verio meters, which are insensitive to low oxygen levels, showed little difference from baseline when testing venous blood on the meter compared to results from the same venous sample measured on a reference instrument. Conclusions: Deviations from the best practice study design of comparing capillary blood glucose results tested on the blood glucose meter with the manufacturer’s stated reference instrument will affect accuracy of blood glucose measurements.

Background: We previously demonstrated in patients with diabetes that displaying blood glucose results in association with color improved their ability to interpret glucose results. Objective: The objective of this study was to investigate the perceptions of health care professionals (HCPs) in specific countries about the value of color on a new glucose meter and to determine if HCP perspectives among countries differ on the value of this approach in clinical practice. Methods: A total of 180 HCPs, including 105 endocrinologists, 34 primary care physicians, 25 diabetes educators, and 16 pharmacists, were recruited from India (n=50), Russia (n=50), China (n=50), and the United States (n=30). These HCPs experienced the OneTouch Select Plus Simple glucose meter online from their own office computer using interactive demonstrations (webpages, meter simulator, and video clips). After providing demographic and current clinical practice insights, HCPs responded to questions about the utility of the color-enhanced glucose meter. Results: Mean age and years in their current professional role for the 180 HCPs was 41.3 (SD 8.1) and 13.3 (SD 6.8) years for endocrinologists, 41.3 (SD 8.3) and 14.1 (SD 6.8) years for primary care physicians, 37.5 (SD 8.7) and 12.7 (SD 6.8) years for diabetes educators, and 35.9 (SD 5.3) and 9.5 (SD 5.2) years for pharmacists. In all, 88% (44/50) of Russian and 83% (25/30) of American HCPs said their patients find it easy to recognize low, in-range, or high blood glucose results compared to 56% (28/50) of HCPs in China and 42% (21/50) in India. Regardless of country, HCPs had less confidence that their patients act on blood glucose results with 52% (26/50) in Russia, 63% (19/30) in the United States, 60% (30/50) in China, and 40% (20/50) in India responding positively. During the interactive online meter experience, HCPs from all countries responded positively to questions about a meter with color features. After reflecting on the value of this meter, most HCPs strongly agreed or agreed their patients would be more inclined to act on results using a meter with color features (Russia: 92%, 46/50; United States: 70%, 21/30; China: 98%, 49/50; India: 94%, 47/50). They also said that color was particularly useful for patients with lower numeracy or education who may struggle with interpreting results (Russia: 98%, 49/50; United States: 77%, 23/30; China: 100%, 50/50; India: 82%, 41/50). Conclusions: This multicountry online study provides evidence that HCPs had high overall satisfaction with the OneTouch Select Plus glucose meter, which uses color-coded information to assist patients with interpreting blood glucose results. This may be especially helpful in patient populations with low numeracy or literacy and limited access to health care and direct interaction with HCPs. [JMIR Diabetes 2018;3(1):e1]

Background: Self-monitoring of blood glucose is crucial for maintaining overall blood glucose (BG) levels. Health care professionals (HCPs) must rapidly assess patient BG data and recommend treatment changes, as appropriate, during short office visits. A meter offering automatic BG pattern recognition and in-the-moment messaging may change how HCPs and patients with diabetes work together to achieve glycemic control.Methods: Two separate studies evaluated the potential benefits of the OneTouch Verio® BG monitoring system. In one study, 64 HCPs were evaluated on their ability to rapidly recognise BG patterns in simulated logbooks compared to using the meter, before completing a survey on potential benefits of the meter to themselves and their patients. In the other study, patients with diabetes used the meter at home for 1 week before also completing a survey.Results: Patients indicated that the meter was simple to use and understand. For HCPs, using the meter to identify BG patterns was significan...

Background: Many patients struggle to interpret and respond appropriately to the numerical blood glucose results displayed on their meter, with many regularly taking no action or self-care adjustment for out-of-range results. We recently reported that a glucose meter that provides automatic onscreen information using a color range indicator (ColorSure Technology) improved the ability of patients to categorize their blood glucose results. Objective: The objective of this study was to examine how ColorSure Technology (or color) affected patient decision making on blood glucose results and how patient numeracy levels influenced such decisions. Methods: We invited 103 subjects (56 with type 2 diabetes and 47 with type 1 diabetes) to a face-to-face in-clinic visit in a diabetes care center and showed them glucose results with or without color via interactive computer or paper logbook exercises. Before participating in these exercises, subjects completed surveys on numeracy and their understanding of blood glucose information. Results: Subjects preferentially acted on high glucose results shown with color (55%, 57/103) compared to results without color (45%, 46/103; P=.001). When shown identical pairs of results, subjects preferentially acted on results shown with color (62%, 64/103) compared to results without color (16%, 16/103) (P

Aims: We previously demonstrated that people with type 2 diabetes (T2DM) can improve their ability to categorize blood glucose (BG) results into low, in range, or high glycemic ranges after experiencing a color range indicator (CRI or ColorSure™ Technology) in a single meter. This study examined whether a CRI was effective in people with type 1 (T1) or T2DM when used in 3 glucose meters. Methods: A total of 179 subjects (139 T2DM and 40 T1DM) classified BG values as low, in range, or high based on individual current knowledge. Subjects then experienced the CRI which showed whether different BG values were low, in range, or high. After CRI interaction, subjects repeated the classification. Results: Following interaction with the CRI, subjects significantly improved their ability to categorize BG results into low, in range, and high glycemic ranges by 27.9% (T2DM) and 27.2% (T1DM) (each P < .001). Improvement was not accompanied by an increase in time spent categorizing results. There was no difference in classification ability between subjects with T1 or T2DM. There was also no correlation between HbA1c, numeracy level, test frequency, or duration of diabetes and the ability to correctly classify results. Subjects agreed the CRI feature helped them easily interpret glucose values and improved their awareness of glucose ranges. Conclusion: Interaction with a CRI improved the ability of subjects with T1 and T2DM to interpret and categorize BG values into recommended glycemic ranges, irrespective of the glucose meter providing the CRI insights.

Background: Cloud-connected diabetes applications enable health care professionals (HCPs) to monitor patient progress and offer the potential for remote consultations. OneTouch Reveal (OTR) is a cloud-based web application that aggregates data from blood glucose (BG) meters or insulin pumps and provides analytics to help patients and HCPs make more informed treatment and lifestyle decisions. This study assessed the experience of patients using OTR and the OneTouch Verio (OTV) BG meter and determined the extent of changes in glycemic control. Methods: Subjects with T1DM (23) or T2DM (17) uploaded BG meter results to OTR for 12 weeks. HCPs remotely reviewed progress using OTR and delivered telephone consultations at 4 and 8 weeks based on OTR insights. Results: After 12 weeks, mean HbA1c decreased by 0.4% ( P < .001) and 25% of subjects had a reduction of ≥1.0%. Reduction in HbA1c was similar in subjects with T1DM and T2DM, although subjects with T1DM started with higher baselines. In subjects with T2DM, mean BG decreased significantly from 175 to 161 mg/dl ( P < .001) with the percentage of above-range BG results decreasing from 33% to 24%. 80% of subjects confirmed OTR detected out-of-range glucose patterns and 84% of these subjects were able to correct the underlying pattern to get BG back in-range. Conclusions: OTR web application in combination with the OTV meter helped subjects with T1DM and T2DM effectively manage their diabetes and was associated with improved BG control over 12 weeks. Real-time visibility to subject data may help HCPs deliver focused and effective remote consultations.

Accurate self-monitoring of blood glucose is a key component of effective self-management of glycemic control. Accurate self-monitoring of blood glucose results are required for optimal insulin dosing and detection of hypoglycemia. However, blood glucose monitoring systems may be susceptible to error from test strip, user, environmental and pharmacological factors. This report evaluated 5 blood glucose monitoring systems that each use Verio glucose test strips for precision, effect of hematocrit and interferences in laboratory testing, and lay user and system accuracy in clinical testing according to the guidelines in ISO15197:2013(E). Performance of OneTouch(®) VerioVue™ met or exceeded standards described in ISO15197:2013 for precision, hematocrit performance and interference testing in a laboratory setting. Performance of OneTouch(®) Verio IQ™, OneTouch(®) Verio Pro™, OneTouch(®) Verio™, OneTouch(®) VerioVue™ and Omni Pod each met or exceeded accuracy standards for user performance and system accuracy in a clinical setting set forth in ISO15197:2013(E).

Aims: The ability of patients to achieve glycemic control depends in part on their ability to interpret and act on blood glucose (BG) results. This clinical study was conducted to determine if a simple on-meter color range indicator (CRI) could improve the ability of patients to categorize BG values into low, in-range, and high glycemic ranges. Methods: The clinical study was conducted in 59 subjects with type 2 diabetes (T2DM). Subjects classified 50 general, 15 before- and 15 after-meal BG values as low, in-range, or high based on their current knowledge. Subjects then interactively experienced the on-meter CRI, which showed whether alternate BG values were low, in-range, or high. After CRI interaction, subjects repeated the original scoring assessment followed by a survey exploring their awareness of glucose ranges. Results: Following interaction with the CRI, subjects improved their ability to categorize general, before-meal and after-meal BG results by 23.4% ± 3.0% (SEM), 14.2% ± 2.4%, and 16.1% ± 2.9%, respectively (all P < .001), into low, in-range, and high glycemic ranges. Improvement was not accompanied by an increase in time spent categorizing results. There was no correlation between subject HbA1c, test frequency, or duration of diabetes and ability to correctly classify results. Subjects agreed the CRI feature helped them easily interpret glucose values and improved their awareness of glucose ranges. Conclusion: A short interactive session with a meter including a CRI feature improved the ability of T2DM subjects to interpret and categorize BG values into recommended ranges.

Background: Mobile diabetes apps enable health care professionals (HCPs) to monitor patient progress, offer remote consultations, and allow more effective and informed treatment decisions between patients and HCPs. The OneTouch Reveal app aggregates data from a blood glucose meter and provides analytics to help patients and HCPs visualize glycemic trends and patterns, enabling more informed treatment and lifestyle decisions. The app also allows patients and HCPs to keep connected by exchanging text messages (short message service [SMS]) or progress reports via email. Objective: The primary objective of our study was to assess changes in glycemic control and overall experiences of patients and HCPs using the app in conjunction with the wireless OneTouch Verio Flex blood glucose meter. Methods: We randomly assigned 137 adults with type 1 (T1DM) or type 2 diabetes mellitus (T2DM) and a glycated hemoglobin (HbA1c) level of ≥7.5% and ≤11.0% to use the glucose meter alone or glucose meter plus the app for 24 weeks. The meter + app group were scheduled to receive diabetes-related text messages from their HCP every 2 weeks (total of 12 texts). Clinical measures and self-reported outcomes were assessed during face-to-face clinic visits between the participant and a diabetes nurse at baseline, week 12, and week 24. Results: In 128 completed participants, HbA1c decreased after 12 and 24 weeks in both the meter-only (n=66) (0.56% and 0.55%, respectively) and meter + app groups (n=62) (0.78% and 0.67%, respectively) compared with baseline (each P

Background: There is a perception that patients with diabetes struggle to produce sufficient blood to fill glucose test strips, including strips with 1-µL fill requirements. The purpose of this study was to determine the volume of blood expressed when these patients perform routine fingersticks using their own lancing device and sampling technique and to evaluate the relationship between blood volume and pain. Methods: Sixty-four patients (type 1 or type 2 diabetes) performed 8 fingersticks using their own lancing device and preferred depth setting and lancing technique. Eight different commercially available lancing systems were used (8 patients/system). Blood volume and perceived pain were recorded after each fingerstick. Results: The mean blood volume across all patients was 3.1 µL (512 fingersticks), with 97% of patients expressing a mean of ≥1.0 µL of blood. There was no correlation between pain response and the volume of blood expressed. Nearly all patients agreed that they could easily and comfortably obtain a 1-µL blood sample, and most patients actually preferred a larger drop size to ease sampling and avoid wasting strips. Conclusion: These results provide evidence across 8 lancing systems that challenge the current perceptions that patients with diabetes struggle to produce sufficient blood samples to fill most test strips, including those with 1-µL fill requirements, and that obtaining larger volumes of blood is more painful. These results are consistent with the previous literature suggesting that patients derive no real benefits from very low strip volumes and generally prefer a blood drop size that enables them to confidently fill their test strip.

Background: Health care professionals (HCPs) routinely review handwritten blood glucose (BG) logbooks during office visits of patients with diabetes. Method: In this study, 64 HCPs were asked to assess glycemic patterns and estimate BG averages in six simulated handwritten logbooks. The HCPs then reviewed the pattern logs and averages in six OneTouch® Verio™IQ meters containing corresponding data sets. Results: The average time needed for pattern review was 7.3 min for handwritten logbooks versus 0.9 min using the meter. The total error rate for logbook pattern identification was 43.0% compared with the meter. The mean percentage deviation between HCP estimates of 30-day BG averages and actual values was 14.5%. Conclusions: The meter is associated with faster and more accurate pattern analysis compared with handwritten logbooks.

A variety of substituted tetrahydropyrido[4,3- d ]pyrimidines was prepared and found to possess gastric antilesion against ethanol-induced lesions in rats. The more potent compounds possessed similar activity against aspirin-induced gastric lesions. A selective group of compounds was determined to be inactive as gastric antisecretory agents in rabbit isolated parietal cells. The antilesion properties of these tetrahydropyrido[4,3- d ]pyrimidines make them a potential alternative to prostaglandin therapy for gastric antilesion therapy and may have clinical utility in peptic ulcer disease.

A variety of substituted tetrahydropyrido[4,3- d ]pyrimidines was prepared and found to possess gastric antilesion against ethanol-induced lesions in rats. The more potent compounds possessed similar activity against aspirin-induced gastric lesions. A selective group of compounds was determined to be inactive as gastric antisecretory agents in rabbit isolated parietal cells. The antilesion properties of these tetrahydropyrido[4,3- d ]pyrimidines make them a potential alternative to prostaglandin therapy for gastric antilesion therapy and may have clinical utility in peptic ulcer disease.

We performed a trial to assess the safety and tolerability of sequential bronchopulmonary segmental lavage with a dilute synthetic surfactant (Surfaxin) in 12 adults with ARDS. Patients received one of three dosing regimens in which aliquots of Surfaxin were administered via a wedged bronchoscope to each of the 19 bronchopulmonary segments. Suctioning was performed 10-30 s after instillation of individual aliquots. Group 1 patients (n = 3) received one 30-ml aliquot of a 2.5-mg/ml concentration of Surfaxin in each segment, followed by a second 30-ml aliquot with a 10-mg/ml concentration. Group 2 patients (n = 4) received two 30-ml aliquots of the 2.5-mg/ml concentration followed by a third lavage with the 10-mg/ml concentration. Group 3 patients (n = 5) received therapy identical to that received by patients in Group 2 and were eligible for repeat dosing 6 to 24 h later. All patients tolerated the procedure. There were no serious adverse experiences ascribed to either the procedure or the surfactant. In the 96 h after treatment initiation, FI(O(2)) decreased from 0.80 to 0.52 and PEEP decreased from 10.3 to 7.6 cm H(2)O. Bronchoscopic "cleansing" of the lungs with dilute Surfaxin may offer a safe and feasible approach to improving outcomes in patients with ARDS. Wiswell TE, Smith RM, Katz LB, Mastroianni L, Wong DY, Willms D, Heard S, Wilson M, Hite RD, Anzueto A, Revak SD, Cochrane CG. Bronchopulmonary segmental lavage with Surfaxin (KL(4)-surfactant) for acute respiratory distress syndrome.

The syntheses and antihypertensive activity of the thieno[3,4- b ]pyran and thieno[2,3- b ]pyran isosteres of the potassium channel opener (PCO) RWJ 26629 (± 2a ) are reported. While the unsubstituted thiophene derivatives were active at 20 mg/kg, introduction of a strong electron withdrawing group in the 2-position of the thieno[3,2- b ] series increased potency. Similar substitution on the thieno[3,4- b ] series significantly lowered potency. Compounds 26 and 30 are approximately 5-fold more potent than the prototypic PCO cromakalim (± 1 ).

Synthese et etude de l'activite antihypertensive d'[aryl-4 piperazino-2' ethyl-3 tetrahydro-1,2,3,4 acetyl-1] furo [3,4-d] pyrimidinedione-2,4

Synthese et etude de l'activite antihypertensive d'[aryl-4 piperazino-2' ethyl-3 tetrahydro-1,2,3,4 acetyl-1] furo [3,4-d] pyrimidinedione-2,4

It has been hypothesized that prolonged achlorhydria causes compensatory elevation of serum gastrin, and that there is an association in rats between sustained hypergastrinemia, hyperplasia of gastric enterochromaffin-like cells, and subsequent formation of gastric carcinoids in 2-year carcinogenicity studies. The present study examined whether daily administration of gastric antisecretory drugs in rats for 4 days could cause hypergastrinemia associated with inhibition of acid output. Rats were dosed orally for 4 days with the histamine H2-receptor antagonist ranitidine or the H+,K+-sensitive ATPase inhibitor omeprazole, and examined on day 5 for effects on gastric acid secretion and serum gastrin. Omeprazole (138 mg/kg/day significantly inhibited gastric acid secretion and increased serum gastrin levels. Large, single daily doses of ranitidine (1000-2000 mg/kg/day) had no effect on 24-hr acid or gastrin secretion; however, ranitidine did inhibit next-day acid secretion with associated increases in serum gastrin when administered in three divided doses. These results with ranitidine support the hypothesis that a sustained gastric antisecretory action will cause a compensatory hypergastrinemia, regardless of the antisecretory agent used. The ability to detect increased serum gastrin levels associated with inhibition of acid secretion, after administration of antisecretory agents for only 4 days, suggest that this short 5-day test may be useful for determining the potential of antisecretory agents to cause hypergastrinemia due to 24-hr inhibition of acid secretion and may be predictive of long-term hyperplastic changes.

Rioprostil, a primary alcohol prostaglandin E1 analog, prevents gastric lesion formation induced by a variety of irritants, including aspirin, in rats and dogs. In the present study, riopro

This investigation examined the effect of rioprostil, a primary alcohol prostaglandin E1 analog, on betazole-stimulated gastric acid secretion and on basal and food-stimulated (postprandial) serum gastrin levels in gastric fistula dogs. Rioprostil inhibited betazole-stimulated gastric acid secretion with an ED50 of 16 (10-24) micrograms/kg, intragastrically. A near-maximal gastric antisecretory dose (100 micrograms/kg, intragastrically) had no effect on basal serum gastrin levels but significantly attenuated the rapid rise in serum gastrin which follows feeding, a result different from that reported for other prostaglandin E1 analogs. A nonantisecretory dose of rioprostil (1.0 micrograms/kg, intragastrically) also attenuated the rise in postprandial serum gastrin. An antigastrin effect using a nonantisecretory dose of an antiulcer agent has not been reported previously and may indicate that rioprostil has a direct inhibitory effect on secretion of gastrin. The ability of rioprostil to inhibit gastric acid secretion and decrease postprandial peak serum gastrin levels, coupled with previously established cytoprotective efficacy, makes it an attractive clinical candidate for the treatment and prevention of peptic ulcer disease.

Rioprostil, a primary alcohol prostaglandin E1 analog, is currently undergoing clinical evaluation for use in the treatment of peptic ulcer disease. Since antacids are often used in conjunction with other antiulcer agents, studies were conducted to determine if concomitantly administered antacid modifies the antiulcer activity of rioprostil. This investigation showed that concomitant administration of antacid (0.25-1.0 ml Maalox) does not inhibit the ability of rioprostil (0.125-4.0 micrograms/kg, p.o.) to prevent ethanol-induced gastric lesions in rats. The antiulcer effect of the drug combination was additive, suggesting that each compound acts independently to prevent gastric bleeding. These results in animals suggest that clinically the use of antacid will not compromise the efficacy of rioprostil and that the combination may be a useful mode of therapy for the treatment of peptic ulcer disease.

Rioprostil, a primary alcohol prostaglandin E1 analog, inhibits gastric acid secretion and prevents gastric lesions induced by a variety of irritants in experimental animals. Because rioprostil is relatively short-acting, it would be of significant benefit clinically if its duration of action could be extended to allow once daily dosing. This investigation demonstrates that when administered via an osmotically driven pump (Osmet, Alza Corp.), rioprostil prevents the acute effects of aspirin on the gastric mucosa of dogs, accelerates the healing of aspirin-induced gastric lesions, and heals preexisting aspirin-induced gastric lesions during chronic administration of aspiring. The potency of rioprostil against acute gastric lesion formation was greatest when delivered from a 24-hr release pump (ED50 = 0.77 micrograms/kg/24 hr) and was 37 times greater than when administered as a single oral bolus. In addition, this activity occurred at doses which had little or no gastric antisecretory activity in betazole-stimulated Heidenhain pouch dogs. When delivered from a 24-hr pump, rioprostil (100 micrograms/kg/24 hr) healed preexisting aspirin-induced gastric lesions within 8 days after removal of aspirin, or after 15 days during continued daily aspirin administration. Additional studies determined that administration of rioprostil at doses of 720, 1440, or 2160 micrograms/kg/24 hr (935-2805 times the gastroprotective ED50 in 24 hr pumps) was well tolerated, with only slight, transient increases in body temperature, softening of the stools, and mild sedation at the highest dose. Administration of rioprostil daily for 5 days at 960 micrograms/kg/24 hr from 24-hr release pumps was also well tolerated by all dogs with no evidence of any accumulation of effect of rioprostil. In summary, administration of rioprostil via an osmotic pump increases its potency and duration of action against the gastric lesion-inducing effect of aspirin, and maintains a wide ratio of safety.

Prostaglandins may have many biological actions including hypotensive and antipeptic ulcer activity. The purpose of this investigation was to determine if the primary alcohol prostaglandin E1 analog rioprostil1 prevents ethanol-induced gastric lesions (antigastrolesive activity), inhibits gastric acid secretion (antisecretory activity), or causes diarrhea in rats when administered topically, and to compare these responses to the effect of rioprostil following enteral (oral or intraduodenal) administration. Rioprostil exhibited antigastrolesive activity in rats when administered either orally or when applied topically. The topical antigastrolesive potency of rioprostil against ethanol-induced lesions [ED50 = 3.7 (0.5-12) micrograms/kg] was similar to its oral potency [ED50 = 1.9 (1.7-2.2) micrograms/kg]. In 4 hr pylorus-ligated rats, topically administered rioprostil inhibited total gastric acid output with a potency [ED50 = 5.1 (2.6-24) mg/kg] similar to intraduodenal administration [ED50 = 3.7 (2.8-5.3) mg/kg]. In addition, in these rats rioprostil increased mucin levels and did not cause dermal irritation. Finally, the incidence of diarrhea was lower when rioprostil was applied topically than when given orally with a 16-fold difference in potency between these two routes of administration. These data show that when rioprostil is applied via the skin it has antigastrolesive, gastric antisecretory and mucus stimulatory effects in rats equal to enteral administration, and a diarrheagenic potency lower than following oral administration. This profile suggests that topical administration of rioprostil may be a useful means of delivery for clinical treatment of peptic ulcer disease.