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1.
BMC Public Health ; 23(1): 1749, 2023 09 08.
Artigo em Inglês | MEDLINE | ID: mdl-37679746

RESUMO

BACKGROUND: Amidst the COVID-19 pandemic, there has been growing concern about the declining mental health and healthy behaviors compared to pre-pandemic levels. Despite this, there is a lack of longitudinal studies that have examined the relationship between health behaviors and mental health during the pandemic. In response, the statewide COVIDsmart longitudinal study was launched. The study's main objective is to better understand the effects of the pandemic on mental health. Findings may provide a foundation for the identification of public health strategies to mitigate future negative impacts of the pandemic. METHODS: Following online recruitment in spring of 2021, adults, ages 18 to 87, filled out social, mental, economic, occupational, and physical health questionnaires on the digital COVIDsmart platform at baseline and through six monthly follow-ups. Changes in the participant's four health behaviors (e.g., tobacco and alcohol consumption, physical activity, and social media use), along with sex, age, loneliness score, and reported social and economic (SE) hardships, were analyzed for within-between group associations with depression and anxiety scores using Mixed Models Repeated Measures. RESULTS: In this study, of the 669 individuals who reported, the within-between group analysis indicated that younger adults (F = 23.81, p < 0.0001), loneliness (F = 234.60, p < 0.0001), SE hardships (F = 31.25, p < 0.0001), increased tobacco use (F = 3.05, p = 0.036), decreased physical activity (F = 6.88, p = 0.0002), and both positive and negative changes in social media use (F = 7.22, p = 0.0001) were significantly associated with worse depression scores. Additionally, females (F = 6.01, p = 0.015), younger adults (F = 32.30, p < 0.0001), loneliness (F = 154.59, p < 0.0001), SE hardships (F = 22.13, p < 0.0001), increased tobacco use (F = 4.87, p = 0.004), and both positive and negative changes in social media use (F = 3.51, p = 0.016) were significantly associated with worse anxiety scores. However, no significant changes were observed in the within-between group measurements of depression and anxiety scores over time (p > 0.05). Physical activity was not associated with anxiety nor was alcohol consumption with both depression and anxiety (p > 0.05). CONCLUSIONS: This study demonstrates the longitudinal changes in behaviors within the context of the COVID-19 pandemic. These findings may facilitate the design of preventative population-based health approaches during the COVID-19 pandemic or future pandemics.


Assuntos
COVID-19 , Pandemias , Adulto , Feminino , Humanos , COVID-19/epidemiologia , Depressão/epidemiologia , Estudos Longitudinais , Virginia/epidemiologia , Ansiedade/epidemiologia
2.
Demography ; 59(1): 293-320, 2022 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-35040475

RESUMO

Do neighborhood conditions affect wealth accumulation? This study uses the National Longitudinal Survey of Youth 1979 cohort and a counterfactual estimation strategy to analyze the effect of prolonged exposure to neighborhood (dis)advantage from emerging adulthood through middle adulthood. Neighborhoods have sizable, plausibly causal effects on wealth, but these effects vary significantly by race/ethnicity and homeownership. White homeowners receive the largest payoff to reductions in neighborhood disadvantage. Black adults, regardless of homeownership, are doubly disadvantaged in the neighborhood-wealth relationship. They live in more-disadvantaged neighborhoods and receive little return to reductions in neighborhood disadvantage. Findings indicate that disparities in neighborhood (dis)advantage figure prominently in wealth inequality and the racial wealth gap.


Assuntos
Negro ou Afro-Americano , População Branca , Adolescente , Adulto , População Negra , Humanos , Características de Residência , Fatores Socioeconômicos
4.
Soc Sci Res ; 61: 142-159, 2017 01.
Artigo em Inglês | MEDLINE | ID: mdl-27886725

RESUMO

Do public policies on gay and lesbian rights affect the incidence of hate crimes based on sexual orientation? We propose that legal inequalities increase hate crimes because they provide discursive opportunities for bias, discrimination, and violence. Legal equality, however, will reduce violence. Using annual panel data from 2000 to 2012, a period of substantial policy change, we analyze how three state policies affect reported hate crimes: same-sex partnerships, employment non-discrimination, and hate crime laws. Hate crime and employment non-discrimination laws that include sexual orientation reduce hate crime incidence. Partnership recognition increases reported hate crimes, though it may not increase actual crime incidence. Because incidence is spatially correlated, policy changes in one state yield spillover benefits in other states. These results provide some of the first quantitative evidence that public policies affect hate crimes based on sexual orientation. Findings confirm the roles of institutional heterosexism and discursive opportunities in producing hate crimes.


Assuntos
Ódio , Homofobia , Políticas , Minorias Sexuais e de Gênero , Sexualidade , Discriminação Social/legislação & jurisprudência , Violência/prevenção & controle , Crime , Vítimas de Crime , Emprego/legislação & jurisprudência , Feminino , Regulamentação Governamental , Homofobia/legislação & jurisprudência , Homofobia/psicologia , Homossexualidade Feminina , Homossexualidade Masculina , Direitos Humanos/legislação & jurisprudência , Humanos , Incidência , Amor , Masculino , Casamento/legislação & jurisprudência , Comportamento Sexual , Parceiros Sexuais
5.
Ophthalmology ; 122(2): 302-7, 2015 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-25270273

RESUMO

OBJECTIVE: AR-13324 is a small-molecule inhibitor of Rho kinase and a norepinephrine transporter. The objective of this 28-day study was to evaluate the ocular hypotensive efficacy and safety of AR-13324 ophthalmic solution compared with a positive control, latanoprost ophthalmic solution, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT). DESIGN: Double-masked, randomized study in 22 private practice ophthalmology clinics. PARTICIPANTS: Participants were required to be adults with a diagnosis of OAG or OHT with unmedicated intraocular pressure (IOP) in the range of 22 to 36 mmHg. METHODS: Patients were randomized to receive AR-13324 ophthalmic solution 0.01%, daily (pm), AR-13324 ophthalmic solution 0.02% daily (pm), or latanoprost 0.005% daily (pm) for 28 days. MAIN OUTCOME MEASURES: The primary efficacy endpoint was the mean diurnal IOP across subjects within the treatment group at day 28. RESULTS: Randomized and treated were 224 patients, 213 (95.1%) of whom completed the study. On day 28, mean diurnal IOP was 20.1, 20.0, and 18.7 mmHg in the AR-13324 0.01%, 0.02%, and latanoprost groups, respectively, representing a decrease from unmedicated baseline of 5.5, 5.7, and 6.8 mmHg (P<0.001). The 5.7-mmHg reduction in IOP by AR-13324 0.02% did not meet the criterion for noninferiority to latanoprost. The most frequently reported adverse event was conjunctival/ocular hyperemia, with a combined incidence of 52%, 57%, and 16%, respectively. On day 28 at 08:00 hours, the incidence of mild to moderate hyperemia by biomicroscopy was 18%, 24%, and 11%, respectively. CONCLUSIONS: AR-13324 0.02% was less effective than latanoprost by approximately 1 mmHg in patients with unmedicated IOPs of 22 to 35 mmHg. The major safety finding was ocular hyperemia, which was more common for both concentrations of AR-13324 than for latanoprost.


Assuntos
Anti-Hipertensivos/uso terapêutico , Benzoatos/uso terapêutico , Glaucoma de Ângulo Aberto/tratamento farmacológico , Pressão Intraocular/efeitos dos fármacos , Proteínas da Membrana Plasmática de Transporte de Norepinefrina/antagonistas & inibidores , Soluções Oftálmicas/uso terapêutico , Prostaglandinas F Sintéticas/uso terapêutico , beta-Alanina/análogos & derivados , Quinases Associadas a rho/antagonistas & inibidores , Administração Tópica , Adulto , Idoso , Idoso de 80 Anos ou mais , Anti-Hipertensivos/efeitos adversos , Benzoatos/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Latanoprosta , Masculino , Pessoa de Meia-Idade , Hipertensão Ocular/tratamento farmacológico , Soluções Oftálmicas/efeitos adversos , Prostaglandinas F Sintéticas/efeitos adversos , Tonometria Ocular , Adulto Jovem , beta-Alanina/efeitos adversos , beta-Alanina/uso terapêutico
6.
Am J Ophthalmol ; 2024 Aug 30.
Artigo em Inglês | MEDLINE | ID: mdl-39218389

RESUMO

PURPOSE: In this study the safety and efficacy of silk-derived protein 4 (SDP-4), also known as amlisimod, eye drops against a vehicle control formulation in patients with moderate to severe dry eye disease (DED) was assessed. SDP-4 is a novel, naturally derived, anti-inflammatory wetting agent that enhances coating on the ocular surface. DESIGN: Exploratory Phase 2, 12- and 8-week, serial cohort, multicenter, double-masked, randomized, vehicle-controlled study. METHODS: In the first cohort (N=305), patients were randomized 1:1:1:1 to SDP-4 (0.1%, 1%, 3% wt./wt.) or vehicle control and dosed two times per day (BID), while in the second cohort patients were randomized 1:1 with 1% wt./wt. SDP-4, the best performing formulation from the first cohort, or vehicle control BID (N=151). Diagnosed DED patients were treated in the United States between April 2019 and May 2021. The first cohort of subjects had moderate to severe baseline symptoms, while the second cohort had moderate baseline symptoms to study the impact of baseline symptoms on SDP-4 performance. Key sign and symptom end points were mean change from baseline in TBUT and total SANDE score (0-100 visual analog scale) throughout the study. RESULTS: SDP-4 (1%) significantly increased TBUT vs the vehicle control (P<0.05) at days 28 and 56 in the first cohort, and patient symptomatology from baseline was reduced by 46% based on subject reported SANDE VAS scores at day 84. Patients with more severe baseline DED symptoms experienced a significantly greater amount of relief than when compared to patients with moderate DED (P<0.05). All treatment groups were well tolerated with a 2.6% total discontinuation rate. CONCLUSIONS: To the best of our knowledge, this was the first-in-human use of SDP-4 in a clinical trial. SDP-4 is a first-in-class protein ingredient that offers a safe and multi-modal treatment approach for alleviating severe DED symptoms within a novel formulation.

7.
J Pain Res ; 17: 3063-3074, 2024.
Artigo em Inglês | MEDLINE | ID: mdl-39308991

RESUMO

Purpose: The recent SENZA-PDN study showed that high-frequency (10kHz) spinal cord stimulation (SCS) provided significant, durable pain relief for individuals with painful diabetic neuropathy (PDN), along with secondary benefits, including improved sleep quality and HRQoL. Given that metabolic factors and chronic neuropathic pain are related, we evaluated potential secondary effects of 10kHz SCS on hemoglobin A1c (HbA1c) and weight in SENZA-PDN participants with type 2 diabetes (T2D). Patients and Methods: This analysis included 144 participants with T2D and lower limb pain due to PDN who received 10kHz SCS during the SENZA-PDN study. Changes in HbA1c, weight, pain intensity, and sleep were evaluated over 24 months, with participants stratified according to preimplantation HbA1c (>7% and >8%) and body mass index (BMI; ≥30 and ≥35 kg/m2). Results: At 24 months, participants with preimplantation HbA1c >7% and >8% achieved clinically meaningful and statistically significant mean reductions in HbA1c of 0.5% (P = 0.031) and 1.1% (P = 0.004), respectively. Additionally, we observed a significant mean weight loss of 3.1 kg (P = 0.003) across all study participants. In subgroups with BMI ≥30 and ≥35 kg/m2, weight reductions at 24 months were 4.1 kg (P = 0.001) and 5.4 kg (P = 0.005), respectively. These reductions were accompanied by a mean pain reduction of 79.8% and a mean decrease in pain interference with sleep of 65.2% at 24 months across all cohorts. Conclusion: This is the first study of SCS to demonstrate long-term, significant, and clinically meaningful reductions in HbA1c and weight in study participants with PDN and T2D, particularly among those with elevated preimplantation HbA1c and BMI. Although the mechanism for these improvements has yet to be established, the results suggest possible direct and indirect metabolic benefits with 10kHz SCS in addition to durable pain relief. Trial Registration: ClincalTrials.gov Identifier, NCT03228420.

8.
Healthc Financ Manage ; 67(3): 122-4, 126, 2013 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-23513762

RESUMO

To ensure a successful transition to ICD-IO, hospitals should: Investigate industry guidelines. Analyze claims using mapping tools. Measure the potential impact on payment. Practice ICD-10 coding in collaboration with payers. Study cost reduction opportunities.


Assuntos
Economia Hospitalar , Classificação Internacional de Doenças , Custos e Análise de Custo , Técnicas de Planejamento , Estados Unidos
9.
JMIR Form Res ; 7: e37550, 2023 Mar 15.
Artigo em Inglês | MEDLINE | ID: mdl-36795656

RESUMO

BACKGROUND: The COVID-19 pandemic has affected people's lives beyond severe and long-term physical health symptoms. Social distancing and quarantine have led to adverse mental health outcomes. COVID-19-induced economic setbacks have also likely exacerbated the psychological distress affecting broader aspects of physical and mental well-being. Remote digital health studies can provide information about the pandemic's socioeconomic, mental, and physical impact. COVIDsmart was a collaborative effort to deploy a complex digital health research study to understand the impact of the pandemic on diverse populations. We describe how digital tools were used to capture the effects of the pandemic on the overall well-being of diverse communities across large geographical areas within the state of Virginia. OBJECTIVE: The aim is to describe the digital recruitment strategies and data collection tools applied in the COVIDsmart study and share the preliminary study results. METHODS: COVIDsmart conducted digital recruitment, e-Consent, and survey collection through a Health Insurance Portability and Accountability Act-compliant digital health platform. This is an alternative to the traditional in-person recruitment and onboarding method used for studies. Participants in Virginia were actively recruited over 3 months using widespread digital marketing strategies. Six months of data were collected remotely on participant demographics, COVID-19 clinical parameters, health perceptions, mental and physical health, resilience, vaccination status, education or work functioning, social or family functioning, and economic impact. Data were collected using validated questionnaires or surveys, completed in a cyclical fashion and reviewed by an expert panel. To retain a high level of engagement throughout the study, participants were incentivized to stay enrolled and complete more surveys to further their chances of receiving a monthly gift card and one of multiple grand prizes. RESULTS: Virtual recruitment demonstrated relatively high rates of interest in Virginia (N=3737), and 782 (21.1%) consented to participate in the study. The most successful recruitment technique was the effective use of newsletters or emails (n=326, 41.7%). The primary reason for contributing as a study participant was advancing research (n=625, 79.9%), followed by the need to give back to their community (n=507, 64.8%). Incentives were only reported as a reason among 21% (n=164) of the consented participants. Overall, the primary reason for contributing as a study participant was attributed to altruism at 88.6% (n=693). CONCLUSIONS: The COVID-19 pandemic has accelerated the need for digital transformation in research. COVIDsmart is a statewide prospective cohort to study the impact of COVID-19 on Virginians' social, physical, and mental health. The study design, project management, and collaborative efforts led to the development of effective digital recruitment, enrollment, and data collection strategies to evaluate the pandemic's effects on a large, diverse population. These findings may inform effective recruitment techniques across diverse communities and participants' interest in remote digital health studies.

10.
Sci Adv ; 8(7): eabl3825, 2022 Feb 18.
Artigo em Inglês | MEDLINE | ID: mdl-35179963

RESUMO

Race and class disparities in COVID-19 cases are well documented, but pathways of possible transmission by neighborhood inequality are not. This study uses administrative data on COVID-19 cases for roughly 2000 census tracts in Wisconsin, Seattle/King County, and San Francisco to analyze how neighborhood socioeconomic (dis)advantage predicts cumulative caseloads through February 2021. Unlike past research, we measure a neighborhood's disadvantage level using both its residents' demographics and the demographics of neighborhoods its residents visit and are visited by, leveraging daily mobility data from 45 million mobile devices. In all three jurisdictions, we find sizable disparities in COVID-19 caseloads. Disadvantage in a neighborhood's mobility network has greater impact than its residents' socioeconomic characteristics. We also find disparities by neighborhood racial/ethnic composition, which can be explained, in part, by residential and mobility-based disadvantage. Neighborhood conditions measured before a pandemic offer substantial predictive power for subsequent incidence, with mobility-based disadvantage playing an important role.

11.
J Diabetes Sci Technol ; 16(5): 1167-1173, 2022 09.
Artigo em Inglês | MEDLINE | ID: mdl-34008442

RESUMO

OBJECTIVE: CeQur Simplicity™ (CeQur, Marlborough, MA) is a 3-day insulin delivery patch designed to meet mealtime insulin requirements. A recently reported 48-week, randomized, multicenter, interventional trial compared efficacy, safety and self-reported outcomes in 278 adults with type 2 diabetes (T2D) on basal insulin therapy who initiated and managed mealtime insulin therapy with a patch pump versus insulin pen. We assessed changes in key glycemic metrics among a subset of patients who wore a continuous glucose monitoring (CGM) device. METHODS: Study participants (patch, n = 49; pen, n = 48) wore a CGM device in masked setting during the baseline period and prior to week 24. Glycemic control was assessed using international consensus guidelines for percentage of Time In Range (%TIR: >70% at 70-180 mg/dL), Time Below Range (%TBR: <4% at <70 mg/dL; <1% at <54 mg/dL), and Time Above Range (%TAR: <25% at >180 mg/dL; <5% at >250 mg/dL). RESULTS: Both the patch and pen groups achieved recommended targets in %TIR (74.1% ± 18.7%, 75.2 ± 16.1%, respectively) and marked reductions in %TAR >180 mg/dL (21.1% ± 19.9%, 19.7% ± 17.5%, respectively) but with increased %TBR <70 mg/dL (4.7% ± 5.2%, 5.1 ± 5.8, respectively), all P < .0001. No significant between-group differences in glycemic improvements or adverse events were observed. CONCLUSIONS: CGM confirmed that the patch or pen can be used to safely initiate and optimize basal-bolus therapy using a simple insulin adjustment algorithm with SMBG. Preference data suggest that use of the patch vs pen may enhance treatment adherence.


Assuntos
Diabetes Mellitus Tipo 1 , Diabetes Mellitus Tipo 2 , Adulto , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes , Insulina
12.
Ophthalmology ; 118(8): 1580-7, 2011 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-21813090

RESUMO

PURPOSE: We studied the 3-year efficacy and safety results of a 4-year study evaluating fluocinolone acetonide (FA) intravitreal implants in eyes with persistent or recurrent diabetic macular edema (DME). DESIGN: Prospective, evaluator-masked, controlled, multicenter clinical trial. PARTICIPANTS: We included 196 eyes with refractory DME. METHODS: Patients were randomized 2:1 to receive 0.59-mg FA implant (n = 127) or standard of care (SOC additional laser or observation; n = 69). The implant was inserted through a pars plana incision. Visits were scheduled on day 2, weeks 1, 3, 6, 12, and 26, and thereafter every 13 weeks through 3 years postimplantation. MAIN OUTCOME MEASURES: The primary efficacy outcome was ≥15-letter improvement in visual acuity (VA) at 6 months. Secondary outcomes included resolution of macular retinal thickening and Diabetic Retinopathy Severity Score (DRSS). Safety measures included incidence of adverse events (AEs). RESULTS: Overall, VA improved ≥3 lines in 16.8% of implanted eyes at 6 months (P=0.0012; SOC, 1.4%); in 16.4% at 1 year (P=0.1191; SOC, 8.1%); in 31.8% at 2 years (P=0.0016; SOC, 9.3%); and in 31.1% at 3 years (P=0.1566; SOC, 20.0%). The number of implanted eyes with no evidence of retinal thickening at the center of the macula was higher than SOC eyes at 6 months (P<0.0001), 1 year (P<0.0001; 72% vs 22%), 2 years (P=0.016), and 3 years (P=0.861). A higher rate of improvement and lower rate of decline in DRSS occurred in the implanted group versus the SOC group at 6 months (P=0.0006), 1 year (P=0.0016), 2 years (P=0.012), and 3 years (P=0.0207). Intraocular pressure (IOP) ≥30 mmHg was recorded in 61.4% of implanted eyes (SOC, 5.8%) at any time and 33.8% required surgery for ocular hypertension by 4 years. Of implanted phakic eyes, 91% (SOC, 20%) had cataract extraction by 4 years. CONCLUSIONS: The FA intravitreal implant met the primary and secondary outcomes, with significantly improved VA and DRSS and reduced DME. The most common AEs included cataract progression and elevated IOP. The 0.59-mg FA intravitreal implant may be an effective treatment for eyes with persistent or recurrent DME. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.


Assuntos
Retinopatia Diabética/tratamento farmacológico , Fluocinolona Acetonida/administração & dosagem , Glucocorticoides/administração & dosagem , Edema Macular/tratamento farmacológico , Corpo Vítreo/efeitos dos fármacos , Catarata/induzido quimicamente , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/fisiopatologia , Método Duplo-Cego , Implantes de Medicamento , Feminino , Fluocinolona Acetonida/efeitos adversos , Angiofluoresceinografia , Glucocorticoides/efeitos adversos , Humanos , Pressão Intraocular/efeitos dos fármacos , Pressão Intraocular/fisiologia , Edema Macular/diagnóstico , Edema Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Recidiva , Retina/efeitos dos fármacos , Retina/patologia , Tomografia de Coerência Óptica , Resultado do Tratamento , Acuidade Visual/efeitos dos fármacos , Acuidade Visual/fisiologia
13.
J Diabetes Sci Technol ; 13(3): 575-583, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-30453761

RESUMO

Currently, patients with diabetes may choose between two major types of system for glucose measurement: blood glucose monitoring (BGM) systems measuring glucose within capillary blood and continuous glucose monitoring (CGM) systems measuring glucose within interstitial fluid. Although BGM and CGM systems offer different functionality, both types of system are intended to help users achieve improved glucose control. Another area in which BGM and CGM systems differ is measurement accuracy. In the literature, BGM system accuracy is assessed mainly according to ISO 15197:2013 accuracy requirements, whereas CGM accuracy has hitherto mainly been assessed by MARD, although often results from additional analyses such as bias analysis or error grid analysis are provided. The intention of this review is to provide a comparison of different approaches used to determine the accuracy of BGM and CGM systems and factors that should be considered when using these different measures of accuracy to make comparisons between the analytical performance (ie, accuracy) of BGM and CGM systems. In addition, real-world implications of accuracy and its relevance are discussed.


Assuntos
Glicemia/análise , Diabetes Mellitus/sangue , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/normas , Aprovação de Equipamentos , Diabetes Mellitus/diagnóstico , Fidelidade a Diretrizes , Humanos , Legislação de Dispositivos Médicos , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Estados Unidos , United States Food and Drug Administration
14.
Diabetes Technol Ther ; 21(5): 273-285, 2019 05.
Artigo em Inglês | MEDLINE | ID: mdl-31025878

RESUMO

Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen. Methods: Adults with type 2 diabetes (n = 278, age: 59.2 ± 8.9 years), were randomized to patch (n = 139) versus pen (n = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets. Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved (P < 0.0001) in both arms, -1.7% ± 0.1% and -1.6% ± 0.1% for patch and pen (-18.6 ± 1.1 and -17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more (P = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin. Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/administração & dosagem , Sistemas de Infusão de Insulina , Insulina/administração & dosagem , Idoso , Glicemia , Diabetes Mellitus Tipo 2/sangue , Feminino , Humanos , Hipoglicemiantes/uso terapêutico , Injeções Intramusculares , Insulina/uso terapêutico , Masculino , Refeições , Pessoa de Meia-Idade , Resultado do Tratamento
16.
J Diabetes Sci Technol ; 12(6): 1211-1219, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29848106

RESUMO

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.


Assuntos
Técnicas Biossensoriais/instrumentação , Glicemia/análise , Cor , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 2/sangue , Adulto , Idoso , Técnicas Biossensoriais/métodos , Automonitorização da Glicemia/instrumentação , Automonitorização da Glicemia/métodos , Apresentação de Dados/normas , Feminino , Hemoglobinas Glicadas/análise , Humanos , Masculino , Pessoa de Meia-Idade , Reino Unido , Adulto Jovem
17.
J Diabetes Sci Technol ; 12(5): 1016-1023, 2018 09.
Artigo em Inglês | MEDLINE | ID: mdl-29845873

RESUMO

BACKGROUND: MARD (mean absolute relative difference) is increasingly used to describe performance of glucose monitoring systems, providing a single-value quantitative measure of accuracy and allowing comparisons between different monitoring systems. This study reports MARDs for the OneTouch Verio® glucose meter clinical data set of 80 258 data points (671 individual batches) gathered as part of a 7.5-year self-surveillance program Methods: Test strips were routinely sampled from randomly selected manufacturer's production batches and sent to one of 3 clinic sites for clinical accuracy assessment using fresh capillary blood from patients with diabetes, using both the meter system and standard laboratory reference instrument. RESULTS: Evaluation of the distribution of strip batch MARD yielded a mean value of 5.05% (range: 3.68-6.43% at ±1.96 standard deviations from mean). The overall MARD for all clinic data points (N = 80 258) was also 5.05%, while a mean bias of 1.28 was recorded. MARD by glucose level was found to be consistent, yielding a maximum value of 4.81% at higher glucose (≥100 mg/dL) and a mean absolute difference (MAD) of 5.60 mg/dL at low glucose (<100 mg/dL). MARD by year of manufacture varied from 4.67-5.42% indicating consistent accuracy performance over the surveillance period. CONCLUSIONS: This 7.5-year surveillance program showed that this meter system exhibits consistently low MARD by batch, glucose level and year, indicating close agreement with established reference methods whilste exhibiting lower MARD values than continuous glucose monitoring (CGM) systems and providing users with confidence in the performance when transitioning to each new strip batch.


Assuntos
Automonitorização da Glicemia/normas , Glicemia/análise , Vigilância de Produtos Comercializados , Fitas Reagentes/normas , Humanos
18.
JMIR Diabetes ; 3(1): e1, 2018 Jan 09.
Artigo em Inglês | MEDLINE | ID: mdl-30291071

RESUMO

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.

19.
Vascul Pharmacol ; 47(1): 57-62, 2007 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-17490917

RESUMO

OBJECTIVE: Nitric oxide (NO) is an important signaling molecule that acts in many tissues to regulate a diverse range of physiological processes. NO has been implicated in a number of cardiovascular diseases. Reduced basal NO synthesis or function may lead to: vasoconstriction, elevated blood pressure and thrombus formation. By contrast, overproduction of NO results in vasodilatation, hypotension, vascular leakage, and disruption of cell metabolism. The purpose of this study was to determine the effects of NO gas directly infused into the arteries. METHODS: The study was performed on 28 rabbits and 10 pigs. We developed a device that enables quantitatively controlled infusion of NO gas, directly into the arteries. RESULTS: We found that administration of NO gas via arteries caused widening of the blood vessels as well as increasing blood flow in the extremity. It emerges that. These effects persist up to 2-3 h after the NO infusion ceased. Although the NO breaks down when diffused in blood, its influence commences rapidly and continues for a relatively long time. CONCLUSIONS: Our findings indicate that, administration of NO into blood vessels causes a long lasting vasodilatation and enhanced blood flow. Despite the fact that NO is broken down rapidly.


Assuntos
Infusões Intra-Arteriais/métodos , Óxido Nítrico/administração & dosagem , Animais , Feminino , Masculino , Óxido Nítrico/farmacologia , Coelhos , Fluxo Sanguíneo Regional/efeitos dos fármacos
20.
RSF ; 3(3): 100-125, 2017 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-28547003

RESUMO

Labor migration offers an important mechanism to reallocate workers when there are regional differences in employment conditions. Whereas conventional wisdom suggests migration rates should increase during recessions as workers move out of areas that are hit hardest, initial evidence suggested that overall migration rates declined during the Great Recession, despite large regional differences in unemployment and growth rates. In this paper, we use data from the American Community Survey to analyze internal migration trends before and during the economic downturn. First, we find only a modest decline in the odds of adults leaving distressed labor market areas during the recession, which may result in part from challenges related to the housing price crash. Second, we estimate conditional logit models of destination choice for individuals who migrate across labor market areas and find a substantial effect of economic factors such as labor demand, unemployment, and housing values. We also estimate latent class conditional logit models that test whether there is heterogeneity in preferences for destination characteristics among migrants. Over all, the latent class models suggest that roughly equal percentages of migrants were motivated by economic factors before and during the recession. We conclude that fears of dramatic declines in labor migration seem to be unsubstantiated.

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