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Diabetic foot ulcers (DFUs) often become infected and are treated with antimicrobials, with samples collected to inform care. Swab samples are easier than tissue sampling but report fewer organisms. Compared with culture and sensitivity (C&S) methods, molecular microbiology identifies more organisms. Clinician perspectives on sampling and processing are unknown. We explored clinician perspectives on DFU sampling-tissue samples/wound swabs-and on processing techniques, culture and sensitivity or molecular techniques. The latter provides information on organisms which have not survived transport to the laboratory for culture. We solicited feedback on molecular microbiology reports. Qualitative study using semi-structured interview, with analysis using a Framework approach. CODIFI2 clinicians from UK DFU clinics. Seven consultants agreed to take part. They reported, overall, a preference for tissue samples over swabbing. Clinicians were not confident replacing C&S with molecular microbiology as the approach to reporting was unfamiliar. The study was small and did not recruit any podiatrists or nurses, who may have discipline-specific attitudes or perspectives on DFU care. Both sampling approaches appear to be used by clinicians. Molecular microbiology reports would not be, at present, suitable for replacement of traditional culture and sensitivity.
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Pé Diabético , Pesquisa Qualitativa , Manejo de Espécimes , Pé Diabético/microbiologia , Pé Diabético/terapia , Humanos , Manejo de Espécimes/métodos , Masculino , Feminino , Reino Unido , Pessoa de Meia-Idade , Adulto , Idoso , Infecção dos Ferimentos/microbiologia , Infecção dos Ferimentos/terapiaRESUMO
BACKGROUND: Current clinical diagnosis pathway for lysosomal storage disorders (LSDs) involves sequential biochemical enzymatic tests followed by DNA sequencing, which is iterative, has low diagnostic yield and is costly due to overlapping clinical presentations. Here, we describe a novel low-cost and high-throughput sequencing assay using single-molecule molecular inversion probes (smMIPs) to screen for causative single nucleotide variants (SNVs) and copy number variants (CNVs) in genes associated with 29 common LSDs in India. RESULTS: 903 smMIPs were designed to target exon and exon-intron boundaries of targeted genes (n = 23; 53.7 kb of the human genome) and were equimolarly pooled to create a sequencing library. After extensive validation in a cohort of 50 patients, we screened 300 patients with either biochemical diagnosis (n = 187) or clinical suspicion (n = 113) of LSDs. A diagnostic yield of 83.4% was observed in patients with prior biochemical diagnosis of LSD. Furthermore, diagnostic yield of 73.9% (n = 54/73) was observed in patients with high clinical suspicion of LSD in contrast with 2.4% (n = 1/40) in patients with low clinical suspicion of LSD. In addition to detecting SNVs, the assay could detect single and multi-exon copy number variants with high confidence. Critically, Niemann-Pick disease type C and neuronal ceroid lipofuscinosis-6 diseases for which biochemical testing is unavailable, could be diagnosed using our assay. Lastly, we observed a non-inferior performance of the assay in DNA extracted from dried blood spots in comparison with whole blood. CONCLUSION: We developed a flexible and scalable assay to reliably detect genetic causes of 29 common LSDs in India. The assay consolidates the detection of multiple variant types in multiple sample types while having improved diagnostic yield at same or lower cost compared to current clinical paradigm.
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Variações do Número de Cópias de DNA , Testes Genéticos , Sequenciamento de Nucleotídeos em Larga Escala , Doenças por Armazenamento dos Lisossomos , Humanos , Doenças por Armazenamento dos Lisossomos/genética , Doenças por Armazenamento dos Lisossomos/diagnóstico , Índia , Variações do Número de Cópias de DNA/genética , Testes Genéticos/métodos , Sequenciamento de Nucleotídeos em Larga Escala/métodos , Polimorfismo de Nucleotídeo Único/genética , Feminino , Masculino , Sondas Moleculares/genéticaRESUMO
AIMS/HYPOTHESIS: The risk of dying within 2 years of presentation with diabetic foot ulceration is over six times the risk of amputation, with CVD the major contributor. Using an observational evaluation of a real-world implementation pilot, we aimed to assess whether for those presenting with diabetic foot ulceration in England, introducing a 12-lead ECG into routine care followed by appropriate clinical action was associated with reduced mortality. METHODS: Between July 2014 and December 2017, ten multidisciplinary diabetic foot services in England participated in a pilot project introducing 12-lead ECGs for new attendees with foot ulceration. Inception coincided with launch of the National Diabetes Footcare Audit (NDFA), whereby all diabetic footcare services in England were invited to enter data on new attendees with foot ulceration. Poisson regression models assessed the mortality RR at 2 and 5 years following first assessment of those receiving care in a participating pilot unit vs those receiving care in any other unit in England, adjusting for age, sex, ethnicity, deprivation, type and duration of diabetes, ulcer severity, and morbidity in the year prior to first assessment. RESULTS: Of the 3110 people recorded in the NDFA at a participating unit during the pilot, 33% (1015) were recorded as having received an ECG. A further 25,195 people recorded in the NDFA had attended another English footcare service. Unadjusted mortality in the pilot units was 16.3% (165) at 2 years and 37.4% (380) at 5 years for those who received an ECG, and 20.5% (430) and 45.2% (950), respectively, for those who did not receive an ECG. For people included in the NDFA at other units, unadjusted mortality was 20.1% (5075) and 42.6% (10,745), respectively. In the fully adjusted model, mortality was not significantly lower for those attending participating units at 2 (RR 0.93 [95% CI 0.85, 1.01]) or 5 years (RR 0.95 [95% CI 0.90, 1.01]). At participating units, mortality in those who received an ECG vs those who did not was lower at 5 years (RR 0.86 [95% CI 0.76, 0.97]), but not at 2 years (RR 0.87 [95% CI 0.72, 1.04]). Comparing just those that received an ECG with attendees at all other centres in England, mortality was lower at 5 years (RR 0.87 [95% CI 0.78, 0.96]), but not at 2 years (RR 0.86 [95% CI 0.74, 1.01]). CONCLUSIONS/INTERPRETATION: The evaluation confirms the high mortality seen in those presenting with diabetic foot ulceration. Overall mortality at the participating units was not significantly reduced at 2 or 5 years, with confidence intervals just crossing parity. Implementation of the 12-lead ECG into the routine care pathway proved challenging for clinical teams-overall a third of attendees had one, although some units delivered the intervention to over 60% of attendees-and the evaluation was therefore underpowered. Nonetheless, the signals of potential mortality benefit among those who had an ECG suggest that units in a position to operationalise implementation may wish to consider this. DATA AVAILABILITY: Data from the National Diabetes Audit can be requested through the National Health Service Digital Data Access Request Service process at: https://digital.nhs.uk/services/data-access-request-service-dars/dars-products-and-services/data-set-catalogue/national-diabetes-audit-nda.
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Pé Diabético , Eletrocardiografia , Humanos , Pé Diabético/mortalidade , Feminino , Masculino , Inglaterra/epidemiologia , Idoso , Projetos Piloto , Pessoa de Meia-Idade , Amputação Cirúrgica/estatística & dados numéricosRESUMO
Objective: Insulin bolus doses derive from glucose levels and planned carbohydrate intake, although fat and protein impact glycemic excursions. We examined the impact of macronutrients and number of daily meals/snacks on glycemic outcomes in youth with type 1 diabetes. Methods: Youth (N = 136, ages 8-17) with type 1 diabetes completed 3-day food records, wore 3-day masked continuous glucose monitoring, and had A1c measurements every 3 months for 1 year. Diet data were analyzed using Nutrition Data System for Research. Longitudinal mixed models assessed effects of macronutrient intake and number of meals/snacks on glycemic outcomes. Results: At baseline, youth (48% male) had mean age of 12.8 ± 2.5 years and diabetes duration of 5.9 ± 3.1 years; 73% used insulin pumps. Baseline A1c was 8.1% ± 1.0%, percent time in range 70-180 mg/dL (%TIR) was 49% ± 17%, % time below range <70 mg/dL (%TBR) was 6% ± 8%, % time above range >180 mg/dL (%TAR) was 44% ± 20%, and glycemic variability as coefficient of variation (CV) was 41% ± 8%; macronutrient intake included 48% ± 5% carbohydrate, 36% ± 5% fat, and 16% ± 2% protein. Most youth (56%) reported 3-4 meals/snacks daily (range 1-9). Over 1 year, greater carbohydrate intake was associated with lower A1c (P = 0.0003), more %TBR (P = 0.0006), less %TAR (P = 0.002), and higher CV (P = 0.03). Greater fat intake was associated with higher A1c (P = 0.006), less %TBR (P = 0.002), and more %TAR (P = 0.005). Greater protein intake was associated with higher A1c (P = 0.01). More daily meals/snacks were associated with lower A1c (P = 0.001), higher %TIR (P = 0.0006), and less %TAR (P = 0.0001). Conclusions: Both fat and protein impact glycemic outcomes. Future automated insulin delivery systems should consider all macronutrients for timely insulin provision. The present research study derived from secondary analysis of the study registered under NCT00999375.
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Glicemia , Diabetes Mellitus Tipo 1 , Insulina , Refeições , Adolescente , Criança , Feminino , Humanos , Masculino , Glicemia/análise , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/sangue , Diabetes Mellitus Tipo 1/tratamento farmacológico , Carboidratos da Dieta/administração & dosagem , Gorduras na Dieta/administração & dosagem , Ingestão de Energia , Hemoglobinas Glicadas/análise , Controle Glicêmico , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Insulina/administração & dosagem , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Nutrientes/administração & dosagemRESUMO
Background: The Omnipod® 5 Automated Insulin Delivery (AID) System was shown to be safe and effective following 3 months of use in people with type 1 diabetes (T1D); however, data on the durability of these results are limited. This study evaluated the long-term safety and effectiveness of Omnipod 5 use in people with T1D during up to 2 years of use. Materials and Methods: After a 3-month single-arm, multicenter, pivotal trial in children (6-13.9 years) and adolescents/adults (14-70 years), participants could continue system use in an extension phase. HbA1c was measured every 3 months for up to 15 months; continuous glucose monitor metrics were collected for up to 2 years. Results: Participants (N = 224) completed median (interquartile range) 22.3 (21.7, 22.7) months of AID. HbA1c was reduced in the pivotal trial from 7.7% ± 0.9% in children and 7.2% ± 0.9% in adolescents/adults to 7.0% ± 0.6% and 6.8% ± 0.7%, respectively, (P < 0.0001), and was maintained at 7.2% ± 0.7% and 6.9% ± 0.6% after 15 months (P < 0.0001 from baseline). Time in target range (70-180 mg/dL) increased from 52.4% ± 15.6% in children and 63.6% ± 16.5% in adolescents/adults at baseline to 67.9% ± 8.0% and 73.8% ± 10.8%, respectively, during the pivotal trial (P < 0.0001) and was maintained at 65.9% ± 8.9% and 72.9% ± 11.3% during the extension (P < 0.0001 from baseline). One episode of diabetic ketoacidosis and seven episodes of severe hypoglycemia occurred during the extension. Children and adolescents/adults spent median 96.1% and 96.3% of time in Automated Mode, respectively. Conclusion: Our study supports that long-term use of the Omnipod 5 AID System can safely maintain improvements in glycemic outcomes for up to 2 years of use in people with T1D. Clinical Trials Registration Number: NCT04196140.
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Diabetes Mellitus Tipo 1 , Adulto , Criança , Humanos , Adolescente , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Hemoglobinas Glicadas , Sistemas de Infusão de Insulina , Glicemia , Automonitorização da GlicemiaRESUMO
BACKGROUND: Although prior research has identified multiple risk factors for diabetic ketoacidosis (DKA), clinicians continue to lack clinic-ready models to predict dangerous and costly episodes of DKA. We asked whether we could apply deep learning, specifically the use of a long short-term memory (LSTM) model, to accurately predict the 180-day risk of DKA-related hospitalization for youth with type 1 diabetes (T1D). OBJECTIVE: We aimed to describe the development of an LSTM model to predict the 180-day risk of DKA-related hospitalization for youth with T1D. METHODS: We used 17 consecutive calendar quarters of clinical data (January 10, 2016, to March 18, 2020) for 1745 youths aged 8 to 18 years with T1D from a pediatric diabetes clinic network in the Midwestern United States. The input data included demographics, discrete clinical observations (laboratory results, vital signs, anthropometric measures, diagnosis, and procedure codes), medications, visit counts by type of encounter, number of historic DKA episodes, number of days since last DKA admission, patient-reported outcomes (answers to clinic intake questions), and data features derived from diabetes- and nondiabetes-related clinical notes via natural language processing. We trained the model using input data from quarters 1 to 7 (n=1377), validated it using input from quarters 3 to 9 in a partial out-of-sample (OOS-P; n=1505) cohort, and further validated it in a full out-of-sample (OOS-F; n=354) cohort with input from quarters 10 to 15. RESULTS: DKA admissions occurred at a rate of 5% per 180-days in both out-of-sample cohorts. In the OOS-P and OOS-F cohorts, the median age was 13.7 (IQR 11.3-15.8) years and 13.1 (IQR 10.7-15.5) years; median glycated hemoglobin levels at enrollment were 8.6% (IQR 7.6%-9.8%) and 8.1% (IQR 6.9%-9.5%); recall was 33% (26/80) and 50% (9/18) for the top-ranked 5% of youth with T1D; and 14.15% (213/1505) and 12.7% (45/354) had prior DKA admissions (after the T1D diagnosis), respectively. For lists rank ordered by the probability of hospitalization, precision increased from 33% to 56% to 100% for positions 1 to 80, 1 to 25, and 1 to 10 in the OOS-P cohort and from 50% to 60% to 80% for positions 1 to 18, 1 to 10, and 1 to 5 in the OOS-F cohort, respectively. CONCLUSIONS: The proposed LSTM model for predicting 180-day DKA-related hospitalization was valid in this sample. Future research should evaluate model validity in multiple populations and settings to account for health inequities that may be present in different segments of the population (eg, racially or socioeconomically diverse cohorts). Rank ordering youth by probability of DKA-related hospitalization will allow clinics to identify the most at-risk youth. The clinical implication of this is that clinics may then create and evaluate novel preventive interventions based on available resources.
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The diagnosis, prognostication, and differentiation of phenotypes of COPD can be facilitated by CT scan imaging of the chest. CT scan imaging of the chest is a prerequisite for lung volume reduction surgery and lung transplantation. Quantitative analysis can be used to evaluate extent of disease progression. Evolving imaging techniques include micro-CT scan, ultra-high-resolution and photon-counting CT scan imaging, and MRI. Potential advantages of these newer techniques include improved resolution, prediction of reversibility, and obviation of radiation exposure. This article discusses important emerging techniques in imaging patients with COPD. The clinical usefulness of these emerging techniques as they stand today are tabulated for the benefit of the practicing pulmonologist.
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Pulmão , Doença Pulmonar Obstrutiva Crônica , Humanos , Pulmão/diagnóstico por imagem , Tomografia Computadorizada por Raios X , Pneumonectomia , Imageamento por Ressonância Magnética , Doença Pulmonar Obstrutiva Crônica/diagnóstico por imagemRESUMO
AIMS: To evaluate psychosocial outcomes for adults with type 1 diabetes (T1D) using the tubeless Omnipod® 5 Automated Insulin Delivery (AID) System. METHODS: A single-arm, multicenter (across the United States), prospective safety and efficacy study of the tubeless AID system included 115 adults with T1D. Participants aged 18-70 years completed questionnaires assessing psychosocial outcomes - diabetes distress (T1-DDS), hypoglycemic confidence (HCS), well-being (WHO-5), sleep quality (PSQI), insulin delivery satisfaction (IDSS), diabetes treatment satisfaction (DTSQ), and system usability (SUS) - before and after 3 months of AID use. Associations among participant characteristics, psychosocial measures and glycemic outcomes were evaluated using linear regression analyses. RESULTS: Adults using the tubeless AID system demonstrated improvements in diabetes-specific psychosocial measures, including diabetes distress, hypoglycemic confidence, insulin delivery satisfaction, diabetes treatment satisfaction, and system usability after 3 months (all P < 0.001). No changes in general well-being or sleep quality were observed. The psychosocial outcomes assessed were not consistently associated with baseline participant characteristics (i.e., age, sex, diabetes duration, glycemic outcomes including percent time in range 70-180 mg/dL, percent time below range < 70 mg/dL, hemoglobin A1c, or insulin regimen). CONCLUSIONS: Use of the Omnipod 5 AID system was associated with significant improvements in diabetes-related psychosocial outcomes for adults with T1D. CLINICAL TRIALS REGISTRATION NUMBER: NCT04196140.
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Diabetes Mellitus Tipo 1 , Adulto , Glicemia , Automonitorização da Glicemia , Diabetes Mellitus Tipo 1/tratamento farmacológico , Diabetes Mellitus Tipo 1/psicologia , Humanos , Hipoglicemiantes/uso terapêutico , Insulina/uso terapêutico , Sistemas de Infusão de Insulina , Insulina Regular Humana/uso terapêutico , Estudos ProspectivosRESUMO
OBJECTIVE: Medicare Advantage (MA), Medicare's managed care program, is quickly expanding, yet little is known about diabetes care quality delivered under MA compared with traditional fee-for-service (FFS) Medicare. RESEARCH DESIGN AND METHODS: This was a retrospective cohort study of Medicare beneficiaries ≥65 years old enrolled in the Diabetes Collaborative Registry from 2014 to 2019 with type 2 diabetes treated with one or more antihyperglycemic therapies. Quality measures, cardiometabolic risk factor control, and antihyperglycemic prescription patterns were compared between Medicare plan groups, adjusted for sociodemographic and clinical factors. RESULTS: Among 345,911 Medicare beneficiaries, 229,598 (66%) were enrolled in FFS and 116,313 (34%) in MA plans (for ≥1 month). MA beneficiaries were more likely to receive ACE inhibitors/angiotensin receptor blockers for coronary artery disease, tobacco cessation counseling, and screening for retinopathy, foot care, and kidney disease (adjusted P ≤ 0.001 for all). MA beneficiaries had modestly but significantly higher systolic blood pressure (+0.2 mmHg), LDL cholesterol (+2.6 mg/dL), and HbA1c (+0.1%) (adjusted P < 0.01 for all). MA beneficiaries were independently less likely to receive glucagon-like peptide 1 receptor agonists (6.9% vs. 9.0%; adjusted odds ratio 0.80, 95% CI 0.77-0.84) and sodium-glucose cotransporter 2 inhibitors (5.4% vs. 6.7%; adjusted odds ratio 0.91, 95% CI 0.87-0.95). When integrating Centers for Medicare and Medicaid Services-linked data from 2014 to 2017 and more recent unlinked data from the Diabetes Collaborative Registry through 2019 (total N = 411,465), these therapeutic differences persisted, including among subgroups with established cardiovascular and kidney disease. CONCLUSIONS: While MA plans enable greater access to preventive care, this may not translate to improved intermediate health outcomes. MA beneficiaries are also less likely to receive newer antihyperglycemic therapies with proven outcome benefits in high-risk individuals. Long-term health outcomes under various Medicare plans requires surveillance.
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Diabetes Mellitus Tipo 2 , Medicare Part C , Idoso , Diabetes Mellitus Tipo 2/tratamento farmacológico , Planos de Pagamento por Serviço Prestado , Humanos , Hipoglicemiantes/uso terapêutico , Sistema de Registros , Estudos Retrospectivos , Estados UnidosRESUMO
In the process of urinary stone formation, several heavy metals and trace elements (HMTE) have been identified among the major constituents of the calculi. The micro-elements within the stones cannot be identified by ordinary laboratory analytical techniques, the latter can only detect the major crystalline component. The objective of the present study was to evaluate the different types of HMTE (no. 22) and their concentrations within the urinary stones. The stone samples were obtained from patients living in different geographical locations (10 countries: 5 Western and 5 non-Western). The number of retrieved stones after open or endoscopic procedures was 1177. The concentrations of the 22 HMTE in the stones were assessed by inductively coupled plasma optical emission spectrometry (ICP-OES). The statistical data were analyzed using Kruskal-Wallis, one-way ANOVA, and SPSS software (version 20). The biochemical stone analysis showed that calcium oxalate was present as a major component in 650 patients (55.2%), calcium phosphate in 317 (26.9%), and uric acid and cystine stones in 210 (17.8%). The analyzed stones showed the presence of HMTE in different concentrations. Significantly higher concentrations of 17 elements (Al, As, Ba, B, Ca, Cd, Co, Cr, Cu, Fe, Mn, Ni, Pb, S, Se, Sr, and Zn) were noted in all stones. Seven elements (Al, As, Se, Sr, Fe, Zn, and Ni) were present in higher concentrations in calcium-based stones. In comparison, eight elements (Mg, B, Ba, Cd, Se, Pb, Sr, and Zn) in higher concentrations were associated with phosphate-based stones. Both uric acid and cystine stones had a higher concentration of sulfur. The concentrations of HMTE in calcium phosphate stones were higher than in calcium oxalate and uric acid stones. Calculi obtained from patients living in western countries contained higher levels of 13 HMTE (B, Ba, Ca, Cd, Co, Cu, Fe, K, Mg, Mo, P, Pb, and Se) than those in non-western countries. The age of calculi-forming patients from non-western countries was younger than those living in western countries. These results may indicate the role of many significant heavy metals and trace elements in the pathogenesis of urinary stone formation. The types and contents of HMTE within urinary stones differ from one country to another. The conventional stone analysis techniques cannot either identify the stone micro-elements or the concentrations of HMTE, so a specific and additional instrument such as the ICP-OES is necessary. Further research work on the urinary stone micro-elemental structure could lead to a new strategy for the prevention of stone formation and recurrence.
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Metais Pesados , Oligoelementos , Cálculos Urinários , Cádmio , Cálcio , Oxalato de Cálcio/análise , Fosfatos de Cálcio/análise , Cistina , Humanos , Chumbo , Metais Pesados/análise , Fosfatos , Enxofre , Oligoelementos/análise , Ácido Úrico , Cálculos Urinários/química , Cálculos Urinários/epidemiologiaRESUMO
Xylitol is a well-known sugar alcohol with exponentially rising market demand due to its diverse industrial applications. Organic agro-industrial residues (OAIR) are economic alternative for the cost-effective production of commodity products along with addressing environmental pollution. The present study aimed to design a process for xylitol production from OAIR via microbial fermentation with Pseudomonas gessardii VXlt-16. Parametric analysis with Taguchi orthogonal array approach resulted in a conversion factor of 0.64 g xylitol/g xylose available in untreated sugarcane bagasse hydrolysate (SBH). At bench scale, the product yield increased to 71.98/100 g (0.66 g/L h). 48.49 g of xylitol crystals of high purity (94.56%) were recovered after detoxification with 2% activated carbon. Cost analysis identified downstream operations as one of the cost-intensive parts that can be countered by adsorbent recycling. Spent carbon, regenerated with acetic acid washing can be reused for six cycles effectively and reduced downstream cost by about ≈32%. The strategy would become useful in the cost-effective production of several biomass-dependent products like proteins, enzymes, organic acids, as well.
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Saccharum , Xilitol , Celulose/química , Custos e Análise de Custo , Fermentação , Hidrólise , Pseudomonas , Saccharum/metabolismo , Xilose/metabolismoRESUMO
Aims: A multidisciplinary team of clinicians and researchers, patients and family members, and representative from national advocacy groups and research organization met to review the literature, highlight gaps, and identify best practices to improve adult care delivery for young adults (YA) with diabetes. Methods: The participants prepared presentations in advance, rotated through sessions, and contributed to group discussions in three areas: physical health, mental health, and quality of life (QoL). Session moderators and scribes used thematic analysis to summarize discussions for each topic. Results: Thematic analysis revealed four foci for addressing physical health, mental health and QoL: 1) best practices to facilitate the process of transfer; 2) age-specific curricula and guidelines for prevention and management of comorbidities and complications; 3) collaboration with behavioral health clinicians to address diabetes distress and mental health disorders; and 4) research on the impact of diabetes on QoL in YA. Conclusion: There was substantial interest and need among adult clinicians to work in concert with pediatric and mental health professionals to identify best practices and future directions to improve healthcare process and diabetes-related outcome measures in YA with diabetes.
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OBJECTIVE: Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. RESEARCH DESIGN AND METHODS: This single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70-180 mg/dL ("time in range"). RESULTS: A total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure. CONCLUSIONS: This tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.
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Diabetes Mellitus Tipo 1 , Insulina , Adolescente , Adulto , Idoso , Glicemia , Criança , Diabetes Mellitus Tipo 1/tratamento farmacológico , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes , Sistemas de Infusão de Insulina , Pessoa de Meia-Idade , Estudos Prospectivos , Adulto JovemRESUMO
OBJECTIVES: To (1) examine the impact of the Diabetes Care Rewards (DCR) program on adherence to care standards and (2) evaluate the economic impact of adherence to care standards. STUDY DESIGN: A retrospective observational cohort study design with propensity matching. Additional covariates adjustment was used to minimize residual imbalance. METHODS: Utilization and cost data were compared between individuals enrolled vs individuals eligible for but not enrolled in the DCR program using a standard mean difference. Individuals were employees or their dependents from self-insured companies throughout the United States. Outcomes included adherence to the care standards, service utilization, and costs. RESULTS: A total of 3318 propensity-matched participants were included. Primary analysis revealed that enrolled members increased adherence to semiannual glycated hemoglobin, annual lipid, and annual urine albumin-creatinine ratio testing. Additionally, enrolled members experienced less utilization of high-acuity services and increased rates of physician visits. In a secondary analysis, the enrolled group was associated with greater pharmaceutical costs but lower medical costs. CONCLUSIONS: A behavioral science- and incentive-based diabetes management program was associated with greater rates of adherence to recommended diabetes monitoring care standards, increased routine clinic visits, decreased hospital admissions, and decreased inpatient days. Anticipated increases in pharmaceutical expenditures were offset by overall lower medical expenditures. Results indicate the economic benefits of adherence to evidence-based standards for diabetes care.
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Diabetes Mellitus , Diabetes Mellitus/terapia , Hemoglobinas Glicadas/análise , Custos de Cuidados de Saúde , Gastos em Saúde , Hospitalização , Humanos , Estudos Retrospectivos , Estados UnidosRESUMO
Continuous subcutaneous insulin infusion (CSII) treatment may improve long-term glycemic outcomes and enhance quality of life compared with a multiple daily injection (MDI) insulin regimen for people with type 1 diabetes. As the number of people treated with CSII via a tubeless insulin pump is increasing, there is growing interest in the long-term glycemic outcomes of this treatment option across diverse populations. This multicenter, retrospective study evaluated glycemic control in 156 adults with type 1 diabetes initiating tubeless insulin pump therapy following transition from either MDI or CSII with a tubed insulin pump. In this study, use of the tubeless insulin pump over 12 months was associated with significant improvement in A1C in adults with type 1 diabetes, most notably in those with an A1C ≥9.0% and those previously treated with MDI.
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[This corrects the article on p. 141 in vol. 38, PMID: 32327886.].
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BACKGROUND: Interstitial lung disease (ILD) is a complex and heterogeneous group of acute and chronic lung diseases of several known and unknown causes. While clinical practice guidelines (CPG) for idiopathic pulmonary fibrosis (IPF) have been recently updated, CPG for ILD other than IPF are needed. METHODS: A working group of multidisciplinary clinicians familiar with clinical management of ILD (pulmonologists, radiologist, pathologist, and rheumatologist) and three epidemiologists selected by the leaderships of Indian Chest Society and National College of Chest Physicians, India, posed questions to address the clinically relevant situation. A systematic search was performed on PubMed, Embase, and Cochrane databases. A modified GRADE approach was used to grade the evidence. The working group discussed the evidence and reached a consensus of opinions for each question following face-to-face discussions. RESULTS: Statements have been made for each specific question and the grade of evidence has been provided after performing a systematic review of literature. For most of the questions addressed, the available evidence was insufficient and of low to very low quality. The consensus of the opinions of the working group has been presented as statements for the questions and not as an evidence-based CPG for the management of ILD. CONCLUSION: This document provides the guidelines made by consensus of opinions among experts following discussion of systematic review of evidence pertaining to the specific questions for management of ILD other than IPF. It is hoped that this document will help the clinician understand the accumulated evidence and help better management of idiopathic and nonidiopathic interstitial pneumonias.
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AIMS: To compare cardiovascular risk factor control in adults with diabetes participating in a national diabetes registry to those in the general population and to ascertain regional differences in diabetes care. METHODS: Adults with diagnosed diabetes in the Diabetes Collaborative Registry (DCR) were compared with those in the National Health and Nutrition Examination Survey (NHANES) from 2015 to 2016; standardized mean difference (SMD)â¯>â¯0.2 defined significance. Regional differences were assessed in the DCR cohort; pâ¯<â¯.05 defined significance. RESULTS: The DCR cohort was older (61 vs. 57â¯years, SMDâ¯=â¯0.38), more insured (99.7% vs. 91.0%, SMDâ¯=â¯0.42), and less ethnically diverse (83% non-Hispanic white vs. 76%, SMDâ¯=â¯0.30) compared with NHANES. The proportion of overweight/obesity, A1câ¯<â¯7% (<53â¯mmol/mol), and BPâ¯<â¯140/90 were similar, but DCR participants had higher proportion with LDLâ¯<â¯2.59â¯mmol/L (61% vs. 41%, SMDâ¯=â¯0.39) and fewer tobacco users (17% vs. 32%, SMDâ¯=â¯0.35). Regionally, obesity, lack of glycaemic control, and tobacco use were highest in the Midwest, BP control was the lowest in the South, and LDL control was lowest in the Northeast. CONCLUSIONS: Significant regional differences in diabetes care delivery and outcomes were identified using a national diabetes registry. Serial analyses of the DCR may supplement national evaluations to deepen our understanding of diabetes care in the US.
Assuntos
Doenças Cardiovasculares/epidemiologia , Doenças Cardiovasculares/prevenção & controle , Complicações do Diabetes/prevenção & controle , Adulto , Idoso , Doenças Cardiovasculares/diagnóstico , Estudos de Coortes , Complicações do Diabetes/diagnóstico , Complicações do Diabetes/epidemiologia , Feminino , Fatores de Risco de Doenças Cardíacas , Humanos , Masculino , Pessoa de Meia-Idade , Sistema de Registros , Fatores de Risco , Inquéritos e Questionários , Estados Unidos/epidemiologiaRESUMO
The T1D Exchange established a learning platform by evaluating the current state of care and engaging 10 diabetes clinics in collaborative quality improvement (QI) activities. Participating clinics are sharing data and best practices to improve care delivery for people with type 1 diabetes. This article describes the design and initial implementation of this platform, known as the T1D Exchange Quality Improvement Collaborative. This effort has laid a foundation for learning from variation in type 1 diabetes care delivery via QI methodology and has demonstrated success in improving processes through iterative testing cycles and transparent sharing of data.