Immunogenicity, Efficacy, and Safety of Biosimilar Insulin Glargine (Gan & Lee Glargine) Compared With Originator Insulin Glargine (Lantus) in Patients With Type 1 Diabetes After 26 Weeks Treatment.

OBJECTIVE: To compare the immunogenicity, safety, and efficacy of Gan & Lee insulin glargine (GL Glargine) with that of the originator insulin glargine (Lantus) in patients with type 1 diabetes mellitus (T1DM). METHODS: This was a phase 3, multicenter, randomized, open-label, equivalence study. Five hundred seventy-six subjects with T1DM were randomized 1:1 to receive either GL Glargine or Lantus treatment for 26 weeks. The primary end point was the percentage of subjects in each treatment group who developed treatment-induced anti-insulin antibody after baseline and up to visit week 26, which was evaluated using a country-adjusted logistic regression model. The study also compared the changes in glycated hemoglobin, and adverse events including hypoglycemia. RESULTS: The percentage of subjects positive for treatment-induced anti-insulin antibody by Week 26 was 25.8% in the GL Glargine treatment group and 25.3% in the Lantus treatment group, with a 90% confidence interval (-5.4, 6.5) of the difference in proportions that fell completely between the similarity margins (-11.3, 11.3). The least squares mean difference between treatment groups for changes in glycated hemoglobin was -0.08 (90% confidence interval: -0.23, 0.06), and the other immunogenicity and safety profiles were comparable. CONCLUSION: GL Glargine demonstrated similar immunogenicity, efficacy, and safety compared to Lantus over 26 weeks in patients with T1DM.

Infections Associated with Resterilized Pacemakers and Defibrillators.

BACKGROUND: Access to pacemakers and defibrillators is problematic in places with limited resources. Resterilization and reuse of implantable cardiac devices obtained post mortem from patients in wealthier nations have been undertaken, but uncertainty around the risk of infection is a concern. METHODS: A multinational program was initiated in 1983 to provide tested and resterilized pacemakers and defibrillators to underserved nations; a prospective registry was established in 2003. Patients who received reused devices in this program were matched in a 1:3 ratio with control patients who received new devices implanted in Canada. The primary outcome was infection or device-related death, with mortality from other causes modeled as a competing risk. RESULTS: Resterilized devices were implanted in 1051 patients (mean [±SD] age, 63.2±18.5 years; 43.6% women) in Mexico (36.0%), the Dominican Republic (28.1%), Guatemala (26.6%), and Honduras (9.3%). Overall, 85% received pacemakers and 15% received defibrillators, with one (55.5%), two (38.8%), or three (5.7%) leads. Baseline characteristics did not differ between these patients and the 3153 matched control patients. At 2 years of follow-up, infections had occurred in 21 patients (2.0%) with reused devices and in 38 (1.2%) with new devices (hazard ratio, 1.66; 95% confidence interval, 0.97 to 2.83; P = 0.06); there were no device-related deaths. The most common implicated pathogens were Staphylococcus aureus and S. epidermidis. CONCLUSIONS: Among patients in underserved countries who received a resterilized and reused pacemaker or defibrillator, the incidence of infection or device-related death at 2 years was 2.0%, an incidence that did not differ significantly from that seen among matched control patients with new devices in Canada.

Hand and Upper Extremity Infections in Intravenous Drug Users: Epidemiology and Predictors of Outcomes.

PURPOSE: Injectable drug use (IDU) is a national epidemic, public health problem, and common cause of hand and upper extremity (UE) infections. This study assesses the epidemiology of the IDU patient population presenting to a Midwestern academic medical center emergency department (ED) and examines predictors influencing morbidity and outcomes. METHODS: A retrospective review was performed using International Classification of Diseases, Ninth Revision (ICD-9) codes to identify all adult patients presenting to the ED with hand/UE infections, with and without concurrent IDU diagnoses, over a period of 2.5 years. Demographics and clinical factors were examined utilizing bivariate and multivariable analyses to identify predictors of outcomes, including not completing outpatient follow-up and leaving against medical advice (AMA). RESULTS: A total of 1,482 patients with 1,754 ED visits for hand/UE infections were identified, including 308 patients with IDU-acquired infections (396 visits) and 1,174 patients with non-IDU infections (1,358 visits). Psychiatric comorbidities and hepatitis C were common in the IDU group (51% and 39%, respectively), and 31% of IDU patients were uninsured. Heroin use was identified in 96% of visits. The IDU infections were more likely to have surgical intervention than those in non-IDU patients (16% vs 6%), and a longer mean length hospital stay (2.4 vs 0.9 days). The IDU patients were more likely than non-IDU patients to leave AMA. In multivariable analysis, IDU, psychiatric comorbidity, and insurance status were independent predictors (P < .05) for leaving AMA. CONCLUSIONS: In the setting of a national epidemic, hand/UE infections due to IDU are a common problem seen by hand surgeons. This study characterizes the growing IDU patient population at an urban academic medical center, examining the largest cohort of these patients to date. TYPE OF STUDY/LEVEL OF EVIDENCE: Prognostic IV.

Serum miR-204 is an early biomarker of type 1 diabetes-associated pancreatic beta-cell loss.

Pancreatic beta-cell death is a major factor in the pathogenesis of type 1 diabetes (T1D), but straightforward methods to measure beta-cell loss in humans are lacking, underlining the need for novel biomarkers. Using studies in INS-1 cells, human islets, diabetic mice, and serum samples of subjects with T1D at different stages, we have identified serum miR-204 as an early biomarker of T1D-associated beta-cell loss in humans. MiR-204 is a highly enriched microRNA in human beta-cells, and we found that it is released from dying beta-cells and detectable in human serum. We further discovered that serum miR-204 was elevated in children and adults with T1D and in autoantibody-positive at-risk subjects but not in type 2 diabetes or other autoimmune diseases and was inversely correlated with remaining beta-cell function in recent-onset T1D. Thus, serum miR-204 may provide a much needed novel approach to assess early T1D-associated human beta-cell loss even before onset of overt disease.

A randomized cross-over trial to determine the effect of a protein vs. carbohydrate preload on energy balance in ad libitum settings.

BACKGROUND: Although high protein diets have been tested in controlled environments for applications to weight management, it is not understood if adding high protein foods to the diet would impact ad libitum energy balance in the absence of other lifestyle changes. METHODS: This double-blinded randomized crossover trial compared the effects of a protein shake (PS) to a carbohydrate shake (CS), consumed prior to each major meal to equate to 20% of total energy needs over the course of the day, on energy balance over two 5-day treatment periods in healthy adults with BMI 20-30 kg/m2. Tri-axial accelerometers estimated physical activity energy expenditure. Ad libitum energy intake was measured in a laboratory kitchen. RESULTS: Energy balance was positive during both treatment periods but was not different between periods. There were no interactions between treatment and preload caloric dose or treatment and BMI status on energy balance. Satiety ratings did not differ for any pairwise comparisons between treatment and caloric dose. Controlling for gender and basal metabolic rate, thermic effect of food was greater for PS than CS. CONCLUSIONS: Preload periods significantly altered the macronutrient composition of the overall diet. This study found limited evidence that carbohydrate or protein preloads have differential effects on energy balance in short-term ad libitum settings. TRIAL REGISTRATION: This trial was pre-registered on clinicaltrials.gov as NCT02613065 on 11/30/2015.

A Case Report of a Breast Implant-Associated Plasmacytoma and Literature Review of Non-ALCL Breast Implant-Associated Neoplasms.

Lymphomas associated with breast implants are rare, with the most common being anaplastic large cell lymphoma (ALCL). Non-ALCL breast implant-associated lymphomas are even more rare, with only a small handful of such neoplasms reported to date. Given the need to better understand these pathologies as well as the increasing clinical and media attention being paid to these diseases, we review the available literature of hematolymphoid neoplasms other than ALCL associated with breast implants and describe the first case of a patient diagnosed with a primary breast implant-associated plasmacytoma.

Global Contributions to Aesthetic Surgery Journal Over the Past Decade.

BACKGROUND: The Aesthetic Surgery Journal (ASJ) is a world-renowned publication with valuable contributions from around the globe. OBJECTIVES: To better characterize the journal's evolving representation of global contributions to aesthetic surgery, the authors examined the author affiliations of all articles published in ASJ over the last decade. METHODS: A PubMed search was performed for all journal articles published in ASJ from January 2008 to August 2018. For each article, the first author's primary affiliation as indexed in MEDLINE was recorded as the source country. Data were tabulated by source country and year. The authorless errata, corrigenda, and Cosmetic Surgery National Data Bank Statistics were excluded from analysis. RESULTS: A total of 1746 articles were published during this period, contributed from 49 distinct countries. All continents other than Antarctica were represented. Higher income countries where aesthetic surgery is more prevalent produced 87% of published articles. The total number of published articles in ASJ has climbed from 77 annually in 2008 to 318 in 2018 as of August. In 2008, 27.3% of articles were from non-US countries, whereas in 2018 this increased to 43.7%. In particular, Turkey, the United Kingdom, Australia, Brazil, and Italy demonstrate steady increases in contributions over the 10-year period. CONCLUSIONS: Publications in ASJ have increased in number over the past decade, and the journal has become increasingly global in its network of contributing authors. The increased global contribution to the ASJ may enhance readers' experience both in the United States and in the world beyond.

Association of multiple chronic conditions and pain among older black and white adults with diabetes mellitus.

BACKGROUND: Aging is often associated with the challenge of navigating daily tasks with a painful chronic medical illness. Yet, there is concern of the number of older adults impacted with more than one chronic condition. Despite the increasing number of adults diagnosed with diabetes and comorbid chronic illnesses, there remains a lack of understanding in how multiple illnesses relate to experiences of pain. To assess the association between multiple chronic conditions and pain, this study aimed to identify clusters of chronic medical conditions and their association with pain among a sample of older Black and White adults diagnosed with diabetes. METHODS: Two hundred and thirty-six participants responded to a series of questions assessing pain frequency and severity, as well as health and social characteristics. A factor analysis was used to categorize clusters of medical conditions, and multiple regression models were used to examine predictors of pain. RESULTS: Seven of the assessed chronic medical conditions loaded on three factors, and accounted for 57.2% of the total variance, with heart disease (factor 1) accounting for 21.9%, musculoskeletal conditions (factor 2) for another 18.4%, and factor 3 (microvascular diseases) accounting for a final 16.9% of the variability among the chronic medical conditions. Covariate-adjusted models showed that fewer years of education and higher scores on the microvascular and musculoskeletal conditions factors were associated with higher pain frequency, with the musculoskeletal conditions factor being the strongest predictor. CONCLUSIONS: Findings from this study compliment existent literature underscoring the prevalence and importance of comorbid diagnoses in relation to pain. Examining health-related factors beyond a single disease diagnosis also provides an opportunity to explore underlying disease co-occurrences that may persist beyond organ system classifications.

Stroke Symptoms With Absence of Recognized Stroke Are Associated With Cognitive Impairment and Depressive Symptoms in Older Adults With Diabetes.

Self-reported stroke symptoms may represent unrecognized cerebrovascular events leading to poorer cognitive and mental health. We examined relationships between stroke symptoms, cognitive impairment, and depressive symptoms in a high-risk sample: 247 adults aged ≥65 with diabetes. Stroke symptoms were assessed using the Questionnaire for Verifying Stroke-free Status, cognitive impairment was measured with the modified Telephone Interview for Cognitive Status, and depressive symptoms were measured using the 15-item Geriatric Depression Scale. In 206 participants without history of stroke/transient ischemic attack, 27.7% reported stroke symptoms, with sudden loss of comprehension most frequently reported (11.7%). Having >1 versus 0 stroke symptoms was associated with greater odds of cognitive impairment (odds ratio = 3.04, 95% confidence interval 1.15-8.05) and more depressive symptoms (b= 2.60,P< .001) while controlling for age, race, gender, education, diabetes duration, diabetes severity, and cardiovascular comorbidities. Better recognition and treatment of cerebrovascular problems in older adults with diabetes may lead to improved cognition and mental health.

Associations of Social Support and Self-Efficacy With Quality of Life in Older Adults With Diabetes.

Older adults are disproportionately affected by diabetes, which is associated with increased prevalence of cardiovascular disease, decreased quality of life (QOL), and increased health care costs. The purpose of the current study was to assess the relationships between social support, self-efficacy, and QOL in a sample of 187 older African American and Caucasian individuals with diabetes. Greater satisfaction with social support related to diabetes (but not the amount of support received) was significantly correlated with QOL. In addition, individuals with higher self-efficacy in managing diabetes had better QOL. In a covariate-adjusted regression model, self-efficacy remained a significant predictor of QOL. Findings suggest the potential importance of incorporating the self-efficacy concept within diabetes management and treatment to empower older adults living with diabetes to adhere to care. Further research is needed to determine whether improving self-efficacy among vulnerable older adult populations may positively influence QOL.

Data-driven Cluster Analysis Reveals Increased Risk for Severe Insulin-Deficient Diabetes in Black/African Americans.

CONTEXT: Diabetes is a heterogenic disease and distinct clusters have emerged, but the implications for diverse populations have remained understudied. OBJECTIVE: Apply cluster analysis to a diverse diabetes cohort in the U.S. Deep South. DESIGN: Retrospective hierarchical cluster analysis of electronic health records from 89,875 patients diagnosed with diabetes between January 1, 2010, and December 31, 2019, at the Kirklin Clinic of the University of Alabama at Birmingham, an ambulatory referral center. PATIENTS: Adult patients with ICD diabetes codes were selected based on available data for 6 established clustering parameters (GAD-autoantibody; HbA1c; BMI; Diagnosis age; HOMA2-B; HOMA2-IR); ∼42% were Black/African American. MAIN OUTCOME MEASURE(S): Diabetes subtypes and their associated characteristics in a diverse adult population based on clustering analysis. We hypothesized that racial background would affect the distribution of subtypes. Outcome and hypothesis were formulated prior to data collection. RESULTS: Diabetes cluster distribution was significantly different in Black/African Americans compared to Whites (P<0.001). Black/African Americans were more likely to have severe insulin deficient diabetes (SIDD) (OR 1.83, CI 1.36-2.45, P<0.001), associated with more serious metabolic perturbations and a higher risk for complications (OR 1.42, 95% CI 1.06-1.90, P=0.020). Surprisingly, Black/African Americans specifically had more severe impairment of beta cell function (HOMA2-B, C-peptide) (P<0.001), while not being more obese or insulin resistant. CONCLUSIONS: Racial background greatly influences diabetes cluster distribution and Black/African Americans are more frequently and more severely affected by SIDD. This may further help explain the disparity in outcomes and have implications for treatment choice.

The Effects of Acute Beetroot Juice Intake on Glycemic and Blood Pressure Responses When Controlling for Medication in Individuals with Type 2 Diabetes: A Pilot Study.

Physical inactivity and poor dietary choices contribute to the rise in cardiometabolic diseases in the United States. It remains critical to identify strategies that may mitigate the negative impact of these behaviors. Several studies have shown that the consumption of dietary inorganic nitrate may improve vascular health and glucose regulation in animal models and some human studies. However, the improvements in glucose regulation have yet to be corroborated in humans with type 2 diabetes (T2D). Therefore, the purpose of this study was to assess the acute effects of beetroot juice (BRJ) on glycemic and hemodynamic responses in individuals with T2D while controlling for medication. Seven participants with a clinical diagnosis of T2D were recruited into this study and were temporarily removed from blood pressure- and glucose-lowering medications. Hemodynamic measurements (pulsewave velocity) and an oral glucose tolerance test (glycemic response) were measured following consumption of either BRJ or a denitrolized placebo. Saliva and blood samples were collected at baseline and two and four hours post supplementation to measure changes in nitrate and nitrite concentrations. We detected significant improvements in total plasma glucose exposure (p = 0.022) and the SVR change score (p = 0.009) in the BRJ condition. This study demonstrated that BRJ consumption can improve oral glucose tolerance in individuals with T2D while controlling for medication; however, future larger-cohort randomized controlled trials are needed to confirm if BRJ is a viable treatment for glucose control in individuals with T2D.

Favourable metabolic effects of a eucaloric lower-carbohydrate diet in women with PCOS.

OBJECTIVE: Diet-induced reduction in circulating insulin may be an attractive nonpharmacological treatment for women with polycystic ovary syndrome (PCOS) among whom elevated insulin may exacerbate symptoms by stimulating testosterone synthesis. This study was designed to determine whether a modest reduction in dietary carbohydrate (CHO) content affects ß-cell responsiveness, serum testosterone concentration and insulin sensitivity in women with PCOS. DESIGN: In a crossover design, two diets ('Standard,' STD, 55:18:27% energy from carbohydrate/protein/fat; lower-carbohydrate, 41:19:40) were provided for 8 weeks in random order with a 4-week washout between. PATIENTS: Thirty women with PCOS. MEASUREMENTS: ß-cell responsiveness assessed as the C-peptide response to glucose during a liquid meal test; insulin sensitivity from insulin and glucose values throughout the test; insulin resistance (HOMA-IR); and total testosterone by immunoassay. RESULTS: Paired t-test indicated that the lower-CHO diet induced significant decreases in basal ß-cell response (PhiB), fasting insulin, fasting glucose, HOMA-IR, total testosterone and all cholesterol measures, and significant increases in insulin sensitivity and dynamic ('first-phase') ß-cell response. The STD diet induced a decrease in HDL-C and an increase in the total cholesterol-to-HDL-C ratio. Across all data combined, the change in testosterone was positively associated with the changes in fasting insulin, PhiB and insulin AUC (P < 0·05). CONCLUSIONS: In women with PCOS, modest reduction in dietary CHO in the context of a weight-maintaining diet has numerous beneficial effects on the metabolic profile that may lead to a decrease in circulating testosterone.

A review of traumatic brain injury trauma center visits meeting physiologic criteria from The American College of Surgeons Committee on Trauma/Centers for Disease Control and Prevention Field Triage Guidelines.

BACKGROUND: Traumatic brain injury (TBI) represents a serious subset of injuries among persons in the United States, and prehospital care of these injuries can mitigate both the morbidity and the mortality in patients who suffer from these injuries. Guidelines for triage of injured patients have been set forth by the American College of Surgeons Committee on Trauma (ACS-COT) in cooperation with the Centers for Disease Control and Prevention (CDC). These guidelines include physiologic criteria, such as the Glasgow Coma Scale (GCS) score, systolic blood pressure, and respiratory rate, which should be used in determining triage of an injured patient. OBJECTIVES: This study examined the numbers of visits at level I and II trauma centers by patients with a diagnosed TBI to determine the prevalence of those meeting physiologic criteria from the ACS-COT/CDC guidelines and to determine the extent of mortality among this patient population. METHODS: The data for this study were taken from the 2007 National Trauma Data Bank (NTDB) National Sample Program (NSP). This data set is a nationally representative sample of visits to level I and II trauma centers across the United States and is funded by the American College of Surgeons. Estimates of demographic characteristics, physiologic measures, and death were made for this study population using both chi-square analyses and adjusted logistic regression modeling. RESULTS: The analyses demonstrated that although many people who sustain a TBI and were taken to a level I or II trauma center did not meet the physiologic criteria, those who did meet the physiologic criteria had significantly higher odds of death than those who did not meet the criteria. After controlling for age, gender, race, Injury Severity Score (ISS), and length of stay in the hospital, persons who had a GCS score ≤13 were 17 times more likely to die than TBI patients who had a higher GCS score (odds ratio [OR] 17.4; 95% confidence interval [CI] 10.7-28.3). Other physiologic criteria also demonstrated significant odds of death. CONCLUSIONS: These findings support the validity of the ACS-COT/CDC physiologic criteria in this population and stress the importance of prehospital triage of patients with TBI in the hopes of reducing both the morbidity and the mortality resulting from this injury.

A simple technique for augmentation of axonal ingrowth into chondroitinase-treated acellular nerve grafts using nerve growth factor.

BACKGROUND AND PURPOSE: Improvement in axonal regeneration may lead to the development of longer nerve grafts and improved outcomes for patients with peripheral nerve injury. Although the use of acellular nerve grafts has been well documented (Groves et al, Exp Neurol. 2005;195:278-292; Krekoski et al, J Neurosci. 2001;21:6206-6213; Massey et al, Exp Neurol. 2008;209:426-445; Neubauer et al, Exp Neurol. 2007;207:163-170; Zuo et al, Exp Neurol. 2002;176:221-228), less is known about the ability of neurotrophic factors to enhance axonal regeneration. This study evaluates axonal ingrowth augmentation using acellular, chondroitinase-treated nerve grafts doped with nerve growth factor (NGF). METHODS: Acellular chondroitinase-treated murine nerve grafts were placed in experimental (NGF-treated grafts) and control (carrier-only grafts) rats. Five days after implantation, axonal regeneration was assessed by immunocytochemistry along with digital image analysis. RESULTS: Higher axon count was observed throughout the length of the nerve in the NGF group (P < 0.0001), peaking at 3 mm from proximal repair (P = 0.02). Although the NGF group displayed a higher axon count per slice, the mean diameter of individual NGF axons was smaller (P < 0.0001), potentially consistent with induction of sensory axons (Rich et al, J Neurocytol. 1987;16:261-268; Sofroniew et al, Annu Rev Neurosci. 2001;24:1217-1128; Yip et al, J Neurosci. 1984;4:2986-2992). CONCLUSION: The simple technique of doping acellular, chondroitinase-treated nerve grafts with NGF can augment axonal ingrowth and possibly preferentially induce sensory axons.

Assessing the quality and reliability of patient information regarding aesthetic fat grafting on YouTube.

PURPOSE: Patients increasingly consult social media regarding aesthetic surgery. Given the popularity of fat transfer operations, this study assesses the quality and reliability of patient information available on YouTube regarding aesthetic fat grafting. METHODS: The terms "fat grafting" and "fat transfer" were searched on YouTube with respect to the terms "face", "breast", "buttock", and "Brazilian butt lift". Filtered by view count, the top 20 unique, English language, aesthetic surgery-related videos for each search combination were reviewed by three independent reviewers for demographic and descriptive characteristics. Videos were rated for information reliability and quality using the modified DISCERN (MD) tool (1 = low, 5 = high) and global quality scale (GQS) (1 = poor, 5 = excellent). RESULTS: Out of 80 total videos, 76% were authored by physicians and 24% by laypersons. The overall mean MD score was 1.5 and the mean GQS was 2.6. Videos authored by physicians outscored those by non-medical authors (MD: 1.6 vs. 1.3; GQS 2.7 vs. 2.2). Board-certified plastic surgeon videos (N = 30) scored higher on both the MD (1.7 vs 1.3) and GQS (3.1 vs 2.2) than those of non-medical authors. On the contrary, videos by laypersons and non-plastic surgeons had 40% more views, twice as many "likes" and nearly double as many subscribers. CONCLUSION: The overall quality of information presented in aesthetic fat grafting procedures videos on YouTube is low and from unreliable sources. Surgeons should educate patients regarding potentially inaccurate information, and professional societies should disseminate high-quality media.

Exploratory study reveals far reaching systemic and cellular effects of verapamil treatment in subjects with type 1 diabetes.

Currently, no oral medications are available for type 1 diabetes (T1D). While our recent randomized placebo-controlled T1D trial revealed that oral verapamil had short-term beneficial effects, their duration and underlying mechanisms remained elusive. Now, our global T1D serum proteomics analysis identified chromogranin A (CHGA), a T1D-autoantigen, as the top protein altered by verapamil and as a potential therapeutic marker and revealed that verapamil normalizes serum CHGA levels and reverses T1D-induced elevations in circulating proinflammatory T-follicular-helper cell markers. RNA-sequencing further confirmed that verapamil regulates the thioredoxin system and promotes an anti-oxidative, anti-apoptotic and immunomodulatory gene expression profile in human islets. Moreover, continuous use of oral verapamil delayed T1D progression, promoted endogenous beta-cell function and lowered insulin requirements and serum CHGA levels for at least 2 years and these benefits were lost upon discontinuation. Thus, the current studies provide crucial mechanistic and clinical insight into the beneficial effects of verapamil in T1D.

A web-based diabetes intervention for physician: a cluster-randomized effectiveness trial.

OBJECTIVE: To determine the effectiveness of a provider-based education and implementation intervention for improving diabetes control. DESIGN: Cluster-randomized trial with baseline and follow-up cross sections of diabetes patients in each participating physician's practice. SETTING: Eleven US Southeastern states, 2006-08. PARTICIPANTS: Two hundred and five rural primary care physicians. INTERVENTION: Multi-component interactive intervention including Web-based continuing medical education, performance feedback and quality improvement tools. Primary Outcome Measures 'Acceptable control' [hemoglobin A1c ≤9%, blood pressure (BP) <140/90 mmHg, low-density lipoprotein cholesterol (LDL) <130 mg/dl] and 'optimal control' (A1c <7%, BP <130/80 mmHg, LDL <100 mg/dl). RESULTS: Of 364 physicians attempting to register, 205 were randomized to the intervention (n= 102) or control arms (n= 103). Baseline and follow-up data were provided by 95 physicians (2127 patients). The proportion of patients with A1c ≤9% was similar at baseline and follow-up in both the control [adjusted odds ratio (AOR): 0.94; 95% confidence interval (CI): 0.61, 1.47] and intervention arms [AOR: 1.16 (95% CI: 0.80, 1.69)]; BP <140/90 mmHg and LDL <130 mg/dl were also similar at both measurement points (P= 0.66, P= 0.46; respectively). We observed no significant effect on diabetes control attributable to the intervention for any of the primary outcome measures. Intervention physicians engaged with the Website over a median of 64.7 weeks [interquartile range (IQR): 45.4-81.8) for a median total of 37 min (IQR: 16-66). CONCLUSIONS: A wide-reach, low-intensity, Web-based interactive multi-component intervention did not improve control of glucose, BP or lipids for patients with diabetes of physicians practicing in the rural Southeastern US.

Patient complexity and diabetes quality of care in rural settings.

PURPOSE: Even though pay-for-performance programs are being rapidly implemented, little is known about how patient complexity affects practice-level performance assessment in rural settings. We sought to determine the association between patient complexity and practice-level performance in the rural United States. BASIC PROCEDURES: Using baseline data from a trial aimed at improving diabetes care, we determined factors associated with a practice's proportion of patients having controlled diabetes (hemoglobin A1c