Genomic Research and American Indian Tribal Communities in Oklahoma: Learning From Past Research Misconduct and Building Future Trusting Partnerships.

Research misconduct and consequential harms have been inflicted upon American Indian/Alaska Native communities for decades. To protect their people and culture and to retain oversight over research, many Native communities have established tribal health research and institutional review boards. The Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study showcases a successful, trusting research collaboration with tribal nations and academic investigators in Oklahoma. In 2006, the TODAY Study investigators proposed a modification of the study protocol to collect biological specimens from participants for genomic analyses and indefinite storage. Partnering American Indian tribal nations elected not to participate in the genomics collection and repository proposal. Reasons included 1) protection of cultural values, 2) concerns regarding community anonymity, 3) a potential threat to tribal services eligibility, 4) broad informed consent language, and 5) vague definitions of data access and usage. The nations believed the proposed genomics analyses presented a risk of harm to their people and nations without clear benefit. Since the 2006 proposal and the advancement of genomics research, many tribal communities in Oklahoma, appreciating the potential benefits of genomic research, are developing policies regarding oversight of/access to data and biological specimens to mitigate risks and provide members and communities with opportunities to participate in safe and meaningful genomic research.

Collaborative implementation of a community-based exercise intervention with a partnering rural American Indian community.

BACKGROUND: The prevalence and socioeconomic burden of childhood obesity and diabetes has increased rapidly in the United States in the last 30 years. American Indians have the highest prevalence of type 2 diabetes among newly diagnosed youth in the country. Contributing factors include environmental, behavioral, and genetic components. Some American Indian tribal communities have explored innovative ways to combat this epidemic including collaborations with academic centers on community-based research. METHOD: From 2012 to 2017, the University of Oklahoma Health Science Center and the Choctaw Nation of Oklahoma partnered on a National Institutes of Health-funded project to determine if financial incentives would elicit an increase in physical activity in Native youth. This was a community-based behavioral intervention for overweight or obese American Indian youth ages 11-20 living in a rural community at risk for developing diabetes. RESULTS: Tribal leaders and staff identified culturally appropriate strategies to aid implementation of the trial in their community. Their identified implementation strategies helped standardize the study in order to maintain study integrity. The mutually agreed strategies included co-review of the study by tribal and University research review boards (but designation of the Choctaw Nation review board as the "Board of Record"), training of community-based staff on research ethics and literacy, standardization of the informed consent process by videotaping all study information, creation of a viable and culturally appropriate timeline for study implementation, adapting tribal wellness center operations to accommodate youth, and development of effective two-way communication through training sessions, on-site coordination, and bi-monthly conference calls. CONCLUSION: In an effort to partner collectively on a randomized clinical research trial to combat childhood diabetes, tribal leaders and staff implemented strategies that resulted in a culturally appropriate and organized community-based behavioral intervention research project.

Monogenic diabetes in overweight and obese youth diagnosed with type 2 diabetes: the TODAY clinical trial.

PurposeMonogenic diabetes accounts for 1-2% of diabetes cases. It is often undiagnosed, which may lead to inappropriate treatment. This study was performed to estimate the prevalence of monogenic diabetes in a cohort of overweight/obese adolescents diagnosed with type 2 diabetes (T2D).MethodsSequencing using a custom monogenic diabetes gene panel was performed on a racially/ethnically diverse cohort of 488 overweight/obese adolescents with T2D in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial. Associations between having a monogenic diabetes variant and clinical characteristics and time to treatment failure were analyzed.ResultsMore than 4% (22/488) had genetic variants causing monogenic diabetes (seven GCK, seven HNF4A, five HNF1A, two INS, and one KLF11). Patients with monogenic diabetes had a statistically, but not clinically, significant lower body mass index (BMI) z-score, lower fasting insulin, and higher fasting glucose. Most (6/7) patients with HNF4A variants rapidly failed TODAY treatment across study arms (hazard ratio = 5.03, P = 0.0002), while none with GCK variants failed treatment.ConclusionThe finding of 4.5% of patients with monogenic diabetes in an overweight/obese cohort of children and adolescents with T2D suggests that monogenic diabetes diagnosis should be considered in children and adolescents without diabetes-associated autoantibodies and maintained C-peptide, regardless of BMI, as it may direct appropriate clinical management.

Impact of lifestyle behavior change on glycemic control in youth with type 2 diabetes.

BACKGROUND: Little is known about the feasibility and impact of lifestyle intervention, determined by change in diet and cardiovascular fitness (CRF), on glycemic control in youth who are overweight with type 2 diabetes. This was examined in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial cohort from across 15 US centers. SUBJECTS: TODAY enrolled 699 youth aged 10 to 17 years with type 2 diabetes <2 years and body mass index ≥85th percentile at baseline. METHODS: Dietary data were collected by an interviewer-administered food frequency questionnaire; CRF was assessed using a submaximal cycle ergometer test. Change from baseline in these variables was analyzed using generalized linear mixed models for both continuous and categorical measures. Models were adjusted for age, baseline HbA1c, treatment group, and medication adherence. Data were collected at baseline, 6, and 24 months. Trial registration ClinicalTrials.gov NCT00081328. RESULTS: At 6 months, ~25% of females and ~33% of males improved CRF. In males, this was related to a decreased HbA1c (P = .001) and a lower percent experiencing glycemic failure (HbA1c ≥8%; P = .007). Females who decreased their saturated fat intake and/or increased their fiber intake had lower HbA1c at month 24 (P = .01 and P = .007, respectively). Males who increased their sweetened beverage intake at 6-month follow-up were at a 1.6-fold higher risk of experiencing glycemic failure (P = .04). CONCLUSIONS: Few youth improved fitness and/or diet over time, although those who did showed a beneficial impact on glycemic outcomes. Although lifestyle behaviors are difficult to change in youth with type 2 diabetes, interventions are needed that are feasible (in scope, complexity, and demands), sustainable, and clinically meaningful.

A clinical trial to maintain glycemic control in youth with type 2 diabetes.

BACKGROUND: Despite the increasing prevalence of type 2 diabetes in youth, there are few data to guide treatment. We compared the efficacy of three treatment regimens to achieve durable glycemic control in children and adolescents with recent-onset type 2 diabetes. METHODS: Eligible patients 10 to 17 years of age were treated with metformin (at a dose of 1000 mg twice daily) to attain a glycated hemoglobin level of less than 8% and were randomly assigned to continued treatment with metformin alone or to metformin combined with rosiglitazone (4 mg twice a day) or a lifestyle-intervention program focusing on weight loss through eating and activity behaviors. The primary outcome was loss of glycemic control, defined as a glycated hemoglobin level of at least 8% for 6 months or sustained metabolic decompensation requiring insulin. RESULTS: Of the 699 randomly assigned participants (mean duration of diagnosed type 2 diabetes, 7.8 months), 319 (45.6%) reached the primary outcome over an average follow-up of 3.86 years. Rates of failure were 51.7% (120 of 232 participants), 38.6% (90 of 233), and 46.6% (109 of 234) for metformin alone, metformin plus rosiglitazone, and metformin plus lifestyle intervention, respectively. Metformin plus rosiglitazone was superior to metformin alone (P=0.006); metformin plus lifestyle intervention was intermediate but not significantly different from metformin alone or metformin plus rosiglitazone. Prespecified analyses according to sex and race or ethnic group showed differences in sustained effectiveness, with metformin alone least effective in non-Hispanic black participants and metformin plus rosiglitazone most effective in girls. Serious adverse events were reported in 19.2% of participants. CONCLUSIONS: Monotherapy with metformin was associated with durable glycemic control in approximately half of children and adolescents with type 2 diabetes. The addition of rosiglitazone, but not an intensive lifestyle intervention, was superior to metformin alone. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; TODAY ClinicalTrials.gov number, NCT00081328.).

Clinical trials in youth-onset type 2 diabetes: needs, barriers, and options.

Youth-onset type 2 diabetes (T2D) is increasingly recognized as a disorder with substantial risk for long-term metabolic, cardiovascular, and renal morbidity and mortality, as well as individual and societal burden. Recent studies suggest that the disorder differs from adult-onset T2D in a variety of ways and that there is an urgent need for an expanded set of treatment options. However, demographic, economic, and social challenges limit the number of eligible candidates for clinical trials in youth-onset T2D, and a growing number trials mandated by regulatory agencies have created a circumstance in which too many trials are chasing too few eligible participants. A solution to this situation will require novel approaches to clinical trial design incorporating collaboration among clinical investigators, pharmaceutical sponsors, and regulatory agencies. If successful, this approach could also serve as a model for clinical trials in other rare and understudied pediatric disorders.

Assessment of Body Mass Index, Sugar Sweetened Beverage Intake and Time Spent in Physical Activity of American Indian Children in Oklahoma.

American Indian (AI) children have a combined overweight and obesity prevalence of 53%. Behaviors that contribute to obesity, such as sugar sweetened beverage (SSB) intake and time spent in physical activity (PA), have been poorly explored in this population. The purpose of this study is to report body mass index (BMI), SSB intake, and time spent in PA of 7-to-13-year-old AI children who reside in rural and urban areas in Oklahoma. Cross-sectional survey study. Self-reported SSB intake in the last month, and time spent in PA were collected via questionnaires. Height and weight were professionally measured. The sample included 124 7-to-13-year-old AI children who attended a diabetes prevention summer camp in 2013. BMI percentile, overweight and obesity prevalence, SSB intake, time spent in PA, and number of participants meeting the Physical Activity Guidelines for Americans. Descriptive characteristics for BMI percentile, overweight and obesity, SSB intake, time spent in PA, and meeting PA recommendations were calculated using means, standard deviations, and frequencies. Independent t test and Chi square analyses were used to test for gender differences. Participants were 10.2 ± 1.5 years old and 57% female. Sixty-three percent were overweight or obese. Children consumed 309 ± 309 kcal/day of SSB and spent 4.4 ± 3.8 h per week in moderate-to-vigorous PA. Approximately 32% met the 2008 Physical Activity Guidelines for Americans. No gender differences were observed. The prevalence of overweight and obesity was higher than previously reported in a similar population, and higher than that of US children in the general population. SSB intake and physical activity levels were also found to be higher in this group than in the general population.

Partnering in research: a national research trial exemplifying effective collaboration with American Indian Nations and the Indian Health Service.

Despite the fact that numerous major public health problems have plagued American Indian communities for generations, American Indian participation in health research traditionally has been sporadic in many parts of the United States. In 2002, the University of Oklahoma Health Sciences Center (Oklahoma City, Oklahoma) and 5 Oklahoma American Indian research review boards (Oklahoma City Area Indian Health Service, Absentee Shawnee Tribe, Cherokee Nation, Chickasaw Nation, and Choctaw Nation) agreed to participate collectively in a national research trial, the Treatment Options for Type 2 Diabetes in Adolescence and Youth (TODAY) Study. During that process, numerous lessons were learned and processes developed that strengthened the partnerships and facilitated the research. Formal Memoranda of Agreement addressed issues related to community collaboration, venue, tribal authority, preferential hiring of American Indians, and indemnification. The agreements aided in uniting sovereign nations, the Indian Health Service, academics, and public health officials to conduct responsible and ethical research. For more than 10 years, this unique partnership has functioned effectively in recruiting and retaining American Indian participants, respecting cultural differences, and maintaining tribal autonomy through prereview of all study publications and local institutional review board review of all processes. The lessons learned may be of value to investigators conducting future research with American Indian communities.

Current treatment options for type 2 diabetes mellitus in youth: today's realities and lessons from the TODAY study.

The incidence of type 2 diabetes in children and adolescents has increased over the last 2 decades, paralleled by an increase in obesity over the same time period. Although the value of lifestyle modification in obese youth is unquestioned, scant evidence for optimal treatment of type 2 diabetes in this age group exists. Despite recent therapeutic drug trials, metformin and insulin are the only medicines currently approved by the U.S. Food and Drug Administration for the treatment of type 2 diabetes in youth. Because of recently amended pharmaceutical regulations, however, it is likely that more antidiabetic medications soon will be added to the armamentarium of therapeutic options for youth with type 2 diabetes. Additionally, the recently published TODAY study comparing safety and efficacy of three treatment regimens in maintaining glycemic control in youth with type 2 diabetes has shed new light on the problem.

Arterial compliance is increased in children with type 2 diabetes compared with normal weight peers but not obese peers.

BACKGROUND: We reported that obesity was associated with increased arterial compliance in children, possibly due to accelerated vascular maturation. Here, we explored the additional burden of type 2 diabetes (T2DM) on vascular function in children. METHODS: Fifty normal weight [body mass index (BMI) 25-75%], 58 obese (BMI ≥ 95%), and 34 children with T2DM diagnosed by American Diabetes Association (ADA) criteria ages 10-18 yr were studied. Large and small artery elasticity (LAEI and SAEI, respectively) were measured by diastolic pulse-wave contour analysis. RESULTS: SAEI was 27% higher in children with T2DM compared to normal weight children (p = 0.005). Mean LAEI for those with T2DM not different from either group. In the group with T2DM, both SAEI and LAEI increased with age up to 16 yr, but declined thereafter. The strongest multivariable model predicting SAEI in children with T2DM combined lean mass, systolic blood pressure (SBP), and glucose (r2 = 0.59); for predicting LAEI, the strongest model included height, SBP, and low-density lipid-cholesterol (r2 = 0.61). CONCLUSION: The lower arterial compliance in older adolescents with T2DM compared to that of their peers without diabetes may indicate a premature maturation of the vascular system; however, follow-up will clarify whether these vascular changes portend an early increase in diabetes-associated cardiovascular disease risk.

Characteristics of patients with hematologic malignancies without seroconversion post-COVID-19 third vaccine dosing.

Objectives: The objective of this study is to explore the characteristics of the subset of patients with hematologic malignancies (HMs) who had little to no change in SARS-CoV-2 spike antibody index value levels after a third mRNA vaccine dose (3V) and to compare the cohort of patients who did and did not seroconvert post-3V to get a better understanding of the demographics and potential drivers of serostatus. Study design: This retrospective cohort study analyzed SARS-CoV-2 spike IgG antibody index values pre and post the 3V data on 625 patients diagnosed with HM across a large Midwestern United States healthcare system between 31 October 2019 and 31 January 2022. Methods: To assess the association between individual characteristics and seroconversion status, patients were placed into two groups based on IgG antibody status pre and post the 3V dose, (-/+) and (-/-). Odds ratios were used as measures of association for all categorical variables. Logistic regressions were used to measure the association between HM condition and seroconversion. Results: HM diagnosis was significantly associated with seroconversion status (P = 0.0003) with patients non-Hodgkin lymphoma six times the odds of not seroconverting compared with multiple myeloma patients (P = 0.0010). Among the participants who were seronegative prior to 3V, 149 (55.6%) seroconverted after the 3V dose and 119 (44.4%) did not. Conclusion: This study focuses on an important subset of patients with HM who are not seroconverting after the COVID mRNA 3V. This gain in scientific knowledge is needed for clinicians to target and counsel these vulnerable patients.

Factors Associated With COVID-19 Breakthrough Infections in Large Midwestern Healthcare System: Implications for Vulnerable Healthcare Personnel.

OBJECTIVE: The aim of the study is to identify factors associated with breakthrough infection among a cohort of Midwestern healthcare personnel (HCP). METHODS: SARS-CoV-2-positive test results between March 1, 2020, and July 31, 2021, were collected from electronic medical records of HCP to identify breakthrough infections. RESULTS: Healthcare personnel who were younger than 35 years, received the Pfizer vaccine, and worked in COVID clinical units had greater adjusted odds of breakthrough infection. COVID infection before full vaccination was associated with reduced odds of breakthrough infection. CONCLUSIONS: Our study concluded that the most vulnerable HCP are younger, working in COVID-19 clinical units, and received Pfizer-BioNTech primary series vaccines. Healthcare personnel who had COVID before vaccination were at reduced risk of breakthrough infection, indicating that supplemental immunity could better protect at-risk HCP groups.

Incidence of COVID-19 reinfection among Midwestern healthcare employees.

Given the overwhelming worldwide rate of infection and the disappointing pace of vaccination, addressing reinfection is critical. Understanding reinfection, including longevity after natural infection, will allow us to better know the prospect of herd immunity, which hinges on the assumption that natural infection generates sufficient, protective immunity. The primary objective of this observational cohort study is to establish the incidence of reinfection of COVID-19 among healthcare employees who experienced a prior COVID-19 infection over a 10-month period. Of 2,625 participants who experienced at least one COVID-19 infection during the 10-month study period, 156 (5.94%) experienced reinfection and 540 (20.57%) experienced recurrence after prior infection. Median days were 126.50 (105.50-171.00) to reinfection and 31.50 (10.00-72.00) to recurrence. Incidence rate of COVID-19 reinfection was 0.35 cases per 1,000 person-days, with participants working in COVID-clinical and clinical units experiencing 3.77 and 3.57 times, respectively, greater risk of reinfection relative to those working in non-clinical units. Incidence rate of COVID-19 recurrence was 1.47 cases per 1,000 person-days. This study supports the consensus that COVID-19 reinfection, defined as subsequent infection ≥ 90 days after prior infection, is rare, even among a sample of healthcare workers with frequent exposure.

ZnT8 autoantibody prevalence is low in youth with type 2 diabetes and associated with higher insulin sensitivity, lower insulin secretion, and lower disposition index.

Aim: ZnT8 autoantibody positivity (ZnT8+) is associated with risk for type 1 diabetes and with metabolic complications in adults. Our aim was to assess prevalence of ZnT8 + in the Treatment of T2D in Adolescents and Youth (TODAY) cohort and describe associated phenotypic outcomes. Methods: TODAY participants were 13.98 ± 2.03 years with a confirmed diagnosis of T2D, BMI percentile of 97.69 ± 3.32 (64% female), and GAD- and IA2- at baseline. ZnT8 autoantibodies were measured at baseline and end of study. Results: 3 of 687 participants (0.29%) were ZnT8 + and there was one conversion (0.15%) from ZnT8- to ZnT8 + during the study. ZnT8A + individuals had higher HbA1c, HDL and LDL cholesterol, and IL-1ß concentrations, and lower BMI, IL-6, and triglyceride concentrations compared to the TODAY cohort and ZnT8A- individuals. They also had higher insulin sensitivity with lower insulin secretion and disposition index, metabolically resembling T1D. All ZnT8 + participants experienced loss of glycemic control on randomized treatment, but exhibited lower rates of diabetic complications than other groups. Conclusion: Given the low rate of complications in ZnT8 + individuals, ZnT8 likely does not impact the clinical course of the disease in this population.

Long-Acting Lipoglycopeptides Can Interfere With Vancomycin Therapeutic Drug Monitoring.

Oritavancin and dalbavancin are long-acting lipoglycopeptides with activity against susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. Though similar in structure to traditional glycopeptide antibiotics like vancomycin, these antibiotics have terminal half-lives >10 days, and, as a result, there is potential for administration of vancomycin to a patient while oritavancin or dalbavancin are still appreciably present in serum. Given the structural similarities, this creates an opportunity for lab assay interference when performing therapeutic drug monitoring for vancomycin. Following higher-than-expected serum vancomycin concentrations in a patient who received both oritavancin and vancomycin within a short time frame, we evaluated the potential for lipoglycopeptide interference with clinical vancomycin assays. Five platforms covering 3 immunoassay technologies were used to quantify vancomycin concentrations in serum spiked with oritavancin or dalbavancin. Oritavancin generated spurious vancomycin concentrations (20%-84% increase) in both enzyme-multiplied immunoassay technique and a particle-enhanced turbidimetric inhibition immunoassay. However, the improper detection of oritavancin was not consistent across all particle-enhanced turbidimetric inhibition immunoassay platforms. Dalbavancin interference was not detected on any of the platforms tested. The interference from oritavancin may result in falsely elevated vancomycin concentrations and, subsequently, inappropriately adjusted vancomycin doses.

Seroprevalence of COVID-19 IgG Antibody in Resident and Fellow Physicians in Milwaukee, Wisconsin: Analysis of a Cross-Sectional Survey.

PURPOSE: Medical trainees are likely at differential risk of exposure to COVID-19 per respective clinical activity. We sought to determine the seroprevalence of COVID-19 antibody (Ab) among resident and fellow physicians with varying degrees of exposure to COVID-19. METHODS: A cross-sectional study of Milwaukee-based resident and fellow physicians, encompassing December 2019-June 2020, was conducted. Relevant variables of interest were ascertained by survey and payroll data, and Abbott ARCHITECT Ab test (index cut-off of ≥1.4) was performed. Descriptive statistics were generated, with 95% CI calculated for the study's primary outcome of seroprevalence. RESULTS: Among survey respondents (92 of 148, 62%), 61% were male, 44% were non-White, mean age was 31 years, 94% had no underlying conditions, and 52% were either family or internal medicine residents. During the study period, ≥32% reported cough, headache, or sore throat and 62% traveled outside of Wisconsin. Overall, 83% thought they had a COVID-19 exposure at work and 33% outside of work; 100% expressed any exposure. Of those exposed at work, 56% received COVID-19 pay, variously receiving 69 mean hours (range: 0-452). Ultimately, 82% (75 of 92) had an Ab test completed; 1 individual (1.3%; 95% CI: 0.0-3.9) tested seropositive, was not previously diagnosed, and had received COVID-19 pay. CONCLUSIONS: The low Ab seroprevalence found in resident and fellow physicians was similar to the concurrently reported 3.7% Ab-positive rate among 2456 Milwaukee-based staff in the same integrated health system. Ultimately, COVID-19 seroconversion may be nominal in properly protected resident and fellow physicians despite known potential exposures.

Real-World Third COVID-19 Vaccine Dosing and Antibody Response in Patients With Hematologic Malignancies.

Purpose: This study sought to describe the changes in immune response to a third dose of either Pfizer's or Moderna's COVID-19 mRNA vaccine (3V) among patients with hematologic malignancies, as well as associated characteristics. Methods: This retrospective cohort study analyzed pre-3V and post-3V data on 493 patients diagnosed with hematologic malignancies across a large Midwestern health system between August 28, 2021, and November 1, 2021. For antibody testing, S1 spike antigen of the SARS-CoV-2 virus titer was used to determine serostatus. Results: Among 493 participants, 274 (55.6%) were seropositive both pre- and post-3V (+/+) while 115 (23.3%) seroconverted to positive from prior negative following the third dose (-/+). The remaining 104 (21.1%) were seronegative both before and after 3V (-/-). No participant was seropositive pre-3V and seronegative post-3V (+/-). Results showed a statistically significant increase in the proportion of seropositivity after receiving a third COVID-19 vaccine (P<0.00001). Response to 3V was significantly associated with the 3V vaccine type (P=0.0006), previous COVID-19 infection (P=0.0453), and malignancy diagnosis (P<0.0001). Likelihood of seroconversion (-/+) after 3V was higher in the group of patients with multiple myeloma or related disorders compared to patients with lymphoid leukemias (odds ratio: 8.22, 95% CI: 2.12-31.79; P=0.0008). Conclusions: A third COVID-19 vaccination is effective in producing measurable seroconversion in many patients with hematologic malignancies. Oncologists should actively encourage all their patients, especially those with multiple myeloma, to receive a 3V, given the high likelihood of seroconversion.

Disparities in Seroprevalence of SARS-CoV-2 Immunoglobulin Antibodies in a Large Midwestern Health Care System.

OBJECTIVES: Increased exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a result of having an essential job is compounded by factors such as age, race, and ethnicity. We used a cross-sectional study design to describe disparities in the seroprevalence of SARS-CoV-2 immunoglobulin G (IgG) test results by demographic characteristics and clinical roles among a cohort of health care workers employed by the largest Midwestern health care system in the United States. METHODS: We collected 16 233 SARS-CoV-2 IgG serum samples from June 8 through July 10, 2020, from a convenience sample of Illinois- and Wisconsin-based adult health care workers. The research team, in collaboration with ACL Laboratories, used a SARS-CoV-2 IgG assay to detect the presence of SARS-CoV-2 IgG antibodies. Study data included SARS-CoV-2 IgG assay results and demographic characteristics of workers (age, sex, race, ethnicity, clinical role, zip code). We generated crude and adjusted odds ratios (ORs) to describe disparities in seroprevalence distribution among demographic and social factors. RESULTS: Of 16 233 IgG serum samples tested, 622 (3.8%) test results were positive for SARS-CoV-2. We found significant disparities in SARS-CoV-2 positivity by age, race, ethnicity, and clinical role. Participants aged 32-82 had lower adjusted ORs (aORs) of positive IgG than participants aged 18-31 (aOR range, 0.54-0.66). Odds of positivity were higher among Black (aOR = 3.86), Asian (aOR = 1.42), and mixed-race (aOR = 1.99) workers than among White workers; among Hispanic workers (aOR = 1.80) than among non-Hispanic workers; and among coronavirus disease 2019 (COVID-19) clinical workers (aOR = 1.86) than among nonclinical workers. CONCLUSIONS: Public health efforts should focus on increasing COVID-19 safety messaging, testing, vaccination, and other prevention efforts for people who are young, non-White, Hispanic, and working in COVID-19-clinical units.

Correction: Using financial incentives to promote physical activity in American Indian adolescents: A randomized controlled trial.

[This corrects the article DOI: 10.1371/journal.pone.0198390.].

Intensive vs. conventional insulin management initiated at diagnosis in children with diabetes: should payer source influence the choice of therapy?

Intensive insulin management (IIM) in type 1 diabetes facilitates improved glycemic control and a reduction in long-term diabetes complications. We hypothesized that IIM can be started at diagnosis without deleterious effects on hemoglobin A1c (A1c), body mass index (BMI), and severe hypoglycemia regardless of payer source. Type 1 diabetes patients aged 0-18 yrs, in an academic endocrinology practice were identified for a retrospective chart review. Fifty-four patients on conventional insulin management (CIM) were compared to 51 on IIM. Insulin regimens, payer, and A1c values were compared at baseline, 12, 15, and 18 months. Secondary analyses included BMI changes and hypoglycemia frequency. Overall mean A1c values for the IIM group (8.15 +/- 1.41) were lower across all time periods compared to the CIM group (8.57 +/- 1.52). Repeated measures anova revealed a significant treatment group effect (p = 0.01) with no time effect (p = 0.87) or interaction (group by time) effect (p = 0.65). Private insurance patients had lower mean A1C values than Medicaid patients (chi(2) = 4.5186, p < 0.05), regardless of regimen. A1c values between IIM and CIM were not statistically different within the Medicaid group. BMI changes between groups were not different. Chi-square analysis for severe hypoglycemia revealed no group differences. In conclusion, IIM had improved glycemic control. Private insurance vs. Medicaid patients had lower mean A1c values regardless of treatment group. Considering Medicaid patients only, IIM was not inferior, and for those with private insurance, IIM was superior. IIM, initiated at diagnosis, is a reasonable approach for newly diagnosed children with diabetes regardless of payer source.