Feasibility and Performance of Hemoglobin A1C Self-Testing During COVID-19 Among African Americans With Type 2 Diabetes.

PURPOSE: The purpose of the study was to determine the feasibility of implementing A1C self-testing at home using the A1CNow® Self Check and to compare the accuracy of the A1CNow to a reference standard in African Americans with type 2 diabetes (T2D). METHODS: African American adults with T2D were recruited from 13 different churches (N = 123). Phase 1, conducted during the early phase of the COVID-19 pandemic, examined the feasibility of A1C assessment using the A1CNow performed at home by untrained participants. Phase 2, conducted when in-person research resumed, compared A1C values concurrently measured using the A1CNow and the DCA Vantage™ Analyzer (reference standard) collected by research staff at church testing sites. RESULTS: In Phase 1, 98.8% of participants successfully completed at least 1 at-home A1C test; the overall failure rate was 24.7%. In Phase 2, the failure rate of staff-performed A1CNow testing was 4.4%. The Bland-Altman plot reveals that A1CNow values were 0.68% lower than DCA values, and the mean differences (A1CNow minus DCA) ranged from -2.6% to 1.2% with a limit of agreement between -1.9% to 0.5%. CONCLUSIONS: A1C self-testing is feasible for use in community settings involving African American adults with T2D. The A1CNow Self-Check underestimated A1C values when compared with the reference standard. Ongoing improvements in point-of-care devices have the potential to expand research and clinical care, especially in underserved communities.

A model for the pandemic and beyond: Telemedicine for all outpatient gastroenterology referrals reduces unnecessary clinic visits.

The ongoing coronavirus disease 2019 pandemic has forced providers to dramatically scale down in-person clinic visits to enforce social distancing and triage care to the neediest patients. We describe our five-month experience with a hybrid gastroenterology electronic consultation programme starting in 2019 in which we perform electronic consultations for every referral regardless of indication as well as directly initiate telephone-based telehealth visits with patients without the need for in-person clinic. Over five consecutive months, 1243 hybrid electronic consultations were performed with 356 (29%) resulting in a clinic appointment. The remaining 887 (71%) electronic consultations were resolved without need for a clinic visit. Five hundred and fourteen (41%) electronic consultations resulted in a directly scheduled procedure without clinic appointment. Eighty-five per cent of electronic consultations were performed on the same day of referral and 98% of electronic consultations were completed in under 20 min. A hybrid electronic consultation model which pre-emptively reviews all outpatient referrals streamlines access to specialty care. Such a model may be implemented rapidly during the current coronavirus disease 2019 pandemic as well as serve as a platform for long-term improvement in efficiency of care.

Diabetes Self-Management Education and Support Culturally Tailored for African Americans: COVID-19-Related Factors Influencing Restart of the TX STRIDE Study.

PURPOSE: The purpose of this substudy was to determine the most acceptable way to restart the Texas Strength Through Resilience in Diabetes Education (TX STRIDE) study safely using remote technologies. Following the emergence of COVID-19, all in-person TX STRIDE intervention and data collection sessions were paused. METHODS: Qualitative descriptive methods using telephone interviews were conducted during the research pause. A structured interview guide was developed to facilitate data collection and coding. Forty-seven of 59 Cohort 1 participants were interviewed (mean age = 60.7 years; 79% female; mean time diagnosed with type 2 diabetes = 11 years). RESULTS: Data categories and subcategories were generated from the interview responses and included: personal experiences with COVID-19, effects of COVID-19 on diabetes self-management, psychosocial and financial effects of COVID-19, and recommendations for program restart. Although some participants lacked technological knowledge, they expressed eagerness to learn how to use remote meeting platforms to resume intervention and at-home data-collection sessions. Six months after the in-person intervention was paused, TX STRIDE restarted remotely with data collection and class sessions held via Zoom. A majority of participants (72.9%) transitioned to the virtual platform restart. CONCLUSIONS: Qualitative findings guided the appropriate implementation of technology for the study, which facilitated a successful restart. High retention of participants through the study transition provides evidence that participants are invested in learning how to manage their diabetes despite the challenges and distractions imposed by COVID-19.

A Resilience Intervention for Adults with Type 2 Diabetes: Proof-of-Concept in Community Health Centers.

BACKGROUND: Given the psychological stress associated with managing type 2 diabetes (T2D), resilience-promoting interventions may particularly benefit populations experiencing high levels of stress (e.g., racial/ethnic minority and lower-income individuals). Federally qualified Community Health Centers (CHCs) primarily serve these patients and are therefore ideal settings for resilience-promoting T2D programs. This proof-of-concept study tested the Resilience-Based Diabetes Self-Management Education (RB-DSME) intervention within a CHC. METHOD: Thirty-five patients with T2D (M age = 51 years, 71% female, 60% Hispanic, 69% annual household income < $20,000) at two clinics within the CHC completed the RB-DSME, consisting of eight bi-weekly classes and two monthly support groups. In this treatment-only design, resilience resources, self-management behaviors, and physical and mental health outcomes were measured at baseline and 6 months. RESULTS: Attendance (M = 7.66/10) and program satisfaction (M = 6.79/7) were high. Participants improved adaption to stress (d = .67), adaptive coping (d = .60), diabetes empowerment (d = .57), and finding positive meaning (d = .85). Large increases in self-management behaviors (d = 1.38) and number of steps (d = 1.11) were also observed. Participants lowered A1C from baseline (M = 8.79%) to 6 months (M = 8.11%; d = .50), along with diabetes distress (d = 1.31), depressive symptoms (d = .80), and general perceived stress (d = .55). CONCLUSION: This study demonstrated the ability of the RB-DSME to improve resilience resources, self-management behaviors, and health outcomes among racial/ethnic minority and lower-income patients with T2D at clinics within a CHC. A larger, randomized trial should more rigorously test the RB-DSME in this clinical setting.

PET ligands [18F]LSN3316612 and [11C]LSN3316612 quantify O-linked-ß-N-acetyl-glucosamine hydrolase in the brain.

We aimed to develop effective radioligands for quantifying brain O-linked-ß-N-acetyl-glucosamine (O-GlcNAc) hydrolase (OGA) using positron emission tomography in living subjects as tools for evaluating drug target engagement. Posttranslational modifications of tau, a biomarker of Alzheimer's disease, by O-GlcNAc through the enzyme pair OGA and O-GlcNAc transferase (OGT) are inversely related to the amounts of its insoluble hyperphosphorylated form. Increase in tau O-GlcNAcylation by OGA inhibition is believed to reduce tau aggregation. LSN3316612, a highly selective and potent OGA ligand [half-maximal inhibitory concentration (IC50) = 1.9 nM], emerged as a lead ligand after in silico analysis and in vitro evaluations. [3H]LSN3316612 imaged and quantified OGA in postmortem brains of rat, monkey, and human. The presence of fluorine and carbonyl functionality in LSN3316612 enabled labeling with positron-emitting fluorine-18 or carbon-11. Both [18F]LSN3316612 and [11C]LSN3316612 bound reversibly to OGA in vivo, and such binding was blocked by pharmacological doses of thiamet G, an OGA inhibitor of different chemotype, in monkeys. [18F]LSN3316612 entered healthy human brain avidly (~4 SUV) without radiodefluorination or adverse effect from other radiometabolites, as evidenced by stable brain total volume of distribution (VT) values by 110 min of scanning. Overall, [18F]LSN3316612 is preferred over [11C]LSN3316612 for future human studies, whereas either may be an effective positron emission tomography radioligand for quantifying brain OGA in rodent and monkey.

Perceived stress, psychological resilience, hair cortisol concentration, and metabolic syndrome severity: A moderated mediation model.

BACKGROUND: Psychological resilience is considered to protect against detrimental effects of perceived stress on cardiovascular and metabolic health, but few studies have tested biological mechanisms underlying these relationships. PURPOSE: This study examined whether psychological resilience moderated the indirect association of perceived stress with Metabolic Syndrome (MetS) severity via hair cortisol concentration (HCC), a retrospective index of hypothalamic pituitary adrenal (HPA) axis activity. METHOD: Participants included 228 adults (73 White, 86 Hispanic, 69 African American; mean age 45.29 years; 68% females). Participants completed questionnaires assessing perceived stress (Perceived Stress Scale) and resilience (Brief Resilience Scale). The first 3 cm of scalp-near hair were analyzed for cortisol concentration using enzyme-linked immunoassay analysis. Cardiometabolic risk factors including blood glucose, lipids, blood pressure, and waist circumference were assessed, from which a sex- and race/ethnicity-specific continuous MetS severity score was calculated. A moderated mediation model was tested using path analysis. RESULTS: Psychological resilience moderated the association of perceived stress with HCC (R2 change for interaction = 0.014, p =  0.043), such that the association of perceived stress and HCC decreased as resilience scores increased. Resilience also moderated the indirect association of perceived stress with MetS severity via HCC (b = -0.039, 95% CI [-0.001; -0.100]), such that HCC mediated the association of greater perceived stress with greater MetS severity only for individuals reporting Brief Resilience Scale scores 3 or below (range: 1.17-5.00). Psychological resilience was also associated with lower MetS severity (ß = -0.227, p =  0.014) independent of perceived stress and HCC. CONCLUSION: Findings suggest that psychological resilience may serve as both a stress buffer and as a direct determinant of cardiometabolic health. These results extend literature on psychological resilience to measures of retrospective HPA axis function and MetS severity in a diverse sample.

Race moderates the association of perceived everyday discrimination and hair cortisol concentration.

The influence of discrimination on hypothalamic-pituitary-adrenal (HPA) axis function is considered to be more pronounced for racial minority versus majority groups, although empirical support for this argument is not strong. This study examined whether the association of perceived discrimination was more strongly associated with long-term, retrospective cortisol output (as measured by hair cortisol concentration [HCC]) among African American compared to White adults. Participants included 141 community-dwelling adults (72 White, 69 African American; mean age 45.8 years; 67% females). The Everyday Discrimination Scale assessed perceived discrimination. The first 3 cm of proximal scalp hair was analyzed for HCC using enzyme-linked immunoassay. Associations between race, perceived discrimination and HCC were examined using hierarchical multiple regression. African Americans had higher HCC than Whites, but both groups reported perceived discrimination with similar frequency. Race moderated the association between perceived discrimination and HCC (R2 interaction = 0.03, p = 0.007) such that perceived discrimination was positively associated with HCC among African Americans (ß = 0.28, p = 0.007), but not Whites (ß = -0.11, p = 0.274). Perceived discrimination did not mediate the association between race and HCC (ß for indirect effect = 0.025, 95% CI [-.003, 0.087]). Although perceived discrimination did not differ between races, perceived discrimination was positively associated with retrospective levels of cortisol in scalp hair among African Americans but not Whites. This may suggest that characteristics of discrimination other than frequency are particularly salient to HPA axis function among African Americans (e.g. attribution, severity, historical context).LAY SUMMARYThis study found that greater perceived discrimination frequency was associated with greater long-term cortisol secretion (i.e. hair cortisol concentration) among African American compared to White adults. Both groups reported similar discrimination frequency, so the uniqueness of African Americans' experience with discrimination may be salient to HPA axis upregulation for this population.

Resilience-based Diabetes Self-management Education: Perspectives From African American Participants, Community Leaders, and Healthcare Providers.

Purpose The purpose of this qualitative, focus group study was to further refine the Resilience-based Diabetes Self-management Education (RB-DSME) recruitment process and intervention, build greater trust in the community, and identify strategies to enhance its sustainability as a community-based intervention in African American church settings. Methods Six 2-hour focus groups (N = 55; 10 men and 45 women) were led by a trained moderator with a written guide to facilitate discussion. Two sessions were conducted with individuals diagnosed with type 2 diabetes mellitus (T2DM) who participated in previous RB-DSME pilot interventions and their family members, two sessions with local church leaders, and two sessions with community healthcare providers who care for patients with T2DM. Two independent reviewers performed content analysis to identify major themes using a grounded theory approach. The validity of core themes was enhanced by external review and subsequent discussions with two qualitative methods consultants. Results There was expressed interest and acceptability of the RB-DSME program. Church connection and pastor support were noted as key factors in building trust and enhancing recruitment, retention, and sustainability of the program. Core themes across all groups included the value of incentives, the need for foundational knowledge shared with genuine concern, teaching with visuals, dealing with denial, balancing the reality of adverse consequences with hope, the importance of social support, and addressing healthcare delivery barriers. Conclusion Focus groups documented the feasibility and potential effectiveness of RB-DSME interventions to enhance diabetes care in the African American community. In clinical practice, inclusion of these core themes may enhance T2DM self-care and treatment outcomes.

Hair cortisol concentration and glycated hemoglobin in African American adults.

BACKGROUND: African Americans have higher diabetes prevalence compared to Whites. They also have elevated cortisol levels - indicating possible HPA axis dysregulation - which may raise blood glucose as part of the biological response to physiological and psychosocial stress. Little is known about chronic cortisol levels in African Americans, and even less about the role of chronically elevated cortisol in type 2 diabetes development in this racial group. PURPOSE: We used analysis of cortisol in hair to examine associations of long-term (∼3months) cortisol levels with glycated hemoglobin (HbA1c) in a group of African American adults. In exploratory analyses, we also studied the relationship of hair dehydroepiandrosterone (DHEA) with HbA1c. METHOD: Participants were 61 community-dwelling African American adults (85% female; mean age 54.30 years). The first 3cm of scalp-near hair were analyzed for cortisol and DHEA concentration using enzyme-linked immunoassay analysis. Glycated hemoglobin was assessed, and regression analyses predicting HbA1c from hair cortisol and DHEA were performed in the full sample and in a subsample of participants (n=20) meeting the National Institute of Diabetes and Digestive Kidney Disease (NIDDK) criteria for type 2 diabetes (HbA1c≥6.5%). RESULTS: In the full sample, HbA1c increased with hair cortisol level (ß=0.22, p=0.04, f(2)=0.10), independent of age, sex, chronic health conditions, diabetes medication use, exercise, and depressive symptoms. In the subsample of participants with an HbA1c≥6.5%, hair cortisol was also positively related to HbA1c (ß=0.45, p=0.04, f(2)=0.32), independent of diabetes medication use. Glycated hemoglobin was unrelated to hair DHEA in both the full sample and HbA1c≥6.5% subsample. CONCLUSION: Long-term HPA axis dysregulation in the form of elevated hair cortisol is associated with elevated HbA1c in African American adults.

Introduction: Political Influence on Bioethical Deliberation.

Twelve personal narratives address the impact of political influence on bioethics. Three commentary articles explore these stories and suggest lessons that can be learned from them. The commentators come from backgrounds that include bioethics, medicine, educational psychology, health care management, and philosophy.

A resilience intervention in African-American adults with type 2 diabetes.

OBJECTIVES: To explore the feasibility and outcomes of a resilience-based diabetes self-management education (RB-DSME) program to improve psychological and physiological health in African-American adults with type 2 diabetes. METHODS: An experimental group (N = 32) received RB-DSME and a comparison group (N = 33) received standard DSME. Psychological and physiological measures were taken at baseline and 6 months. ANCOVAs assessed whether the experimental group improved its overall outcome relative to the comparison group, while controlling for baseline scores. RESULTS: The experimental group's outcomes were significantly improved vis-à-vis the comparison group for diabetes knowledge, positive meaning, HDL cholesterol, and fasting blood glucose. CONCLUSIONS: The RB-DSME shows feasibility and promise for enhancing health; a full-scale randomized trial is warranted.

123I-iododexetimide preferentially binds to the muscarinic receptor subtype M1 in vivo.

UNLABELLED: The muscarinic M1 receptor (M1R) is highly involved in cognition, and selective M1 agonists have procognitive properties. Loss of M1R has been found in postmortem brain tissue for several neuropsychiatric disorders and may be related to symptoms of cognitive dysfunction. (123)I-iododexetimide is used for imaging muscarinic acetylcholine receptors (mAchRs). Considering its high brain uptake and intense binding in M1R-rich brain areas, (123)I-iododexetimide may be an attractive radiopharmaceutical to image M1R. To date, the binding affinity and selectivity of (123)I-iododexetimide for the mAchR subtypes has not been characterized, nor has its brain distribution been studied intensively. Therefore, this study aimed to address these topics. METHODS: The in vitro affinity and selectivity of (127)I-iododexetimide (cold-labeled iododexetimide), as well as its functional antagonist properties (guanosine 5'-[γ-(35)S-thio]triphosphate [GTPγ(35)S] assay), were assessed on recombinant human M1R-M5R. Distributions of (127)I-iododexetimide and (123)I-iododexetimide in the brain were evaluated using liquid chromatography-mass spectrometry and storage phosphor imaging, respectively, ex vivo in rats, wild-type mice, and M1-M5 knock-out (KO) mice. Inhibition of (127)I-iododexetimide and (123)I-iododexetimide binding in M1R-rich brain areas by the M1R/M4R agonist xanomeline, or the antipsychotics olanzapine (M1R antagonist) and haloperidol (low M1R affinity), was assessed in rats ex vivo. RESULTS: In vitro, (127)I-iododexetimide displayed high affinity for M1R (pM range), with modest selectivity over other mAchRs. In biodistribution studies on rats, ex vivo (127)I-iododexetimide binding was much higher in M1R-rich brain areas, such as the cortex and striatum, than in cerebellum (devoid of M1Rs). In M1 KO mice, but not M2-M5 KO mice, (127)I-iododexetimide binding was strongly reduced in the frontal cortex compared with wild-type mice. Finally, acute administration of both an M1R/M4R agonist xanomeline and the M1R antagonist olanzapine was able to inhibit (123)I-iododexetimide ex vivo, and (123)I-iododexetimide binding in M1-rich brain areas in rats, whereas administration of haloperidol had no effect. CONCLUSION: The current results suggest that (123)I-iododexetimide preferentially binds to M1R in vivo and can be displaced by M1R ligands. (123)I-iododexetimide may therefore be a useful imaging tool as a way to further evaluate M1R changes in neuropsychiatric disorders, as a potential stratifying biomarker, or as a clinical target engagement biomarker to assess M1R.

Positivity and indicators of health among African Americans with diabetes.

OBJECTIVES: To examine the utility of the positivity ratio to distinguish differences in psychological and physiological health in African Americans with type 2 diabetes. METHODS: Study participants (N = 93) were recruited through radio and church announcements and grouped by their positivity ratio. RESULTS: Multivariate analyses showed flourishing individuals had the highest resilience and lowest depressive symptoms and HbA1c (A1C), whereas depressed individuals recorded the lowest resilience and highest depressive symptoms and A1C. Small to large effect sizes were reported. CONCLUSIONS: Further support for the utility and generalizability of the positivity ratio was provided. Cultivating positive emotions may improve the health of individuals with type 2 diabetes.