A patient-centered comparative effectiveness research study of culturally appropriate options for diabetes self-management.

This project compared the effectiveness of two evidence-based models of culturally competent diabetes health promotion: The Diabetes Self-Management Support Empowerment Model (DSMS), and The Chronic Care Model (CCM). Our primary outcome was improvement in patient capacity for diabetes self-management as measured by the Diabetes Knowledge Questionnaire (DKQ) and the Patient Activation Measure (PAM). Our secondary outcome was patient success at diabetes self-management as measured by improvement in A1c, depression sores using the PHQ-9, and Body Mass Index (BMI). We also gathered data on the cultural competence of the program using the Consumer Assessment of Healthcare Providers and Systems Cultural Competence Set (CAHPS-CC). We compared patient outcomes in two existing sites in Albuquerque, New Mexico that serve a large population of Latino diabetes patients from low-income households. Participants were enrolled as dyads-a patient participant (n=226) and a social support participant (n=226). Outcomes over time and by program were analyzed using longitudinal linear mixed modeling, adjusted for patient participant demographic characteristics and other potential confounding covariates. Secondary outcomes were also adjusted for potential confounders. Interactions with both time and program helped to assess outcomes. This study did not find a difference between the two sites with respect to the primary outcome measures and only one of the three secondary outcomes showed differential results. The main difference between programs was that depression decreased more for CCM than for DSMS. An exploratory, subgroup analysis revealed that at CCM, patient participants with a very high A1c (>10) demonstrated a clinically meaningful decrease. However, given the higher cultural competence rating for the CCM, statistically significant improvement in depression, and the importance of social support to the patients, results suggest that a culturally and contextually situated diabetes self-management and education program design may deliver benefit for patients, especially for patients with higher A1c levels.

Evidence-based practice strategies for faculty professional development in clinical translational research at Institutional Development Award (IDeA) state institutions in the Mountain West.

The Mountain West Clinical Translational Research - Infrastructure Network (MW CTR-IN), established in 2013, is a research network of 13 university partners located among seven Institutional Development Award (IDeA) states targeting health disparities. This is an enormous undertaking because of the size of the infrastructure network (encompassing a third of the US landmass and spanning four time zones in predominantly rural and underserved areas, with populations that have major health disparities issues). In this paper, we apply the barriers, strategies, and metrics to an adapted educational conceptual model by Fink (2013). Applying this model, we used four tailored approaches across this regional infrastructure network to: (1) assess individual faculty specific needs, (2) reach out and engage with faculty, (3) provide customized services to meet the situational needs of faculty, and (4) utilize a "closed communication feedback loop" between Professional Development (PD) core and MW CTR-IN faculty within the context of their home institutional environment. Summary statement results from participating faculty show that these approaches were positive. Grounded in best educational practice approaches, we have an opportunity to refine and build from this sound foundation with implications for future use in other CTR-IN networks and institutions in the IDeA states.

Association Between Patient Factors and the Effectiveness of Wearable Trackers at Increasing the Number of Steps per Day Among Adults With Cardiometabolic Conditions: Meta-analysis of Individual Patient Data From Randomized Controlled Trials.

BACKGROUND: Current evidence supports the use of wearable trackers by people with cardiometabolic conditions. However, as the health benefits are small and confounded by heterogeneity, there remains uncertainty as to which patient groups are most helped by wearable trackers. OBJECTIVE: This study examined the effects of wearable trackers in patients with cardiometabolic conditions to identify subgroups of patients who most benefited and to understand interventional differences. METHODS: We obtained individual participant data from randomized controlled trials of wearable trackers that were conducted before December 2020 and measured steps per day as the primary outcome in participants with cardiometabolic conditions including diabetes, overweight or obesity, and cardiovascular disease. We used statistical models to account for clustering of participants within trials and heterogeneity across trials to estimate mean differences with the 95% CI. RESULTS: Individual participant data were obtained from 9 of 25 eligible randomized controlled trials, which included 1481 of 3178 (47%) total participants. The wearable trackers revealed that over the median duration of 12 weeks, steps per day increased by 1656 (95% CI 918-2395), a significant change. Greater increases in steps per day from interventions using wearable trackers were observed in men (interaction coefficient -668, 95% CI -1157 to -180), patients in age categories over 50 years (50-59 years: interaction coefficient 1175, 95% CI 377-1973; 60-69 years: interaction coefficient 981, 95% CI 222-1740; 70-90 years: interaction coefficient 1060, 95% CI 200-1920), White patients (interaction coefficient 995, 95% CI 360-1631), and patients with fewer comorbidities (interaction coefficient -517, 95% CI -1188 to -11) compared to women, those aged below 50, non-White patients, and patients with multimorbidity. In terms of interventional differences, only face-to-face delivery of the tracker impacted the effectiveness of the interventions by increasing steps per day. CONCLUSIONS: In patients with cardiometabolic conditions, interventions using wearable trackers to improve steps per day mostly benefited older White men without multimorbidity. TRIAL REGISTRATION: PROSPERO CRD42019143012; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=143012.

The associations between COVID-19 diagnosis, type 1 diabetes, and the risk of diabetic ketoacidosis: A nationwide cohort from the US using the Cerner Real-World Data.

OBJECTIVE: To assess the risk of new-onset type 1 diabetes mellitus (T1D) diagnosis following COVID-19 diagnosis and the impact of COVID-19 diagnosis on the risk of diabetic ketoacidosis (DKA) in patients with prior T1D diagnosis. RESEARCH DESIGN AND METHODS: Retrospective data consisting of 27,292,879 patients from the Cerner Real-World Data were used. Odds ratios, overall and stratified by demographic predictors, were calculated to assess associations between COVID-19 and T1D. Odds ratios from multivariable logistic regression models, adjusted for demographic and clinical predictors, were calculated to assess adjusted associations between COVID-19 and DKA. Multiple imputation with multivariate imputation by chained equations (MICE) was used to account for missing data. RESULTS: The odds of developing new-onset T1D significantly increased in patients with COVID-19 diagnosis (OR: 1.42, 95% CI: 1.38, 1.46) compared to those without COVID-19. Risk varied by demographic groups, with the largest risk among pediatric patients ages 0-1 years (OR: 6.84, 95% CI: 2.75, 17.02) American Indian/Alaskan Natives (OR: 2.30, 95% CI: 1.86, 2.82), Asian or Pacific Islanders (OR: 2.01, 95% CI: 1.61, 2.53), older adult patients ages 51-65 years (OR: 1.77, 95% CI: 1.66, 1.88), those living in the Northeast (OR: 1.71, 95% CI: 1.61, 1.81), those living in the West (OR: 1.65, 95% CI: 1.56, 1.74), and Black patients (OR: 1.59, 95% CI: 1.47, 1.71). Among patients with diagnosed T1D at baseline (n = 55,359), 26.7% (n = 14,759) were diagnosed with COVID-19 over the study period. The odds of developing DKA for those with COVID-19 were significantly higher (OR 2.26, 95% CI: 2.04, 2.50) than those without COVID-19, and the largest risk was among patients with higher Elixhauser Comorbidity Index. CONCLUSIONS: COVID-19 diagnosis is associated with significantly increased risk of new-onset T1D, and American Indian/Alaskan Native, Asian/Pacific Islander, and Black populations are disproportionately at risk. In patients with pre-existing T1D, the risk of developing DKA is significantly increased following COVID-19 diagnosis.

Preoperative vitamin D deficiency is associated with increased risk of postoperative hypocalcemia after total thyroidectomy.

Prior single-institution studies suggest that preoperative vitamin D deficiency (VDD) is associated with postoperative hypocalcemia and a prolonged length of hospital stay following total thyroidectomy. In this study, we employ a multi-institutional, de-identified electronic health records database to address this issue. We hypothesize that total thyroidectomy patients with preoperative VDD will be at an increased associated risk of postoperative hypocalcemia and hospitalization. Using Cerner Health Facts, we identified 2447 patients who underwent total or subtotal thyroidectomy between 2008 and 2016 and who had a documented 25-hydroxyvitamin D concentration obtained within 12 months of the surgery date using International Classification of Diseases 9/10, Current Procedural Terminology and Healthcare Common Procedure Coding System codes. Data from 984 patients who underwent total thyroidectomy were analyzed. Analysis of variance models estimated the effect of VDD on postoperative numerical variables. Multiple logistic regression estimated the risk of postoperative hypocalcemia and hospital stay, adjusting for any imbalanced demographic variables and operative characteristics. On average, postoperative total calcium concentrations in the VDD group were lower by 0.3 mg/dL compared with that of the non-VDD group (p<0.01). The risk of postoperative hypocalcemia was 2.2 times higher in the VDD group compared with the non-VDD group (p<0.01). Although the length of hospital stay after thyroidectomy was longer in the VDD group compared with the non-VDD group (p=0.03), VDD is not an independent risk factor for prolonged hospitalization following thyroidectomy (p=0.13). VDD is associated with a higher risk of hypocalcemia following total thyroidectomy. Prethyroidectomy operative screening for VDD should be considered.

AMPK is activated during lysosomal damage via a galectin-ubiquitin signal transduction system.

Lysosomal damage activates AMPK, a regulator of macroautophagy/autophagy and metabolism, and elicits a strong ubiquitination response. Here we show that the cytosolic lectin LGALS9 detects lysosomal membrane breach by binding to lumenal glycoepitopes, and directs both the ubiquitination response and AMPK activation. Proteomic analyses have revealed increased LGALS9 association with lysosomes, and concomitant changes in LGALS9 interactions with its newly identified partners that control ubiquitination-deubiquitination processes. An LGALS9-inetractor, deubiquitinase USP9X, dissociates from damaged lysosomes upon recognition of lumenal glycans by LGALS9. USP9X's departure from lysosomes promotes K63 ubiquitination and stimulation of MAP3K7/TAK1, an upstream kinase and activator of AMPK hitherto orphaned for a precise physiological function. Ubiquitin-activated MAP3K7/TAK1 controls AMPK specifically during lysosomal injury, caused by a spectrum of membrane-damaging or -permeabilizing agents, including silica crystals, the intracellular pathogen Mycobacterium tuberculosis, TNFSF10/TRAIL signaling, and the anti-diabetes drugs metformin. The LGALS9-ubiquitin system activating AMPK represents a novel signal transduction system contributing to various physiological outputs that are under the control of AMPK, including autophagy, MTOR, lysosomal maintenance and biogenesis, immunity, defense against microbes, and metabolic reprograming. ABBREVIATIONS: AMPK: AMP-activated protein kinase; APEX2: engineered ascorbate peroxidase 2; ATG13: autophagy related 13; ATG16L1: autophagy related 16 like 1; BMMs: bone marrow-derived macrophages; CAMKK2: calcium/calmodulin dependent protein kinase kinase 2; DUB: deubiquitinase; GPN: glycyl-L-phenylalanine 2-naphthylamide; LLOMe: L-leucyl-L-leucine methyl ester; MAP1LC3/LC3: microtubule associated protein 1 light chain 3; MAP3K7/TAK1: mitogen-activated protein kinase kinase kinase 7; MERIT: membrane repair, removal and replacement; MTOR: mechanistic target of rapamycin kinase; STK11/LKB1: serine/threonine kinase 11; TNFSF10/TRAIL: TNF superfamily member 10; USP9X: ubiquitin specific peptidase 9 X-linked.

AMPK, a Regulator of Metabolism and Autophagy, Is Activated by Lysosomal Damage via a Novel Galectin-Directed Ubiquitin Signal Transduction System.

AMPK is a central regulator of metabolism and autophagy. Here we show how lysosomal damage activates AMPK. This occurs via a hitherto unrecognized signal transduction system whereby cytoplasmic sentinel lectins detect membrane damage leading to ubiquitination responses. Absence of Galectin 9 (Gal9) or loss of its capacity to recognize lumenal glycans exposed during lysosomal membrane damage abrogate such ubiquitination responses. Proteomic analyses with APEX2-Gal9 have revealed global changes within the Gal9 interactome during lysosomal damage. Gal9 association with lysosomal glycoproteins increases whereas interactions with a newly identified Gal9 partner, deubiquitinase USP9X, diminishes upon lysosomal injury. In response to damage, Gal9 displaces USP9X from complexes with TAK1 and promotes K63 ubiquitination of TAK1 thus activating AMPK on damaged lysosomes. This triggers autophagy and contributes to autophagic control of membrane-damaging microbe Mycobacterium tuberculosis. Thus, galectin and ubiquitin systems converge to activate AMPK and autophagy during endomembrane homeostasis.

Hypothyroidism, Sex, and Age Predict Future Thromboembolic Events Among Younger People.

PURPOSE: Aberrant thyroid function causes dysregulated metabolic homeostasis. Literature has demonstrated hypercoagulability in hypothyroidism, suggesting a risk for thromboembolic events (TEE). We hypothesize that individuals with hypothyroidism will experience more clinically-diagnosed TEE than euthyroid individuals. METHODS: De-identified patient data from the University of New Mexico Health Sciences Center were retrieved using thyrotropin (TSH; thyroid-stimulating hormone) for case-finding from 2005 to 2007 and ICD billing codes to identify TEE during the follow-up period of 10 to 12 years. Diagnoses affecting coagulation were excluded and 12 109 unique enrollees were categorized according to TSH concentration as Hyperthyroid (n = 510), Euthyroid (n = 9867), Subclinical Hypothyroid (n = 1405), or Overtly Hypothyroid (n = 327). Analysis with multiple logistic regression provided the odds of TEE while adjusting for covariates. RESULTS: There were 228 TEEs in the cohort over 5.1 ±â€…4.3 years of follow-up. Risk of TEE varied significantly across study groups while adjusting for sex, race/ethnicity, levothyroxine, oral contraceptive therapy, and visit status (outpatient vs non-outpatient), and this risk was modified by age. Overt Hypothyroidism conferred a significantly higher risk of TEE than Euthyroidism below age 35, and Hyperthyroidism conferred an increased risk for TEE at age 20. Analysis also demonstrated a higher age-controlled risk for a subsequent TEE in men compared with women (odds ratio [OR] = 1.36; 95% confidence interval [CI], 1.02-1.81). Subanalysis of smoking status (n = 5068, 86 TEE) demonstrated that smokers have 2.21-fold higher odds of TEE relative to nonsmokers (95% CI, 1.41-3.45). CONCLUSIONS: In this retrospective cohort study, Overt Hypothyroidism conferred increased risk of TEE over the next decade for individuals younger than 35 years of age, as compared with Euthyroidism.

Characterizing health researcher barriers to sharing results with study participants.

INTRODUCTION: Research participants want to receive results from studies in which they participate. However, health researchers rarely share the results of their studies beyond scientific publication. Little is known about the barriers researchers face in returning study results to participants. METHODS: Using a mixed-methods design, health researchers (N = 414) from more than 40 US universities were asked about barriers to providing results to participants. Respondents were recruited from universities with Clinical and Translational Science Award programs and Prevention Research Centers. RESULTS: Respondents reported the percent of their research where they experienced each of the four barriers to disseminating results to participants: logistical/methodological, financial, systems, and regulatory. A fifth barrier, investigator capacity, emerged from data analysis. Training for research faculty and staff, promotion and tenure incentives, and funding agencies supporting dissemination of results to participants were solutions offered to overcoming barriers. CONCLUSIONS: Study findings add to literature on research dissemination by documenting health researchers' perceived barriers to sharing study results with participants. Implications for policy and practice suggest that additional resources and training could help reduce dissemination barriers and increase the return of results to participants.

Health researchers' experiences, perceptions and barriers related to sharing study results with participants.

BACKGROUND: Although research participants are generally interested in receiving results from studies in which they participate, health researchers rarely communicate study findings to participants. The present study was designed to provide opportunity for a broad group of health researchers to describe their experiences and concerns related to sharing results (i.e. aggregate study findings) with research participants. METHODS: We used a mixed-methods concurrent triangulation design, relying on an online survey to capture health researchers' experiences, perceptions and barriers related to sharing study results with participants. Respondents were health researchers who conduct research that includes the consent of human subjects and hold a current appointment at an accredited academic medical institution within the United States. For quantitative data, the analytic strategy focused on item-level descriptive analyses. For the qualitative data, analyses focused on a priori themes and emergent subthemes. RESULTS: Respondents were 414 researchers from 44 academic medical institutions; 64.5% reported that results should always be shared with participants, yet 60.8% of respondents could identify studies in which they had a leadership role where results were not shared. Emergent subthemes from researchers' reasons why results should be shared included participant ownership of findings and benefits of results sharing to science. Reasons for not sharing included concerns related to participants' health literacy and participants' lack of desire for results. Across all respondents who described barriers to results sharing, the majority described logistical barriers. CONCLUSIONS: Study findings contribute to the literature by documenting researchers' perspectives and experiences about sharing results with research participants, which can inform efforts to improve results sharing. Most respondents indicated that health research results should always be shared with participants, although the extent to which many respondents described barriers to results sharing as well as reported reasons not to share results suggests difficulties with a one-size-fits-all approach to improving results sharing.

Efficacy of equine-assisted psychotherapy in veterans with posttraumatic stress disorder.

BACKGROUND: Posttraumatic stress disorder (PTSD) is a common and debilitating disorder among war veterans. Although complementary and alternative therapies are gaining acceptance in the treatment of PTSD, the efficacy of animal-based therapies in this disorder is unknown. The goal of equine-assisted psychotherapy (EAP) is to improve the social, emotional, and/or cognitive functions of individuals with PTSD. OBJECTIVE: This study aims to explore the effects of EAP on PTSD symptoms. We hypothesized that veterans with PTSD who participate in a standardized EAP program for 1 h per week for 6 weeks would experience decreased PTSD symptoms and would demonstrate increased resilience as compared with individuals who do not receive EAP intervention. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: We conducted a sequentially assigned, two-arm parallel group trial comparing 6 weeks of EAP with standard, previously established, ongoing PTSD therapy. Therapy was conducted at a community EAP facility in conjunction with an academic University Hospital. Twenty adult veterans with symptomatic PTSD completed the study. Ten adult veterans with previously diagnosed PTSD were assigned to EAP and received directed interaction with trained horses for one hour a week in groups of 3 or 4 individuals, while also continuing their previously established therapies. A certified therapist supervised the sessions, and a professional horse handler was also present. Results were compared with those from 10 adult veterans who only received their standard previously established PTSD care as prescribed by their provider. MAIN OUTCOME MEASURES: Changes in salivary cortisol, scores for the PTSD Check List-Military Version (PCL-M) and the Connor-Davidson Resilience Scale (CD-RISC) after 6 weeks of study were measured. RESULTS: Of the 20 enrolled patients, 10 served in Afghanistan, 5 served in Iraq, and 3 served in Vietnam. Subjects were (47 ±â€¯14) years old, were predominantly male, and had a body mass index of (29 ±â€¯7) kg/m2. They had (9.2 ±â€¯6.1) years of military service and carried 66% ±â€¯37% service-connected disability. PCL-M scores declined significantly in both groups and CD-RISC scores increased significantly in the EAP group. There was no difference between the groups with respect to the magnitude of change. CONCLUSION: As compared to the control group, a 6-week EAP program did not produce a statistically significant difference with respect to PCL-M and CD-RISC scores, or salivary cortisol. However, our results suggest that EAP may work as well as standard therapy with respect to these parameters. This study supports further inquiry into EAP as a potentially efficacious alternative for veterans suffering from PTSD. TRIAL REGISTRATION: ClinicalTrials.gov NCT #03039361.

A Perplexing Case of Pituitary Apoplexy Masquerading as Recurrent Meningitis.

In this article, we present an exceptional case of pituitary apoplexy in which a patient presented with meningeal symptoms of headache, stiff neck, and nausea rather than the classical findings of ophthalmoplegia and/or vision loss. The patient has had 2 similar presentations with cerebrospinal fluid showing neutrophilic pleocytosis, as well as a computed tomography scan showing a prominent pituitary gland. On current presentation, the patient's vital signs were stable and the physical examination was remarkable for nuchal rigidity. Magnetic resonance imaging of the head revealed an expansile pituitary gland lesion measuring 2.0 × 1.7 × 1.5 cm with upward displacement of the overlying optic chiasm. Cerebrospinal fluid showed neutrophilic pleocytosis, low glucose, high protein content, and negative bacterial and fungal cultures. Surgical decompression subsequently revealed findings consistent with pituitary apoplexy. This is the first known case in which a patient had recurrent episodes of meningitis due to pituitary apoplexy in the absence of a clinical deterioration. Early identification of apoplexy masquerading as meningitis will allow early surgical intervention, if necessary, to prevent complications, recurrence, and morbidity. As such, the presence of sterile meningitis in patients with a known pituitary adenoma should be considered for prompt surgical evaluation.

Learning and memory performance following acute intranasal insulin administration in abstinent smokers.

The highest incidence of relapse to smoking occurs within the first 2 weeks of a cessation attempt. In addition to enhanced nicotine craving, this phase of smoking cessation is also marked by learning and memory dysfunction. Many smokers are not able to overcome these symptoms, and they relapse to smoking shortly after trying to quit. In two clinical studies, we evaluated intranasal insulin for efficacy in improving learning and memory function during nicotine withdrawal. Our first study was a crossover evaluation (N = 19) following 20 hr of smoking abstinence. Study 2 was a parallel design study (N = 50) following 16 hr of abstinence. Intranasal insulin (60 IU) dose was administered in both studies and cognitive function was measured using California Verbal Learning Test-II. Intranasal insulin did not improve learning over the 5 verbal learning trials. In addition, intranasal insulin did not improve either short- or long-delay recall in either study. In summary, the one-time administration of intranasal insulin does not improve verbal learning and memory in smokers. Whether longer administration schedules may be of benefit should be evaluated in future studies.

A Comprehensive Approach to Community Recruitment for Clinical and Translational Research.

INTRODUCTION: Recruitment and engagement for clinical and translational research is challenging, especially among medically underserved and ethnic or racial minority populations. METHODS: We present a comprehensive model developed through the Clinical and Translational Science Center at the University of New Mexico Health Sciences Center that addresses three critical aspects of participant recruitment. RESULTS: The components of the model are: 1) Recruitment from within UNM to UNM-centered studies, 2) recruitment from within UNM to community-based studies, and 3) recruitment from outside UNM to UNM-centered studies. CONCLUSIONS: This model has increased research participant recruitment, especially among medically underserved populations, and offers generalizable translational solutions to common clinical and translational research challenges, especially in settings with similar demographic and geographic characteristics.

What is the Role of Race and Ethnicity in the Development Of Thionamide-Induced Neutropenia?

Thionamides are anti-thyroid drugs (ATD) used to treat autonomous thyrotoxicosis. Although efficacious, these medications carry a risk of neutropenia or agranulocytosis. Some risk factors for ATD-induced neutropenia have been identified, including dose, age, and female sex, but the role of race and ethnicity has not been well studied. We hypothesize that there will be no effect of race or ethnicity on the change in Absolute Neutrophil Count (ANC) following initiation of ATD therapy. Data from the Electronic Medical Record at UNM HSC were obtained using a standard database query. Inclusion criteria were the prescription of an ATD, an ANC recorded within 30 days of initiating ATD therapy (Pre-ATD), and an ANC recorded 75 - 365 days after starting an ANC (Post-ATD). Patients taking other agents known to cause neutropenia were excluded. Racial and ethnic groups were assigned as follows: Hispanic, Non-Hispanic White, Native American, Black/African American, and Asian/Pacific Islander. Post-ATD ANC was defined as the nadir ANC after ATD initiation. "Delta ANC" was defined as ((Post-ATD ANC) - (Pre-ATD ANC)). ANOVA analysis with Bonferroni-adjusted post-hoc testing and multiple regression were performed to examine differences in the mean changes in ANC across ethnic groups. One hundred and twenty-three adult patients met inclusion and exclusion criteria and were included in the analysis. The Native American group showed a significantly greater Post-ATD ANC and Delta-ANC as compared to the other groups (p<0.001). In this cohort of New Mexicans with thyrotoxicosis, Native American race was protective against thionamide-induced neutropenia.

Management of Asymptomatic Patients With Positive Coronary Artery Calcium Scans.

BACKGROUND: The widespread availability of the coronary artery calcium scan to diagnose coronary artery atheroma semiquantitatively and its prognostic significance has frequently resulted in a difficult therapeutic decision for physicians caring for asymptomatic patients. PATIENTS AND RISK FACTORS: Of particular concern are patients over 40 years of age and young adults characterized by multiple cardiovascular risk factors. The correct prognostic interpretation of coronary artery calcium scores and the potential benefits and risks of various therapeutic modalities need to be understood. CONCLUSION: This review describes the therapeutic choices available to endocrinologists and provides recommendations for various treatment options.

INSULIN TIMING: A PATIENT-CENTERED APPROACH TO IMPROVE CONTROL IN TYPE 1 DIABETES.

OBJECTIVE: The goal of insulin therapy in type 1 diabetes (T1D) is to reduce hemoglobin A1C (A1C) to ≤7.0% (53 mmol/mol) with minimal hypoglycemia. We investigated the possibility that "insulin timing" would improve A1C without incurring severe hypoglycemia in volunteers with T1D over a 6-month observation period. METHODS: Forty healthy adult volunteers with T1D were randomly assigned for 6 months to either a control group or an insulin timing group. The primary endpoint was the difference in A1C between the two groups. As a secondary endpoint, both groups were further divided to assess the importance of the baseline A1C in determining the response to timing. The insulin timing algorithm altered the time when the meal dose of insulin was injected or infused from 30 minutes before the meal to 15 minutes after the meal, depending upon the premeal blood glucose concentration. RESULTS: An improvement in mean A1C was observed in the timing group compared with no change in the control group, but this improvement did not reach statistical significance (P>.05). In contrast, when the two groups were analyzed according to baseline A1C, the timing volunteers with baseline A1C values in the upper half (separated by the A1C median of 7.45% [57.9 mmol/mol]) of the timing group had a more robust response to timing (decline in A1C) than the upper half of the control group (P<.05). CONCLUSION: Insulin timing is a patient-centered translational approach that is safe and effective in improving A1C in individuals with T1D with an elevated A1C. ABBREVIATIONS: A1C = hemoglobin A1C ANOVA = analysis of variance CGM = continuous glucose monitoring CSII = continuous subcutaneous insulin infusion MDI = multiple daily injection T1D = type 1 diabetes.

DOES PRE-OPERATIVE VITAMIN D DEFICIENCY PREDICT POSTOPERATIVE HYPOCALCEMIA AFTER THYROIDECTOMY?

OBJECTIVE: Postoperative hypocalcemia is frequent after total thyroidectomy. The role of pre-operative vitamin D levels in the pathogenesis of this condition has not been studied under the most current guidelines for evaluation of the role of vitamin D in calcium homeostasis. We hypothesized that patients who are vitamin D deficient (VDD) pre-operatively are more likely to suffer from postoperative hypocalcemia, thereby requiring prolonged hospitalization. METHODS: A retrospective chart review of patients undergoing total thyroidectomy at the University of New Mexico Hospital between 2005 and 2014 was performed. Patients who underwent intentional parathyroidectomy were excluded. The study included 30 patients who had a 25-hydroxyvitamin D levels obtained within 12 months before surgery. RESULTS: Twelve patients who were VDD (25-hydroxyvitamin D ≤20 ng/mL) were compared to 18 patients who did not have VDD (non-VDD; 25-hydroxyvitamin D >20 ng/mL). The mean nadir postoperative ionized calcium concentration was lower in the VDD group (0.99 ± 0.10 vs. 1.06 ± 0.06 mmol/L, P = .04) (reference range = 1.15-1.27 mmol/L), as was the postoperative concentration of phosphorus (3.48 ± 0.60 vs. 4.17 ± 0.84 mg/dL, P = .03). VDD patients had a longer length of stay (4.3 ± 4.4 vs. 1.7 ± 1.5 days, P = .03). Three patients in the VDD group required intravenous calcium for treatment of symptomatic hypocalcemia, but none of the non-VDD patients required this intervention (P = .054). CONCLUSION: Pre-operative vitamin D deficiency is associated with an increased risk of postoperative hypocalcemia and a prolonged length of stay in patients undergoing total thyroidectomy. Vitamin D replacement before thyroidectomy may improve postsurgical outcomes in VDD patients. ABBREVIATIONS: BMI = body mass index non-VDD = non-vitamin D deficient PTH = parathyroid hormone VDD = vitamin D deficient.

Association of passive and active smoking with pre-diabetes risk in a predominantly Hispanic population.

Smoking is the leading cause of avoidable death and is associated with type 2 diabetes (T2D) risk. Previous studies on the impact of passive smoking have not been applied to a Hispanic-majority population. We investigated the association between active smoking, exposure to environmental tobacco smoke (ETS), and pre-diabetes risk in a New Mexico population. We hypothesized that pre-diabetes risk increases with increasing smoking status after adjustment for important covariates. We screened 219 adults from an ongoing study who were categorized according to their smoking status (never smoker, current smoker, previous smoker) and their exposure to ETS (exposed or unexposed). Glucose homeostasis status was assigned using A1c: no diabetes (A1c <5.7%), pre-diabetes (A1c 5.7-6.4%), and T2D (A1c >6.4%). Among 160 patients with complete data, 51.6% had no diabetes and 48.4% had pre-diabetes. The mean age was 44.8±13.5 years. The study population was predominantly female (64.4%), and the ethnic composition was 44.4% Hispanic, 39.4% non-Hispanic White (NHW), 10.6% American Indian, 2.5% African-American, and 3.1% other. Using a logistic model with 2-way interactions, all predicted probabilities for being at risk for pre-diabetes were significant at the 0.001 level for smoking status and ETS exposure after adjusting for age, sex, ethnicity, family history of diabetes, alcohol consumption, BMI, and blood pressure. Active or passive smoking is independently associated with pre-diabetes risk.