Faculty Bibliography

STATEMENT OF PROBLEM OR QUESTION (ONE SENTENCE): T2D patients needing insulin adjustments require multiple clinic visits for titration, but face barriers (missed work, transportation costs, clinic co-pays) all of which disproportionately affect vulnerable populations. OBJECTIVES OF PROGRAM/INTERVENTION (NO MORE THAN THREE OBJECTIVES): MITI aims to be clinically efficacious, patientcentered, and highly accessible (only requires text messaging and phone calls). DESCRIPTION OF PROGRAM/INTERVENTION, INCLUDING ORGANIZATIONAL CONTEXT (E.G. INPATIENT VS. OUTPATIENT, PRACTICE OR COMMUNITY CHARACTERISTICS): MITI is an efficacious, patient-centered, accessible program that remotely guides T2D patients to their correct basal insulin dose (glargine, detemir). Eligible patients have T2D, an A1c >8%, a phone that can text, and need titration of basal insulin. Patients referred by their providers are enrolled on a secure website which sends a weekday text message asking 'What was your fasting blood sugar this morning?' Each day the MITI nurse checks the website for alarm values (extreme high or low values). Once a week, the MITI nurse calls patients and, using the MITI titration algorithm, advises them on dose adjustments. The goal of the program is to find the optimal basal insulin dose (OID), which is the dose that achieves a fasting blood sugar between 80 and 130 (or the maximal dose of 50 units). MITI lasts a maximum of 12 weeks. When the program ends, patients return to usual care. MEASURES OF SUCCESS (DISCUSS QUALITATIVE AND/OR QUANTITATIVE METRICS WHICH WILL BE USED TO EVALUATE PROGRAM/INTERVENTION): Using a single-group, quasiexperimental approach, we examined the proportion of patients reaching OID within 12 weeks, the mean number of days required to reach OID, and reductions in fasting glucose and A1c. We described participant response rates, staff time required to deliver the intervention, and patient time saved. Qualitative interviews were also conducted. FINDINGS TO DATE (IT IS NOT SUFFICIENT TOSTATE FINDINGS WILL BE DISCUSSED): Of the 71 participants who completed the program, 86% reached OID, 5.6% did not reach OID, and 8.5% terminated the program early. Those reaching OID did so in a mean of 21 (SD 21) days. Fasting glucose levels decreased from 209 (SD 77) mg/dl to 140 (SD 45), and mean A1c (for those with follow up labs thus far) decreased from 11.6% (SD 1.9) to 10.0% (SD 2.2). Ninety-one percent of text prompts received a response from the participant. Mean staff time required to deliver MITI was 16 min (SD 5) per participant per week, and patients reported a mean time saving of 150 (SD 74) min each time an in-person visit was averted. Qualitative interviews suggest that clinical staff perceived MITI to be a preferred alternative to clinic-based insulin titration, one that resulted in good care without interfering with clinic flow. Patients reported that the enrollment process was easy and that MITI motivated them to eat healthier food, take their insulin, and check their blood sugars. Because of MITI they reported feeling more connected to their medical team. KEYLESSONS FORDISSEMINATION(WHAT CANOTHERS TAKE AWAY FOR IMPLEMENTATION TO THEIR PRACTICE OR COMMUNITY?): MITI is a clinically efficacious, patient-centered and accessible program for the titration of basal insulin for T2D patients. By eliminating the need for in-person access, MITI proves especially helpful for vulnerable populations. Patients and staff found MITI to be convenient, time-saving, and motivating for patients

Introduction: Obstructive sleep apnea (OSA) and insomnia are two of the most common sleep disorders worldwide. Both conditions are associated with detrimental health consequences. Participation in clinical trials remains essential in understanding screening, diagnosing and treatment. However, the extent to which minority populations are represented in clinical trials that focus on sleep disorders is not yet known. Methods: We queried the Clinicaltrials.gov website, the registry that includes trials conducted in the U.S. and globally to characterize trials (observational and interventional) that focused on OSA and insomnia. All registered trials conducted from 2000 to November 28, 2016 were included. Results: Of the 230,894 trials registered in Clinicaltrials.gov, 826 trials were related to sleep disorders. Of the sleep disorders trials, 34% included drugs, 28% included a device, and 20% were behavioral. Half of the trials were completed (54%) and less than 10% were active, but not yet recruiting or recruiting by invitation only. Eighty percent of the trials were treatment related. Of the 826 sleep trials, 21% reported results, and 12% reported information on race/ethnicity enrollment. Overall, 7,321 of participants in these studies were white followed by 1,461 black, 624 Asian, 551 Hispanic, and 283 'other or unknown'. Conclusion: These results suggest that the number of minority populations in sleep disorders trials are relatively low, specifically compared to the number of trials reported overall. OSA and insomnia treatments are efficacious and effective in the general population. However, the extent to which treatments are effective and utilized by minority populations is not clear; this may in part be related to limited participation in clinical trials. Without appropriate representation in clinical trials, it is difficult to assess which screening, diagnostic, and treatment options work best for minorities, and which factors may influence uptake of treatment. Failure to address this issue may contribute to the increasing disparities in sleep health

Introduction: According to the Center for Disease Control and Prevention (CDC), 3 out of 4 Americans have a heart age (age, sex, systolic blood pressure, treatment for hypertension, smoking, diabetes, HDL cholesterol, total cholesterol and 10-year cardiovascular risk) that is five times greater than their chronological age. Non-Hispanic blacks and Hispanics are even at greater risk with an average heart age 11 times greater than their chronological age. Evidence linking short sleep duration with cardiovascular disease (CVD) may inform future behavioral strategies to reduce CVD risk, heart age, and accelerated aging (heart age greater than chronological age), especially among racial/ethnic minorities who are at greater risk of poor sleep and CVD. Methods: Using data from 2011-2012 and 2013-2014 National Health and Nutrition Examination Survey (NHANES), we investigated whether short sleep duration (<7 hrs/24 hr. period) was associated with accelerated aging and whether this association differed across race/ethnicity. Heart age was calculated based on the Framingham Study Heart Age Calculator, a well-established composite CVD risk predictor. Results: The majority of the population were women (52%) with a high school degree or more (63%). Sixty-six percent were Non- Hispanic (NH)-white, 12% were NH-black, and 15% were Hispanic. NH white adults were more likely than non-Hispanic black and Hispanic adults to sleep at least 7 hours everyday (67.6% vs 50.3% and 63.1%, respectively p<0.05). NH- white adults had lower mean accelerated age (7.2 years) than NH- black adults (8.8 years) and Hispanic adults (10 years) (p<0.05). Regression models showed: a) accelerated aging was significantly associated with race/ethnicity; b) short sleep duration explained 14% of the association between race and accelerated aging; c) accelerated aging was significantly associated with short sleep; and d) race explained 14% of the association between short sleep and accelerated aging. Conclusion: Compared with non-Hispanic Whites, non-Hispanic black and Hispanic adults have greater levels of heart age and accelerated aging, and short sleep duration significantly contributes to this difference. Future studies should investigate the longitudinal effects of improved sleep on heart age and accelerated aging

The current study assessed the prevalence of diabetes across four different physical activity lifestyles and infer through machine learning which combinations of physical activity, sleep, stress, and body mass index yield the lowest prevalence of diabetes in Blacks and Whites. Data were extracted from the National Health Interview Survey (NHIS) dataset from 2004-2013 containing demographics, chronic diseases, and sleep duration (N = 288,888). Of the total sample, 9.34% reported diabetes (where the prevalence of diabetes was 12.92% in Blacks/African Americans and 8.68% in Whites). Over half of the sample reported sedentary lifestyles (Blacks were more sedentary than Whites), approximately 20% reported moderately active lifestyles (Whites more than Blacks), approximately 15% reported active lifestyles (Whites more than Blacks), and approximately 6% reported very active lifestyles (Whites more than Blacks). Across four different physical activity lifestyles, Blacks consistently had a higher diabetes prevalence compared to their White counterparts. Physical activity combined with healthy sleep, low stress, and average body weight reduced the prevalence of diabetes, especially in Blacks. Our study highlights the need to provide alternative and personalized behavioral/lifestyle recommendations to generic national physical activity recommendations, specifically among Blacks, to reduce diabetes and narrow diabetes disparities between Blacks and Whites.

Clinical trials generate gold standard medical evidence, but are often criticized for the lack of population representativeness. We performed a comparative meta-analysis of drug trials that focus on older adults (&gt;= 65 years old) and adults (18-64 years old). The major finding is that a higher percentage of geriatric drug trials were terminated or withdrawn than that of adult drug trials.

Action Through Churches in Time to Save Lives (ACTS) of Wellness was a cluster randomized controlled trial developed to promote colorectal cancer screening and physical activity (PA) within urban African American churches. Churches were recruited from North Carolina (n = 12) and Michigan (n = 7) and were randomized to intervention (n = 10) or comparison (n = 9). Intervention participants received three mailed tailored newsletters addressing colorectal cancer screening and PA behaviors over approximately 6 months. Individuals who were not up-to-date for screening at baseline could also receive motivational calls from a peer counselor. The main outcomes were up-to-date colorectal cancer screening and Metabolic Equivalency Task (MET)-hours/week of moderate-vigorous PA. Multivariate analyses examined changes in the main outcomes controlling for church cluster, gender, marital status, weight, and baseline values. Baseline screening was high in both intervention (75.9%, n = 374) and comparison groups (73.7%, n = 338). Screening increased at follow-up: +6.4 and +4.7 percentage points for intervention and comparison, respectively (p = .25). Baseline MET-hours/week of PA was 7.8 (95% confidence interval [6.8, 8.7]) for intervention and 8.7 (95% confidence interval [7.6, 9.8]) for the comparison group. There were no significant changes (p = .15) in PA for intervention (-0.30 MET-hours/week) compared with the comparison (-0.05 MET-hours/week). Among intervention participants, PA increased more for those who participated in church exercise programs, and screening improved more for those who spoke with a peer counselor or recalled the newsletters. Overall, the intervention did not improve PA or screening in an urban church population. These findings support previous research indicating that structured PA opportunities are necessary to promote change in PA and churches need more support to initiate effective peer counselor programs.

BACKGROUND OR AIMS: Poor enrollment plagues most clinical trials. Furthermore, despite mandates to improve minority representation in clinical trial participation, little progress has been made. We investigated the knowledge and attitudes of adolescents related to clinical trials and made race/ethnicity comparisons in an attempt to identify a possible educational intervention target. METHODS: Students aged 13-18 years in southeast Michigan were offered participation through a class at one high school or two academic summer enrichment programs that drew from multiple high schools (73% response). Questionnaires previously validated in adults were administered. Non-Hispanic whites were compared with minorities using Wilcoxon rank-sum tests. RESULTS: Of the 82 respondents, the median age was 16 years (interquartile range: 15-17 years); 22 (28%) were white, 41 (51%) were African American, 11 (14%) were multiracial, 2 (2%) were American Indian or Alaska Native, 1 (1%) was Asian, 3 (4%) were Native Hawaiian or other Pacific Islander, and 2 respondents did not report a race (but did report Hispanic ethnicity). Nine (12%) were Hispanic. Only 27 (33%) had ever heard of a clinical trial. On a scale from 1 (most receptive) to 5 (least receptive) for learning more about a clinical trial for a relevant medical condition, the median score was 2 (interquartile range: 1-3) and for participating in a clinical trial for a relevant medical condition was 2 (interquartile range: 2-3). Overall knowledge was poor, with a median of 46% (interquartile range: 23%-62%) of knowledge answers correct. Knowledge was reduced (p = 0.0006) and attitudes were more negative (p = 0.05) in minorities than non-Hispanic whites, while minorities also endorsed more substantial barriers to trial participation (p = 0.0002). Distrust was similar between minority students and non-Hispanic whites (p = 0.15), and self-efficacy was greater in non-Hispanic whites (p = 0.05). CONCLUSION: Educational interventions directed toward adolescents that address knowledge, attitudes, and distrust in order to improve clinical trial awareness and receptivity overall are needed and may represent a tool to address disparities in minority enrollment in clinical trials.