Intervening on Metabolic Dysfunction-Associated Steatotic Liver Disease in Latino/a and Black Patients with Diabetes: A Feasibility Pilot.

INTRODUCTION: Patients with type 2 diabetes (T2D), particularly those from historically marginalized racial and ethnic groups, are at high risk of poor outcomes from metabolic dysfunction-associated steatotic liver disease (MASLD). Evidence-based management (EBM) of MASLD can prevent its progression to cirrhosis and poor outcomes, yet rates of EBM of MASLD are low in T2D. METHODS: In this pilot study of ten participants, we examined the feasibility and acceptability of a telehealth intervention that delivered EBM of MASLD in Latino/a and Black patients with T2D in the Duke Healthcare System. The intervention included: (a) MASLD education; (b) diet/lifestyle counseling; (c) T2D medication adjustment (i.e., to promote liver health) and (d) ordering of clinically indicated tests and referrals. This 3-month intervention was delivered by an endocrinologist over three virtual study visits. Phone interviews were conducted at study conclusion. We examined rates of recruitment, retention, T2D medication adjustment, and ordering of clinically indicated tests/referrals. RESULTS: The median age of our cohort was 54.0 (44.0, 59.0); six and four participants self-identified as Latino/a ethnicity and Black race, respectively. Retention rate in this study was 100% (n = 10/10), and all scheduled visits were completed (n = 30/30). Recruitment occurred over one month, and the rate was 25.8% (n = 8/31) by telephone call and 10% (n = 2/20) by electronic health record message. The intervention was highly acceptable based on a median Treatment Acceptability and Preferences score of 4.0 (4.0, 4.0). In exit interviews, all participants reported improved understanding of MASLD and its link to diabetes. All participants received T2D medication adjustment (n = 5/10) and/or clinically indicated testing/referral (n = 10/10) for the purpose of improving MASLD. CONCLUSIONS: We demonstrated that a telehealth intervention designed to proactively deliver EBM of MASLD was feasible and acceptable in a cohort of Latino/a and Black patients with T2D. Opportunities existed to better align each participants' care with guideline-based care of MASLD.

EXpanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND): Protocol and Baseline Data for a Randomized Trial.

BACKGROUND: Approximately 10-15 % of individuals with type 2 diabetes have persistently poorly-controlled diabetes mellitus (PPDM) despite receiving available care, and frequently have comorbid hypertension. Mobile monitoring-enabled telehealth has the potential to improve outcomes in treatment-resistant chronic disease by supporting self-management and facilitating patient-clinician contact but must be designed in a manner amenable to real-world use. METHODS: Expanding Technology-Enabled, Nurse-Delivered Chronic Disease Care (EXTEND) is an ongoing randomized trial comparing two 12-month interventions for comorbid PPDM and hypertension: 1) EXTEND, a mobile monitoring-enabled self-management intervention; and 2) EXTEND Plus, a comprehensive, nurse-delivered telehealth program incorporating mobile monitoring, self-management support, and pharmacist-supported medication management. Both arms leverage a novel platform that uses existing technological infrastructure to enable transmission of patient-generated health data into the electronic health record. The primary study outcome is difference in HbA1c change from baseline to 12 months. Secondary outcomes include blood pressure, weight, implementation barriers/facilitators, and costs. RESULTS: Enrollment concluded in June 2023 following randomization of 220 patients. Baseline characteristics are similar between arms; mean age is 54.5 years, and the cohort is predominantly female (63.6 %) and Black (68.2 %), with a baseline HbA1c of 9.81 %. CONCLUSION: The EXTEND trial is evaluating two mobile monitoring-enabled telehealth approaches that seek to improve outcomes for patients with PPDM and hypertension. Critically, these approaches are designed around existing infrastructure, so may be amenable to implementation and scaling. This study will promote real-world use of telehealth to maximize benefits for those with high-risk chronic disease.

Clinical Outcomes Among High-Risk Primary Care Patients With Diabetic Kidney Disease: Methodological Challenges and Results From the STOP-DKD Study.

BACKGROUND/OBJECTIVE: Slowing the progression of diabetic kidney disease (DKD) is critical. We conducted a randomized controlled trial to target risk factors for DKD progression. METHODS: We evaluated the effect of a pharmacist-led intervention focused on supporting healthy behaviors, medication management, and self-monitoring on decline in estimated glomerular filtration rate (eGFR) for 36 months compared with an educational control. RESULTS: We randomized 138 individuals to the intervention group and 143 to control. At baseline, mean (SD) eGFR was 80.7 (21.7) mL/min/1.73m 2 , 56% of participants had chronic kidney disease and a history of uncontrolled hypertension with a baseline SBP of 134.3 mm Hg. The mean (SD) decline in eGFR by cystatin C from baseline to 36 months was 5.0 (19.6) and 5.9 (18.6) mL/min/1.73m 2 for the control and intervention groups, respectively, with no significant between-group difference ( P =0.75). CONCLUSIONS: We did not observe a significant difference in clinical outcomes by study arm. However, we showed that individuals with DKD will engage in a pharmacist-led intervention. The potential explanations for a lack of change in DKD risk factors can be attributed to 5 broad issues, challenges: (1) associated with enrolling patients with low eGFR and poor BP control; (2) implementing the intervention; (3) limited duration during which to observe any clinical benefit from the intervention; (4) potential co-intervention or contamination; and (5) low statistical power.

Longitudinal Evaluation of Reproductive Endocrine Function in Men with ACTH-Dependent Cushing Syndrome.

CONTEXT: Hypogonadism may be caused by Cushing syndrome (CS) and may intensify its adverse consequences. OBJECTIVE: To determine the frequency of male hypogonadism before and after curative surgery for CS, and its cause. DESIGN: Post-hoc analyses of prospective cohort studies. SETTING: Clinical research center. PATIENTS: Men with ACTH-dependent CS. Cohort 1 (C1) (n=8, age 32.5±12 y; studied 1985-1989); Cohort 2 (C2) (n=44, 42.7 ± 15.1 y; studied 1989-2021). INTERVENTIONS: C1: Every 20-minute blood sampling for 24h before and 1-40 months after surgical cure. Three subjects underwent GnRH stimulation tests pre- and post-surgery. C2: Hormone measurements at baseline and 6 and 12 months (M) post-cure. MAIN OUTCOME MEASURES: C1: LH, FSH, LH pulse frequency and LH response to GnRH. C2: LH, FSH, testosterone (T), free T, fT4, T3, TSH and UFC levels and frequency of hypogonadism pre- and post-surgery. RESULTS: C1: mean LH and LH pulse frequency increased after surgery (p < 0.05) without changes in LH pulse amplitude, mean FSH, or peak gonadotropin response to GnRH. C2: 82% had baseline hypogonadism (total T 205 ± 28 ng/dL). Thyroid hormone levels varied inversely with UFC and cortisol. LH, total and free T, and SHBG increased at 6M and 12M post surgery, but hypogonadism persisted in 51% at 6M and in 26% at 12M. CONCLUSION: Hypogonadism in men with CS is widely prevalent but reversible in ∼75% of patients one year after surgical cure and appears to be mediated through suppression of hypothalamic GnRH secretion, and modulated by thyroid hormones.

The Final Frontier in Diabetes Care: Implementing Research in Real-World Practice.

Despite extensive evidence related to the prevention and management of type 2 diabetes (T2D) and its complications, most people at risk for and people who have diabetes do not receive recommended guideline-based care. Clinical implementation of proven care strategies is of the utmost importance because without this, even the most impressive research findings will remain of purely academic interest. In this review, we discuss the promise and challenges of implementing effective approaches to diabetes prevention and care in the real-world setting. We describe successful implementation projects in three critical areas of diabetes care-diabetes prevention, glycemic control, and prevention of diabetes-related complications-which provide a basis for further clinical translation and an impetus to improve the prevention and control of T2D in the community. Advancing the clinical translation of evidence-based care must include recognition of and assessment of existing gaps in care, identification of barriers to the delivery of optimal care, and a locally appropriate plan to address and overcome these barriers. Care models that promote team-based approaches, rather than reliance on patient-provider interactions, will enhance the delivery of contemporary comprehensive diabetes care.

Racial Disparities in Evidence-Based Management of Metabolic Dysfunction-Associated Steatotic Liver Disease in Patients With Type 2 Diabetes.

OBJECTIVE: To assess frequency of evidence-based management (EBM) of metabolic dysfunction-associated steatotic liver disease (MASLD) in patients with type 2 diabetes (T2D), and to examine for racial/ethnic disparities in the receipt of EBM. METHODS: We conducted a cross-sectional analysis of patients with T2D and presumptive MASLD in an academic health care system between 2019 and 2021. Presumptive MASLD was defined as at least 1 alanine aminotransferase value ≥30 U/L with exclusions for alcohol overuse, viral hepatitis, liver transplantation, chemotherapy use, and liver disease other than MASLD. We calculated the proportion of patients receiving EBM, defined as a composite of liver ultrasound, transient elastography, or hepatology evaluation. We also examined the association between race/ethnicity and EBM via a logistic regression model. RESULTS: Our sample included 6532 patients; mean age was 58.0 (SD 13.1), 41.7% were female and 3.9%, 26.6%, 58.7%, and 5.8% were of Latino/a/x ethnicity, non-Latino (NL) Black race, NL White race, and NL Asian race, respectively. Rates of EBM were low overall (11.5%), with lower odds of EBM in NL Black versus NL White patients (adjusted odds ratio 0.75; 95% confidence interval 0.59, 0.96). Odds of hepatology evaluation and placement of MASLD diagnosis codes were also lower in NL Black versus NL White patients. CONCLUSION: Racial disparities exist in the receipt of EBM among patients with T2D and presumptive MASLD. These findings highlight the need for research to identify drivers of disparities, and to support development of clinical interventions that equitably facilitate EBM of MASLD in patients with T2D.

Predicting health outcomes with intensive longitudinal data collected by mobile health devices: a functional principal component regression approach.

BACKGROUND: Intensive longitudinal data (ILD) collected in near real time by mobile health devices provide a new opportunity for monitoring chronic diseases, early disease risk prediction, and disease prevention in health research. Functional data analysis, specifically functional principal component analysis, has great potential to abstract trends in ILD but has not been used extensively in mobile health research. OBJECTIVE: To introduce functional principal component analysis (fPCA) and demonstrate its potential applicability in estimating trends in ILD collected by mobile heath devices, assessing longitudinal association between ILD and health outcomes, and predicting health outcomes. METHODS: fPCA and scalar-to-function regression models were reviewed. A case study was used to illustrate the process of abstracting trends in intensively self-measured blood glucose using functional principal component analysis and then predicting future HbA1c values in patients with type 2 diabetes using a scalar-to-function regression model. RESULTS: Based on the scalar-to-function regression model results, there was a slightly increasing trend between daily blood glucose measures and HbA1c. 61% of variation in HbA1c could be predicted by the three preceding months' blood glucose values measured before breakfast (P < 0.0001, [Formula: see text]). CONCLUSIONS: Functional data analysis, specifically fPCA, offers a unique tool to capture patterns in ILD collected by mobile health devices. It is particularly useful in assessing longitudinal dynamic association between repeated measures and outcomes, and can be easily integrated in prediction models to improve prediction precision.

Diabetes distress in Veterans with type 2 diabetes mellitus: Qualitative descriptive study.

Diabetes distress (DD) is a negative psychosocial response to living with type 2 diabetes mellitus (T2DM). We sought insight into Veterans' experiences with DD in the context of T2DM self-management. The four domains in the Diabetes Distress Scale (i.e. regimen, emotional, interpersonal, healthcare provider) informed the interview guide and analysis (structural coding using thematic analysis). The mean age of the cohort (n = 36) was 59.1 years (SD 10.4); 8.3% of patients were female and 63.9% were Black or Mixed Race; mean A1C was 8.8% (SD 2.0); and mean DDS score was 2.4 (SD 1.1), indicating moderate distress. Veterans described DD and challenges to T2DM self-management across the four domains in the Diabetes Distress Scale. We found that (1) Veterans' challenges with their T2DM self-management routines influenced DD and (2) Veterans experienced DD across a wide range of domains, indicating that clinical interventions should take a "whole-person" approach.Trial Registration: NCT04587336.

Evaluating Therapeutic Inertia in Two Telehealth Interventions for Type 2 Diabetes: Secondary Analyses of a Randomized Trial.

Introduction: Although therapeutic inertia is a known driver of suboptimal type 2 diabetes control, little is known about how to combat this phenomenon. We analyzed randomized trial data to determine whether a comprehensive telehealth intervention was more effective than a less structured telehealth approach (telemonitoring and care coordination) at promoting treatment intensification in poorly controlled diabetes. Methods: Patients with poorly controlled type 2 diabetes were randomized 1:1 to telemonitoring/care coordination or a comprehensive telehealth intervention, which included an active, study provider-guided medication management component. Prospectively collected medication lists were used to determine whether treatment intensification occurred for each patient during 3-month intervals throughout the study period. To examine between-arm differences in treatment intensification over time, we fit a generalized estimation equation model. In each arm, hemoglobin A1c levels at the beginning and end of each 3-month interval were used to distinguish between therapeutic inertia and potentially appropriate nonintensification of treatment. Results: The mean, model-estimated likelihood of treatment intensification during 3-month intervals was 61.3% in the comprehensive telehealth group versus 48.6% for telemonitoring/care coordination (odds ratio 1.7, 95% confidence interval 1.2-2.2; p = 0.0007), with no evidence that treatment effect varied over time (p = 0.54). Treatment intervals with observed therapeutic inertia were more common in the telemonitoring/care coordination arm than the comprehensive telehealth arm (116/300, 39% vs. 57/275, 21%). Conclusions: A comprehensive telehealth approach that integrated protocol-guided medication management increased treatment intensification and reduced therapeutic inertia compared with a less structured telehealth approach. The studied approaches may serve as examples of how systems might use telehealth to combat therapeutic inertia. Clinical Trial Registration: ClinicalTrials.gov NCT03520413.

Expanding Technology-Enabled Nurse-Delivered Chronic Disease Care: EXTEND.

Mobile monitoring-enabled technologies could enhance telehealth for chronic illness care. EXTEND is an active comparator randomized trial (N=220) of two 24-month interventions: 1) mobile monitoring as a self-management tool (EXTEND); and 2) a 12-month nurse and pharmacist-delivered telehealth intervention incorporating mobile monitoring, self-management support, and medication management that is followed by a 12-month self-management period (EXTEND Plus). EXTEND Plus is a pragmatic approach to integrating mobile monitoring-enabled telehealth for patients uncontrolled diabetes and hypertension into existing clinical infrastructure.

Mobile Monitoring-Enabled Telehealth for Patients with Complex Chronic Illnesses.

Telehealth has the potential to improve management of poorly controlled chronic diseases relative to clinic-based care alone. Mobile monitoring-enabled technologies could enhance telehealth for chronic illness care. Implementation in practice settings would rely on automated integration of data into the electronic health record (EHR). We describe the integration and visualization of data from four remote monitoring devices into the EHR that is coupled with the evaluation of an evidence-based nurse and pharmacist-led telehealth care model for patients with uncontrolled diabetes and hypertension. Using this new pragmatic infrastructure, clinicians use the EHR to prescribe for patients a suite of devices. Alerts are placed upon the data that notify a clinician when values go above or below set thresholds. These data are visualized in the clinical record and clinicians use the EHR as a tool for efficiently delivering and documenting patient telehealth encounters.

Prescribing of evidence-based diabetes pharmacotherapy in patients with metabolic dysfunction-associated steatohepatitis.

INTRODUCTION: Metabolic dysfunction-associated steatohepatitis (MASH) is highly prevalent in type 2 diabetes (T2D). Pioglitazone and glucagon-like peptide-1 receptor agonists (GLP-1RA) are medications used in T2D that can resolve MASH and should be considered in all patients with T2D and MASH. We assessed prescription rates of evidence-based T2D pharmacotherapy (EBP) in MASH, and ascertained racial/ethnic disparities in prescribing. RESEARCH DESIGN AND METHODS: We conducted a cross-sectional study on patients in Duke University Health System with diagnosis codes for T2D and MASH between January 2019 and January 2021. Only patients with ≥1 primary care or endocrinology encounter were included. The primary outcome was EBP, defined as ≥1 prescription for pioglitazone and/or a GLP-1RA during the study period. A multivariable logistic regression model was used to examine the primary outcome. RESULTS: A total of 847 patients with T2D and MASH were identified; mean age was 59.7 (SD 12) years, 61.9% (n=524) were female, and 11.9% (n=101) and 4.6% (n=39) were of Black race and Latino/a/x ethnicity, respectively. EBP was prescribed in 34.8% (n=295). No significant differences were noted in the rates of EBP use across racial/ethnic groups (Latino/a/x vs White patients: adjusted OR (aOR) 1.82, 95% CI 0.78 to 4.28; Black vs White patients: aOR 0.76, 95% CI 0.44 to 1.33, p=0.20). CONCLUSIONS: EBP prescriptions, especially pioglitazone, are low in patients with T2D and MASH, regardless of race/ethnicity. These data underscore the need for interventions to close the gap between current and evidence-based care.

Rolling out PRIDE in All Who Served: Barriers and Facilitators for Sites Implementing an LGBTQ+ Health Education Group for Military Veterans.

BACKGROUND/OBJECTIVE: The Veterans Health Administration (VHA) PRIDE in All Who Served health education group (PRIDE) was developed to improve health equity and access to care for military veterans who are lesbian, gay, bisexual, transgender, queer, and/or other sexual/gender-diverse identities (LGBTQ+). This 10-week program rapidly spread to over 30 VHA facilities in 4 years. Veterans receiving PRIDE experience improved LGBTQ+ identity-related resilience and reductions in suicide attempt likelihood. Despite PRIDE's rapid spread across facilities, information is lacking on implementation determinants. The current study's goal was to clarify determinants of PRIDE group implementation and sustainment. METHODS: A purposive sample of VHA staff (N = 19) with experience delivering or implementing PRIDE completed teleconference interviews January-April 2021. The interview guide was informed by the Consolidated Framework for Implementation Research. Rapid qualitative matrix analysis was completed with methods to ensure rigor (e.g., triangulation and investigator reflexivity). RESULTS: Key barriers and facilitators of PRIDE implementation were heavily related to facility inner setting (what is happening inside the facility), including implementation readiness (e.g., leadership support for LGBTQ+-affirming programming, access to LGBTQ+-affirming care training) and facility culture (e.g., systemic anti-LGBTQ+ stigma). Several implementation process facilitators enhanced engagement at sites, such as a centrally facilitated PRIDE learning collaborative and a formal process of contracting/training for new PRIDE sites. DISCUSSION/CONCLUSION: Although aspects of the outer setting and larger societal influences were mentioned, the majority of factors impacting implementation success were at the VHA facility level and therefore may be more readily addressable through tailored implementation support. The importance of LGBTQ+ equity at the facility level indicates that implementation facilitation should ideally address institutional equity in addition to implementation logistics. Combining effective interventions with attention to local implementation needs will be required before LGBTQ+ veterans in all areas will benefit from PRIDE and other health equity-focused interventions.

Factors Associated With Diabetes Distress Among Patients With Poorly Controlled Type 2 Diabetes.

Objective: Examine factors associated with increased diabetes distress (DD) among patients with type 2 diabetes with DD assessed by Diabetes Distress Scale (DDS) total and subscale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress). Methods: Cross-sectional analysis of data from veterans with persistently poorly controlled diabetes mellitus. Multivariable linear regression models included baseline patient characteristics (independent variables) and DDS total and subscale scores (dependent variable). Results: The cohort's (N = 248) mean age was 58 years (SD 8.3); 21% were female, 79% were non-White, and 5% were Hispanic/Latinx. Mean hemoglobin A1c (HbA1c) was 9.8%, and 37.5% had moderate to high DD. Hispanic/Latinx ethnicity (ß=0.41; 95% CI 0.01, 0.80), baseline HbA1c (0.07; 95% CI 0.01,0.13), and higher Personal Health Questionnaire-8 (PHQ-8) scores (0.07; 95% CI 0.05, 0.09) were associated with higher total DD. Hispanic/Latinx ethnicity (0.79; 95% CI 0.25, 1.34) and higher PHQ-8 (0.05; 95% CI 0.03, 0.08) were associated with higher interpersonal-related distress. Higher HbA1c (0.15; 95% CI 0.06, 0.23) and higher PHQ-8 scores (0.10; 95% CI 0.07, 0.13) were associated with higher regimen-related distress. The use of basal insulin (0.28; 95% CI 0.001, 0.56) and higher PHQ-8 (0.02; 95% CI 0.001, 0.05) were associated with higher physician-related distress. Higher PHQ-8 (0.10; 95% CI 0.07, 0.12) was associated with higher emotional burden. Conclusion: Hispanic/Latinx ethnicity, depressive symptoms, uncontrolled hyperglycemia, and insulin use were associated with higher risk for DD. Future research should explore these relationships, and interventions designed to reduce diabetes distress should consider accounting for these factors.

Research-practice partnerships: Adapting a care coordination intervention for rural Veterans over 3 years at multiple sites.

PURPOSE: Rural Veterans are more likely than urban Veterans to qualify for community care (Veterans Health Administration [VHA]-paid care delivered outside of VHA) due to wait times ≥30 days and longer travel times for VHA care. For rural Veterans receiving both VHA and community care, suboptimal care coordination between VHA and community providers can result in poor follow-up and care fragmentation. We developed Telehealth-based Coordination of Non-VHA Care (TECNO Care) to address this problem. METHODS: We iteratively developed and adapted TECNO Care with partners from the VHA Office of Rural Health and site-based Home Telehealth Care in the Community programs. Using templated electronic health record notes, Home Telehealth nurses contacted Veterans monthly to facilitate communication with VHA/community providers, coordinate referrals, reconcile medications, and follow up on acute episodes. We evaluated TECNO Care using a patient-level, pre-post effectiveness assessment and rapid qualitative analysis with individual interviews of Veterans and VHA collaborators. Our primary effectiveness outcome was a validated care coordination quality measure. We calculated mean change scores for each care continuity domain. FINDINGS: Between March 2019 and October 2021, 83 Veterans received TECNO Care. Veterans were predominately White (86.4%) and male (88.6%) with mean age 71.4 years (SD 10.4). Quantitative data demonstrated improvements in perceived care coordination following TECNO Care in 7 categories. Qualitative interviews indicated that Veterans and Home Telehealth nurses perceived TECNO Care as beneficial and addressing an area of high need. CONCLUSIONS: TECNO Care appeared to improve the coordination of VHA and community care and was valued by Veterans.

Simplifying therapy to assure glycemic control and engagement (STAGE) in poorly-controlled diabetes: A pilot study.

In this single-arm pilot study, we demonstrated feasibility and acceptability of an insulin simplification intervention in patients with persistent, poorly-controlled type 2 diabetes on complex insulin regimens. While not powered to assess clinical outcomes, we observed neither worsened glycemic control nor increased hypoglycemia.

Transition from pediatric to adult care in type 1 diabetes mellitus: a longitudinal analysis of age at transfer and gap in care.

INTRODUCTION: Adolescents and young adults (AYAs) with type 1 diabetes (T1D) are at risk of suboptimal glycemic control and high acute care utilization. Little is known about the optimal age to transfer people with T1D to adult care, or time gap between completing pediatric care and beginning adult endocrinology care. RESEARCH DESIGN AND METHODS: This retrospective, longitudinal study examined the transition of AYAs with T1D who received endocrinology care within Duke University Health System. We used linear multivariable or Poisson regression modeling to assess the association of (1) sociodemographic and clinical factors associated with gap in care and age at transfer among AYAs and (2) the impact of gap in care and age at transfer on subsequent glycemic control and acute care utilization. RESULTS: There were 214 subjects included in the analysis (54.2% female, 72.8% white). The median time to transition and age at transition were 8.0 months and 21.5 years old, respectively. The median gap in care was extended by a factor of 3.39 (95% CI=1.25 to 9.22, p=0.02) for those who did not see a mental health provider pre-transfer. Individuals who did not see a diabetes educator in pediatrics had an increase in mean age at transition of 2.62 years (95% CI=0.93 to 4.32, p<0.01). The post-transfer emergency department visit rate was increased for every month increase in gap in care by a relative factor of 1.07 (95% CI=1.03 to 1.11, p<0.01). For every year increase in age at transition, post-transfer hospitalization rate was associated with a reduction of a relative factor of 0.62 (95% CI=0.45 to 0.85, p<0.01) and emergency department visit rate by 0.58 (95% CI=0.45 to 0.76, p<0.01). CONCLUSIONS: Most AYAs with T1D have a prolonged gap in care. When designing interventions to improve health outcomes for AYAs transitioning from pediatric to adult-based care, we should aim to minimize gaps in care.