A1C Reduction Research Articles

12314 Effectiveness Of Continuous Glucose Monitors In Patients With Type 2 Diabetes On Washington Medicaid Or Financial Assistance

Abstract Disclosure: A. Deng: None. A. Thirumalai: None. J. Lin: None. M. Weber: None. S. Zuo: None. Continuous glucose monitors (CGMs) have become more accessible for patients with type 2 diabetes mellitus (T2DM) on one insulin injection per day who have either commercial or Medicare plans. However, there are still strict requirements for patients with Washington State Medicaid, creating disparities in diabetes care for vulnerable populations. The aim of this study is to assess the effectiveness and adherence of CGMs in patients with T2DM on Washington State Medicaid plans or institutional financial assistance who are prescribed at least one insulin injection daily, similar to Medicare requirements. This ongoing prospective cohort study enrolled 40 adult patients with T2DM, baseline A1C greater than 7%, and prescribed at least one insulin injection per day from three Harborview Medical Center clinics. Through grant funding, patients were provided with Freestyle Libre 2 CGMs for 6 months. Since this is an ongoing study, we present preliminary results of patients who completed 3 months of CGM use. Effectiveness was measured by the change in A1C from baseline to 3 months after initiation of the CGM (primary outcome) and change in CGM glycemic metrics on ambulatory glucose profile (AGP) from baseline to 3 months after initiation of CGM (secondary outcomes). Assessment of adherence to the CGMs involved tracking the percentage of CGM data captured from the AGP reports recorded at each visit and monitoring dispense history. Twenty patients reached the 3-month follow-up with a median age of 59 years; 60% female, 70% non-English speaking; 45% with Medicaid, and 55% with Harborview Financial Assistance as insurance coverage. Median baseline A1C was 9.2%, duration of diabetes was 10 years, number of diabetes medications was 3, daily insulin injections of 2, and number of blood glucose checks per day was 1. At first CGM download (2 weeks), the median time in range (TIR, glucose 70-180 mg/dL) was 53.5%, coefficient of variation was 35.3% and percent of data captured was 80%. At 3-month follow-up, the median reduction in A1c was –1.2% (IQR -1.8, -0.5). On CGM, the median TIR had increased to 60.5%, coefficient of variation had improved to 31.5% and percent of data captured was 79%. In this ongoing study, preliminary findings show encouraging early evidence of improved glycemic control after CGMs were initiated and patients sustained greater than 70% CGM data captured at 3 months. These results should be interpreted with caution given the small number of participants with results at 3 months. Nonetheless, once the study is complete, the outcomes may be used to inform eligibility requirements for continuous glucose monitors in patients with Washington Medicaid or Harborview Financial Assistance. Presentation: 6/3/2024

6488 Factors associated with the response to SGLT2 inhibitors and GLP-1 Receptor Agonists in Veterans with Type 2 Diabetes

Abstract Disclosure: S. Hashmi: None. K. Samson: None. G. Arora: None. S. Azad: None. D. Awad: None. C.V. Desouza: None. Background: SGLT2 inhibitors and GLP1 agonists are recommended as first line pharmacological therapy (along with metformin) for type 2 DM, particularly in patients with CKD, CVD, or HF. Despite their effectiveness, there is limited evidence available to predict which patient subsets will respond favorably to SGLT2 inhibitors or GLP1 agonist. Purpose of study: To determine if baseline characteristics can predict response to therapy and to compare the differences in characteristics between SGLT2 inhibitor and GLP1 agonist groups. Methodology: Retrospective study of veterans ages 19-89 yr with T2DM initiated on treatment from Jan 1, 2015, to Dec 31, 2022, with either SGLT2 inhibitor or GLP 1 agonist for at least 6 months. The cohort comprised 866 patients, of which 544 individuals met the inclusion criteria (332 in the GLP-1 agonist group and 212 in the SGLT2 inhibitor group). Baseline characteristics assessed included age, sex, race, comorbidities, weight, BMI, HbA1c, eGFR, BP and lipids. Treatment response thresholds were defined as an HbA1c reduction of more than 0.5 percentage points and more than 3% of pretreatment weight loss, evaluated 6-12 months after initiating treatment. A complete response was defined as both treatment thresholds being met. Statistical analysis involved Chi-Square tests and independent samples t-test between variables of interest. Logistic regression was conducted with the dichotomous complete response outcome, for variables with bivariate p-values less than 0.10, in addition to variables preselected for inclusion based on the clinical relevance. Results: Three variables were statistically significant in the final logistic regression with complete response outcome. Patients on GLP1 had an increased adjusted odds of having a complete outcome (AOR: 2.45 (95% CI: 1.45, 4.15) relative to patients on SGLT2. In addition, older patients (AOR: 1.34 (95% CI: 1.02, 1.74)) and patients with a higher baseline HbA1c (AOR: 1.18 (95% CI: 1.02, 1.36)) had increased adjusted odds of having a complete response relative to patients 10 years younger and patients with an A1c 1 unit lower, respectively. 72.6% of patients on GLP1 agonists achieved the A1c response goal, in contrast to 48.6% on SGLT2 inhibitors (p < 0.001). Also, 47.6 % of individuals achieved weight loss goals on GLP1 agonist as compared to 41 % on SGLT2 inhibitor. A greater proportion of females (66.7%) achieved the A1c reduction goal compared to males (45.9%) on SGLT2 inhibitors (p = 0.04). Conclusion: Individuals receiving GLP-1 agonists had a twofold increased odds of achieving A1c reduction and weight loss goals after a 6-12 month treatment period compared to those prescribed SGLT2 inhibitors. Older patients and patients with higher baseline A1c levels had greater odds of reaching A1c and weight loss threshold whereas other baseline variables were not significantly associated with the outcome. Presentation: 6/3/2024

The Ambulatory Diabetes Outreach Program (ADOP): Rigorous Evaluation of a Pharmacist and Nurse-Led Care Model.

Although several systematic reviews found that ambulatory diabetes mellitus (DM) interventions involving pharmacists generally yielded better outcomes than the ones that did not, existing studies have limitations in rigor and study design. To examine the intention-to-treat effects of the Ambulatory Diabetes Outreach Program (ADOP) on participants' A1c values and healthcare utilization over a 52-month follow-up period. Difference-in-differences with staggered adoption. Specifically, we employed the Callaway and Sant'Anna's "group-time average treatment effect" estimator using not-yet treated as controls adjusting for patient's age, BMI, sex, race, comorbidity, payor, and socio-economic status. All patients with at least one ADOP treatment encounter from July 2017 to October 2021, regardless of program completion or length of exposure to the program. ADOP, a collaborative population health program led by pharmacists and nurse specialists to provide individualized type 2 DM management and education within a large and diverse health system. Patients' A1c values and healthcare utilization, including inpatient admission, inpatient days, and numbers of visits to the emergency department, urgent care, and primary care in recent 6months. ADOP participation was associated with an overall average reduction of 1.04 percentage points (95%CI - 1.12, - 0.95) in A1c level. Similar A1c reductions were also observed in the subgroups by sex and race/ethnicity. An average of 2months were required to reach the overall average effect, which persisted over 4years. Compared to the respective utilization levels pre-intervention, participants also had average reductions in inpatient admissions by 32.4%, inpatient days by 81.6%, visits to the emergency department by 21.6%, and primary care by 17.9%. The results suggest that a collaborative model of pharmacist and nurse-led type 2 DM intervention was effective in improving A1c outcomes and reducing healthcare utilization in the long term.

Real-world evaluation of the effects of tirzepatide in patients with type 2 diabetes mellitus.

Tirzepatide is a first-in-class combination glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 receptor agonist (GLP1-RA) approved for treatment of adults with type 2 diabetes mellitus (T2DM) and chronic weight management. The aim of this analysis was to assess the real-world efficacy of tirzepatide in patients with T2DM. This retrospective observational study evaluated patients with T2DM from a large urban academic medical centre who received at least 3 months of continuous tirzepatide treatment. The primary outcome was change in A1C from following tirzepatide treatment. Secondary outcomes included change in body weight and body mass index (BMI) after tirzepatide was initiated. A total of 1896 patient charts were reviewed, and 612 patients were evaluated for the primary outcome. Over a median time period of 10.4 months, treatment with tirzepatide resulted in a mean A1C reduction of 1.02 ± 1.48% (p < 0.001). A total of 570 patients were evaluated for the secondary outcomes. Tirzepatide was associated with a mean reduction in body weight of 7.3 ± 9.3 kg (p < 0.001) and a mean reduction in BMI of 2.5 kg/m2. Greater A1C lowering and weight loss was observed in patients without prior GLP1-RA treatment compared to those switched to tirzepatide from GLP1-RA. In a real-world population of US patients with T2DM, tirzepatide was associated with clinically and statistically significant reductions in A1C and body weight. Greater reductions in both A1C and body weight were observed among patients who were GLP1-RA naïve compared to patients switched from GLP1-RA to tirzepatide.

Improved Clinical Outcomes with the Combination Therapy of a Glucagon-like Peptide-1 Receptor Agonists and a Sodium-glucose Cotransporter-2 Inhibitor in Overweight/Obese People with Type 2 Diabetes: Real-world Evidence from the Indian Subcontinent.

Type 2 diabetes (T2D) mellitus is increasing exponentially in India, with overweight/obesity being prime contributors. This study aimed at assessing the clinical impact of the combination therapy of a glucagon-like peptide-1 receptor agonist (GLP-1RA) injection (inj.) and a sodium-glucose cotransporter-2 inhibitor (SGLT-2i) in overweight/obese patients from the Indian subcontinent. In two real-world evidence (RWE) studies (RWE1 and 2), we retrospectively observed the effect of the combination therapy of a GLP-1RA, injection dulaglutide (DU) 1.5 mg/week, and an SGLT-2i, canagliflozin (CAN) 100 mg/day at weeks 16, 32, and 52 on HbA1c, body weight (weight), systolic blood pressure (SBP), lipids, change in doses of antidiabetic agents (ADA) and antihypertensive agents (AHA) in overweight/obese Asian Indian subjects with T2D, who had suboptimal glycemic control. A total of 95 T2D patients [51 males (M), 44 females (F)] completed the two RWE studies. In RWE 1, 40 patients (20 M/20 F), mean [standard deviation (SD)] age 49.4 (10.7) years (Y), weight 92.6 (6.6) kg, body mass index (BMI) 30.6 (2.3) kg/m2, duration of T2D 8.1 (3.2) Y, completed the study. At week 32, the mean (SD) reduction in A1c (%) was -1.3% [8.4 (0.7) to 7.1 (0.3); p < 0.01] and mean (SD) weight (kg) loss was -5.5 [92.6 (6.6) to 87.9 (7.02); p < 0.00001]. This group was then followed up until week 52. In RWE 2, 55 patients (31 M/24 F), age 51 (5.8) Y, weight 92.6 ± 3.4 kg, BMI 31.1 ± 2.1 kg/m2, SBP 142.4 ± 3.9 mm Hg, estimated glomerular filtration rate (eGFR) 62 ± 5 mL/minute/1.73 m2, with 8.4 ± 3.3 Y duration of diabetes met the inclusion criteria. In 71% of subjects, A1c decreased by -1.4% [8.5 ± 0.4 to 7.1 ± 0.2; p < 0.0001] at week 16 and was 6.8 ± 0.3 (p = 0.0002) in 18% at week 32. A statistically significant (SS) improvement in glycemic control, weight, and improvement in cardiovascular (CV) risk factors was observed with the GLP-1RA/SGLT-2i combination, which was well tolerated.

Longitudinal Care Management for Diabetes and Hypertension

Addressing common sources of chronic disease leads to improved patient health, as well as presenting a scalable target for the improvement of value-based care outcomes. Improving patients’ self-management skills and quality of life is the key goal of chronic disease management. Mitigating high-costs and slowing disease progression create mutual success for both patients and health care systems. By training nurses to deliver a refined model of longitudinal care management, Corewell Health West was able to achieve improved chronic disease control and create additional capacity among primary care providers. The initial focus of the longitudinal care program was diabetes and hypertension management. Corewell Health created a Multidisciplinary Approach to Disease Over Time (MADOT) framework to guide care management for patients with multiple chronic conditions or who are facing long recovery journeys. The framework emphasizes timely and actionable patient identification, regular contact between patients and health care staff that prioritizes patient goals and assesses their “readiness to change,” and specialized skills development for health care staff. The framework has shown success among patients with uncontrolled diabetes (A1c ≥8.0). Of the targeted interventions carried out for more than 1,000 patients since January 2022, 608 patients fully completed the program; these patients demonstrated an average 2.24-percentage point reduction in hemoglobin A1c. Of those 608 patients, 364 had a pre-intervention hemoglobin A1c level ≥9.0 and achieved an average 3.02-percentage point reduction in hemoglobin A1c. Similarly, patients who graduated from the program saw greater improvement in systolic blood pressure than patients who disenrolled or declined interventions.

Evaluation of remote pharmacist intervention on type 2 diabetes hemoglobin A1c reduction in an accountable care organization

Background The value of clinical pharmacists for ambulatory internal medicine clinics is well recognized, including their role in hemoglobin A1c (HbA1c) reduction in patients with type 2 diabetes mellitus (T2DM). However, there is a lack of data evaluating the clinical impact of remote, referral-based pharmacy programs. Methods This multicenter, cohort, retrospective chart review study analyzed the impact of pharmacist interventions on blood glucose control in patients aged 18 years and older who were diagnosed with T2DM with an HbA1c of 8.5% or greater and referred to the clinical pharmacy team for medication evaluation. Primary care providers may have accepted or rejected pharmacist recommendations. The primary study outcome was the mean change in HbA1c from baseline to follow-up at 2 to 5 months. Secondary outcomes included appropriate use of American Diabetes Association–indicated secondary prevention and any occurrence of glycemia-related events (i.e., T2DM-related emergency room visits or hospitalizations). Results At the conclusion of the study, the mean change in HbA1c from baseline to follow-up at 2 to 5 months was −2.7% and −0.6% for the accepted and rejected intervention groups, respectively (t = −2.94, P = 0.0068). Conclusions The results of this study suggest that remote pharmacist intervention significantly improves blood glucose control in adults with T2DM.

Clinical Outcomes of Rural Patients with Diabetes Treated by ECHO-Trained Providers Versus an Academic Medical Center.

Despite clinical practice guidelines prioritizing cardiorenal risk reduction, national trends in diabetes outcomes, particularly in rural communities, do not mirror the benefits seen in clinical trials with emerging therapeutics and technologies. Project ECHO supports implementation of guidelines in under-resourced areas through virtual communities of practice, sharing of best practices, and case-based learning. We hypothesized that diabetes outcomes of patients treated by ECHO-trained primary care providers (PCPs) would be similar to those of patients treated by specialists at an academic medical center. Specialists from the University of New Mexico (UNM) launched a weekly diabetes ECHO program to mentor dyads consisting of a PCP and community health worker at ten rural clinics. We compared cardiorenal risk factor changes in patients with diabetes treated by ECHO-trained dyads to patients treated by specialists at the UNM Diabetes Comprehensive Care Center (DCCC). Eligible participants included adults with type 1 diabetes, type 2 diabetes on insulin, or diabetes of either type with A1c > 9%. The primary outcome was change from baseline in A1c in the ECHO and DCCC cohorts. Secondary outcomes included changes in body mass index (BMI), blood pressure, cholesterol, and urine albumin to creatinine ratio (UACR). Compared to the DCCC cohort (n = 151), patients in the ECHO cohort (n = 856) experienced greater A1c reduction (-1.2% vs -0.6%; p = 0.02 for difference in difference). BMI decreased in the Endo ECHO cohort and increased in the DCCC cohort (-0.2 vs. +1.3 kg/m2; p = 0.003 for difference in difference). Diastolic blood pressure declined in the Endo ECHO cohort only. Improvements of similar magnitude were observed in low-density lipoprotein cholesterol in both groups. UACR remained stable in both groups. ECHO may be a suitable intervention for improving diabetes outcomes in rural, under-resourced communities with limited access to a specialist.

Clinical Outcomes of Metabolic Surgery on Diuretic Use in Patients With Heart Failure

The beneficial impacts of metabolic surgery (MS) on patients with heart failure (HF) are incompletely characterized. We aimed to describe the cardiac and metabolic effects of MS in patients with HF and hypothesized that patients with HF would experience both improved metabolic and HF profiles using glycemic control and diuretic dependency as surrogate markers. In this single-center, university-affiliated academic study in the United States, a review of 2,342 hospital records of patients who underwent MS (2017 to 2023) identified 63 patients with a medical history of HF. Preoperative characteristics, 30-day outcomes, and up to 2-year biometric and metabolic outcomes, medication usage, and emergency department utilization were collected. At 24 months, mean body mass index change was -16 kg/m2 (p <0.001) that corresponded to a mean percentage total body weight loss of 29% (p <0.001). Weight loss was accompanied by significant reductions in hemoglobin A1c (p <0.001) and a 65% decrease in diuretic use at 24 months after surgery (p <0.001). Similarly, emergency visits for cardiac conditions (p = 0.06) and intravenous diuresis (p = 0.07) trended favorably at 1 year after surgery compared with 1 year before surgery but were not statistically significant. In conclusion, in patients with HF who were carefully selected, MS appears to provide significant reduction in oral diuretic dependency, and metabolic improvements with trends toward lower rates of emergency department utilization.

Unveiling contrasts in microbiota response: A1c control improves dysbiosis in low-A1c T2DM, but fails in high-A1c cases—a key to metabolic memory?

IntroductionType 2 diabetes mellitus (T2DM) is associated with dysbiosis in the gut microbiota (MB). Individually, each medication appears to partially correct this. However, there are no studies on the response...

Effectiveness of Jena DM® Herbal Formulation as Complementary Therapy to Conventional Oral Hypoglycemic Agents in Type-2 Diabetes Mellitus: A Quasi-experimental Study.

There is vast preclinical evidence that indicates that extracts from several Artemisia plant species have significant antidiabetic benefits. However, clinical evidence is limited to this effect. We sought to evaluate the effectiveness ofJena DM® (anArtemisia annua-based poly-herbal formulation) on glycemic control (Hb A1C) and insulin metabolism (HOMA), when administered as a complementary therapy in type-2 diabetes mellitus (T2DM). This study was supported by a research grant (JRD005) from Jena Herbals (U) Ltd, which is a local herbal medicines manufacturing facility in Uganda. We conducted a 12-week quasi-experimental study, involving 118 patients under routine follow-up at a diabetes and endocrinology clinic. Random assignment to either conventional or experimental study groups was done using a random number generator (Microsoft Excel version 16.0). Participant sociodemographic and clinical data as well as whole blood samples (3-5 mL) were obtained at scheduled clinic visits. Medication adherence was assessed using the Hill-Bone Scale, and adverse drug events (ADEs) using the Naranjo causality and the National Institute of Allergy and Infectious Diseases, Division of AIDS (DAIDS) scales. Group differences in glycemic control (HbA1C), fasting serum insulin (FSI) indices (% HOMA2-B, HOMA-IR), and other cardiometabolic parameters were assessed using independent samples t-test, and Pearson chi-square statistical tests were used. A p-value <0.05 was considered statistically significant. Ethical approvals were obtained before the study commencement. 12-week daily complementary therapy withJena DM® showed no significant effect on Hb A1C reduction (0.1 (95% CI: -0.56, 0.80) %;p=0.798); however, we observed a significant reduction in total body weight (2.0 (95% CI: 0.73, 3.28) kg;p=0.002). The overall frequency of self-reported ADEs including dizziness was significantly higher among patients that usedJena DM® (p=0.001).Epigastric pain was the most severe ADE necessitating clinical management. There was no significant difference in the homeostatic model assessment for insulin resistance (HOMA2-IR) between study groups. In contrast to a few studies that previously showed significanthypoglycemic effects ofArtemisia-basedextracts, this study did not show a statistically significant reduction on HbA1C during a 12-week complementary use ofJena DM® in patients withT2DM. Based on the findings of this study, future research should evaluate the long-term effects ofJena DM® on body weight, overall insulin metabolism, and the subsequent effect on glycemic control in T2DM.

The effects of diabetes self-management programs on clinical and patient reported outcomes in older adults: a systematic review and meta-analysis.

With diabetes self-management continuing to become more complex for older adults, self-management programs have been shown to support this population in meeting their multifaceted medical needs. Building on our previous systematic review and meta-analysis, we aimed to update the literature on the effectiveness of diabetes self-management programs and investigate the impact of specific self-management interventions on clinical and patient-reported outcomes. We updated our literature search in the following databases: Medline, EMBASE, PsychINFO, CINAHL and Cochrane Database of Randomized Controlled Trials from November 2013 to July 2023 for studies that may fit our inclusion criteria. Two independent reviewers screened and extracted data from the included group of studies. A total of 17 studies with 21 comparison arms met the inclusion criteria, totalling 5976 older adults (3510 individuals randomized to self-management programming and 2466 to usual care). The pooled effectiveness of diabetes self-management programs in older adults on glycemic control (hemoglobin A1C) was a reduction of -0.32 (95% CI -0.44, -0.19). Specifically, the most effective approach on glycemic control (A1C) was the use of feedback (-0.52%; 95% CI -0.68, -0.36). Overall, self-management programs improved behaviour change outcomes, with feedback interventions being most effective (standardized mean difference [SMD] 0.91; 95% CI 0.39, 1.43). The effect of self-management programs on body mass index, weight and lipids were statistically and clinically significant. The evidence for diabetes self-management programs for older adults demonstrates a small but clinically meaningful reduction in A1C, improvement in patient-reported outcomes (behaviour, self-efficacy, knowledge), and other clinical outcomes (BMI, weight and lipids). The specific strategy used in diabetes self-management programs for older adults should be considered to achieve optimal results on outcomes.

Evaluation of a pharmacist-led personal continuous glucose monitor workflow to improve glycemic management in an internal medicine clinic

BackgroundThe use of personal continuous glucose monitors (CGMs) in patients with diabetes has increased substantially and is expected to continue to increase as CGMs become more affordable and insurance plans improve coverage. The utilization of CGMs has improved diabetes management and reduced hypoglycemic events. ObjectivesTo create pharmacist-led personal CGM workflow and evaluate its impact on glycemic management in patients with diabetes. Practice DescriptionThe study took place at an Internal Medicine Clinic. The practice providers include 2 medical doctors, 5 physician assistants, 2 nurse practitioners, and 1 clinical pharmacist. Practice InnovationTo create and implement a sustainable pharmacy led CGM workflow for enhanced CGM use within an internal medicine clinic. Evaluation MethodsThis was a prospective, investigator-initiated pilot study conducted at an Atrium Health Internal Medicine clinic over 28 weeks. In this pilot, 42 patients were qualifying candidates with diabetes and personal CGM use. In addition, 30 patients were followed until study completion and included into final analysis. ResultsThe average baseline A1c was reduced from 8.3% to 7.1% over a 3- to 6-month period. The pharmacist-led CGM workflow revealed a statistically significant reduction in A1c from baseline by an average of 1.2% (95% CI −0.6 to −1.8, P = 0.0006). On average, patients were enrolled for 19.9 weeks and had an average of 5 visits during this time. During the study duration, 100 medications changes were implemented under the existing clinical pharmacist practitioner agreement between the pharmacists and the provider. Overall, 58 Current Procedural Terminology 95251 codes were billed yielding $7052.00 in billed CGM services for the clinic. This project generated 40.6 provider relative value units. ConclusionThe utilization of a pharmacist-led personal CGM workflow can improve diabetes outcomes.

Impact of Risk Stratification in Patients With Diabetes Mellitus in a Health System Specialty Pharmacy Setting

Background: Integrated pharmacist care into health systems results in significant A1c reduction and improved outcomes in patients with diabetes. However, little is known about the adoption of Health System Specialty Pharmacy (HSSP) chronic disease management (CDM) services within diabetes clinics. Risk stratification is proven to enhance care in various patient populations. Objective: The objective of this study is to describe how the implementation of risk stratification in the HSSP setting results in optimized patient outcomes in diabetes. Method: This is a retrospective descriptive study reporting the results of expanding the HSSP care model to implement risk stratified CDM services for patients with diabetes. A total of 285 patients were enrolled in the HSSP CDM pharmacy services and were stratified into high- or low-risk groups. Results: Eighty-eight patients were stratified as high-risk with an average baseline A1c of 11.47% and a most recent average of 8.84%. The remaining 285 patients were stratified into the low-risk group. Their average baseline A1c was 7.48% and the last recorded average A1c was 7.15%. Patients not enrolled in HSSP CDM services (N = 100) had a lower reduction in average A1c compared to patients enrolled in the program. Conclusion: Patients stratified into high- and low-risk groups had greater reductions in A1c compared to patients who did not use HSSP CDM services. These results showcase the success of risk stratification and demonstrate the impact HSSP has on patients needing CDM services and outlines a strategy to provide the greatest impact in a high-volume patient population.

The efficacy and safety of sodium-glucose cotransporter-2 inhibitors in solid organ transplant recipients: A scoping review.

Sodium glucose co-transporter 2 (SGLT2) inhibitors are used for the treatment of diabetes and for their cardiovascular and kidney benefits in patients with or without diabetes. Use in solid organ transplant recipients is controversial because transplant recipients were excluded from the major clinical trials assessing SGLT2 inhibitors. The goal of this review was to assess the available literature regarding the use of SGLT2 inhibitors in solid organ transplant recipients. A PubMed search was conducted for studies published in English through December 31, 2023. Studies were excluded if they were meta-analyses, review articles, commentaries, single case reports, or invitro studies, or did not involve the use of SGLT2 inhibitors in solid organ transplant recipients with a diabetic, cardiovascular, or kidney outcome being assessed. In the final review, 20 studies were included: kidney (n = 15), heart (n = 4), and liver/lung/kidney (n = 1) transplant recipients. SGLT2 inhibitors had similar A1c reduction efficacy and were found to be weight neutral with possible weight reduction effects. Cardiovascular and kidney outcomes were not adequately assessed in the available studies. Adverse effects were reported to occur at a similar rate in transplant recipients compared to the general population. SGLT2 inhibitors were initiated ≥1-year post-transplant in most transplant recipients included in these studies. The overall safety and antihyperglycemic efficacy of SGLT2 inhibitors in kidney and heart transplant recipients is similar to the general population. Data assessing SGLT2 inhibitors use in solid organ transplant recipients for longer durations are needed.

Comparative efficacy and safety of weekly dulaglutide versus weekly insulin in type 2 diabetes: A network meta-analysis of randomized clinical trials

BackgroundAdvancements in type 2 diabetes mellitus (T2DM) therapy, notably with weekly agents like glucagon-like peptide-1 receptor agonists (GLP-RAs) such as dulaglutide, offer promising outcomes in clinical practice. The emergence of once-weekly insulin adds to this therapeutic arsenal. This research aims to explore and compare the efficacy and safety profiles of these agents in diabetes management, facilitating informed decision-making for optimizing their utilization in clinical practice. MethodsA systematic search of PubMed, Scopus, Cochrane, and Web of Science databases was conducted. The research protocol was registered at OSF registries (https://osf.io/gd67x). The primary outcome of interest was the change in hemoglobin A1C (HbA1c), with secondary outcomes including the change in fasting plasma glucose, body weight, prevalence of hypoglycemia, and treatment discontinuation due to adverse events. The evaluation of bias risk was conducted utilizing the RoB2 tool developed by the Cochrane Collaboration. Statistical analysis was performed using RStudio version 4.3.2 with the meta package version 7.0–0 and the netmeta package version 2.9–0. Confidence in network meta-analysis estimates was evaluated using the CINeMA (Confidence In Network Meta-Analysis). Heterogeneity was assessed by comparing the magnitude of the common between-study variance (τ2) for each outcome with empirical distributions of heterogeneity variances. ResultsDulaglutide 1.5 mg (mg) weekly demonstrated superior reduction in hemoglobin A1C (HbA1c) compared to insulin, with a mean difference (MD) of −0.35 (95 % CI: −0.51 to −0.19). Additionally, Dulaglutide 1.5 mg exhibited greater weight loss, with an MD of −3.12 (95 % CI: −3.55 to −2.68). However, it also showed a higher rate of adverse events, with an odds ratio (OR) of 1.40 (95 % CI: 1.12 to 1.75) compared to insulin. Both doses of Dulaglutide (1.5 mg and 0.75 mg) had lower prevalence of hypoglycemia compared to insulin, with ORs of 0.60 (95 % CI: 0.41 to 0.87) and 0.59 (95 % CI: 0.41 to 0.86), respectively. There was no significant difference in treatment discontinuation among the treatment groups. ConclusionDulaglutide, particularly at higher doses, demonstrates superior efficacy in lowering hemoglobin A1C and reducing hypoglycemia risk compared to Icodec insulin in type 2 diabetes management. However, its use is also associated with a higher incidence of adverse events. Clinicians should carefully consider these factors when selecting optimal treatment strategies for patients with type 2 diabetes mellitus.

Clinical Telepharmacy: Addressing Care Gaps in Diabetes Management for an Underserved Urban Population Using a Collaborative Care Model.

Introduction: Optimal chronic care management is limited by low health care access and health literacy among underserved populations. We introduced clinical pharmacy services to enhance our patient-centered home model, which serves mostly Medicare/Medicaid-insured patients. Primary care providers (PCP) refer patients with uncontrolled diabetes to the pharmacist for chronic disease management between PCP appointments to bring A1c to goal under a collaborative agreement. This workflow existed before the COVID-19 pandemic and was primarily in-person visits. Our model transitioned to telehealth, where pharmacy services continued via audio/video visits to avoid disruption in care. Methods: A collaborative scope of practice within care guidelines was developed with PCPs. Established patients with uncontrolled diabetes were referred to the clinical pharmacist. The workflow remained consistent through January 1, 2019 to January 31, 2020 (pre-COVID), and April 1, 2020 to October 31, 2021 (post-COVID). February and March 2020 were excluded due to changing operational processes at the pandemic onset. The pharmacist independently saw patients for medication-related interventions and ordered associated labs within the scope of practice. The program was retrospectively evaluated via process metrics (visit volume and intervention types) and clinical outcome (A1c reduction). Results: A total of 105 patients were referred for diabetes management during the study period. These were in-person pre-COVID (95%) and shifted to entirely audio/video (100%) post-COVID. Impact of pharmacy services was sustained through the change in care model: an A1c reduction of more than 0.5% was observed in 65% (n = 20) and 69% (n = 49) of patients managed by the pharmacist, pre- and post-COVID, respectively. Pharmacy visit volumes were 86 versus 308, respectively. Conclusion: Pharmacy referral and visit volumes increased over the pandemic, made possible via telehealth. The goal attainment rate observed pre-COVID was amplified even with the growth in services over time. Clinical pharmacy services delivered through audio/video telehealth visits may be equally effective compared to face-to-face services.

Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial.

Black adolescents with type 1 diabetes (T1D) are at increased risk for suboptimal diabetes health outcomes; however, evidence-based interventions for this population are lacking. Depression affects a high percentage of youth with T1D and increases the likelihood of health problems associated with diabetes. Our aim was to test whether baseline levels of depression moderate the effects of a brief eHealth parenting intervention delivered to caregivers of young Black adolescents with T1D on youths' glycemic control. We conducted a multicenter randomized controlled trial at 7 pediatric diabetes clinics located in 2 large US cities. Participants (N=149) were allocated to either the intervention group or a standard medical care control group. Up to 3 intervention sessions were delivered on a tablet computer during diabetes clinic visits over a 12-month period. In a linear mixed effects regression model, planned contrasts did not show significant reductions in hemoglobin A1c (HbA1c) for intervention adolescents compared to controls. However, adolescents with higher baseline levels of depressive symptoms who received the intervention had significantly greater improvements in HbA1c levels at 6-month follow-up (0.94%; P=.01) and 18-month follow-up (1.42%; P=.002) than those with lower levels of depression. Within the intervention group, adolescents had a statistically significant reduction in HbA1c levels from baseline at 6-month and 18-month follow-up. A brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms. ClinicalTrials.gov NCT03168867; https://clinicaltrials.gov/study/NCT03168867.

499 Physiological and Metabolomic Effects of a Community-Based Cardiorenal Protective Diet Intervention in African Americans with Chronic Kidney Disease and Hypertension

OBJECTIVES/GOALS: Chronic kidney disease (CKD) impacts 15% of US adults and African American (AA) persons are disproportionately affected with more than 3 times higher risk of kidney failure when compared to Caucasian persons. This study evaluated the physiological and metabolomic effects of increased fruits and vegetables (F&amp;V) on cardio-renal risk factors. METHODS/STUDY POPULATION: This pilot trial used a prospective, 2-group, randomized study design to evaluate a F&amp;V intervention (N=46), where participants received a prescribed amount of fresh, base-producing F&amp;V compared to a wait-list control (WL) condition (N=45). All participants were African American adults (≥18 years), had self-reported hypertension, and had CKD (Stage 1-3) on screening spot-urine microalbumin test. Participants were measured at baseline and 6 weeks post-intervention. Clinical data (i.e., systolic and diastolic blood pressure, lipid panel, hemoglobin A1C, BMI [body mass index], and albumin to creatinine ratio) were collected. Targeted metabolomic quantitative analysis was performed followed by LC-MS/MS and FIA-MS/MS. Linear mixed models evaluated analyte expression and clinical data. RESULTS/ANTICIPATED RESULTS: AA participants (N=91) were aged 58 ± 10.2 years, 66% female, and 54% had incomes ≤$50,000. T-tests compared change scores (baseline to 6-weeks) between groups. The F&amp;V group demonstrated a significant reduction in BMI of -4.7 ± 10.5 kg/m² compared to a 1.9 ± 8.3 kg/m² increase in the WL group, p&lt;.01. Further, the F&amp;V group demonstrated a reduction in total cholesterol of -15.4 ± 58.8 mg/dL compared to a 17.7 ± 68.8 mg/dL increase in the WL group, p&lt;.05. Non-significant reductions in hemoglobin A1c were found in the F&amp;V versus the WL group. Metabolomic analysis indicated significant variation with an increase of suggestive key biomarkers for worse CKD in the WL versus F&amp;V groups at 6-weeks. DISCUSSION/SIGNIFICANCE: Consumption of only 2 cups of F&amp;V via a community-based intervention reduced CVD risk factors in AA adults with CKD and HTN and resulted in molecular/biochemical changes which may improve long-term kidney health. Further investigation may lead to development of cost-effective dietary intervention models to improve CKD outcomes in AA persons.

Combination Therapy of Endoscopic Gastric Remodeling with GLP-1RA for the Treatment of MASLD.

The mainstay of treatment for metabolic dysfunction-associated steatotic liver disease (MASLD) is weight loss. Endoscopic gastric remodeling (EGR) and glucagon-like peptide-1 receptor agonist (GLP-1RA) are effective weight loss therapies. This study aims to assess the effect of combining EGR with GLP-1RA on liver-related outcomes and weight profile. This is a retrospective study of a prospectively collected registry of patients with MASLD and compensated advanced chronic liver disease (cACLD) who underwent EGR. Patients were categorized as (1) monotherapy: EGR alone and (2) combination therapy: GLP-1RA prescribed within 6months prior to or after EGR. Outcomes included changes in noninvasive tests of hepatic fibrosis, weight profile, and insulin resistance status at 12months. Thirty patients (body mass index 40.7 ± 9.3kg/m2) were included. Of these, 12 patients (40%) underwent EGR monotherapy, and 18 patients (60%) underwent EGR + GLP-1RA combination therapy. Combination therapy group experienced greater improvements in fibrosis compared to monotherapy group (alanine aminotransferase: reduction by 55 ± 23% vs 29 ± 22% (p = 0.008), NAFLD fibrosis score: reduction by 181 ± 182% vs 30 ± 83% (p = 0.04), liver stiffness measurement on transient elastography: reduction by 54 ± 12% vs 14 ± 45% (p = 0.05)). There were greater reductions in hemoglobin A1c and homeostatic model assessment for insulin resistance in combination therapy compared to monotherapy (p < 0.05). At 12months, the combination therapy group experienced 18.2 ± 6.6% TWL, while monotherapy group experienced 9.6 ± 3.3% TWL (p = 0.004). In patients with MASLD and cACLD, combination of EGR with GLP-1RA is associated with greater improvements in hepatic fibrosis, weight profile, and insulin resistance compared to EGR alone.