A1C Reduction Research Articles

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&V) on cardio-renal risk factors. METHODS/STUDY POPULATION: This pilot trial used a prospective, 2-group, randomized study design to evaluate a F&V intervention (N=46), where participants received a prescribed amount of fresh, base-producing F&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&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<.01. Further, the F&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<.05. Non-significant reductions in hemoglobin A1c were found in the F&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&V groups at 6-weeks. DISCUSSION/SIGNIFICANCE: Consumption of only 2 cups of F&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.

Abstract P468: Correlation Among A1c Improvement, Weight Reduction, and Decreased ASCVD Risk in Participants Enrolled for Type 2 Diabetes Remission: Outcomes at 1 Year From an RCCT Using Whole-Body Digital Twin Technology

Background and Aims: The effects of digital twin (DT) technology for remission of T2D on cardiovascular risk reduction is unknown. We evaluated the effectiveness of the DT to improve A1c and body weight and ASCVD risk, in patients enrolled to achieve remission of T2DM. DT platform uses AI and Internet of Things, to integrate multi-dimensional data to give precision nutrition and health recommendations via the mobile app and by coaches. Materials and Methods: Data from 208 participants who had been on DT for 1 year were analyzed. Remission was defined as A1C levels less than 6.5% without medication for over 3 months. Outcomes included the change in HbA1c, body weight and change in ASCVD risk scores. The DT uses a machine learning algorithm to integrate clinical and sensor data to predict personal glucose response. Patients were connected to continuous glucose monitoring (CGM) throughout the study and self-recorded dietary intake using the mobile app. Results: The study participants had a mean diabetes duration of 3.7±2.7 years and a mean age of 44±8.5 years. Based on the ADA criteria, at 1 year, 72.6% (n=151/208) continued to be under remission. The mean 10-year ASCVD risk (%) at baseline was 7.9 (±7.8, 95% CI 6.8 to 8.9) which reduced to 3.6 (±4, 95% CI 3.1 to 4.2) at 360 days, p&lt;0.0001. A1c (%) at baseline was 8.9 (±1.8, 95% CI 8.7 to 9.2, minimum 5.5, maximum 16.2) which reduced to 6 (±0.6, 95% CI 5.9 to 6.1, minimum 4.7, maximum 9.2), p&lt;0.0001. Body weight (kg) at baseline was 78 (±14.3, 95% CI 76.1 to 79.9) which reduced to 70.4 (±12.9, 95% CI 68.7 to 72.1), p&lt;0.0001. There was a significant correlation between the reduction in A1c and ASCVD (Pearson r 0.41, 95% CI 0.31 to 0.5, p&lt;0.0001). Similarly, there was a significant correlation between the reduction in body weight and ASCVD (Pearson r 0.25, 95% CI 0.12 to 0.3, &lt;0.0001). At baseline, there were 49% of participants who had low risk score (&lt;5%), 16% as borderline risk (5-7.5%), 27% as intermediate risk (7.5-19.9), 8% as high risk (&gt;20%) that at 1 year shifted to 77% as low risk, 11% as borderline, 11% as intermediate risk and 1% as high-risk scores. Conclusion: The implementation of digital twin (DT) technology, utilizing AI and Internet of Things, demonstrated significant potential in T2DM management in participants enrolled to achieve remission. In our study with 208 participants, DT effectively reduced A1c levels, body weight, and ASCVD risk scores over 360 days. The correlations between reductions in A1c, body weight, and ASCVD underscore the potential of DT as a transformative tool in diabetes and cardiovascular risk management.

Abstract P278: 1-year Outcomes of A1c Reduction, Weight Loss, and Lowered QRISK3 Scores in Type 2 Diabetes Remission: Insights From an RCCT Leveraging Whole-Body Digital Twin Technology

Background and Aims: The effects of digital twin (DT) technology for remission of T2D on cardiovascular risk reduction is unknown. We evaluated the effectiveness of the DT to improve A1c and body weight and QRISK3 (QResearch Cardiovascular Disease Risk Algorithm 3), which is a prediction algorithm to estimate the 10-year risk for developing cardiovascular disease (CVD), in patients enrolled to achieve remission of T2DM. DT platform uses AI and Internet of Things, to integrate multi-dimensional data to give precision nutrition and health recommendations via the mobile app and by coaches. Materials and Methods: We evaluated the data from prospective cohort of 204 participants who had been on DT for 1 year. Remission was defined as A1C levels less than 6.5% without medication for over 3 months. Outcomes included the change in HbA1c, body weight and change in QRISK3 scores. The DT uses a machine learning algorithm to integrate clinical and sensor data to predict personal glucose response. Patients were connected to continuous glucose monitoring (CGM) throughout the study and self-recorded dietary intake using the mobile app. Results: The study participants had a mean diabetes duration of 3.7±2.6 years and a mean age of 44±8.2 years. Based on the ADA criteria, at 1 year, 73% (n=149/204) continued to be under remission. The mean QRISK3 at baseline was 12.6 (±10.7, 95% CI 11.2 to 14) which significantly reduced to 9.5 (±7.9, 95% CI 8.5 to 10.6) at 360 days, p=0.0009. A1c (%) at baseline was 8.9 (±1.8, 95% CI 8.6 to 9.1, minimum 5.5, maximum 16.2) which reduced to 6 (±0.6, 95% CI 5.9 to 6, minimum 4.7, maximum 9.2), p&lt;0.0001. Body weight (kg) at baseline was 78.3 (±14.2, 95% CI 76.4 to 80.2) which reduced to 70.7 (±12.8, 95% CI 69 to 72.4), &lt;0.0001. There was a significant correlation between the reduction in body weight and QRISK3 (Pearson r 0.24 95% CI 0.1 to 0.3, p=0.0004). However, the correlation between the reduction in A1c and QRISK3 (Pearson r 0.04, 95% CI -0.09 to 0.18, p=0.53 ns) was comparable. At baseline, there were 53% of participants who had low risk score (&lt;10), 28% as intermediate risk (10-20), 19% as high risk (&gt;20%) that at 1 year shifted to 67% as low risk, 23% as intermediate risk and 10% as high-risk scores. Conclusion: Incorporating the Digital Twin (DT) technology, which blends AI and IoT for tailored health guidance, our RCCT indicated significant 1-year advancements in A1c, weight, and QRISK3 scores among T2DM patients aiming for remission. The transformative potential of DT is evident, particularly in shifting a majority of participants towards lower cardiovascular risk categories.

A Randomized Controlled Trial to Improve Unmet Social Needs and Clinical Outcomes Among Adults with Diabetes.

Adults with type 1 or type 2 diabetes often face financial challenges and other unmet social needs to effective diabetes self-management. Whether a digital intervention focused on addressing socioeconomic determinants of health improves diabetes clinical outcomes more than usual care. Randomized trial from 2019 to 2023. A total of 600 adults with diabetes, HbA1c ≥ 7.5%, and self-reported unmet social needs or financial burden from a health system and randomized to the intervention or standard care. CareAvenue is an automated, e-health intervention with eight videos that address unmet social needs contributing to poor outcomes. Primary outcome was HbA1c, measured at baseline, and 6 and 12months after randomization. Secondary outcomes included systolic blood pressure and reported met social needs, cost-related non-adherence (CRN), and financial burden. We examined main effects and variation in effects across predefined subgroups. Seventy-eight percent of CareAvenue participants completed one or more modules of the website. At 12-month follow-up, there were no significant differences in HbA1c changes between CareAvenue and control group (p = 0.24). There were also no significant between-group differences in systolic blood pressure (p = 0.29), met social needs (p = 0.25), CRN (p = 0.18), and perceived financial burden (p = 0.31). In subgroup analyses, participants with household incomes 100-400% FPL (1.93 (SE = 0.76), p < 0.01), 201-400% FPL (1.30 (SE = 0.62), p < 0.04), and > 400% FPL (1.27 (SE = 0.64), p < 0.05) had significantly less A1c decreases compared to the control group. On average, CareAvenue participants did not achieve better A1c lowering, met needs, CRN, or perceived financial burden compared to control participants. CareAvenue participants with higher incomes achieved significantly less A1c reductions than control. Further research is needed on social needs interventions that consider tailored approaches to population subgroups. ClinicalTrials.gov ID NCT03950973, May 2019.

The Impact of Hypoglossal Nerve Stimulation on Secondary Health Outcomes.

Objectives: Obstructive sleep apnea (OSA) is a prevalent sleep disorder that can increase the risk of hypertension, diabetes, obesity, and cardiovascular diseases. Hypoglossal nerve stimulation (HGNS) is an alternative therapy for OSA in patients who cannot tolerate continuous positive airway pressure. Understanding the impact of HGNS on blood pressure, hemoglobin A1C (A1C), and body mass index (BMI) currently remains limited. Methods: A retrospective review study of HGNS outcomes at a single practice from January 2020 to November 2022 was conducted. Inclusion/exclusion criteria were based on HGNS eligibility and postoperative titration study. Statistical analysis and data management were performed using statistical software, R (v.4.2.1; R Core Team). Paired Student's T test, Fisher's exact test, and McNemar's exact test were utilized for statistical analysis. P values less than .05 were considered statistically significant. Results: Sixty-three patients were included in this study. A significant decrease in mean apnea-hypopnea index was noted following HGNS (mean change -28; P < .0001). Similar significant decreases were also seen in mean arterial pressures (mean change -8.4, P < .0001). There was a significant change in overall antihypertensive medication requirements and in requirements ≥3 medications (P < .0005, P = .03). There was a trend toward reduction in A1C; however, there was no change in BMI or number of diabetes medications taken. Conclusions: Our results reinforce previous findings that HGNS is an effective treatment option for carefully selected patients with OSA. In addition, our findings suggest that HGNS may improve patients' quality of life while minimizing OSA associated morbidity.

Glucagon-like Peptide-1 Receptor Agonists-A Potential New Medication for Pediatric Metabolic-Dysfunction-Associated Steatotic Liver Disease (MASLD).

Metabolic-dysfunction-associated steatotic liver disease (MASLD) is the most common liver disease in children in the US and, if untreated, may progress to end-stage liver disease. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown improvement in MASLD markers in adults with type 2 diabetes mellitus (T2DM). Currently, there is a lack of medications available for the treatment of pediatric MASLD. We aimed to provide preliminary data on the effects of GLP-1 RAs on markers of MASLD in a retrospective study, in an effort to bridge this gap in the pharmacotherapies available. Nine patients from a T2DM clinic who met the following inclusion criteria were included in this study: patients diagnosed with pre-diabetes or T2DM, prescribed a GLP-1 RA in the prior 12 months, and having alanine aminotransferase (ALT) elevated to twice the upper limit of the normal range, indicating evidence of MASLD. The average change between baseline and the first measurement after starting a GLP-1 RA was calculated for ALT, hemoglobin A1c, and BMI. ALT decreased by an average of 98 points. A1c decreased by an average of 2.2 points. BMI decreased by an average of 2.4 points. There was greater reduction in ALT and A1c compared to BMI, suggesting that improvement in MASLD may be independent of weight loss. This is a preliminary study that shows potential, and prospective studies are needed to evaluate the effects of GLP-1 RAs in the management of pediatric MASLD.

Vitamin D therapy's preventive effect in type 2 diabetes mellitus

Diabetes type II (DM II) is becoming more common, and it is highly harmful to several bodily systems. It's critical to keep DM II under control in order to avoid consequences like diabetic nephropathy, peripheral neuropathy, and damage to the retina. The fact that vitamin D lowers hemoglobin A1c (HbA1c) levels is just one of its many benefits. It boosts insulin's sensitivity and secretion. To find pertinent data, we thoroughly searched PubMed, a Medline, PMC, and Google Scholar. Following the application process of the inclusion and exclusion criteria, the studies' quality was assessed using the Cochrane bias analysis, the SANRA (Scale for the Testing of Narrative Review Articles) checklist, the AMSTAR (A Measuring Tool to Assess A Systematic Reviews) criteria, and the AMSTAR criteria. Data has been collected from 14 studies, of which 5 case reports, 3 general articles about DM II and vitamin D, 1 review of the literature, and 8 systematic reviews or meta-analyses.&#x0D; Three were narrative reviews and three were randomized controlled studies. The clinical significance of vitamin D treatment in type 2 diabetes is also evaluated in this study from the perspectives of glucose metabolism and adverse effects such retinopathy, neurotoxicity, and proteinuria. In terms of hemoglobin A1c (HbA1c) reduction, the relief of diabetic neuropathy and nephropathy symptoms, and the reduction of oxidative stress brought on by hypoglycemia in the retinal cells, vitamin D improved glucose levels clinically.&#x0D; One of the essential vitamins for diabetics is vitamin D..

Association Between Adherence, A1C Improvement, and Type of Continuous Glucose Monitoring System in People with Type1 Diabetes or Type2 Diabetes Treated with Intensive Insulin Therapy.

Use of continuous glucose monitoring (CGM) systems by people with diabetes is associated with improved glycemic outcomes, including lower glycated hemoglobin (A1C). Less is known about adherence to CGM systems, whether glycemic outcomes are impacted by levels of adherence, or whether adherence rates differ between types of CGM systems-intermittently scanned CGM (isCGM) or real-time CGM (rtCGM). A retrospective analysis of de-identified US administrative health claims and linked laboratory data was conducted using the Merative™ MarketScan® Research Database. The cohort included CGM-naïve people with type1 diabetes (T1D) or type2 diabetes treated with intensive insulin therapy (T2D-IIT) who initiated rtCGM or isCGM between August1, 2019 and March31, 2021 (defined as the index date). Adherence was calculated over a 12-month period using the proportion of days covered (PDC) with PDC ≥ 0.8 defined as adherent. A1C values were obtained within 6months of the index date. A total of 7669 individuals were identified. Subgroups included T1D using isCGM (n = 1578), T1D using rtCGM (n = 1244), T2D-IIT using isCGM (n = 3567), and T2D-IIT using rtCGM (n = 1280). After 12months, PDC was 0.71 (0.30)-0.72 (0.31) (mean(SD)) for T1D and T2D-IIT rtCGM users and 0.55 (0.34)-0.56 (0.34) for T1D and T2D-IIT isCGM users. The proportion of adherent users (PDC ≥ 0.8) was 56.8-59.7% for rtCGM users and 36.3-37.6% for isCGM users. Overall, regardless of diabetes type, the odds of adherence were over two times higher for rtCGM users compared to isCGM users. For those with available A1C information (T1D n = 213; T2D-IIT n = 346), independent of CGM type, adherence to CGM was associated with a greater reduction in A1C and more people reaching A1C targets of < 7.0% or < 8.0%. For people with T1D or T2D-IIT, higher adherence to CGM is associated with greater reductions in A1C, and higher adherence rates were observed with rtCGM systems than with isCGM systems.

Long-Term Results of a Digital Diabetes Self-Management and Education Support Program Among Adults With Type 2 Diabetes: A Retrospective Cohort Study.

The purpose of this study is to examine the long-term impact of a digital diabetes self-management education and support (DSMES) program on A1C among adults with type 2 diabetes (T2DM). Data analyzed were from a retrospective cohort of commercially insured members with T2DM enrolled in the Omada for Diabetes program between January 1, 2019, and January 31, 2022 (n = 1,322). Linear mixed models measured changes in A1C and weight across 12 months (collected at baseline and every 3 months over 1 year) overall and stratified by A1C at baseline (≥8% vs <8%). On average, members were 53.5 years old, 56.9% female, and 71.5% White, with a mean baseline body mass index (BMI) of 36.9 and A1C of 7.6%. Members with baseline A1C ≥8% demonstrated clinically and statistically significant adjusted mean reductions in A1C during follow-up, from 9.48% at baseline to 7.33%, 7.57%, 7.59%, and 7.47% at 3, 6, 9, and 12 months, respectively. Those with A1C <8% maintained glycemic stability (6.73%, 6.50%, 6.54%, 6.62%, and 6.51%, respectively). Collectively, members experienced a -1.17 kg/m2 mean reduction in BMI over 12 months. This study provides real-world evidence that members with elevated baseline A1C (≥8%) enrolled in a digital DSMES program experienced clinically meaningful and statistically significant reductions in A1C. Those with baseline A1C within goal treatment range (<8%) maintained glycemic stability over 1 year. The findings support existing evidence that scalable digital DSMES solutions can help individuals with T2DM manage their condition.

Endocrinology/Primary Care Pharmacy Collaboration vs Endocrinology Care Alone in Patients With Type 2 Diabetes and A1c >9.

Background: Type 2 diabetes (T2D) requires close collaboration between patients and their care management team, often including endocrinology. Primary care pharmacist impact on diabetes management in collaboration with endocrinology is not well established. Objective: To assess if pharmacy and endocrinology collaboration results in a greater A1c reduction in patients with T2D vs endocrinology alone. Methods: This retrospective, observational cohort study was conducted in adult outpatients with T2D and baseline A1c >9% who saw endocrinology within 1 year preceding the study period (January 1, 2021 to January 1, 2022). Patients were included if they had a follow-up A1c 6 months (±90 days) from index date and completed at least 1 endocrinology visit during the study period. Patients managed by endocrinology/primary care pharmacist collaboration (Endo/PharmD) were compared with those who received endocrinology care alone (Endo). Primary outcome was change in A1c from baseline to 6 months. Secondary outcomes included total number of completed visits and percentage of patients achieving A1c <6.5%, <7%, <8%, and <9% between groups at 6 months. Results: A total of 418 patients were included (22 Endo/PharmD, 396 Endo). The change in follow-up A1c was not significantly different between groups, -0.481% (standard error [SE] = 0.396); P = 0.6179. Endo/PharmD patients had significantly more provider visits during the study period (5.3 ± 2.3 vs 2.3 ± 1.2; P < 0.001). No significant difference was observed in odds of A1c goal attainment between groups at 6 months. Conclusion and Relevance: Endocrinology/primary care pharmacist collaboration occurred infrequently but was associated with a trend toward greater A1c reduction in patients with T2D and A1c >9%.

De-escalating treatment indications for patients who achieve metabolic goals

IntroductionRobust evidence exists regarding initiation, intensification or modification of treatments. Recommendations to de-escalate therapy are lacking, specifically in diabetes. A successful treatment de-intensification reduces overtreatment, polypharmacy, and risk of adverse effects. ObjectiveTo encompass current recommendations for deprescribing common drugs and create a consensus among health professionals. MethodsWe reviewed four databases for deprescribing approaches published between 2010 and 2022. Articles were divided into different groups of drugs (for uric-acid, hypoglycemic, lipid-lowering, and psychotropic drugs). ResultsHypoglycemic agents: strategies were limited to newer agents and insulin regimens for elderly individuals. Reducing insulin was associated with 1.1% reduction of A1c over time. SGLT2i and GLP-1RAs dose reduction depends on adverse events. Lipid-lowering agents: studies show that patients with very low cholesterol have fewer cardiovascular events without associated increased risk. Antihypertensive agents: Younger patients, lower systolic blood pressure, and few comorbidities are ideal characteristics for discontinuation. Uric acid therapy: we found no recommendation for dose de-escalation. Poor treatment adherence is associated with episodes of gout and deforming arthritis in the long term. ConclusionDeprescribing hypoglycemic, statins, antihypertensives, and urate-lowering agents may be feasible in selected patients, but periodic surveillance is important. More evidence is necessary to support this decision entirely.

Impact of Initiating a GLP1 Agonist and/or SGLT2 Inhibitor Therapy on De-Escalation and Discontinuation of Insulin and Diabetes Control When Managed by an Interprofessional Collaborative Team.

An FQHC in Denver, Colorado developed and implemented an interprofessional care model to collaboratively manage type 2 diabetes mellitus (T2DM). Utilizing the 340B program, the team protocolized ADA Guidelines to promote the early adoption of first-line medications, glucagon-like peptide1 receptor agonists (GLP1 RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2is) to improve patient outcomes. To assess the impact of interprofessional collaborative management versus standard care on early initiation of a SGLT2i and/or GLP1 RA as first-line therapies to enhance (1) deprescribing of insulin, (2) reducing overbasalization of insulin through insulin de-escalation, and (3) effectively lowering A1C levels in adult primary care patients with T2DM. This was a retrospective chart review of adult patients with T2DM who were initiated on a GLP1 RA and/or a SGLT2i. To determine the effects of initiating GLP1 RA and/or SGLT2i therapy on insulin usage and glycemic control, the total daily dose (TDD) of insulin before initiation was compared with the most recent TDD post-initiation to evaluate deprescribing. To determine the impact on overbasalization, pre-initiation and post-initiation insulin doses were evaluated. The effectiveness of GLP1 RA and/or SGLT2i in lowering A1C levels was determined by comparing the A1C prior to initiation with the A1C postinitiation. To evaluate the influence of interprofessional collaborative care on insulin deprescribing, overbasalization, and diabetes control, relevant measures were compared between patients receiving collaborative care versus standard care. Of the 60 total patients treated with insulin, 46.6% were deprescribed insulin, with a majority in the interprofessional collaborative group (93.1%) compared to standard care (6.9%). A total of 78.3% of patients benefited from a reduction in A1C following the initiation of a GLP1 RA and/or SGLT2i. The greatest A1C reduction was -2.9% in the group receiving metformin in addition to a GLP1 RA and a SGLT2i. Patients who received interprofessional collaborative care had an average A1c reduction of -2.9% compared to-1.1% with standard care. Most patients initially overbasalized on insulin experienced a reduction in overbasalization after initiating GLP1 RA and/or SGLT2i. There was a notable A1C reduction, de-escalation, and deprescribing of insulin in patients receiving interprofessional collaborative care.

Tirzepatide Prescribing Practices and Efficacy in Patients with Diabetes and Chronic Kidney Disease at a Large Tertiary Care Center in the United States.

Chronic kidney disease is a frequent complication of diabetes mellitus. Tirzepatide is the first dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved for glycemic control in patients with type 2 diabetes. We present the efficacy and prescribing practices of tirzepatide in a cohort with diabetes and chronic kidney disease in a large tertiary care setting. We retrospectively identified new outpatient tirzepatide prescriptions in adults ≥18 years with diabetes and chronic kidney disease stages 1-5 from 2022 to 2023 across the Barnes Jewish Hospital system (St Louis, Missouri). We identified 102 subjects with chronic kidney disease and diabetes who started tirzepatide between 2022 and 2023, and used for ≥6 months. Mean duration of tirzepatide use in our cohort was 13.89 ± 2.51 months. Among subjects who stopped, 57% (n=4) were due to limited medication availability or lack of insurance coverage. Tirzepatide use led to a significant reduction in hemoglobin A1c by 1.15%, weight by nearly 10%, systolic and diastolic blood pressure, and total cholesterol (p<0.05 for all). We found that tirzepatide was an effective therapy with significant benefits on glycemic control, blood pressure, cholesterol, and weight in subjects with diabetes and chronic kidney disease treated at a tertiary care facility.

Efficacy and safety of once-weekly basal insulin versus once-daily basal insulin in patients with type 2 diabetes: A systematic review and meta-analysis

Background: Once-weekly insulin is expected to improve treatment compliance and durability and lead to better glycemic control. Several clinical trials on once-weekly insulin have recently been published. We conducted a systematic review and meta-analysis to investigate the efficacy and safety of once-weekly insulin versus once-daily insulin in type 2 diabetes (T2D). Methods: The following databases were searched for studies: PubMed, EMBASE, and Cochrane library (From January 1, 1946 to May 9, 2023). All randomized trials comparing weekly versus daily insulin in T2D were eligible for inclusion. Data analysis was performed using STATA 17.0 software (Stata Corporation, College Station, TX). The main outcomes and indexes included reduction in Hemoglobin A1c (HbA1c), fasting plasma glucose and bodyweight, proportion of patients achieving HbA1c &lt; 7%, time-in-range 70 to 180 mg/dL and adverse events. Results: This systematic review and meta-analysis included 7 randomized controlled studies involving 2391 patients (1347 receiving 1-week insulin and 1044 receiving 1-day insulin). Once-weekly insulin was not inferior to once-daily insulin in HbA1c change [estimated treatment difference (ETD) = −0.05; 95% confidence intervals (CI): −0.14 to 0.04), HbA1c &lt; 7% (odds ratio = 1.14; 95% CI: 0.87–1.50), fasting plasma glucose (ETD = 0.09; 95% CI: −0.19 to 0.36) and body weight loss (ETD = 0.27; 95% CI: −0.36 to 0.91). In terms of time-in-range 70 to 180 mg/dL, weekly insulin was superior to daily insulin (MTD = 3.84; 95% CI: 1.55–6.08). Icodec was associated with higher incidence of all adverse events (odds ratio = 1.20; 95% CI: 1.03–1.48; P = .024), but did not result in high risk of serious and severe adverse events. Moreover, icodec and Basal Insulin Fc did not result in higher incidence of hypoglycemia compared with insulin daily. Conclusion: Our meta-analysis found that insulin weekly was well tolerated and effective for glycemic control. Once-weekly insulin was not inferior to once-daily insulin in both efficacy and safety in T2D.

Liraglutide and Robust A1C Reductions Among People With Type 2 Diabetes Requiring Appetite Control: A Review of Two Cases.

Liraglutide and Robust A1C Reductions Among People With Type 2 Diabetes Requiring Appetite Control: A Review of Two Cases.

Comparison of the efficacy of anti-diabetic medications as add-on to metformin in type 2 diabetes mellitus from a real-world database

BackgroundMetformin is recommended as a first-line drug in the guidelines of the treatment for type 2 diabetes mellitus. However, high-quality evidence from clinical trials directly comparing the degree of hypoglycemic effect of combination therapy of metformin and a hypoglycemic agent with a different mechanism of action with that of monotherapy of a hypoglycemic drug is lacking. We aimed to examine whether combination therapy of hypoglycemic agents with metformin showed antagonism, addition, or synergism compared to monotherapy with hypoglycemic agents other than metformin regarding hemoglobin A1c levels.MethodsThis retrospective cohort study used a medical information database in Japan. Non-insulin anti-hyperglycemic agents with different mechanisms of action were classified into eight drug classes. A monotherapy cohort and a combination therapy added to the metformin cohort were defined. The change in hemoglobin A1c levels was evaluated to compare the treatment effect between the cohorts.ResultsA total of 13,359 patients with type 2 diabetes mellitus in the monotherapy cohort and 1,064 in the metformin combination therapy cohort were identified. A comparison of the change from baseline HbA1c level by drug class between the two cohorts showed a similar trend. Among those treated with dipeptidyl peptidase-4 inhibitor and sodium-glucose co-transporter-2 inhibitor, no clinically significant difference was observed between the two cohorts (0.00% and -0.07% for unadjusted, 0.15% and -0.03% for propensity score matching-adjusted, and 0.09% and -0.01% for inverse probability treatment weighting-adjusted analysis).ConclusionsAccording to the results of this study, the effect of dipeptidyl peptidase-4 inhibitor or sodium-glucose co-transporter-2 inhibitor added to metformin seems to be additive with respect to the reduction in hemoglobin A1c.

Pilot study to test the safety, tolerability and feasibility of dulaglutide during a low-energy diet for weight loss and improved glycaemic control

IntroductionDiabetes and obesity are significant public health concerns. Previous studies have demonstrated that low energy diets are effective in promoting weight loss and inducing diabetes remission. However, hunger is a...