Reduction In HbA1c Research Articles

Glucagon-Like Peptide-1 Receptor Agonist-Experienced Adults with Type 2 Diabetes Switching to Once-Weekly Semaglutide in a Real-World Setting: SURE Program Post Hoc Analysis.

To investigate outcomes in adults with type 2 diabetes who switched to once-weekly (OW) semaglutide from another glucagon-like peptide-1 receptor agonist (GLP-1RA) in clinical practice. This post hoc analysis used data from the SemaglUtide Real-world Evidence (SURE) program, which included nine observational studies investigating the initiation of OW semaglutide in people with type 2 diabetes in routine clinical practice. Using a random coefficient-adjusted mixed model for repeated measurements, changes in glycosylated hemoglobin (HbA1c), body weight, and body mass index were analyzed for GLP-1RA-experienced patients who had at least one documented HbA1c value within the 12weeks before switching to OW semaglutide. In addition, descriptive statistics were used for HbA1c, body weight target achievement, and safety data. Of the 3,505 patients included in the nine SURE studies, 651 switched to OW semaglutide from another GLP-1RA. GLP-1RA-experienced patients who switched to OW semaglutide demonstrated a 0.67%-point [95% confidence interval (CI) -0.74; -0.60, p<0.0001] reduction in HbA1c, and a 3.69-kg [95% CI -3.98; -3.41, p<0.0001] reduction in body weight over 30weeks. A body weight reduction of≥5% was achieved by 27.6% of patients, and 33.3% of patients with baseline HbA1c≥7% achieved HbA1c<7% at end of study. No new safety concerns were identified. Data from this post hoc analysis suggest that, for those not adequately responding to treatment with other GLP-1RAs, switching to OW semaglutide could provide additional glycemic and weight benefits with the convenience of an OW dosing regimen.

Efficacy of Dapagliflozin + Sitagliptin + Metformin Versus Sitagliptin + Metformin in T2DM Inadequately Controlled on Metformin Monotherapy: A Multicentric Randomized Trial.

A slower adoption rate of fixed dose combinations (FDC) in diabetes management is partly due to insufficient data. This study evaluates the safety and efficacy of an FDC of dapagliflozin + sitagliptin + metformin hydrochloride extended release (XR), compared to a dual FDC of sitagliptin + metformin hydrochloride XR among patients with type2 diabetes mellitus (T2DM) with poor glycemic control when treated with metformin monotherapy. A total of 274 patients with T2DM were randomized (1:1) to either armX, receiving FDC of dapagliflozin (10mg) + sitagliptin (100mg) + metformin hydrochloride XR (1000mg) (Dapa + Sita + Met) tablets, or armY, receiving sitagliptin phosphate (100mg) + metformin hydrochloride XR (1000mg) (Sita + Met) tablets, and treated for 16weeks. The outcome measures included changes in hemoglobinA1c (HbA1c)(%), fasting plasma glucose (FPG), 2-h post-prandial glucose (PPG), weight, and the proportion of patients achieving target HbA1c levels of < 7.0% by week16 of the study period. The reduction in HbA1c at week16 was significantly higher in armX than in armY [estimated treatment difference (ETD), -0.65% (95%CI -0.76 to -0.53; P < 0.0001)]. ArmX showed a marked decrease in FPG [ETD -15.42mg/dl; 95%CI (17.63, 13.22; P < 0.0001)], PPG [ETD -30.39mg/dl; 95%CI (35.59, 25.19; P < 0.0001)], and weight [ETD -1.47kg; 95%CI (1.59, 1.28; P < 0.0001)] after 16weeks. In armX, 54% of patients reached HbA1c < 7.0% compared to 29.9% in armY. The incidence of adverse events was comparable [13.14% (armX) vs 12.4% (armY)]. There was no severe hypoglycemia-led treatment discontinuation. Among patients with T2DM who have poor glycemic control with metformin monotherapy, triple FDC (Dapa + Sita + Met) effectively helped achieve better glycemic response compared to dual FDC (Sita + Met), with a comparable safety and tolerability profile. CTRI/2022/01/039857.

Long-Term clinical efficacy of liraglutide for type 2 diabetes: real-world evidence and outcomes from Pakistan.

Liraglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, has demonstrated efficacy in improving glycemic control and promoting weight loss in clinical trials. However, real-world data from diverse populations, particularly from South Asia, are limited. The study aims to evaluate the long-term efficacy and safety of liraglutide in a real-world setting among Pakistani patients with type 2 diabetes mellitus (T2DM). A retrospective cohort study of 624 patients initiated on liraglutide was conducted. Data were collected at baseline and 6, 12, 18, and 24 months. Primary outcomes were HbA1c and weight changes. Secondary outcomes included fasting plasma glucose, lipid profile, and blood pressure. Statistical analyses were performed using appropriate methods. In study population the mean HbA1c reduction of -1.45 ± 0.67% was observed at 24 months, with 30.6% achieving HbA1c ≤ 7.5%. A rapid and sustained weight loss of -7.51 kg was achieved, with 27.2% experiencing ≥5% weight loss. Additionally, liraglutide led to a significant reduction in LDL cholesterol, with 46.7% of patients achieving a ≥ 10% reduction at 24 months. Liraglutide was well-tolerated, with a low discontinuation rate of 4.6%. Liraglutide demonstrated sustained efficacy and safety in a diverse Pakistani population with T2DM, regardless of baseline characteristics. These findings support the use of liraglutide as an effective treatment option for T2DM in real-world clinical practice.

Evaluating the use of glucagon‐like peptide‐1 receptor agonists in a matched cohort of kidney and liver transplant recipients

AbstractBackgroundDiabetes mellitus (DM) and obesity are common among solid organ transplant recipients, but are associated with an increased risk of graft failure.AimAlthough glucagon‐like peptide‐1 receptor agonists (GLP‐1 RAs) are effective for managing both conditions in the general population, there is limited evidence regarding their use among transplant recipients.MethodThe effect of GLP‐1 RAs on post‐transplant glucose control (defined as haemoglobin A1c [HbA1c]) among 37 liver and kidney transplant patients was compared to a control cohort. Secondary outcomes included change in total daily insulin requirements and oral DM agents, estimated glomerular filtration rate (eGFR), weight, and body mass index (BMI). Adverse events attributed to GLP‐1 RAs, hypoglycaemia, incidence of pancreatitis, biopsy‐proven acute rejection, graft loss, and death were assessed. Ethical approval was granted by the Henry Ford Health Institutional Review Board (Reference no: 15959) and the study conforms with the US Federal Policy for the Protection of Human Subjects.ResultsWe observed that patients receiving GLP‐1 RAs had a median reduction in HbA1c of 0.5% and reduction in insulin and oral anti‐DM agents compared to the control group without GLP‐1 RAs. There were statistically significant reductions in both weight and BMI in the GLP‐1 RA group. Our observed incidence of adverse events was similar to previous literature. Unlike other smaller studies, a decline in eGFR was observed in the GLP‐1 RA group. There were no differences in incidence of biopsy‐proven acute rejection, graft loss, or death.ConclusionWhen compared to patients without GLP‐1 RA therapy, GLP‐1 RAs modestly reduced HbA1c and insulin requirements and statistically reduced weight/BMI review at 6 months. GLP‐1 RAs, even if initiated early post‐transplant, were seemingly safe and effective. Larger, prospective studies are warranted to evaluate the safety and efficacy of GLP‐1 RAs in this population.

Efficacy of flash glucose monitoring on HbA1c in type 2 diabetes: An individual patient data meta-analysis of real-world evidence

AimsThere is a growing body of evidence demonstrating the benefit of flash glucose monitoring in type 2 diabetes mellitus (T2DM). This individual patient data meta-analysis aimed to investigate the impact of commencing flash glucose monitoring on HbA1c in people living with T2DM treated with insulin in a real-world setting MethodsA meta-analysis of eight observational studies which assessed change in HbA1c at 3–6 months following initiating flash glucose monitoring for which Abbott Diabetes Care could provide individual patient data was performed. Studies included adults with T2DM managed with insulin and baseline HbA1c between 8.0 %–12.0 % (64–108 mmol/mol). A one-stage model was created to explore heterogeneity. ResultsA total of 803 patients were included in the analysis (mean(SD) age: 62.8(11.4) years, BMI: 32.2(6.8) kg/m2, baseline HbA1c 9.0(0.9) % [75 (10) mmol/mol]). Commencement of flash glucose monitoring was associated with an HbA1c reduction of 0.89 % (95 % CI 0.71 to 1.08) (9.8 mmol/mol (95 % CI 7.8 to 11.8)) at 3–6 months. In the one stage model, age, BMI and baseline HbA1c accounted for the substantial heterogeneity observed between studies. ConclusionsCommencement of flash glucose monitoring was associated with a significant reduction in HbA1c at 3–6 months in a real-world setting in T2DM managed with insulin.

Effectiveness Of non-Pharmacological Strategies in The Management of Type 2 Diabetes In Primary Care: A Systematic Review And Network Meta-analysis

Introdução Despite the increasing number of drugs and various guidelines on the management of type 2 diabetes mellitus (T2DM), several patients continue with the disease uncontrolled. There are several non-pharmacological treatments available for managing T2DM, but various of them have never been compared directly to determine the best strategies. Objective: This study evaluated the comparative effects of non-pharmacological strategies in the management of T2DM in primary care or community settings. Métodos We have performed a systematic review and network meta-analysis (NMA) following the Cochrane collaboration and reported according to the preferred reporting items for systematic reviews and meta-analyses (PRISMA) Statement. We included randomized controlled trials if non-pharmacological strategies in the management of type 2 diabetes were applied in adult patients with T2DM in primary care. The primary outcome was glycemic control (glycated hemoglobin [HbA1c] [%]). We developed search strategies for Embase, Medline, Latin American and Caribbean Health Sciences Literature, Cochrane Central Register of Controlled Trials, Trip database, Scopus, Web of Science, Cumulative Index to Nursing and Allied Health Literature (CINAHL). Four reviewers assessed the studies for their eligibility and their risk of bias in pairs and independently. A NMA have been performed using Stata Statistical Software 18 (Stata Statistical Software: Release 18. College Station, TX, StataCorp LLC, USA). Resultados After removing duplicates, the search strategies yielded 4314 studies. After a thorough evaluation of the references, 129 studies encompassing a total of 35,975 individuals have been included in this review. Twenty and three strategies were founded. The most frequent strategy was diabetes self-management and support (DSMES), followed by diabetes self-management education, technology enabled DSMES, self-monitoring of blood glucose, multidisciplinary approach, health coach, benchmarking, low carb diet, low fat diet, plate diet, food substitution diet, yoga, leaflet, group outpatient visit model, patient-centered communication and shared decision making, and some combinations among two or more strategies. The most frequent comparator has been usual care (92%). The consistency assumption could be accepted at the overall level of each treatment ( test for inconsistency: chi2( 8) =11.01, p= 0.2011). Regarding relative rankings, DSMES associated with social support showed a 35% probability of being the best treatment in terms of HbA1c reduction, followed by plate diet (16.9%), low fat diet (11.8%) and food substitution diet (10%). Discussão e conclusões Although several systematic reviews have evaluated the effectiveness of these strategies in the management of T2DM,to the best of our knowledge to date, there are no systematic reviews and NMA considering the direct and indirect effects of non-pharmacological interventions targeting a greater control of T2DM. Conclusion: This review has founded 23 non-pharmacological strategies in the management of type 2 diabetes in primary care, being the most frequent DSMES, and DSMES associated with social support presented the highest probability to be the best in terms of HbA1c reduction. This research has been supported by the São Paulo Research Foundation (Grant number: 2021/07229-0)

IDiabetes platform—enhanced phenotyping of patients with diabetes for precision diagnosis, prognosis and treatment: study protocol for a cluster-randomised controlled study in Tayside, Scotland

Introduction and aimDiabetes is a global health emergency with increasing prevalence and diabetes-associated morbidity and mortality. One of the challenges in optimising diabetes care is translating research advances in this...

Effects of Integrated Care Approaches to Address Co-occurring Depression and Diabetes: A Systematic Review and Meta-analysis.

Depressive symptoms frequently co-occur with diabetes and, when unaddressed, can function to worsen diabetes control and increase the risk of diabetes-related morbidity. Integrated care (IC) approaches aim to improve outcomes among people with diabetes and depression, but there are no current meta-analyses examining their effects. In our study we summarize the effects of IC approaches to address depression and diabetes and examine moderating effects of IC approaches (e.g., behavioral intervention used; type of IC approach). A systematic search was conducted of PubMed, PsycInfo, CINAHL, and ProQuest. Two reviewers triaged abstracts and full-text articles to identify relevant articles. Randomized controlled trials with enrollment of participants with diabetes and depressive symptoms and with provision of sufficient data on depression scores and hemoglobin A1c were included. Two reviewers extracted demographic information, depression scores, diabetes outcomes, intervention details, and the risk of bias for each study. From 517 abstracts, 75 full-text reports were reviewed and 31 studies with 8,843 participants were analyzed. Among 26 studies with reporting of HbA1c, IC approaches were associated with a significant between-group difference regarding the percent decrease of HbA1c (d = -0.36, 95% CI -0.52 to -0.21). Studies that included a combination of behavioral interventions (behavioral activation with cognitive behavioral therapy) showed greater reductions in HbA1c. Among 23 studies with reporting of depressive symptoms, the pooled effect of IC approaches lowered depressive scores by 0.72 points (95% CI -1.15 to -0.28). The inclusion of a wide range of IC approaches increased study heterogeneity. A random effects model and sensitivity analyses mitigated this limitation. IC approaches are associated with improved glycemia and depressive symptoms in comparison with treatment as usual.

Effects of saffron (Crocus sativus L.) supplementation on cardiometabolic Indices in diabetic and prediabetic overweight patients: a systematic review and meta-analysis of RCTs.

The incidence of diabetes mellitus (DM) is increasing worldwide, and there is growing interest in the potential use of natural compounds as an alternative treatment for managing DM. Several research studies have investigated the impact of saffron consumption on managing and improving metabolic profiles in patients with DM, and they have shown promising results. The study aims to systematically review and perform a meta-analysis to evaluate the potential effects of saffron and its extract on cardiometabolic indicators in diabetic and prediabetic overweight patients. We conducted a comprehensive systematic review and meta-analysis, searching PubMed, Scopus, Web of Science, Embase, and Google Scholar for all relevant studies published before April 20, 2024. We extracted weighted (WMD) or standardized (SMD) mean differences (before-after) and 95% confidence intervals (95%CI) of the outcomes and conducted meta-analyses using R. The study protocol was registered in PROSPERO (CRD42024538380). Out of the studies screened, 15 RCTs were selected for inclusion in the systematic review and meta-analysis. These studies collectively involved 869 participants, 438 in the intervention group and 431 in the control group. Notably, our results showed that saffron supplementation led to significant changes in FBS (MD: - 8.75mg/dL, 95% CI [- 14.75; - 2.76], P < 0.01), HbA1C (MD: - 0.34%, 95% CI [- 0.39; - 0.9], P < 0.01), TG (MD: - 13.28 mg/dL, 95% CI [- 22.82; - 3.75], P < 0.01), SBP (MD: - 5.33 mmHg, 95% CI [- 8.99-1.67], P = 0.04), DBP (MD: - 1.02 mmHg, 95% CI [- 3.91; 1.86], P = 0.03), AST (MD: - 1.32 IU/L, 95% CI [- 1.72, - 0.93], P < 0.01) levels in T2DM patients compared to placebo or no supplementation, indicating its potential as a therapeutic intervention. However, there was no significant effect on Insulin secretion (MD: - 0.15 µU/ml, 95% CI [- 2.1763; 1.8689], P = 0.88), HOMA (MD: - 0.35%, 95% CI [- 1.34;0.63], P = 0.48), TC (MD: - 4.86 mg/dL, 95% CI [- 9.81-0.09], P = 0.54), HDL (MD: 0.18 mg/dL, 95% CI [- 0.93; 1.29], P = 0.74), LDL (MD: - 1.77 mg/dL, 95% CI [- 5.99-2.45], P = 0.41), TNF-α (MD: - 0.34 pg/mL, 95% CI [- 0.99-0.30], P = 0.29), creatinine (MD: 2.83 mg/dL, 95% CI [2.29, 3.37], P = 0.31) and BUN (MD: - 0.44 mg/dL, 95% CI [- 1.43, 0.55], P = 0.38). Saffron may improve specific CMI indices in overweight patients with diabetes or prediabetes, including significant reductions in FBS, HbA1C, TG, SBP, and AST. However, it did not significantly affect HDL, TC, LDL, insulin secretion, HOMA, DBP, TNF-α, ALT, Cr, or BUN. Further research with more trials and extended follow-up periods is needed to confirm and expand these findings.

Real-world glycaemic outcomes in children and young people on advanced hybrid closed-loop therapy: A population-based study in Western Australia.

To evaluate real-world glycaemic outcomes in children with type 1 diabetes (T1D) commencing advanced hybrid closed loop therapy (AHCL) and to explore these outcomes based on the cohort's clinical and socioeconomic characteristics. A single-centre, population-based retrospective study in children commencing AHCL (Smart Guard, Control IQ, CamAPS) with minimum 70% data from two-weeks CGM pre-AHCL was conducted between December 2021 and June 2023 in Western Australia. CGM metrics (time in range (TIR) 3.9-10 mmol/L, time below range (TBR) < 3.9 mmol/L, glucose management indicator (GMI)) were analysed at baseline, monthly and 6 months. HbA1c at baseline and 6 months were also collected. The proportion meeting glycaemic targets of TIR > 70%, TBR < 4% and GMI < 7.0% were determined. Change in TIR from baseline to 6 months was examined by the following characteristics: %TIR, age group and Index of Relative Socioeconomic Disadvantage (IRSD) of residential postcode. CGM data of 309 children, mean (SD) age 12.4 (3.2) years were analysed. Glycaemia improved from baseline to 6 months with (mean) TIR +8% (95% CI 7, 9; P ≤ 0.001), GMI -0.3% (95% CI -0.3, -0.2; P < 0.001) and (median) TBR -0.3% (95% CI -0.4, -0.1; P < 0.001). Proportion meeting glycaemic targets increased from 13.3% at baseline to 30.6% at 6 months. Improvement in TIR did not differ based on age group or IRSD Quintile. Greater increase in TIR was seen in those with lowest TIR at baseline (+20.9%, -0.2%; P < 0.001 for baseline TIR < 40%, >70%). There was a 0.27% reduction in HbA1c in 6 months (n = 116) (P < 0.001). AHCL improves glycaemia, irrespective of age and socioeconomic characteristics, with greatest changes seen in those with lowest baseline TIR.

Regular high-intensity ergocycle training effective in reduction in BMI, percentage of body fat, HbA1c, and improving muscle mass in in patients with type 2 diabetes

This study aims to examine the effects of high-intensity ergocycle training on four key parameters crucial for managing type 2 diabetes (T2D): Body Mass Index (BMI), body fat percentage, Hemoglobin A1C (HbA1c), and muscle mass. A total of 24 male patients with T2D, aged 41-65, participated in the study and underwent a high-intensity ergocycle training intervention, conducted three times per week for eight weeks. Parameters such as HbA1c, BMI, PBF, and SM were observed before and after the intervention. Data analysis techniques included paired sample t-tests and independent sample t-tests with a significance level of 5%. The results indicated a significant reduction in HbA1c, BMI, and PBF, as well as a significant increase in SM before and after the high-intensity ergocycle training intervention (p ≤ 0.05). Additionally, we observed a reduction in ∆-HbA1c, ∆-BMI, ∆-PBF, and an increase in ∆-SM between groups (p ≤ 0.05). These findings demonstrate that regular high-intensity ergocycle training is significantly effective in reducing BMI, body fat percentage, and HbA1c levels while increasing muscle mass in patients with T2D. This result provides solid evidence that high-intensity ergocycle training can be used as a modality to improve insulin resistance in patients with T2D.

Impact of an Ambulatory Clinical Pharmacy Population Health Initiative on HbA1c Reduction and Value-Based Measures: A Retrospective, Single-Center Cohort Study

Background: Studies of pharmacists’ clinical programs have demonstrated improvements in controlling chronic diseases. However, significantly less data are available regarding pharmacist impact in a value-based Patient-Centered Medical Home (PCMH). The present study assessed a population health initiative to incorporate pharmacists for the management of type 2 diabetes (T2D), hypertension, and hyperlipidemia in a PCMH. Methods: This was a single-center retrospective cohort study of patients with T2D and baseline glycated hemoglobin (HbA1c) greater than 9%. Patients were excluded if they received care from an endocrinology provider or were lost to follow-up during the observation window of 1 January 2023 through 31 July 2023. Patients were analyzed in two cohorts: (1) patients who received any outpatient care from a clinical pharmacist (pharmacist cohort) and (2) patients who did not receive any outpatient care from a clinical pharmacist (usual care cohort). The primary outcome was the proportion of patients achieving an HbA1c of less than 8%. Secondary outcomes included blood pressure control and receipt of guideline-directed statin therapy. Results: Ninety-one patients were identified, twenty-nine in the pharmacist cohort and sixty-two in the usual care cohort. The overall population was older (mean age ~66 years), 59% female, and racially diverse (&lt;50% Caucasian). HbA1c less than 8% was achieved in 34% of patients in the pharmacist cohort and 29% of patients in the usual care cohort (p = 0.001). A blood pressure goal of less than 140/90 mmHg was achieved more frequently in the pharmacist cohort (90% vs. 61%, p = 0.006), but guideline-directed statin therapy was similar between groups (90% vs. 79%, p = 0.215). Conclusions: Pharmacists can play an integral role within a PCMH to improve value-based measures for HbA1c and blood pressure control. Further research is needed to assess the impact of pharmacist care on statin use and economic outcomes.

Impact of Multistrain Probiotic Supplementation on Glycemic Control in Type 2 Diabetes Mellitus-Randomized Controlled Trial.

Hyperglycemia, a key characteristic of type 2 diabetes mellitus (T2DM), highlights the need for effective management strategies. This study aims to analyze the impact of multistrain probiotic supplementation on glycemic control in T2DM patients. During a 24-week randomized controlled trial involving 130 participants, subjects were assigned to either a probiotic group or a placebo group. The key outcomes included fasting blood glucose (FBG), postprandial blood glucose (PPBG), glycated hemoglobin (HbA1c) levels, and lipid profiles, assessed at baseline and post-intervention. The results indicated a significant reduction in HbA1c (p = 0.004) and increased HDL-c (p = 0.023) and improvements in lipid profiles in the probiotic group, alongside a trend toward decreased FBG and PPBG. No serious adverse effects were reported, indicating good tolerance of probiotics. These findings suggest that probiotics may positively influence metabolic parameters in T2DM patients, supporting their potential as a complementary dietary intervention. Further research is needed to understand the underlying mechanisms and enhance probiotic formulations for diabetic control.

Short-Term Impact of Digital Mental Health Interventions on Psychological Well-Being and Blood Sugar Control in Type 2 Diabetes Patients in Riyadh.

Type 2 diabetes (T2D) management is complicated by psychological factors, yet mental health interventions are not routinely integrated into diabetes care. This study investigated the impact of a digital mental health intervention on psychological well-being and glycemic control in T2D patients. A quasi-experimental study was conducted with 120 T2D patients divided into intervention (n = 60) and control (n = 60) groups. The intervention group received a one-month digital mental health intervention alongside standard care. Psychological well-being (PHQ-9, GAD-7, and DDS) and glycemic control (HbA1c) were assessed at baseline and post-intervention. The intervention group showed significant improvements in HbA1c levels (-0.5%, p = 0.032), PHQ-9 (-3.1, p = 0.001), GAD-7 (-2.8, p = 0.006), and DDS (-7.7, p = 0.012) scores compared to the control group. Strong correlations were observed between psychological improvements and HbA1c reductions. Higher engagement with the digital platform was associated with greater improvements in both psychological and glycemic outcomes. Integrating digital mental health interventions into T2D care can significantly improve both psychological well-being and glycemic control. These findings support a more holistic approach to diabetes management that addresses both mental and physical health aspects.

Oral Semaglutide Use in Type2 Diabetes: A Pooled Analysis of Clinical and Patient-Reported Outcomes from Seven PIONEER REAL Prospective Real-World Studies.

Oral semaglutide is a glucagon-like peptide1 receptor agonist (GLP-1RA) approved for improving glycemic control in adults with type2 diabetes (T2D). The PIONEER REAL program evaluates clinical and patient-reported outcomes of oral semaglutide treatment as part of routine clinical practice across 13 countries. Here, data from Canada, Denmark, Italy, the Netherlands, Sweden, Switzerland, and the UK are pooled and analyzed to address treatment satisfaction as well as glycated hemoglobin (HbA1C) and body weight changes in relevant subgroup analyses. This pooled analysis encompasses seven country-specific, non-interventional, multicenter, phase4, prospective, single-arm clinical studies assessing the use of oral semaglutide in adults with T2D. Primary endpoint was the change in HbA1C from baseline to end of study (EOS), and secondary endpoints included changes in body weight and treatment satisfaction. For the analyses, results were stratified by age, T2D duration, and oral semaglutide dose at EOS as well as baseline HbA1C, body weight, and body mass index. Oral semaglutide treatment was initiated by 1615 participants. At EOS, 1222 (76%) participants out of the 1483 (92%) who completed the study were on treatment. Estimated changes in HbA1C and body weight from baseline to week38 were - 1.0%-point (95%CI - 1.08 to - 0.97; P < 0.0001) and - 5.0% (CI - 5.37 to - 4.72; P < 0.0001). Treatment satisfaction increased significantly during the study. Shorter T2D duration interacted with higher HbA1C reduction and body weight loss. Interaction was also observed between higher baseline HbA1C and more pronounced decrease in HbA1C. No significant interactions were detected between clinical outcomes and age or physician setting. The PIONEER REAL pooled analysis shows that people initiating oral semaglutide treatment experience improved glycemic control and body weight loss across age groups and T2D duration. This occurs regardless of specialist or primary care practice setting and is accompanied by an increased treatment satisfaction. NCT04559815 (Canada), NCT04537637 (Denmark), NCT05230615 (Italy), NCT04601740 (the Netherlands), NCT04601753 (Sweden), NCT04537624 (Switzerland), NCT04862923 (UK).

Abstract 4115652: Effect of the sodium-glucose co-transporter 2 inhibitor, Dapagliflozin, on ventricular repolarization electrocardiographic parameters: DAPA-ECG study

Background: In patients with type 2 diabetes (T2D), hyperglycemia and glycemic variability lead to prolongation and greater heterogeneity of ventricular repolarization, manifested on the electrocardiogram through an increase in QT, QTc, TpeakTend (TpTe) intervals and the TpTe/QT ratio, increasing the risk of potentially malignant arrhythmias. Dapagliflozin has demonstrated efficacy in reducing cardiovascular events in T2D patients and in the risk of serious ventricular arrhythmias and sudden cardiac death. However, the exact mechanisms by which dapagliflozin confers this protection have not yet been fully elucidated. Goals/Aims: The main objective of the study was to evaluate the impact of dapagliflozin on the TpTe interval of patients with T2D, and secondarily, it examined its impact on various electrocardiographic parameters such as the QT and QTc intervals, the TpTf/QT ratio, QT dispersion, J-T peak interval, QRS-T angle and heart rate. Methods: This randomized, prospective, multicenter and open-label study involved 174 patients with T2D, divided into two groups: one treated with dapagliflozin and the other with optimized medical therapy without iSGLT2. Clinical, electrocardiographic, laboratory and echocardiographic evaluations were carried out at the beginning and after three months. The statistical analysis included means, standard deviations, quartiles, and frequencies, with 95% confidence intervals, using Chi-square (or Fisher) and t-test (or Mann-Whitney) for initial differences, and a linear mixed-effects model to evaluate the results, adopting a significance level of 0.05. Results: The TpTe interval was significantly reduced in the dapagliflozin group from 76.87 ± 12.47 to 67.80 ± 10.34 (p&lt;0.001), and the QTc interval reduced from 424.07 ± 30.76 to 411.26 ± 25.31 (p=0.022). The TpTe/QT ratio in the dapagliflozin group was shortened from 0.20 ± 0.03 to 0.18 ± 0.02 (p&lt;0.001). Both groups showed reductions in mean blood glucose and HbA1c, with a greater decrease observed in the control group. No significant changes were recorded in other variables analyzed. Conclusion: In patients with T2D, dapagliflozin significantly reduced the duration of the TpTe and QTc intervals, in addition to the TpTe/QT ratio. These findings indicate a decrease in ventricular electrical remodeling with a potential cardioprotective effect of dapagliflozin, which would partly explain its benefits in reducing potentially malignant ventricular arrhythmias and sudden cardiac death.

Abstract 4137479: Integrating Ambulatory Care Pharmacists into Value-Based Primary Care: A Scalable Model for Addressing Cardiometabolic Disease

Background: Chronic disease is common, costly, and complicated. In the shift to value-based payment models, interventions to engage patients and improve disease control are necessary to reduce morbidity, mortality, and cost. The use of ambulatory pharmacists has demonstrated improved management of chronic diseases. Traditionally, ambulatory pharmacists are employed by healthcare systems. In this study, we test if integrating ambulatory pharmacists hired, trained, and managed by a retail pharmacy into value-based primary care (VBPC) clinics improves care. Hypothesis: Integrating a Walgreens pharmacist empowered by collaborative drug therapy management agreements (CDTM) into Village Medical (VMD) clinics will improve indicators of chronic disease control. Aims: Improve hemoglobin A1c (HbA1c) in patients with type 2 diabetes (T2D) and systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements in patients with hypertension (HTN). Methods: An ambulatory pharmacist was embedded into VMD clinics in Phoenix, Arizona under the supervision of VMD primary care providers via a CDTM. The pharmacist provided education, coaching, and medication management by prescribing and titrating therapies for treating T2D and HTN - enabled by access to pharmacy dispensing data. β was generated from difference-in-differences (DID) analyses with propensity score matched controls. Results: 125 patients had T2D, and 43 patients had HTN in the intervention group with 250 and 86 in the matched control group, respectively. The mean age was 65 years, 54% were female, 2% non-English speaking, and 29% racial/ethnic minorities. The average baseline HbA1c was 9% in the intervention group and 10% in the matched cohort. The average baseline SBP was 146 mmHg in the intervention group and 142 mmHg in the matched cohort. The β in the T2D group was -1.61% (p&lt;0.001) while the β in the HTN group was -10.2 mmHg (p&lt;0.01) for SBP and -2.0 mmHg (p=0.42) for DBP. Conclusion: We saw significant reductions in SBP and HbA1c in the pharmacist-managed group compared with matched controls. These results demonstrate that pharmacist integration into VBPC clinics may improve measures of chronic disease known to be associated with morbidity and mortality.

MECHANISMS OF ACTION OF PROTEIN SHAKES IN NORMALIZING METABOLIC PROCESSES, THEIR ROLE IN IMPROVING GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES, AND IN PREVENTING CARDIOVASCULAR DISEASES

This review article delves into the significance of protein shakes, particularly whey protein, in various health and fitness contexts. The primary focus is on their biochemical properties, metabolic benefits, and their role in supporting muscle mass, weight loss, and metabolic health. The article synthesizes findings from multiple studies to highlight the potential of protein shakes in improving glycemic control, reducing inflammation, and enhancing overall health, particularly for individuals with type 2 diabetes, obesity, and sarcopenia. The review also explores the effectiveness of protein shakes in athletic performance and recovery, as well as their impact on glucose metabolism and homeostasis. It underscores the necessity for further research to optimize the use and dosage of protein shakes for diverse populations to fully harness their benefits. Whey proteins are rich in essential amino acids, particularly leucine, which stimulates muscle protein synthesis via the mTOR pathway. This makes them highly effective in muscle building and recovery. Whey protein consumption enhances glycemic control by increasing insulin secretion and improving insulin sensitivity. Studies have shown significant reductions in fasting glucose levels and HbA1c in patients with type 2 diabetes. Protein shakes aid in weight loss by promoting satiety and increasing thermogenesis. They help maintain muscle mass during weight loss, which is crucial for sustaining metabolic rate. Clinical trials have demonstrated their efficacy in reducing body fat and improving metabolic markers. Whey protein, combined with resistance training, significantly improves muscle mass and strength in older adults, helping to prevent sarcopenia. This is essential for maintaining physical functionality and reducing the risk of falls and fractures. In the rehabilitation of patients with severe obesity, protein shakes are effective in reducing body weight, improving metabolic health, and maintaining muscle mass. They play a crucial role in comprehensive rehabilitation programs that include diet and physical exercise. Protein shakes support metabolic adaptations by preserving muscle mass and enhancing thermogenesis, which helps maintain a high metabolic rate and prevent weight regain. Whey proteins enhance muscle mass and strength, speed up recovery after training, and boost endurance. They also support the immune system and reduce oxidative stress, contributing to better overall athletic performance . Proteins shakes aid in regulating blood glucose levels and improving insulin sensitivity, which is crucial for preventing and managing diabetes. Their antioxidant and anti-inflammatory properties further enhance metabolic health.

Cardiovascular, Metabolic, and Safety Outcomes with Semaglutide by Baseline Age: Post Hoc Analysis of SUSTAIN6 and PIONEER6.

The high risk of cardiovascular events in people with type2 diabetes increases with age. The cardiovascular effects of once-weekly subcutaneous and once-daily oral semaglutide versus placebo in people with type2 diabetes at high cardiovascular risk were investigated in the SUSTAIN6 and PIONEER6 cardiovascular outcomes trials, respectively. It is unknown whether the effects of semaglutide are age dependent. This post hoc analysis evaluated cardiovascular, metabolic, and safety outcomes with semaglutide versus placebo in age subgroups (≤ 60; > 60 to ≤ 65; > 65 to ≤ 70; and > 70years) pooled from SUSTAIN6 and PIONEER6. Major adverse cardiovascular events (composite of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), changes from baseline in glycated hemoglobinA1c (HbA1c) and body weight, and adverse events were analyzed. Semaglutide reduced major adverse cardiovascular events and its components versus placebo across age subgroups (most hazard ratios < 1.0; pinteraction > 0.05). The treatment difference in HbA1c reduction was greater in those aged ≤ 60years than in older subgroups (pinteraction = 0.01). Reductions in body weight with semaglutide versus placebo were consistent across agesubgroups (pinteraction = 0.124). Serious adverse events or severe hypoglycemic episodes did not differ between semaglutide and placebo across age subgroups. Semaglutide consistently reduced major adverse cardiovascular events and body weight versus placebo across age subgroups; its safety profile did not differ with age. These results suggest that relaxing HbA1c targets based solely on age may not always be required for people with type2 diabetes. SUSTAIN6 (NCT01720446) and PIONEER6 (NCT02692716) are registered at ClinicalTrials.gov.

Curalin supplement as add-on therapy for type 2 diabetes Mellitus

AimsTo examine the efficacy and safety of Curalin, as a supplement to anti-diabetic drugs (ADD). Methods135 patients were enrolled in the study. Among them, 109, ages 18–85 years, with HA1c 7.5–10 % under treatment with ADD were randomized 1:1 to receive Curalin supplement or placebo. The primary efficacy endpoint was the change in HbA1c after 3 months. The secondary endpoint was a decrease in HbA1c by more than 0.5 % and by more than 1 %. The exploratory endpoints included the Diabetes Treatment Satisfaction Questionnaire (DTSQ), clinical and laboratory results. ResultsAfter 3 months, the mean reduction in HbA1c was 1.30 % (SD = 0.79) in the Curalin group compared to 0.10 % (SD = 0.70) in the placebo group (P < 0.0001). A decrease in HbA1c of ≥ 0.5 % was observed in 90.0 % of Curalin patients versus 19.0 % of placebo patients (P < 0.0001). HbA1c reduction of ≥ 1 % occurred in 64.0 % of Curalin patients and 11.9 % of placebo patients (P < 0.0001). Curalin patients reported higher satisfaction (DTSQ) with no severe adverse events. ConclusionsCuralin treatment significantly reduced HbA1c over a period of 3 months and was well-tolerated.