Significant Reduction In HbA1c Research Articles

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<0.001) while the β in the HTN group was -10.2 mmHg (p<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.

Real-World HbA1c Changes Among Type 2 Diabetes Mellitus Patients Initiating Treatment With a 1.0 Mg Weekly Dose of Semaglutide for Diabetes.

Background: Medical management of patients with type 2 diabetes mellitus (T2DM) is complex because of the chronic nature of the disease and its associated comorbidities. Injectable once-weekly semaglutide for diabetes (OW sema T2D) is a type of glucagon-like peptide-1 receptor agonist approved for the treatment of patients with T2DM. Objectives: To describe patient characteristics and HbA1c changes for patients prescribed 1.0 mg maintenance dose OW sema T2D. Methods: This retrospective study included adult patients with T2DM with a pre-index glycated hemoglobin (HbA1c) of at least 7%, initiating treatment with OW sema T2D between January 1, 2018, and December 31, 2019, and prescribed a 1.0 mg maintenance dose. Patients were identified in the Optum Research Database and were included if they had continuous health plan enrollment for at least 12 months prior to (pre-index) and at least 12 months following (post-index) the date of the first OW sema T2D claim (index). Dose at initiation and prescriber specialty were captured. Change in HbA1c between the latest post-index and pre-index HbA1c measurement was calculated among all patients and among those with at least 90 days of continuous treatment (persistent patients). Results: A total of 2168 patients were included in this study. On average, patients were taking 13.5 different classes of medications. The majority of patients had lipid metabolism disorder (90.8%), hypertension (86.6%), diabetes with complications (86.8%), or other nutritional/endocrine/metabolic disorders (72.5%). The mean HbA1c reduction was 1.2% (P < .001). Patients persistent with OW sema T2D (n =1280) had a mean HbA1c reduction of 1.4% (P < .001). The mean (SD) days covered with a 1.0 mg maintenance dose was 236.1 (94.1) days. Discussion: Despite being medically complex, the patients in this real-world study experienced significant reductions in HbA1c following initiation of OW sema T2D. Conclusions: A 1.0 mg maintenance dose of OW sema T2D is an effective treatment for T2DM in the real world.

Effectiveness and Safety of GLP-1 Receptor Agonists in Patients with Type 1 Diabetes.

Background: GLP-1 receptor agonists (GLP-1RA) are used in the management of type II diabetes mellitus or obesity, although its role in patients with type I diabetes mellitus (T1DM) has been debated. This study aimed to investigate the efficacy and safety of GLP-1RA in patients with T1DM using real-world data. Methods: This multicenter, retrospective study was conducted at three tertiary medical centers in Riyadh, Saudi Arabia. The study followed up patients (>16 years old) with T1DM treated with insulin followed by GLP-1RA add-on therapy. The efficacy outcomes included changes in HbA1c, body weight, and insulin requirements from baseline to each follow-up visit. The main safety outcomes assessed included hypoglycemic events and gastrointestinal (GI) adverse events. Results: The study included 144 patients with a mean age of 33.0 ± 10.1 years. Semaglutide was the most used GLP-1RA (63.9%) followed by liraglutide (34.0%). From baseline to 3-month follow-up, HbA1c (mean difference (MD) = -0.8%; p = 0.0053), weight (MD = -2.4 kg; p = 0.0253), and daily basal insulin dose (MD = -2.1 units; p = 0.0349) were significantly reduced. Likewise, HbA1c (MD = -0.5%; p = 0.0004), weight (MD = -3.6 kg; p < 0.0001), and daily basal insulin (MD = -2.4 units; p = 0.0282) were significantly reduced at the 4-6-month follow-up. The significant reductions in HbA1c, weight, and daily basal insulin levels were consistent for up to 18-month follow-up. Only one patient had a major hypoglycemic event, whereas 8.3% of the patients had GI adverse events. Conclusions: Overall, significant improvements in glycemic control, weight loss, and insulin requirements were observed with the use of GLP-1RA in patients with T1DM, with a limited number of GI adverse events.

Beneficial Effects of a Freeze-Dried Kale Bar on Type 2 Diabetes Patients: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.

Type 2 diabetes (T2D) is one of the most common global diseases, with an ever-growing need for prevention and treatment solutions. Kale (Brassica oleracea L. var. acephala) offers a good source of fiber, minerals, bioavailable calcium, unsaturated fatty acids, prebiotic carbohydrates, vitamins, health-promoting secondary plant metabolites, as well as higher amounts of proteins and essential amino acids compared to other vegetables. The objective of this study was to investigate whether daily intake of freeze-dried kale powder can provide health benefits for T2D patients vs. placebo. This study was designed as a 12-week, blinded, randomized, controlled trial. Thirty T2D patients were randomly assigned to either a placebo bar (control) or a kale bar (intervention). Participants in the intervention group were instructed to consume three bars/day, each containing 26.25 g of freeze-dried kale (corresponding to approx. 341 g fresh kale/day). At baseline and 12 weeks, all participants underwent an oral glucose tolerance test (OGTT), 24 h blood pressure measurements, DEXA scans, and fasted blood samples were taken. A significant reduction in HbA1c, insulin resistance, body weight, and calorie intake was observed in the intervention group compared to control. Positive trends were detected in fasted blood glucose and LDL-cholesterol for those in the kale intervention group. No significant differences were found in total body fat mass and area under the curve glucose 240 min OGTT. Given the positive effects of high daily kale intake observed in this study, further research with a larger sample size is needed to better understand the health benefits of kale bars. This could potentially lead to new dietary recommendations for patients with T2D.

One-year outcomes of a digital twin intervention for type 2 diabetes: a retrospective real-world study

This retrospective observational study, building on prior research that demonstrated the efficacy of the Digital Twin (DT) Precision Treatment Program over shorter follow-up periods​​, aimed to examine glycemic control and reduced anti-diabetic medication use after one-year in a DT commercial program. T2D patients enrolled had adequate hepatic and renal function and no recent cardiovascular events. DT intervention powered by artificial intelligence utilizes precision nutrition, activity, sleep, and deep breathing exercises. Outcome measures included HbA1c change, medication reduction, anthropometrics, insulin markers, and continuous glucose monitoring (CGM) metrics. Of 1985 enrollees, 132 (6.6%) were lost to follow-up, leaving 1853 participants who completed one-year. At one-year, participants exhibited significant reductions in HbA1c [mean change: -1.8% (SD 1.7%), p < 0.001], with 1650 (89.0%) achieving HbA1c below 7%. At baseline, participants were on mean 1.9 (SD 1.4) anti-diabetic medications, which decreased to 0.5 (SD 0.7) at one-year [change: -1.5 (SD 1.3), p < 0.001]. Significant reductions in weight [mean change: -4.8 kg (SD 6.0 kg), p < 0.001], insulin resistance [HOMA2-IR: -0.1 (SD 1.2), p < 0.001], and improvements in β-cell function [HOMA2-B: +21.6 (SD 47.7), p < 0.001] were observed, along with better CGM metrics. These findings suggest that DT intervention could play a vital role in the future of T2D care.

Metabolic Effects of Liposuction on Glucose and Insulin Homeostasis with and Without Abdominal Fat Removal.

Liposuction is a common cosmetic procedure aimed at addressing localized fat deposits. While metabolic disruptions associated with adiposity are well documented, the specific impacts of liposuction on metabolic parameters remain unclear. Seventeen individuals underwent liposuction inclusive of the abdominal area, while eleven underwent liposuction excluding the abdomen. Metabolic parameters including glucose, insulin, HOMA-IR, HbA1c, and C-peptide levels were measured preoperatively and postoperatively at 1, 3, and 6 months. Both groups exhibited significant postoperative reductions in glucose, insulin, HOMA-IR, HbA1c, and C-peptide levels. However, the abdominal liposuction group demonstrated more pronounced reductions of these variables. These findings suggest that addressing abdominal adiposity may provide greater metabolic benefits following liposuction. Further research is warranted to explore the long-term sustainability and clinical implications of these metabolic improvements with additional markers. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

Effect of ertugliflozin on left ventricular function in type 2 diabetes and pre-heart failure: the Ertu-GLS randomized clinical trial

BackgroundThe therapeutic effects of ertugliflozin, a sodium-glucose cotransporter 2 inhibitor, on cardiovascular outcome are not fully understood. This study aimed to evaluate the efficacy and safety of ertugliflozin on cardiac function in people with type 2 diabetes and pre-heart failure.MethodsWe conducted a 24-week randomized, double-blind, placebo-controlled trial involving individuals with type 2 diabetes inadequately controlled with antidiabetic medications. Participants with left ventricular hypertrophy, E/e’ >15, or impaired left ventricular global longitudinal strain (LVGLS) were randomized 1:1 to receive either ertugliflozin (5 mg once daily) or a placebo. The primary outcome was the change in LVGLS. Secondary outcomes included changes in left ventricular mass index (LVMI) and left ventricular ejection fraction (LVEF). Prespecified exploratory outcomes, including angiotensin-converting enzyme 2 (ACE2) and angiotensin (1–7) levels, were also assessed.ResultsA total of 102 individuals (mean age, 63.9 ± 9.2 years; 38% women) were included. The ertugliflozin group showed a significant improvement in LVGLS (− 15.5 ± 3.1% to − 16.6 ± 2.8%, P = 0.004) compared to the placebo group (− 16.7 ± 2.7% to − 16.4 ± 2.6%, P = 0.509), with a significant between-group difference (P = 0.013). Improvements in LVMI and LVEF were also observed. Additionally, significant reductions in HbA1c, systolic blood pressure, whole-body and visceral fat, uric acid, proteinuria, N-terminal pro–B-type natriuretic peptide, and lipoprotein(a) were noted. ACE2 and angiotensin (1–7) levels significantly increased in the ertugliflozin group compared to the placebo group and correlated with changes in LVGLS [r = 0.456, P < 0.001 for ACE2; r = 0.541, P < 0.001 for angiotensin (1–7)]. Adverse events were similar between the two groups.ConclusionsThis study demonstrated that ertugliflozin has beneficial effects on left ventricular function in individuals with type 2 diabetes and pre-heart failure, and it provided insights into potential underlying mechanisms.Clinical trial registration ClinicalTrials.gov Identifier: NCT03717194.

8699 ​​Efficacy of Glucagon-like Peptide-1 Analogs In Women With Polycystic Ovary Syndrome: A Systematic Review and Meta-Analysis of Randomized Clinical Trials

Abstract Disclosure: F.A. Kelly: None. A.D. Lôbo: None. I.P. da Silva: None. J.C. Cardoso: None. M.S. Barros: None. F.D. Pessôa: None. M.G. Leite: None. R.Y. Ura Sudo: None. A.M. De Almeida: None. F.A. Moraes: None. V. Morbach: None. M.C. Souza: None. P.G. Lima: None. M.P. Lima: None. I.B. Andrade: None. M.B. Jardine: None. L.M. Lopes: None. Polycystic ovary syndrome (PCOS) affects one in ten women of reproductive age, painting a complex picture of metabolic dysfunction. Its hallmark triad includes irregular menstrual cycles, androgen excess, and polycystic ovaries. Beyond infertility concerns, PCOS carries a heavy burden of metabolic imbalances, often characterized by insulin resistance, dyslipidemia, and chronic low-grade inflammation. These intertwined factors place women with PCOS at increased risk for type 2 diabetes and cardiovascular disease, posing a significant long-term health challenge. Current first-line treatments like metformin focus mainly on managing insulin resistance and regulating menstrual cycles. However, unmet needs remain in addressing the broader metabolic derangements and preventing associated health complications. In light of this, glucagon-like peptide-1 (GLP-1) analogs have emerged as potential game-changers in the PCOS treatment landscape. Their multifaceted effects on metabolism beyond blood sugar regulation offer a promising avenue for optimizing care and improving long-term health outcomes in women with PCOS. This meta-analysis aims to evaluate the use of GLP-1 analogs on patients with PCOS to reduce body mass index (BMI), glycated hemoglobin (HbA1C), fasting blood glucose (FBG), high density lipid (HDL), low density lipid (LDL) and triglyceride. PubMed, Embase, and Cochrane databases were systematically searched for randomized controlled trials (RCT) comparing the use of GLP-1 analogs to placebo or other therapies in patients with PCOS. Treatment effects for continuous endpoints were pooled through mean differences (MD) with 95% confidence intervals. Heterogeneity was evaluated with the Cochran Q test, the prediction interval and I² statistics. Statistical analysis was performed in Revman 5.4. The results were reported following the Preferred Reporting Items for Systematic Review (PRISMA) guidelines.A total of 4 RCTs with 228 patients were included, of whom 137 were randomized to GLP-1 therapy, 58 to placebo, and 33 to other treatments. Over a mean follow-up time of 24 weeks, patients submitted to GLP-1 analogs presented significant decreases in HbA1C (MD -1.40%; 95% CI -1.64 to -1.16; p&amp;lt;000001; I²=0% ), FBG (MD -4.40 mg/dL; 95% CI -7.63 to -1.17; p=0.008; I²=0%) and HDL-c (MD -0.82 mg/dL; 95% CI -1.33 to -0.31; p=0.002; I²=3%); and a nonsignificant increase in LDL-c (MD 0.37 mg/dL; 95% CI -1.30 to 2.03; p=0.67; I²=0%); and nonsignificant decrease in BMI (MD -1.28 Kg/m²; 95% CI -3.18 to 0.63; p=0.19; I²=98%), and triglyceride (MD -10.50 mg/dL; 95% CI -22.81 to 1.81; p=0.09; I²=0%).In this meta-analysis of RCTs of patients with PCOS, the use of GLP-1 analogs showed a significant reduction in HbA1C, FBG, and HDL-c. A larger sample size of people are needed for further statistical analyses. Presentation: 6/3/2024

8756 Telemonitoring Use For Uncontrolled Type 2 Diabetes Management: A Systematic Review And Meta-Analysis Of Randomized Controlled Trials

Abstract Disclosure: F.A. Kelly: None. M.G. Leite: None. R.Y. Ura Sudo: None. F.A. Moraes: None. V. Morbach: None. E. Pasqualotto: None. I.P. da Silva: None. M.S. Barros: None. P.G. Lima: None. A.D. Lôbo: None. F.D. Pessôa: None. J.C. Cardoso: None. L.M. Lopes: None. M.B. Jardine: None. M.P. Lima: None. A.M. De Almeida: None. I.B. Andrade: None. M. Cavalcanti Souza: None. In the dynamic landscape of healthcare, the integration of telemedicine is reshaping how chronic conditions, such as type 2 diabetes (T2D), are managed. As we delve into the evolving paradigm of healthcare delivery, there is a growing interest in understanding the potential of telemedicine compared to traditional or "usual care" models for T2D. The prevalence of T2D globally underscores the need for innovative, patient-centric solutions that go beyond geographical constraints. Telemedicine, with its promise of real-time monitoring, improved patient engagement, and personalized care, stands out as a potential game-changer in the pursuit of optimal diabetes management. We aimed to perform a meta-analysis of the strategic redesign of healthcare services, harnessing information and communication technology (ICT) to enhance T2D management and glycemic control, providing timely interventions, and improving patient outcomes. This systematic review and meta-analysis followed the Preferred Reporting Items for Systematic Review (PRISMA) guidelines. PubMed, Web of Science, Scopus, and Cochrane databases were searched for randomized controlled trials (RCTs) comparing ICT interventions to usual care for T2D management. A random-effects model was used to calculate the mean differences (MDs) with 95% confidence intervals (CIs). Heterogeneity was evaluated with I² statistics. Statistical analysis was performed with Software R, version 4.3.1.A total of 46 studies comprising 26,129 patients were included, of whom 16,443 were randomized to ICT and 9,686 to usual care. Compared with usual care, ICT significantly reduced HbA1c (MD -0.36%; 95% CI -0.49, -0.23; p&amp;lt;0.001; I²=74%) and fast blood glucose (FBG) (MD -0.37 mg/dL; 95% CI -0.58, -0.15; p&amp;lt;0.001; I²=47%). There was no significant difference between groups for body mass index (MD -0.17 Kg/m²; 95% CI -0.47, 0.13; p=0.274; I²=89%), total cholesterol (MD -0.06 mmol/L; 95% CI -0.18, 0.05; p=0.287; I²=68%), low-density lipoprotein cholesterol (LDL-c) (MD -0.37 mmol/L; 95% CI -/ 0.93, 0.19; p=0.193, I²=97%), high-density lipoprotein cholesterol (HDL-c) (MD -0.29 mg/dL; 95% CI -0.78, 0.20; p=0.249; I²=92%), triglyceride (MD 0.02 mmol/L; 95% CI -0.33, 0.37; p=0.896; I²=99%).In this meta-analysis of RCTs of patients with T2D, ICT was associated with a significant reduction in HbA1c and FBG, compared with usual care. Presentation: 6/1/2024

7490 Comparative Clinical Analysis of DPP-4 inhibitors and SGLT2 inhibitors; Switch Study in Real-World Setting

Abstract Disclosure: H. Choe: None. M. Kwak: None. J. Lee: None. Y. Choi: None. E. Hong: None. Objective: Dipeptidyl peptidase-4 inhibitors (DPP-4i) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) represent two distinct pharmacological pathways in the management of type 2 diabetes, both aiming to improve glycemic control without risk of hypoglycemia. Metabolic implications and glycemic control associated with the interchange between SGLT2i and DPP-4i are scarce. This study aimed to evaluate the effect of switching between SGLT2i and DPP4i on various clinical parameters in Korean patients with type 2 diabetes. Methods: We conducted a retrospective cohort study at Hallym University Dongtan Sacred Heart Hospital, using clinical data warehouse. Baseline measurements and follow-up data at 3 months were collected for parameters including hemoglobin A1c (HbA1c), blood pressure, lipid profile, liver enzymes, renal function, and other metabolic markers. Results: Between 2015 and 2023, 104 participants switched from SGLT2 inhibitors to DPP4 inhibitors, while 321 switched in the opposite direction. Initially, those who switched from SGLT2 inhibitors to DPP4 inhibitors presented with lower baseline HbA1c levels (7.22 ± 0.73% versus 7.42 ± 0.76%, P = 0.017) and higher estimated glomerular filtration rates (eGFR) (95.2 ± 23.1 versus 85.9 ± 23.7 mL/min/1.73m², P = 0.001) compared to those who switched from DPP4 inhibitors to SGLT2 inhibitors. At three months of follow-up, the SGLT2 inhibitors to DPP4 inhibitors group exhibited a more significant reduction in HbA1c (adjusted β 0.22, 95% CI 0.03 to 0.40, P = 0.023), especially in patients with reduced eGFR (&amp;lt;60 mL/min/1.73 m²) (β 1.2, 95% CI 0.30 to 2.11, P = 0.013; P for interaction = 0.005). On the other hand, the DPP4 inhibitors to SGLT2 inhibitors group showed a greater decrease in fasting glucose levels (β -9.73, 95% CI -17.6 to -1.86, P = 0.016), along with more pronounced reductions in liver enzymes AST (β -4.15, 95% CI -6.49 to -1.81, P &amp;lt; 0.001) and ALT (β -6.42, 95% CI -9.58 to -3.27, P &amp;lt; 0.001), and a significant increase in hematocrit (β 3.31, 95% CI 2.36 to 4.26, P &amp;lt; 0.001) compared to the initial group. Conclusions: The study concludes that in Korean patients with type 2 diabetes, switching from SGLT2 inhibitors to DPP4 inhibitors is associated with a greater reduction in HbA1c, particularly in those with reduced renal function. Conversely, switching from DPP4 inhibitors to SGLT2 inhibitors results in more substantial improvements in fasting glucose and liver enzyme levels, suggesting differential benefits depending on the direction of the medication switch. Presentation: 6/3/2024

ID: 314772 10 kHz SCS Treatment of Painful Diabetic Neuropathy: Significant Reductions in HbA1c, Weight, and Pain

ID: 314772 10 kHz SCS Treatment of Painful Diabetic Neuropathy: Significant Reductions in HbA1c, Weight, and Pain

Effects of glucagon-like peptide-1 receptor agonists on glycated haemoglobin and continuous glucose monitoring metrics as adjunctive therapy to insulin in adults with type 1 diabetes: A meta-analysis of randomized controlled trials.

To conduct a meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on glycated haemoglobin (HbA1c) and continuous glucose monitoring (CGM) metrics as an adjunct to insulin therapy in adults with type 1 diabetes mellitus (T1D). A systematic literature search was conducted through Medline (via PubMed), Cochrane Library, and Google Scholar up to 27 May 2024. Dual-independent study selection, data extraction, and quality assessment were performed. Results were summarized using random-effects meta-analysis. Six RCTs were identified, involving a total of 378 individuals with T1D. The use of GLP-1RAs in addition to standard insulin therapy was associated with a significant reduction in HbA1c (mean difference [MD] -0.21%, 95% confidence interval [CI] -0.36 to -0.06; p = 0.007) and a similar time in range (TIR) compared to placebo (MD -0.22%, 95% CI -2.39 to 1.95; p = 0.84). GLP-1RA therapy resulted in a significantly higher time below range (MD 1.13%, 95% CI 0.50 to 1.76; p < 0.001) and a lower time above range compared with placebo (MD -1.83%, 95% CI -2.51 to -1.15; p < 0.001). Nonsignificant differences were noted for the secondary outcomes, including the mean amplitude of glucose excursion, continuous overall net glycaemic action for 60 min, mean daily glucose, coefficient of variation, and mean standard deviation of weekly glucose levels. Our findings suggest that, in individuals with T1D, add-on therapy with GLP-1RAs does not confer significant benefits in terms of CGM metrics and is associated with a longer time below the target glycaemic range.

Efficacy and safety of GLP-1 analog ecnoglutide in adults with type 2 diabetes: a randomized, double-blind, placebo-controlled phase 2 trial

Glucagon-like peptide-1 (GLP-1) analogs are important therapeutics for type 2 diabetes and obesity. Ecnoglutide (XW003) is a novel, long-acting GLP-1 analog. We conducted a Phase 2, randomized, double-blind, placebo-controlled study enrolling 145 adults with T2DM. Participants were randomized to 0.4, 0.8, or 1.2 mg ecnoglutide or placebo as once-weekly injections for 20 weeks. The primary objective was to evaluate the efficacy of ecnoglutide, as measured by HbA1c change from baseline at Week 20. Secondary endpoints included body weight, glucose and lipid parameters, as well as safety. We show that, at end of treatment, the 0.4, 0.8, and 1.2 mg groups had statistically significant HbA1c reductions from baseline of −1.81%, −1.90%, and −2.39%, respectively, compared to −0.55% for placebo (P < 0.0001). At end of treatment, 71.9% of the 1.2 mg group had HbA1c ≤ 6.5% versus 9.1% on placebo, and 33.3% had body weight reductions ≥5% versus 3.0% for placebo. Ecnoglutide was generally safe and well tolerated. China Drug Trials Registry CTR20211014.

The Endogenous Inhibitor of CETP, apoC1, Remains Ineffective In Vivo after Correction of Hyperglycemia in People with Type 1 Diabetes.

ApolipoproteinC1 (apoC1) is the main physiological inhibitor of the cholesterol ester transfer protein (CETP). Increased CETP activity is associated with macrovascular complications in patients with type 1 diabetes (T1D). ApoC1 has lost its ability to inhibit CETP in patients with T1D, and in vitro glycation of apoC1 increases CETP activity, suggesting that hyperglycemia could be a factor implicated in the loss of the inhibitory effect of apoC1 on CETP. Thus, we aimed to see whether improvement of glycemic control might restore apoC1 inhibitory effect on CETP. We studied 98 patients with T1D and HbA1c > 9% at baseline and 3 months after improvement of glycemic control by a medical intervention (insulin introduction or changes in multi-injection therapy or pump therapy introduction/therapeutic education for all patients). CETP activity was assessed by a radioactive method and plasma apoC1 levels were measured by ELISA. The different isoforms of apoC1 were determined by mass spectrometry. CETP activity was not significantly modified after improvement of glycemic control, despite a significant reduction in mean HbA1c (8.7 ± 1.7 vs. 10.8 ± 2, p < 0.0001). No association between plasma apoC1 and CETP activity was observed in patients with T1D at baseline, nor at 3 months, even in the subgroup of patients with optimal control (3-month HbA1c < 7%). We did not find any glycated form of apoC1 using mass spectrometry in people with T1D. Hyperglycemia in vivo does not seem to be a major factor implicated in the loss of apoC1 ability to inhibit CETP activity observed in T1D. Other factors, such as qualitative abnormalities of lipoproteins, could be involved. Our data emphasize the fact that hyperglycemia is not the only factor involved in lipid abnormalities and macrovascular complications in T1D. Clinical trial reg. no. NCT02816099 ClinicalTrials.gov.

The impact of time-restricted eating on beta-cell function in adults with type 2 diabetes: a randomized cross-over trial.

Time-restricted eating (TRE) which consists of restricting the eating window to typically 4-8h (while fasting for the remaining hours of the day) has been proposed as a non-pharmacological strategy with cardio-metabolic benefits but little is known about its metabolic impact in type 2 diabetes (T2DM). We evaluated whether TRE can improve pancreatic beta-cell function and metabolic status in overweight individuals with early T2DM. In a randomized cross-over trial, 39 participants [mean 2.9 years of diabetes duration, baseline glycated hemoglobin (HbA1c) 6.6% ± 0.7% and body mass index (BMI) 32.4 ± 5.7 kg/m2] were randomized to either an initial intervention consisting of 6-weeks of TRE (20h-fasting/4h-eating) or standard lifestyle. The primary outcome of beta-cell function was assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2) derived from an oral glucose tolerance test. Trial registration: clinicaltrials.gov NCT05717127. As compared to standard lifestyle, TRE induced a 14% increase in ISSI-2 (+14.0 ± 39.2%, p = 0.03) accompanied by 14% reduction of hepatic insulin resistance as evaluated by HOMA-IR [-11.6% (-49.3-21.9), p = 0.03]. Fasting glucose did not differ between interventions, but TRE yielded a significant reduction in HbA1c (-0.32 ± 0.48%, p <0.001). These metabolic improvements were coupled by a reduction of body weight of 3.86% (-3.86 ± 3.1%, p <0.001) and waist circumference of 3.8 cm (-3.8 ± 7.5 cm, p = 0.003). TRE improved beta-cell function and insulin resistance in overweight patients with early diabetes, accompanied by beneficial effects on adiposity.

Health outcomes of telemonitoring of patients with type-2 diabetes mellitus: One-year results from a randomized controlled trial (Optimizing care of Patients via Telemedicine In Monitoring and aUgmenting their control of diabetes Mellitus).

Telehealth increases care accessibility to patients with type-2 diabetes mellitus but the duration of its implementation to sustain optimal glycaemic control remains unclear. This study aimed to assess the health outcomes of these patients using the Optimizing care of Patients via Telemedicine In Monitoring and aUgmenting their control of diabetes Mellitus (OPTIMUM) home tele-monitoring (HTM) system 6 months post-intervention, compared to standard care. An open-labelled randomized controlled trial involving 330 participants with type-2 diabetes mellitus, aged 26-65 years, and suboptimal glycaemic control (HbA1c = 7.5%-10%) was conducted. Intervention group received OPTIMUM HTM for 6 months followed by usual care for another 6 months, while control group received usual care for 12 months. OPTIMUM HTM includes in-app video-based tele-education, tele-monitoring of the blood pressure, capillary glucose and weight via Bluetooth devices and mobile applications, followed by algorithm-based tele-management by the OPTIMUM HTM team. Assessments using self-care inventory scale and medication adherence were administered for both groups at baseline, 6-month, and 12-month timepoints. Complete data from 156 (intervention) and 159 (control) participants, with comparable demographic profiles, were analysed. Both groups showed a significant reduction in HbA1c from baseline (p < 0.001). From 6-month to 12-month time-points, the intervention group was twice as likely to maintain their HbA1c ≤ 8% (adjusted odds ratio = 2.02, 95%CI = 1.18-3.49; p < 0.011). The intervention group demonstrated higher scores for self-care behaviours (adjusted odds ratio = 3.83 [95%CI = 1.68-5.97], p = 0.001) and not skipping medications (adjusted odds ratio = 2.32 [95%CI = 1.09-4.97], p = 0.030) at 12 months. The OPTIMUM HTM system enabled patients to maintain their glycaemic control beyond the intervention period. The favourable outcomes could be the effect of telehealth in sustaining self-care behaviour and medication adherence.

Effectiveness of shared decision-making for glycaemic control among type 2 diabetes mellitus adult patients: A systematic review and meta-analysis.

In diabetes care and management guidelines, shared decision-making (SDM) implementation is explicitly recommended to help patients and health care providers to make informed shared decisions that enable informed choices and the selection of treatments. Despite widespread calls for SDM to be embedded in health care, there is little evidence to support SDM in the management and care of diabetes. It is still not commonly utilized in routine care settings because its effects remain poorly understood. Hence, the current systematic review and meta-analysis aimed to evaluate the effectiveness of SDM for glycaemic control among type 2 diabetes adult patients. Literature sources were searched in MEDLINE, PubMed, Cochrane library and HINARI bibliographic databases and Google Scholar. When these records were searched and reviewed, the PICO criteria (P: population, I: intervention, C: comparator, and O: outcome) were applied. The extracted data was exported to RevMan software version 5.4 and STATA 17 for further analysis. The mean differences (MD) of glycated hemoglobin (HbA1c) were pooled using a random effect model (REM), and sub-group analysis were performed to evaluate the effect size differences across the duration of the follow-up period, modes of intervention, and baseline glycated hemoglobin level of patient groups. The sensitivity analysis was performed using a leave-one-out meta-analysis to quantify the impact of each study on the overall effect size in mean difference HbA1c%. Finally, the statistically significant MD of HbA1c% between the intervention groups engaged in SDM and control groups received usual care was declared at P ˂0.05, using a 95% confidence interval (CI). In the database search, 425 records were retrieved, with only 17 RCT studies fulfilling the inclusion criteria and were included in the meta-analysis. A total of 5416 subjects were included, out of which 2782(51.4%) were included in trial arms receiving SDM and 2634(48.6%) were included in usual diabetes care. The Higgins (I2) test statistics were calculated to be 59.1%, P = 0.002, indicating statistically significant heterogeneity was observed among the included studies, and REM was used as a remedial to estimate the pooled MD of HbA1c% level between patients who participated in SDM and received usual care. As a result, the pooled MD showed that the SDM significantly lowered HbA1c by 0.14% compared to the usual care (95% CI = [-0.26, -0.02], P = 0.02). SDM significantly decreased the level of HbA1c by 0.14% (95% CI = -0.28, -0.01, P = 0.00) when shared decisions were made in person or face-to-face at the point of care, but there was no statistically significant reduction in HbA1c levels when patients were engaged in online SDM. In patients with poorly controlled glycaemic level (≥ 8%), SDM significantly reduced level of HbA1c by 0.13%, 95% CI = [-0.29, -0.03], P = 0.00. However, significant reduction in HbA1c was not observed in patients with ˂ 8%, HbA1c baseline level. Overall, statistically significant reduction of glycated hemoglobin level was observed among T2DM adult patients who participated in shared decision-making compared to those patients who received diabetes usual care that could lead to improved long-term health outcomes, reducing the risk of diabetes-related complications. Therefore, we strongly suggest that health care providers and policy-makers should integrate SDM into diabetes health care and management, and further study should focus on the level of patients' empowerment, health literacy, and standardization of decision supporting tools to evaluate the effectiveness of SDM in diabetes patients.

Efficacy and safety of insulin glargine 300 U/mL in people with type 2 diabetes in China: The INITIATION study.

To evaluate the efficacy and safety of insulin glargine 300 U/mL (Gla-300) in people with suboptimally controlled type 2 diabetes (T2D) in China. INITIATION (NCT05002933) was a prospective, interventional, multicentre, single-arm, phase IV study conducted in China. Individuals with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin (insulin experienced) were included. The primary endpoint was the change in HbA1c from baseline to week 24. Safety assessments included hypoglycaemia and adverse events (AEs). In total, 568 participants were enrolled and 562 initiated Gla-300 treatment (189 in the insulin-naïve subgroup; 373 in the insulin-experienced subgroup). At week 24, the mean ± standard error (SE) change in HbA1c from baseline was -0.91% ± 0.05% (-9.9 ± 0.5 mmol/mol; P < .0001). Significant HbA1c reductions were also observed in the insulin-naïve (mean ± SE change: -1.38% ± 0.09% [-15.1 ± 1.0 mmol/mol]) and insulin-experienced (-0.68% ± 0.05% [-7.4 ± 0.5 mmol/mol]) subgroups (both P < .0001). During the 24-week treatment period, the incidence of confirmed hypoglycaemia (plasma glucose ≤ 3.9 mmol/L) was 39.7% for all hypoglycaemia and 13.3% for nocturnal hypoglycaemia; the incidence of severe hypoglycaemia was low (0.5%). Overall, treatment-emergent AEs (TEAEs) were reported in 126 participants (22.4%), with no serious treatment-related TEAEs. Gla-300 was effective in improving glycaemic control and had a relatively low risk of hypoglycaemia in people with suboptimally controlled T2D who were insulin naïve or switching from another basal insulin in China.

PIONEER REAL Sweden: A Multicentre, Prospective, Real-World Observational Study of Oral Semaglutide Use in Adults with Type2 Diabetes in Swedish Clinical Practice.

The study was designed to assess outcomes with once-daily oral semaglutide in adults with type2 diabetes (T2D) naïve to injectable glucose-lowering agents, in Swedish clinical practice. In this non-interventional, multicentre study, participants initiated oral semaglutide and were followed for 34-44weeks. The primary endpoint was glycated haemoglobin (HbA1c) change from baseline to end of study (EOS). Secondary endpoints included body weight (BW) change from baseline to EOS, proportion of participants achieving HbA1c < 7%, and proportion achieving both a HbA1c reduction ≥ 1% and BW reduction of ≥ 3% or ≥ 5%, at EOS. Participants completed Diabetes Treatment Satisfaction Questionnaires (DTSQ status/change) and a dosing conditions questionnaire. A total of 187 participants (mean age 62.5years) initiated oral semaglutide. Baseline mean HbA1c and BW were 7.8% (n = 177) and 96.9kg (n = 165), respectively. Estimated mean changes in HbA1c and BW were - 0.88%-points (95% confidence interval [CI] - 1.01 to - 0.75; P < 0.0001) and - 4.72% (95%CI - 5.58 to - 3.86; P < 0.0001), respectively. At EOS, 64.6% of participants had HbA1c < 7%, and 22.9% achieved HbA1c reduction of ≥ 1% and BW reduction of ≥ 5%. DTSQ status and change scores improved by 1.44 (P = 0.0260) and 12.3 points (P < 0.0001), respectively. Oral semaglutide was easy or very easy to consume for 86.4% of participants. Most common adverse events (AEs) were gastrointestinal disorders; nine participants (4.8%) had serious AEs; one (0.5%) experienced severe hypoglycaemia. In this real-world study population, we observed significant reductions in HbA1c and BW in people living with T2D when prescribed semaglutide tablets as part of routine clinical practice in Sweden, with improved treatment satisfaction among participants and no new safety concerns. NCT04601753.