Significant Reduction In HbA1c Research Articles

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<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<0.001; I²=74%) and fast blood glucose (FBG) (MD -0.37 mg/dL; 95% CI -0.58, -0.15; p<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 (<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 < 0.001) and ALT (β -6.42, 95% CI -9.58 to -3.27, P < 0.001), and a significant increase in hematocrit (β 3.31, 95% CI 2.36 to 4.26, P < 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.

REAL life study of subcutaneous SEMaglutide in patients with type 2 diabetes in SPain: Ambispective, multicenter clinical study. Results in the GLP1-experienced cohort

ObjectiveTo evaluate the efficacy of switching to once-weekly subcutaneous semaglutide in patients with type 2 diabetes mellitus (T2DM) who were previously treated with other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) in a real-world setting in Spain. MethodsThe REAL Life study of SEMaglutide in Patients with Type 2 diabetes in Spain (REALSEM-SP) was conducted in four endocrinology departments in Madrid, Spain. Adult patients with T2DM who were prescribed once-weekly (OW) subcutaneous semaglutide and had been previously treated with other GLP-1 RAs were included. Baseline characteristics, including demographic, anthropometric, and laboratory variables, were recorded at baseline and at 6 ± 3 and 12 ± 3 months of follow-up. The primary outcome was the change in HbA1c at 12 ± 3 months of follow-up, with secondary outcomes including changes in weight, BMI, and other glycemic parameters. ResultsA total of 267 patients were included in the analysis, with a mean age of 61.6 years and a mean T2DM duration of 11.3 years. The majority of patients had grade 1 or 2 obesity at baseline. Switching to OW-semaglutide was associated with a significant reduction in HbA1c from baseline to 13 months (−0.35 % ± 0.81). Patients who reached the 1.0 mg OW-dose showed a significant reduction in HbA1c compared to those on the ≤0.5 mg OW-dose. Significant reductions in weight, BMI, and fasting plasma glucose were also observed. Adverse events were mostly gastrointestinal and led to treatment withdrawal in few cases. ConclusionSwitching to OW-subcutaneous semaglutide in patients with T2DM previously treated with other GLP-1 RAs was associated to improvements in glycemic control and weight management in a real-world setting in Spain. These findings support the use of OW-semaglutide as an effective option for patients with T2DM who require additional glycemic control and weight management.

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.

The role of treatment of hepatitis C with direct-acting antiviral agents on glycaemic control in diabetic patients: An updated systematic review and meta-analysis.

Recent studies suggested that successful clearance of chronic Hepatitis C Virus (HCV) by using direct-acting antiviral (DAA) agents could improve glycemic control in patients with diabetes; however, some studies failed to identify this benefit. We conducted a systematic review and meta-analysis to assess the impact of sustained virologic response (SVR) after treatment with DAA agents on glycemic control. Embase, Scopus and PubMed were searched through March 26th, 2023, for all studies evaluating whether eradication of HCV infection with DAAs is associated with an impact on glycemic control. Only studies with data on glycemic control, including haemoglobin A1c (HbA1c), fasting glucose, or Homeostatic Model Assessment for Insulin Resistance (HOMA-IR), at least 12-week post-SVR were included. Sixteen studies met our eligibility criteria and were included in qualitative analysis. The mean HbA1c was 8.05% (95% CI: 7.79%-8.31%) before treatment and 7.19% (95% CI: 6.98%-7.39%) after treatment. There was a significant mean absolute reduction in HbA1c of 0.72% (95% CI: 0.52%-0.93%) with high heterogeneity between studies (I2 = 91.7%). The reduction in HbA1c remained significant in the subgroup analysis at 3 months follow up post SVR [0.74% (95% CI: 0.57%-0.91%)] and at least 6 months follow up [0.66% (95% CI: 0.23%-1.10%)]. We found a significant reduction in HbA1C after SVR in patients with type 2 diabetes mellitus, reflecting better glycemic control with HCV eradication. This data highlights an important extrahepatic benefit of HCV eradication.

Treatment Outcomes of Dipeptidyl Peptidase-4 Inhibitors and Sodium-Glucose Co-Transporter-2 Inhibitors in Diabetes Mellitus with Poor Glycemic Control

Background: Diabetes, a progressive disease necessitating multifaceted pharmacological interventions for glycemic control, commonly employs Dipeptidyl Peptidase-4 inhibitors (DPP-4i) and Sodium-Glucose Co-Transporter-2 inhibitors (SGLT-2i). The ongoing challenge lies in determining the superior option for safety and efficacy. Objective: This study aims to describe the treatment outcomes of DPP-4 inhibitors (DPP-4i) and Sodium- Glucose Co-Transporter-2 inhibitors (SGLT-2i) in individuals with diabetes mellitus (DM) receiving metformin with poor glycemic control. Methods: This prospective study was conducted at the Endocrinology Outpatient Department of Dhaka Medical College Hospital, Dhaka, and included 90 individuals with diabetes mellitus who met the selection criteria. Divided into two groups, Group I (n=45) received DPP-4 inhibitors plus metformin, and Group II (n=45) received SGLT2 inhibitors plus metformin. Baseline data, including HbA1c, fasting blood glucose (FBG), blood glucose 2 hours after breakfast, weight, lipid profile, and serum creatinine, were recorded at the first visit and 12 weeks. Safety was assessed based on adverse drug effects. Results: After 12 weeks, both groups exhibited significant reductions in HbA1c, FBG, and postprandial blood glucose levels. However, the SGLT-2i group demonstrated significant improvements in HbA1c (P&lt;0.012), fasting plasma glucose (P&lt;0.003), and postprandial glucose levels (P&lt;0.001), along with a reduction in body weight (P&lt;0.042). Hypoglycemia rates were low and balanced between groups. Notably, SGLT-2i usage correlated with an increased incidence of urinary tract infections (13.33% vs. 6.66% in DPP-4i) and exclusive genital infections (11.11%, P&lt;0.022). Conclusion: Diabetic patients receiving SGLT-2 inhibitors had better glycemic control and body weight improvements in comparison to DPP-4 inhibitors. However, SGLT-2 inhibitors encountered more genital infections than DPP-4 inhibitors. J MEDICINE 2024; 25: 107-114

Could Online Education Replace Face-to-Face Education in Diabetes? A Systematic Review.

Diabetes Self-Management Education and Support (DSMES) is a critical component of diabetes care. This study aims to examine the effect of online-based educational interventions on diabetes management compared to face-to-face interventions. A systematic review was conducted by searching three databases for studies in English or Spanish between December 2023 and March 2024. The inclusion criteria were studies that compared face-to-face DSMES with online interventions. The follow-up duration of the trials ranged from 1 to 12months. Multidisciplinary teams delivered online DSMES through various means, including Short Message Service (SMS), telephone calls, video calls, websites, and applications. Online DSMES was found to be comparable to face-to-face interventions in terms of glycated hemoglobin (HbA1c) levels in people with type 1 diabetes (T1D). In contrast, online interventions that focus on weight management in people with type 2 diabetes (T2D) have shown a significant reduction in HbA1c compared to face-to-face interventions. Online DSMES was found to be superior in terms of quality of life and cost-effectiveness in both T1D and T2D. None of the analyzed studies explored the differences between individual and group methodologies. The current evidence indicates that online DSMES services provide at least comparable biomedical benefits to face-to-face interventions, suggesting that online interventions could be incorporated into clinical practice as a complement or reinforcement. However, further research is needed to explore the potential benefits and effectiveness of online group sessions in DSMES.

Efficacy and safety of glucagon-like peptide-1 receptor agonists on prediabetes: a systematic review and meta-analysis of randomized controlled trials

BackgroundPrediabetes is a condition preceding the development of diabetes and is associated with an increased risk of a number of complications. The primary mode of management is thought to be lifestyle modification. Pharmacological therapy, such as glucagon-like peptide-1 receptor agonists (GLP-1RAs), were not well addressed in the literature and were only evaluated in trials as secondary and exploratory outcomes with a limited sample size. Here, GLP-1RAs are evaluated as a comprehensive therapy approach for patients with prediabetes.MethodsA comprehensive search of Web of Science, SCOPUS, PubMed, and Cochrane was performed on May 5, 2023, to retrieve randomized controlled trials (RCTs) comparing the effect of GLP-1RAs to placebo and/or lifestyle modification on prediabetes reversion to normoglycemia, prevention of overt diabetes, glycemic control, anthropometric parameters, and lipid profiles. Review Manager (RevMan) version 5.4 was used. The quality of RCTs was assessed using the revised version of the Cochrane Risk of Bias Tool. GRADE was performed to evaluate the certainty of evidence.ResultsTwelve trials involving 2903 patients in the GLP-1RAs group and 1413 in the control group were included in the meta-analysis. Low quality of evidence revealed that GLP-1RAs significantly increased the incidence of prediabetes reversion to the normoglycemic state [RR = 1.76, 95% CI (1.45, 2.13), P < 0.00001] and moderate quality of evidence showed that GLP-1RAs significantly prevented new-onset diabetes [RR = 0.28, 95% CI (0.19, 0.43), P < 0.00001]. Significant reductions in HbA1c, fasting plasma glucose, body weight, waist circumference, triglycerides, and LDL were observed in the GLP-1RAs arm (P < 0.05). However, higher incidences of gastrointestinal disorders were reported in the GLP-1RAs group (P < 0.05).ConclusionsGLP-1RAs combined with lifestyle modification proved to be a more effective therapy for managing prediabetic patients than lifestyle modification alone, with a tolerable safety profile. Future guidelines should consider GLP-1RAs as an adjunct to lifestyle modification in the management of prediabetic patients to provide better management and improve treatment adherence.

Real-World Use of Oral Semaglutide in Adults with Type 2 Diabetes in the PIONEER REAL Netherlands Multicentre, Prospective, Observational Study.

In this phase 4, multicentre, prospective, non-interventional PIONEER REAL Netherlands study, we assessed clinical outcomes associated with once-daily oral semaglutide use in real-world clinical practice in adults living with type 2 diabetes (T2D) naïve to injectable glucose-lowering medication. Participants initiated on oral semaglutide were followed for 34-44weeks. Change in glycated haemoglobin (HbA1c) from baseline (BL) to end of study (EOS) was the primary endpoint; secondary endpoints included change in body weight (BW) from BL to EOS, the proportion of participants with HbA1c<7.0% at EOS and the composite endpoints of HbA1c reduction≥1.0%-points with BW reduction≥3% or≥5% at EOS. Treatment satisfaction was assessed using the Diabetes Treatment Satisfaction Questionnaire (DTSQ status/change). Safety was evaluated in all participants who initiated oral semaglutide treatment. Oral semaglutide was initiated in 187 participants; 94.1% completed the study and 78.6% remained on treatment at EOS. At BL, 54.0% of participants were male, mean age was 58.8years, mean duration of T2D was 8.7years and mean body mass index was 35.1kg/m2; mean HbA1c was 8.6% and mean BW was 103.1kg. Significant improvements from BL to EOS were observed for HbA1c and BW (estimated change [95% confidence interval]:-1.16%-points [-1.48 to-0.85]; p<0.0001, and-5.84kg [-6.88 to-4.80]; p<0.0001, respectively). At EOS, 47.5% of participants had an HbA1c level<7.0%; 41.8% and 35.5% of participants achieved composite endpoints of HbA1c reduction≥1.0%-points plus BW reduction≥3% or≥5%, respectively. DTSQ status and change scores improved by 2.1 (p=0.0003) and 10.8 points (p<0.0001), respectively. Oral semaglutide was easy or very easy to consume for 81.5% of participants. Adverse events were mostly mild/moderate, with gastrointestinal disorders being the most common. In this real-world population, we reported clinically significant reductions in HbA1c and BW, improved treatment satisfaction and no new safety concerns. A graphical abstract is available with this article. NCT04601740.

Efficacy of Glucagon-like Peptide-1 Receptor Agonists in Overweight/Obese and/or T2DM Adolescents: A Meta-analysis Based on Randomized Controlled Trials

The aim of this meta-analysis was to investigate the effect of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on blood glucose and weight in adolescents with overweight/obesity and/or type 2 diabetes mellitus (T2DM) aged <18 years. PubMed, Embase, Web of Science, and Cochrane Library were searched for all randomized controlled trials (RCTs) up to August 2023 comparing GLP-1RAs with placebo in overweight/obese and/or T2DM adolescents and extracted relevant data for meta-analysis. Fourteen RCTs were included in the meta-analysis with a total of 1,262 participants. Results revealed that the GLP-1RAs group had a more significant reduction in glycosylated hemoglobin A1c (HbA1c; risk difference (RD)=-0.34%, p<0.001) than the control group. However, there was no difference in fasting plasma glucose [fasting plasma glucose (FPG); RD=-2.07 mg/dL, p=0.065] between the two groups. Nonetheless, the experimental group that received exenatide showed no significant reduction in HbA1c (p=0.253) and FPG (p=0.611) between the two groups. The GLP-1RAs group had a more significant decline in body weight (RD=-4.28 kg, p=0.002) and body mass index (BMI) (RD=-1.63 kg/m2, p=0.002) compared to the control group. The experimental group was given liraglutide (RD=-2.31 kg, p=0.038) or exenatide (RD=-2.70 kg, p<0.001). Compared to the control group, the experimental group had a more significant drop in body weight than the control group. However, for the experimental group that received liraglutide, the BMI had a no significant reduction between the two groups (RD=-0.81 kg/m2, p=0.260). For the experimental group using exenatide, BMI declined more significantly in the intervention group than in the control group (RD=-1.14 kg/m2, p<0.001). This study showed that GLP-1RAs reduced HbA1c, FPG, and weight loss in overweight/obese and/or T2DM adolescents. Liraglutide was better than exenatide in terms of glucose reduction. Nevertheless, in terms of weight control, exenatide was more effective than liraglutide.

Real-world Impact of 3 and 4.5 mg Doses of Dulaglutide on Weight and Hemoglobin A1c in Patients With Type 2 Diabetes Mellitus.

Limited real-world data on the benefits and risks associated with 3 and 4.5 mg doses of dulaglutide currently exists, making it difficult to determine the impact of dose titration for patients currently managed with dulaglutide 1.5 mg weekly. To determine the impact of dulaglutide 3 and 4.5 mg doses on weight and hemoglobin A1c (HbA1c) in patients with type 2 diabetes mellitus (T2DM), in clinical practice. Retrospective, observational study of adult T2DM patients receiving dulaglutide 3 or 4.5 mg weekly within a large, university-affiliated, primary care network. The primary outcome was change in weight and HbA1c from baseline to 24 weeks. Secondary outcomes included incremental changes in weight and HbA1c, and describing trends related to dose reductions. Ninety-five patients were included, 62 in the dulaglutide 3 mg group and 33 in the dulaglutide 4.5 mg group. After 24 weeks, the mean changes in weight and HbA1c from baseline were -1.8 kg (P < 0.01) and -0.4% (P < 0.01) in the 3 mg group, and -4.2 kg (P < 0.01) and -0.4% (P = 0.119) in the 4.5 mg group. Incremental change in weight and HbA1c among patients who were titrated from dulaglutide 3 to 4.5 mg weekly were -2.6 kg (P < 0.01) and -0.2% (P = 0.04), respectively. Titration from dulaglutide 1.5 to 3 mg resulted in significant reductions in weight and HbA1c after 24 weeks. Additional, statistically significant, reductions in weight and HbA1c were seen when patients were further titrated to dulaglutide 4.5 mg weekly.