Significant Improvement In HbA1c Research Articles

Flash Glucose Monitoring is Associated with HbA1c Improvement in Type 2 Diabetes Managed with Multiple Daily Injections of Insulin in the UK: A Retrospective Observational Study.

There is a growing body of evidence demonstrating the benefit of flash glucose monitoring in people living with type 2 diabetes mellitus (T2DM). This real-world study aimed to evaluate the effect of initiating flash glucose monitoring on change in HbA1c after 3-6months in adults living with T2DM treated with multiple daily injections of insulin. A retrospective observational study using data from ten clinical centres in the UK for adults with T2DM treated with multiple daily injections of insulin for at least 1year was conducted. Patients who had been using the FreeStyle Libre/Libre 2 Flash Glucose Monitoring System for at least 3months with baseline HbA1c 64-108mmol/mol (8.0-12.0%) recorded up to 3months prior to system use were included. Pregnant patients and those on dialysis were excluded. Patients with an HbA1c value measured 3-6months after commencing flash glucose monitoring were included in the final analysis for evaluation of change. In total, 87 patients were included in the final analysis (mean age, 60.0 ± 11.8years, 60.9% male, mean body mass index (BMI), 31.6 ± 5.4 [mean ± SD]). From a mean baseline HbA1c of 80 ± 11mmol/mol (9.5% ± 1.0%), HbA1c lowered by 11 ± 14mmol/mol (1.0% ± 1.3%) at 3-6months (p < 0.0001). A decrease was observed independent of age, baseline HbA1c, sex, duration of insulin use and BMI subgroups. Initiation of flash glucose monitoring was associated with a clinically and statistically significant improvement in HbA1c in a real-world setting at 3-6months.

Impact of a community pharmacy-based medication therapy management program on clinical and humanistic outcomes in patients with uncontrolled diabetes: a randomised controlled trial

This study was aimed to evaluate the impact of community pharmacy (CP)-based medication therapy management (MTM) program on clinical and humanistic outcomes in patients with uncontrolled diabetes. An open label, parallel-group randomised controlled trial was undertaken at a community pharmacy in Riyadh city, Kingdom of Saudi Arabia. Patients with a diagnosis of uncontrolled diabetes (HbA1c of ≥ 8%) meeting the eligibility criteria were randomised to receive either the MTM programme provided by pharmacists or standard care. The primary outcome was change in HbA1c over 6 months. Secondary outcomes included: changes in clinical parameters (blood pressure (BP), lipid profile, serum creatinine (SCr) and albumin-to- creatinine ratio (ACR)), types of drug-related problems (DRPs), health service utilization (HSU), adherence, diabetes distress and overall patient satisfaction with the service at 6-month. A sufficiently powered sample of 160 participants with a mean age was 50 years (SD ± 11.9) was recruited. The majority of the patients (68.1%) were male and had diabetes for more than eight years [IQR 3, 14]. After adjusting for baseline HbA1c, compared to the control group, the mean HbA1c level was 0.02% (p = 0.929) and 0.2% (p = 0.47) lower in the intervention arm at 3-month and 6-month respectively. However, these differences were not statistically significant. Nonetheless, within each arm, there was a significant improvement in HbA1c from baseline. Furthermore, the intervention arm demonstrated improvement in BP control (SBP lowered by 3.2 mmHg (p = 0.05) and DBP lowered by 3.8 mmHg (p = 0.008)). During the study period, none of the participants in the intervention group reported hospitalization or ER visits compared to 14 patients in the control group [OR 0.069 (95% CI 0.004, 1.3)]. Patient satisfaction as measured by Patient Satisfaction with Pharmacist Services Questionnaire 2.0 (PSPSQ 2.0) was significantly higher among MTM program participants compared to standard care (p = 0.00001). Patients in the MTM program were eight times more likely to be adherent compared to the patients in the standard care [OR 7.89 (95% CI 3.6, 17.4)]. MTM program metrics showed that per patient, the pharmacists spent a median of 35 [IQR 30, 44.5] minutes at the initial visit and 20 [IQR 10, 25] minutes during the 6-month visit. The number of DRPs had significantly dropped in the intervention arm at 3 and 6-month (p = 0.0001). In conclusion, CP-based MTM program can improve health outcomes and prevent hospitalisations in patients with diabetes. These findings support the implementation of CP-based MTM services for patients with diabetes in the Kingdom of Saudi Arabia.

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

Wearable monitoring device based on an internet management platform improves metabolic parameters in type 2 diabetes patients: a prospective pilot study

ABSTRACT Objectives This pilot study aimed to prospectively investigate the effects of a wearable monitoring device, based on an Internet management platform, on the comprehensive management of type 2 diabetes mellitus (T2DM) patients. Methods A total of 120 hospitalized patients with T2DM were enrolled and randomly divided into the control group and the intervention group. Patients in the control group only received conventional diabetes treatments, while patients in the intervention group were provided with a wearable monitoring device in addition to conventional diabetes treatments. Moreover, the wearable device could connect to an Internet platform for diabetes management and upload self-monitoring data. All patients were followed for 3 months. The changes in parameters representing glucose metabolism, blood lipids, renal function, and patient satisfaction were compared between the two groups. All results were analyzed on an intention-to-treat basis. Results One hundred twenty subjects met all criteria and agreed to participate in this study. During the follow-up period, 5 and 4 subjects were lost to follow-up in the intervention and control groups, respectively. Compared with the control group, the blood glucose of the intervention group decreased significantly after 3 months (p < 0.05). Subgroup analysis found that females, those younger than 60 years, with baseline glycated hemoglobin A1c (HbA1c) levels of 8% or greater, and patients with good adherence showed significant improvements in HbA1c (p < 0.05). However, there was no significant difference in blood lipid and renal function. The intervention group showed a better adherence rate to blood glucose, comprehensive adherence rate, and diabetes treatment satisfaction (p < 0.05). One subject in the intervention group and two subjects in the control group reported mild hypoglycemia. No other adverse events such as infections and skin allergies occurred in the two groups. Conclusion The intervention of a wearable monitoring device based on an Internet management platform significantly improved blood glucose control in T2DM patients, as well as the overall adherence rate and patient satisfaction with treatment. Clinical Trial Registration NCT04973644.

Oral Semaglutide in Routine Clinical Practice: Characteristics of People with Type 2 Diabetes Started on the Drug and Changes in Their Clinical Parameters after 24 Weeks of Treatment.

Background/Objectives: Semaglutide is the unique once-daily oral glucagon-like receptor agonist presently available. Aims of this study were to describe clinical characteristics of patients with type 2 diabetes (T2D) initiating oral semaglutide, to assess its effects on glycemic control, body weight (BW) and its tolerability in routine clinical practice. Methods: Electronic medical records from two Italian diabetes clinics were evaluated. Mean glycated hemoglobin (HbA1c) and BW were assessed in adults with T2D before and 6 months after oral semaglutide prescription. Treatment discontinuation and safety data were reported. Results: A total of 192 patients initiating oral semaglutide (44% female) presented a mean age of 66 years, a diabetes duration of 10 years, HbA1c of 7.9% and a BW of 82.6 kg. Almost 50% of patients were obese. Mean HbA1c and BW changes from baseline to follow up were -0.7% and -2.6 kg, respectively. Greater HbA1c reduction was observed in patients with baseline HbA1c ≥ 8% and with diabetes duration <5 years. The composite endpoint of HbA1c ≤7% and a weight loss ≥5% was achieved in 22.5% of the participants. A total of 40 patients (20.8%) discontinued treatment: 26 because of gastrointestinal adverse events, and 10 due to limited effectiveness in lowering HbA1c and/or BW. Conclusions: In a real clinical setting, patients initiating oral semaglutide showed suboptimal metabolic control, short diabetes duration and obesity; a significant improvement in HbA1c and BW was achieved mainly in patients with a more recent diabetes diagnosis, supporting the use of oral semaglutide in the early phase of the disease.

Measuring the effectiveness of hybrid diabetes care over 90 days through continuous data monitoring in type 2 diabetic patients.

Diabetes Mellitus, a global health challenge, affects 537 million individuals. Traditional management relies on periodic clinic visits, but technological advancements, including remote monitoring, offer transformative changes. Telemedicine enhances access, convenience, adherence, and glycemic control. Challenges include trust-building and limitations in face-to-face interactions. Integrating remote monitoring with in-person healthcare creates a hybrid approach. This study evaluates the impact on Type 2 Diabetes patients over 3 months. A retrospective case-control observational study. Inclusion criteria involved previous Type 2 Diabetes diagnosis and a minimum 3-month GluCare model period with two physical visits. Patients in the case group had in-clinic visits, bi-weekly app engagement, and monthly body weight readings. Control group had in-clinic visits only. Outcomes measured included HbA1c, lipid profile, CV risk, eGFR, urine Albumin/Creatinine Ratio, Uric Acid, and CRP. Case group showed significant HbA1c improvements (-2.19%), especially in higher baseline levels. Weight, BMI, LDL, total cholesterol, and CVD risk also improved. Controls showed smaller improvements. Higher digital interactions correlated with better outcomes. Patients with ≥11 interactions showed significant reductions in HbA1c (-2.38%) and weight (-6.00 kg). The GluCare.Health hybrid model demonstrates promising outcomes in Type 2 diabetes management. The integration of in-clinic consultations with continuous remote monitoring leads to substantial improvements in glycemic control and clinical parameters. The study highlights the importance of patient engagement in achieving positive outcomes, with higher digital interactions associated with greater reductions in HbA1c and weight. The hybrid approach proves more effective than digital-only interventions, emphasizing the need for comprehensive, end-to-end solutions in diabetes care.

De-Intensification from Basal-Bolus Insulin Therapy to Liraglutide in Type 2 Diabetes: Predictive Value of Mean Glycaemia during Fasting Test.

Successful conversion from insulin therapy to glucagon-like peptide 1 receptor agonist (GLP-1RA) with basal insulin in well-controlled patients has already been demonstrated. However, the data concerning individuals with poor glycaemic control are scarce. The aim of this work was to assess the success rate of insulin therapy to liraglutide transition in poorly controlled diabetes in a real-world clinical setting and to define predictors of success. We are the first to present the method of a fasting test as a way to identify the patients at higher risk of failure after treatment de-intensification. The retrospective observational study analyzed data of 62 poorly controlled obese diabetic patients on high-dose insulin therapy, who were subjected to a 72 h fasting test during hospitalization and subsequently switched to liraglutide ± basal insulin therapy. During the fasting, all antidiabetic treatment was discontinued. Patients were classified as responders if they remained on GLP-1RA treatment after 12 months. Non-responders restarted the basal-bolus insulin (BBI) regimen. Development of glycated hemoglobin (HbA1c) and body weight in both groups, alongside with parameters associated with the higher risk of return to the BBI regimen, were analyzed. A total of 71% of patients were switched successfully (=responders). Responders had more significant improvement in HbA1c (-6.4 ± 19.7 vs. -3.4 ± 22.9 mmol/mol) and weight loss (-4.6 ± 7.1 vs. -2.5 ± 4.0). Statistically significant difference between groups was found in initial HbA1c (75.6 ± 17.9 vs. 90.5 ± 23.6; p = 0.04), total daily dose of insulin (67.6 ± 36.4 vs. 90.8 ± 32.4; p = 0.02), and mean glycaemia during the fasting test (6.9 ± 1.7 vs. 8.6 ± 2.2 mmol/L; p < 0.01). This study confirms that therapy de-intensification in poorly controlled patients with a BBI regimen is possible. Higher baseline HbA1c, total daily insulin dose, and mean glucose during fasting test are negative predictive factors of successful therapy de-escalation.

Long-term assessment of the NHS hybrid closed-loop real-world study on glycaemic outcomes, time-in-range, and quality of life in children and young people with type 1 diabetes

Hybrid closed-loop (HCL) systems seamlessly interface continuous glucose monitoring (CGM) with insulin pumps, employing specialised algorithms and user-initiated automated insulin delivery. This study aimed to assess the efficacy of HCLs at 12 months post-initiation on glycated haemoglobin (HbA1c), time-in-range (TIR), hypoglycaemia frequency, and quality of life measures among children and young people (CYP) with type 1 diabetes mellitus (T1DM) and their caregivers in a real-world setting. Conducted between August 1, 2021, and December 10, 2022, the prospective recruitment took place in eight paediatric diabetes centres across England under the National Health Service England’s (NHSE) HCL pilot real-world study. A cohort of 251 CYP (58% males, mean age 12.3 years) with T1DM participated (89% white, 3% Asian, 4% black, 3% mixed ethnicity, and 1% other). The study utilised three HCL systems: (1) Tandem Control-IQ AP system, which uses the Tandem t:slim X2 insulin pump (Tandem Diabetes Care, San Diego, CA, USA) with the Dexcom G6® CGM (Dexcom, San Diego, CA, USA) sensor; (2) Medtronic MiniMed™ 780G with the Guardian 4 sensor (Medtronic, Northridge, CA, USA); and (3) the CamAPS FX (CamDiab, Cambridge, UK) with the Ypsomed insulin pump (Ypsomed Ltd, Escrick, UK) and Dexcom G6® CGM.All systems were fully funded by the NHS. Results demonstrated significant improvements in HbA1c (average reduction at 12 months 7 mmol/mol; P < 0.001), time-in-range (TIR) (average increase 13.4%; P < 0.001), hypoglycaemia frequency (50% reduction), hypoglycaemia fear, and quality of sleep (P < 0.001) among CYP over a 12-month period of HCL usage. Additionally, parents and carers experienced improvements in hypoglycaemia fear and quality of sleep after 6 and 12 months of use. In addition to the improvements in glycaemic management, these findings underscore the positive impact of HCL systems on both the well-being of CYP with T1DM and the individuals caring for them.

Patient-centered nutrition education improved the eating behavior of persons with uncontrolled type 2 diabetes mellitus in North Ethiopia: a quasi-experimental study.

Improving the clinical outcome of people with type 2 diabetes mellitus by modifying their eating behavior through nutrition education is an important element of diabetes self-management. Significant data from the literature supports this idea, however in the Ethiopian setting, there is a practice gap. Therefore, the purpose of this study was to assess how patient-centered nutrition education affected the eating behavior and clinical outcomes of people with uncontrolled type 2 diabetes mellitus. In this quasi-experimental trial, 178 people with uncontrolled type 2 diabetes were purposely assigned to the intervention (n = 89) or control (n = 89) arm. The intervention arm was given patient-centered nutrition education, whereas the control arm received the routine care. Eating behavior and clinical outcome indicators such as HbAc, lipid profile, anthropometric indices, and blood pressure were assessed in both groups at the start and completion of the intervention. All scale variables were tested for normality and log transformed when appropriate. The baseline characteristics of the intervention and control groups were compared using the t-test for continuous variables and the chi-square test for categorical variables. The effect of nutrition education was determined using a difference in differences (DID) approach. P < 0.05 was established as the criterion of significance. Food selection (DID = 15.84, P < 0.001), meal planning (DID = 31.11, P < 0.001), and calorie needs (DID = 37.65, P < 0.001) scores were statistically higher in the nutrition education arm. Furthermore, their overall eating behavior score (DID = 27.06, P < 0.001) was statistically greater than the controls. In terms of clinical outcomes, the overall picture reveals that the intervention did not outperform over the routine care. However, in comparison to the controls, the intervention arm showed clinically significant improvement in HbA1c (DID = -0.258, P = 0.485). Patient-centered nutrition education has resulted in positive adjustments in the eating behavior of people with uncontrolled type 2 diabetes mellitus. Furthermore, it has shown a great potential for improving their glycemic control.

The Role of Continuous Positive Airway Pressure (CPAP) Therapy in Obstructive Sleep Apnea With Metabolic Syndrome: Does It Affect the Outcomes?

Background Of all fatalities occurring globally each year caused by noncommunicable diseases, obstructive sleep apnea (OSA) and obesity are associated with an increased risk of sudden death and cardiovascular mortality. Metabolic syndrome and its comorbidities are linked to OSA. The three essential elements of the metabolic syndrome are improper lipid metabolism, hypertension, and insulin resistance. The effect of continuous positive airway pressure (CPAP) on metabolic syndrome elements and related symptoms and whether CPAP therapy helps reverse the syndrome was studied. Methods The present study is prospective pre-post research conducted at a tertiary care center in Nagpur, Hingna, India. The cases included were of moderate to severe or worse OSA, older than 18 years, willing for CPAP therapy with no previous or current CPAP therapy. They had a history of excessive drowsiness during the day. The cases excluded from the study were those with an active, persistent breathing ailment requiring treatment, intervention, or diagnosis of dyslipidemia, diabetes mellitus, or hypertension, past or present, or evidence of damage to the vital end organs. Components of the metabolic syndrome were assessed at the beginning and end of three months of CPAP therapy. Findings Eighty-five cases were enrolled in the study, of which 79 completed it. The majority of cases were male, comprising 48 individuals, accounting for 60.8% of the total cohort. Additionally, 54 cases, representing 68.4% of the group, had hypertension. The average age of the participants was 53.95 years ± 6.84 years. The BMI mean was 30.4 kg/m2 ± 4.642, with a waist-hip ratio of 0.964 ± 0.056 and a neck circumference of 40.66 cm ± 3.37. The study population scored 12.53 ± 2,616 on the Epworth Sleepiness Scale. The study population's apnea-hypopnea index/respiratory disturbance index ratio was 16.118 ± 4.868, a moderate risk score. After three months of CPAP therapy, there was a significant improvement in glycated hemoglobin (HbA1c), tetraiodothyronine (T4), high-density lipoprotein (HDL), and oxygen desaturation, and they were also statistically significant. In the study group, there was a decrease in systolic and diastolic blood pressure of 2.21 mm Hg and 0.26 mm Hg, respectively. Other indicators, including HbA1c, fasting and post-meal blood sugar, triglycerides, and HDL cholesterol, were significantly lower. We observed in the less than 50-year-old age group better improvement in systolic blood pressure of 0.49 mm Hg, diastolic blood pressure improvement of 0.32 mm Hg, and fasting blood sugar improvement of 14.59 mg/dl, and in the age group of more than 50, better improvements in post-meal blood sugar of 9.7 mg/dl, along with a statistically significant change in triglyceride with an improvement of 16.26 mg/dl, P value less than 0.05. Interpretation After three months of CPAP therapy, there was a significant improvement in HbA1c, T4, HDL, and oxygen desaturation, and they were also statistically significant. Fourteen (17.72%) cases of post-CPAP therapy no longer met the requirements for the syndrome. There was an improvement in the blood pressure's diastolic and systolic values, fasting and post-prandial sugar levels, HbA1C, and triglyceride levels. Patients over 50 years old showed better improvement in post-meal and triglyceride levels. Females improved blood pressure and triglycerides, whereas males responded better to blood sugar levels.

Probiotics and synbiotics for glycemic control in diabetes: A systematic review and meta-analysis of randomized controlled trials

The escalating prevalence of diabetes mellitus may benefit from add-on therapeutic approaches. Given the recognized need for an updated synthesis of the literature, this systematic review and meta-analysis aimed to synthesize and critically assess the available randomized controlled trials (RCTs) that investigate the efficacy of probiotics and synbiotics on glycemic control in patients with Type 1 (T1DM) and Type 2 (T2DM) diabetes mellitus. Comprehensive searches were conducted on PubMed, Embase, CINAHL, Scopus, and Web of Science, focusing on adults with T1DM or T2DM. All comparators were deemed eligible. Primary outcomes included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), and insulin levels. Only RCTs were included, and the Cochrane RoB2 tool assessed the risk of bias. Random-effect models facilitated data analysis, supplemented by sensitivity, subgroup analyses, and meta-regressions. A total of 537 records were screened, resulting in 41 RCTs for analysis, which comprises 2991 (54% females) patients with diabetes. The meta-analysis revealed statistically significant improvements in HbA1c (standardized mean difference (SMD)=-0.282, 95% CI: [-0.37,-0.19], p<0.001), FPG (SMD=-0.175, 95% CI: [-0.26,-0.09], p<0.001), and insulin levels (SMD=-0.273, 95% CI: [-0.35,-0.20], p<0.001). A medium degree of heterogeneity between studies was found in HbA1c (I2=62.5%), FPG (I2=71.5%), and insulin levels (I2=66.4%) analyses. Subgroup analyses indicated that the efficacy varied based on the type of strains used and the country. Multispecies strains were particularly effective in improving HbA1c levels. The study findings suggest that probiotics and synbiotics may be effective as complementary therapies for managing diabetes. Additionally, the study underscores the need for further tailored research that considers variables such as strain types and geographical factors to deepen the understanding of the role of these interventions in diabetes care. PROSPERO (CRD42023396348).

Real-World Use of Oral and Subcutaneous Semaglutide in Routine Clinical Practice in the UK: A Single-Centre, Retrospective Observational Study.

Semaglutide, the only glucagon-like peptide-1 receptor agonist (GLP-1 RA) available in subcutaneous and oral formulation for treatment of type 2 diabetes (T2D), has demonstrated clinically significant improvements in glycaemic control and weight in clinical trials. This study aimed to gain insights into the use of both formulations and evaluate their clinical effectiveness in a secondary care clinic in Wales. This was a retrospective observational analysis of adults with T2D initiated on oral or subcutaneous semaglutide. Changes from baseline in glycated haemoglobin (HbA1c), weight and other metabolic parameters were evaluated. At baseline, participants (n = 103) had a mean age of 57.3years, mean HbA1c of 79.1mmol/mol (9.38%), mean weight of 111.8kg and body mass index (BMI) of 39.6kg/m2 (no statistically significant differences between oral and subcutaneous groups). At 6-month follow-up, statistically significant improvements in HbA1c (- 19.3mmol/mol [- 1.77%] and - 20.8mmol/mol [- 1.90%]), body weight (- 9.0kg and - 7.2kg), and BMI (- 3.3kg/m2 and - 2.5kg/m2) were observed for oral and subcutaneous semaglutide, respectively. No statistically significant differences between the formulations were observed, and safety profiles were comparable. Both formulations of semaglutide provided clinically and statistically significant reductions in HbA1c and weight in real-world practice. Oral GLP-1 RA may offer a practical and effective option for the management of T2D.

Pioglitazone as Add-on THERAPY in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Dapagliflozin and Metformin: Double-Blind, Randomized, Placebo-Controlled Trial.

This study assessed the efficacy and safety of triple therapy with pioglitazone 15 mg add-on versus placebo in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin and dapagliflozin. In this multicenter, double-blind, randomized, phase 3 study, patients with T2DM with an inadequate response to treatment with metformin (≥1,000 mg/day) plus dapagliflozin (10 mg/day) were randomized to receive additional pioglitazone 15 mg/day (n=125) or placebo (n=125) for 24 weeks. The primary endpoint was the change in glycosylated hemoglobin (HbA1c) levels from baseline to week 24 (ClinicalTrials.gov identifier: NCT05101135). At week 24, the adjusted mean change from baseline in HbA1c level compared with placebo was significantly greater with pioglitazone treatment (-0.47%; 95% confidence interval, -0.61 to -0.33; P<0.0001). A greater proportion of patients achieved HbA1c <7% or <6.5% at week 24 with pioglitazone compared to placebo as add-on to 10 mg dapagliflozin and metformin (56.8% vs. 28% for HbA1c <7%, and 23.2% vs. 9.6% for HbA1c <6.5%; P<0.0001 for all). The addition of pioglitazone also significantly improved triglyceride, highdensity lipoprotein cholesterol levels, and homeostatic model assessment of insulin resistance levels, while placebo did not. The incidence of treatment-emergent adverse events was similar between the groups, and the incidence of fluid retention-related side effects by pioglitazone was low (1.5%). Triple therapy with the addition of 15 mg/day of pioglitazone to dapagliflozin plus metformin was well tolerated and produced significant improvements in HbA1c in patients with T2DM inadequately controlled with dapagliflozin plus metformin.

Adaptation to Telehealth of Personalized Group Visits for Late Stage Diabetic Kidney Disease.

The COVID-19 pandemic resulted in an unprecedented shift in the delivery of outpatient medical care, including the rapid transition of services from in-person to telehealth. We adapted an evidence-based personalized health planning group visit care model traditionally offered in-person to telehealth to support the care of patients with type 2 diabetes mellitus (T2D) and chronic kidney disease (CKD). Despite the need to leverage telehealth technologies to better support self-management for patients with CKD, scant evidence exists on how to do so. We conducted prospective adaptations of in-person evidence-based group visit model for telehealth delivery for patients with CKD and T2D. Intervention adaptations are reported using the Framework for Reporting Adaptations and Modifications (FRAME) taxonomy. The adapted virtual group visit care model was pilot tested among adults with T2D and stage 3b or 4 CKD. Feasibility outcomes included recruitment, attendance, satisfaction, and self-reported goal progress. Clinical outcomes were evaluated using Wilcoxon signed rank tests and included hemoglobin A1C (HbA1c), diastolic and systolic blood pressure, body mass index, and estimated glomerular filtration rate. Adaptation areas included outreach, visit format, educational materials design and access, staffing, and patient engagement strategies. 39% (43) of patients (110) contacted verbalized interest, and 58% (25) of those participated. 72% completed >6 group sessions. 68% of patients reported completing one or more health goals, with nutrition and physical activity being the most common. We observed a statistically significant improvement in HbA1c (p = 0.0176) six months post-program participation. Adapting evidence-based interventions for telehealth delivery is challenging due to the risk of altering an intervention's core components responsible for observed benefits. We adapted an in-person group visit model for the care of T2D and CKD for telehealth delivery. The telehealth approach was feasible and preliminary data suggested it improved relevant health and patient-recorded outcomes up to six months post-program completion. The approaches used here may be applicable to the adaptation of other clinical programs for telehealth delivery.

Enhancing Chronic-Disease Education through Integrated Medical and Social Care: Exploring the Beneficial Role of a Community Teaching Kitchen in Oregon.

Teaching kitchens (TKs) are rapidly being utilized as models to integrate culinary education and chronic-disease education into healthcare settings. Our observational study details the structure and organizational processes (e.g., referral, services, medical and social care integration) of the Community TK at Providence Milwaukie Hospital in Portland, OR. We utilize electronic medical-record data from engaged TK participants (n = 3077) to evaluate between the association of engagement and clinical outcomes (e.g., HbA1c, blood pressure, weight and cholesterol). Mean baseline HbA1c of Highly Engaged TK patients with diabetes (n = 88) reduced from 9.8% to 8.6% at 6 months (p < 0.0001) and sustained significant reductions at 12, 18, 24, 30, and 36 months (p < 0.05). Highly Engaged patients with hypertension (n = 152) had significant, sustained reductions in blood pressure (p < 0.0001). Engaged patients in the same high-risk groups also had significant improvements in HbA1c and blood pressure. Both engagement subgroups had moderate improvements in weight change and cholesterol. This study shows promising associations of TK services that promote chronic-disease self-management with improved clinical outcomes among higher risk patients (e.g., high blood pressure, high HbA1c, high low-density lipoprotein) with different medical issues (e.g., diabetes, obesity) and social barriers (e.g., food insecurity).

Personalized Intervention in Correcting Insulin Injection Errors and its Impact on A1C in the Study: A Cross-sectional Study

Background: Ever since the discovery of insulin, it has become an inevitable part of diabetes management in both type 1 and type 2 diabetes (T2D). Administering insulin subcutaneously following the correct insulin injection technique is often flawed in a considerable number of people with diabetes. Incorrect insulin techniques lead to poor glycemic control and invite serious adversities. Aims and Objectives: The study aims to evaluate impact of imparting educational intervention on reducing insulin injection errors and subsequent improvement in glycated hemoglobin in people with T2D. Materials and Methods: The study employed a survey-based cross-sectional design to evaluate the impact of the educational interventions on the injection techniques for the diabetes cohort. The data were collected from people with T2D visiting the outpatient department of four different comprehensive diabetes research centers in Kerala, India. All the statistical analysis was performed using R version 4.2.3. Results: Results showed a significant reduction in the HbA1c in people with type 2 diabetes. Conclusion: The cross-sectional study demonstrates that repeated educational interventions contribute to statistically significant improvement in HbA1c.

Longitudinal Trends in Glycemic Outcomes and Technology Use for Over 48,000 People with Type 1 Diabetes (2016-2022) from the T1D Exchange Quality Improvement Collaborative.

Previous studies revealed that HbA1c increased overall in the U.S. in the past decade. Additionally, health inequities in type 1 diabetes (T1D) outcomes by race-ethnicity and insurance type persist. This study examines the trends in HbA1c from 2016 to 2022 stratified by race-ethnicity and insurance in a large multicenter national database. We analyzed glycemic outcomes and diabetes device use trends for over 48,000 people living with type 1 diabetes (PwT1D) from three adult and twelve pediatric centers in the T1D Exchange Quality Improvement Collaborative (T1DX-QI), comparing data from 2016-2017 with data from 2021-2022. The mean HbA1c in 2021-2022 was lower at 8.4% compared to the mean HbA1c in 2016-2017 of 8.7% (0.3% improvement; p<0.01). Over the same period, the percentage of PwT1D using a continuous glucose monitor (CGM), insulin pump, or hybrid closed-loop system increased (45%, 12%, and 33%, respectively). However, these improvements were not equitably demonstrated across racial-ethnic groups or insurance types. Racial-ethnic and insurance-based inequities persisted over all seven years across all outcomes; comparing non-Hispanic White and non-Hispanic Black PwT1D, disparate gaps in HbA1c (1.2-1.6%), CGM (30%), pump (25-35%), and HCLS (up to 20%) are illuminated. Population-level data on outcomes, including hemoglobin A1c (HbA1c), can provide trends and insights into strategies to improve health for PwT1D. The T1DX-QI cohort showed a significant improvement in HbA1c from 2016-2022. Improvements in diabetes device use are also demonstrated. However, these increases were inconsistent across all racial-ethnic groups or insurance types, an important focus for future T1D population health improvement work.

Utility of residual SYNTAX score to predict clinical outcome after acute myocardial infarction

Abstract Aims Acute myocardial infarction (AMI) represents a huge health burden and a growing economical challenge, particularly with recurrent major adverse cardiovascular events (MACE). Large attention is critically mandated to identify population at higher risk for recurrent MACE to maximize secondary preventive measures. This study aimed to evaluate the utility of residual SYNTAX Score (RSS) after percutaneous coronary intervention (PCI) to the culprit vessel(s) in patients with AMI (STEMI or NSTEMI) to predict 6-months clinical outcomes. Methods and results A total of 492 eligible AMI patients were recruited through a period of 12 months. The RSS was systematically calculated after the PCI procedures. Median RSS was 4 (minimum 0–maximum 47.5). RSS showed excellent association to mid-term clinical outcomes. At cut-off value of RSS 3 had robust prediction for subsequent heart failure (HF), recurrent AMI, unplanned revascularization and the composite of MACE (P &amp;lt; 0.001). A significantly higher RSS was found in those who developed heart failure through the 6-months follow up period compared to those who did not (10 vs. 3, P &amp;lt; 0.001). Similar significant difference was found for recurrent ACS (11.5 vs. 3, P &amp;lt; 0.001), unplanned revascularization (15 vs. 3, P &amp;lt; 0.001) and occurrence of MACE (12 vs. 3, P &amp;lt; 0.001). Conclusions RSS is a sensitive predictor for 6-months adverse clinical outcomes after AMI. Calculating RSS at the end of PCI can guide intensification of secondary preventive measures. Ability of RSS- tailored management to impact clinical outcomes in high-risk patients is to be evaluated.Improvement, with subsequent amelioration of LV diastolic function. The Dapa group had a significantly greater improvement in LVEF at four months and six months compared to the Empa group. While the Empa group showed a significant improvement in HbA1C at six months compared to the Dapa group. Additional Content An author video to accompany this abstract is available on https://academic.oup.com/eurheartjsupp. Please click on the arrow next to ‘More Content’ and then click on ‘Author videos’.

Effects of low-versus high-volume high-intensity interval training on glycemic control and quality of life in obese women with type 2 diabetes: A randomized controlled trial

Background/objectiveComparison between different training volumes of high-intensity interval training (HIIT) is understudied in type 2 diabetes. This study aimed to compare the effects of low- and high-volume HIIT on glycemic control, blood lipids, blood pressure, anthropometric adiposity measures, cardiorespiratory fitness, and health-related quality of life (HRQoL) in women with type 2 diabetes. MethodsSeventy-two obese women with type 2 diabetes aged 36–55 were randomly assigned to a low-volume HIIT group (i.e., 2 × 4-min high-intensity treadmill exercise at 85%–90% of peak heart rate, with a 3-min active recovery interval in between), a high-volume HIIT group (i.e., 4 × 4-min high-intensity treadmill exercise at 85%–90% of peak heart rate, with three 3-min active recovery intervals in between), and a non-exercising control group. Patients in HIIT groups exercised three days a week for 12 weeks. All patients received oral hypoglycemic medications with no calorie restrictions. The outcome measures were glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), 2-hour postprandial blood glucose (2-hr PPBG), total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL), systolic blood pressure (SBP), diastolic blood pressure (DBP), body mass index (BMI), waist circumference (WC), waist-to-hip ratio, time to maximal exhaustion determined from a maximal treadmill exercise test (i.e., a measure of cardiorespiratory fitness), and HRQoL assessed by the 12-item Short Form (SF-12) Health Survey. ResultsThe low- and high-volume HIIT groups showed significant improvements in all outcome measures compared to the baseline and the non-exercising group (P < 0.05), except for DBP in the low-volume HIIT group (p > 0.05). Also, both low- and high-volume HIIT groups showed similar improvements in TC, HDL, SBP, DBP, BMI, WC, waist-to-hip ratio, and the SF-12 scores, with no significant between-groups difference (p > 0.05). The high-volume HIIT group, however, showed more significant improvements in HbA1c, FBG, 2-hr PPBG, TG, LDL, and treadmill time to maximal exhaustion than the low-volume HIIT group (p < 0.05). The non-exercising group showed non-significant changes in all outcome measures (p > 0.05). ConclusionLow-volume HIIT could be equally effective as high-volume HIIT for improving TC, HDL, blood pressure, anthropometric adiposity measures, and HRQoL in obese women with type 2 diabetes. Nevertheless, high-volume HIIT could have a greater impact on glycemic control, TG, LDL, and cardiorespiratory fitness in these patients. Trial registrationClinicalTrials.gov, NCT05110404.

Improvements in cardiovascular disease risk factors associated with modest weight loss following treatment in patients with binge-eating disorder and obesity.

Modest weight losses may be associated with improvements in cardiovascular disease risk factors (CVDRF) in patients with obesity. The effects of weight losses on CVDRF in persons with binge-eating disorder (BED) are unknown. This study prospectively examined changes in CVDRF among patients receiving behaviorally-based weight-loss treatment (BBWLT) who attained modest weight losses (≥5 to <10% and ≥10%). Of 191 participants, CVDRF variables were re-assessed in 168 participants at posttreatment and in 151 at 12-month follow-up. Participants who attained ≥5 to <10% weight loss were compared to those who did not on CVDRFs (total cholesterol, HDL, LDL, triglycerides, HbA1C, mean plasma glucose, heart rate, and systolic/diastolic blood pressure); similar comparisons were completed for those who attained ≥10% weight loss. At posttreatment, ≥5 to <10% weight loss (N = 42; 25.0%) was associated with significant improvements in HbA1c and mean plasma glucose, whereas ≥10% weight loss (N = 40, 23.8%) was associated with significant improvements in total cholesterol, triglycerides, HbA1c, mean plasma glucose, and heart rate. At 12-month follow-up, ≥5 to <10% weight loss (N = 17; 11.1%) was related to significant improvements on HDL, triglycerides, HbA1c, and mean plasma glucose, whereas ≥10% weight loss (N = 40, 26.0%) was associated with significant improvements on all the CVDRF variables (except blood pressure). Modest weight loss is associated with significant improvements in CVDRFs in patients with BED and obesity following treatment and at 12-month follow-up. Future work should examine whether improvements in CVDRF are attributable to weight loss per se and/or to other related lifestyle changes. Individuals with binge-eating disorder and obesity who attain modest weight loss following treatment exhibit improvements in various measures of cardiovascular disease risk compared to those who do not. While weight loss has been challenging for individuals with binge-eating disorder, clinicians should inform patients of the potential health benefits of modest weight loss. Future research should investigate whether weight loss itself and/or related behavioral lifestyle changes drive improved cardiovascular disease risk factors.