Significant Reduction In HbA1c Levels Research Articles

Transdisciplinary Tactics and Prospects for Medical and Commercial Advancement in Kefir

Background: Kefir, a fermented milk beverage with a rich cultural heritage, has garnered significant attention due to its health benefits and commercial potential. This study explores the convergence of medical science, technology, and market dynamics to position kefir as a functional food with therapeutic applications. Objective: The study aimed to evaluate the health benefits of kefir, optimize its production processes, and investigate its therapeutic potential in chronic diseases and injuries. Methods: A randomized controlled trial was conducted with participants divided into kefir and control groups. Pre- and post-intervention health assessments were performed, measuring cardiovascular health, blood sugar levels, immune response markers, and neurological function. Biochemical analyses of blood samples were conducted to identify changes due to kefir consumption. Statistical analyses were performed using SPSS version 25. For process optimization, Response Surface Methodology (RSM) was applied to optimize fermentation conditions. Experimental studies included in vitro cell culture experiments and in vivo animal models to assess kefir’s effects on diabetes, Alzheimer's disease, and cancer. Microbial analysis was performed using genomic and proteomic techniques, and consumer sensory evaluations were conducted for new kefir formulations. Results: The kefir group showed a significant reduction in mean blood sugar levels from 96.62 mg/dL to 85.18 mg/dL (t-statistic=5.16, p=0.000004), while the control group showed no significant change. Optimized production conditions were determined to be a temperature of 25°C, fermentation time of 24 hours, and a grain-to-milk ratio of 0.1, achieving a quality score of 500. In the diabetes model, the kefir-treated group had a significant reduction in HbA1c levels (6.75) compared to the control group (7.41) (t-statistic=6.14, p=8.12×10^-8). For Alzheimer's disease, amyloid plaque deposition decreased significantly in the kefir group (37.34) versus the control group (50.13) (t-statistic=5.70, p=4.29×10^-7). In the cancer model, tumor growth was significantly reduced in the kefir group (64.18) compared to the control group (98.10) (t-statistic=7.45, p=5.09×10^-10). Microbial counts were highest and most stable under Condition A (11.05×10^7, SD=6.33×10^5). Consumer sensory evaluations of soymilk-based kefir resulted in a mean score of 3.1 (SD=1.32). Conclusion: Kefir demonstrates significant health benefits, including blood sugar regulation, and therapeutic potential in managing diabetes, Alzheimer's disease, and cancer. Optimized production conditions enhance its commercial viability. Future research should focus on long-term effects and real-world applications to validate these findings.

Moderating Effect of Depression on Glycemic Control in an eHealth Intervention Among Black Youth With Type 1 Diabetes: Findings From a Multicenter Randomized Controlled Trial.

Black adolescents with type 1 diabetes (T1D) are at increased risk for suboptimal diabetes health outcomes; however, evidence-based interventions for this population are lacking. Depression affects a high percentage of youth with T1D and increases the likelihood of health problems associated with diabetes. Our aim was to test whether baseline levels of depression moderate the effects of a brief eHealth parenting intervention delivered to caregivers of young Black adolescents with T1D on youths' glycemic control. We conducted a multicenter randomized controlled trial at 7 pediatric diabetes clinics located in 2 large US cities. Participants (N=149) were allocated to either the intervention group or a standard medical care control group. Up to 3 intervention sessions were delivered on a tablet computer during diabetes clinic visits over a 12-month period. In a linear mixed effects regression model, planned contrasts did not show significant reductions in hemoglobin A1c (HbA1c) for intervention adolescents compared to controls. However, adolescents with higher baseline levels of depressive symptoms who received the intervention had significantly greater improvements in HbA1c levels at 6-month follow-up (0.94%; P=.01) and 18-month follow-up (1.42%; P=.002) than those with lower levels of depression. Within the intervention group, adolescents had a statistically significant reduction in HbA1c levels from baseline at 6-month and 18-month follow-up. A brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms. ClinicalTrials.gov NCT03168867; https://clinicaltrials.gov/study/NCT03168867.

Effect of Bergenia ligulata (Wall.) in type 2 diabetes mellitus: A randomized placebo-controlled trial

IntroductionGlobally 8.8 % of people aged 20–79 years have diabetes. Diabetes mellitus (DM) is a group of metabolic disorders characterized by hyperglycemia. Bergenia ligulata (Wall.) is a small, perennial, rhizomatous flowering herb used medicinally in India.The present study aimed to evaluate the effect of B. ligulata rhizome as an adjuvant in decreasing blood glucose levels in type-II diabetes mellitus. MethodsForty patients were enrolled in a single-blind, randomized, placebo-controlled study; twenty patients were assigned to each of the test and control groups. Only those currently using 2 or less oral hypoglycaemic agents were included. Subjects took B. ligulata (4 gm) or placebo in capsule form, orally, for 8 weeks. Fasting blood sugar (FBS) and postprandial blood sugar (PPBS) were measured at baseline, fourth week, and end of the trial. Haemoglobin A1c (HbA1c) and quality of life (Asian Diabetes Quality of Life; ADQOL) scores were measured at baseline and the end of the trial. Data were statistically analyzed using analysis of variance (ANOVA), student's t-test, chi-square, and Fisher exact test to assess the effect of the intervention. ResultsAfter 8 weeks of treatment, the decrease in mean fasting blood sugar (FBS) level showed a significant difference between groups (Cohen's d= -0.457, 95 % confidence intervals (CIs) -0.174 to -1.082). PPBS level was significantly reduced in the test group compared to the control group (Cohen's d= -1.457, 95 % confidence interval (CIs) -0.749 to -2.150). There was a statistically significant reduction in HbA1c level in the test group compared to the control group (Cohen's d= -0.798, 95 % confidence interval (CIs) -0.148 to -1.438). B. ligulata was found to be more effective in improving ADQOL scores than placebo (Cohen's d = 0.762, 95 % confidence interval (CIs) 0.115 to 1.400). No B. ligulata related adverse events were observed. ConclusionB. ligulata appears to be an effective adjuvant treatment for type 2 diabetes mellitus. It reduced FBS, PPBS, and HbA1c and improved ADQOL scores significantly compared to the placebo. However, for more valid results, larger samples are needed. Clinical trial registration noCTRI /2019/05/019087.

A multicentre, double-blind, placebo-controlled, randomized, parallel comparison, phase 3 trial to evaluate the efficacy and safety of pioglitazone add-on therapy in type 2 diabetic patients treated with metformin and dapagliflozin.

To investigate the efficacy and safety of pioglitazone compared to placebo when added to metformin plus dapagliflozin, a sodium-glucose cotransporter-2 (SGLT2) inhibitor, for patients with type 2 diabetes mellitus (T2DM). In a multicentre study, with a randomized, double-blind, placebo-controlled design, 249 Korean patients with T2DM suboptimally managed on metformin and dapagliflozin were assigned to receive either pioglitazone (15 mg daily) or placebo for 24 weeks, followed by a 24-week pioglitazone extension. Primary outcomes included changes in glycated haemoglobin (HbA1c), with secondary outcomes assessing insulin resistance, adiponectin levels, lipid profiles, liver enzymes, body weight and waist circumference. Pioglitazone administration resulted in a significant reduction in HbA1c levels (from 7.80% ± 0.72% to 7.27% ± 0.82%) compared with placebo (from 7.79% ± 0.76% to 7.69% ± 0.86%, corrected mean difference: -0.42% ± 0.08%; p < 0.01) at 24 weeks. Additional benefits from pioglitazone treatment included enhanced insulin sensitivity, increased adiponectin levels, raised high-density lipoprotein cholesterol levels and reduced liver enzyme levels, resulting in improvement in nonalcoholic fatty liver disease liver fat score. Despite no serious adverse events in either group, pioglitazone therapy was modestly but significantly associated with weight gain and increased waist circumference. Adjunctive pioglitazone treatment in T2DM inadequately controlled with metformin and dapagliflozin demonstrates considerable glycaemic improvement, metabolic benefits, and a low risk of hypoglycaemia. These advantages must be weighed against the potential for weight gain and increased waist circumference.

Glycemic Control, Weight Management, Cardiovascular Safety, and Cost-Effectiveness of Semaglutide for Patients with Type 2 Diabetes Mellitus: A Rapid Review and Meta-analysis of Real-World Studies.

Semaglutide is a high-profile glucose-lowering drug that medical decision-makers have acknowledged in recent years. This rapid review aims to provide evidence-based clinical recommendations for the treatment of type 2 diabetes mellitus (T2DM) with semaglutide. We conducted a rapid review of randomized controlled trial (RCT)-based meta-analyses (MAs) and systematic reviews (SRs) of cost-effectiveness analyses (CEAs) compared to other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or placebo in patients with T2DM. Prospective cohort real-world studies (RWS) were also retrieved and subjected to MA. Four databases, including PubMed, the Cochrane Library, Embase, and ISPOR, were searched from inception to 5 March 2023. The outcomes of interest were hemoglobin A1c (HbA1c), body weight, major adverse cardiovascular events (MACE), and economic outcomes such as quality-adjusted life-years and total cost. We identified 33 publications: 22 RCT-based MAs, 1 SR of CEAs, and 10 RWS. Evidence showed that semaglutide at usual doses was associated with superior reductions in HbA1c and weight compared to most GLP-1 RAs in patients with T2DM who were drug naive, receiving basal insulin, or using oral hypoglycemic agents, and it was also associated with a lower number of MACE and was more cost-effective. Further, once-weekly semaglutide resulted in a significant reduction in HbA1c levels (-1.1%) and body weight (-4.88kg) in routine clinical practice. This review consolidates the positive current evidence base for prescribing semaglutide to patients with T2DM, but further rigorous studies are still urgently required to develop practice guidelines as innovative drugs become commercially available.

Effectiveness of Continuous Glucose Monitoring on Metrics of Glycemic Control in Type 2 Diabetes Mellitus: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

To provide a systematic review and meta-analysis synthesizing the findings of randomized controlled trials (RCTs) of continuous glucose monitors (CGMs) in the management of adults with type 2 diabetes mellitus (T2DM) on glucose control and clinical outcomes. MEDLINE, Embase, and Cochrane were searched for RCTs that assessed the effectiveness of real-time CGM (rt-CGM) or flash CGM (FGM) in adults (≥18 years) with T2DM that reported on at least 1 of the following outcomes: hemoglobin A1c (HbA1c), time in range, time in hyperglycemia, or time in hypoglycemia. The GRADE approach was used to assess certainty of evidence for primary outcomes. Fourteen RCTs assessing CGM were included, with 825 patients in 9 RCTs using rt-CGM and 822 in 5 RCTs using FGM. Moderate certainty of evidence indicated that use of CGM had a modest but statistically significant reduction in HbA1c levels of about 0.32%. Our analyses of each device type separately showed similar reductions in HbA1c (0.34% and 0.33%, respectively, for rt-CGM and FGM), with trends for improvement in other glucose metrics favoring rt-CGM over self-monitored blood glucose. Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results. However, the duration of the included RCTs was relatively short and few studies reported on important clinical outcomes, such as adverse events, emergency department use, or hospitalization. Longer term studies are needed to determine if the short-term improvements in glucose control leads to improvements in clinically important outcomes.

Effect of tirzepatide on glycaemic control and weight loss compared with other glucagon-like peptide-1 receptor agonists in Japanese patients with type 2 diabetes mellitus.

To compare the therapeutic effects of glucose-dependent insulinotropic polypeptide (GIP)/ glucagon-like peptide-1 receptor agonists (GLP-1RAs) or GLP-1RAs in Japanese patients with type 2 diabetes (T2D). We systematically searched PubMed, MEDLINE, EMBASE, and the Cochrane Library up to July 2023. Randomized controlled trials (RCTs) that compared GLP-1RAs or GIP/GLP-1RAs in Japanese patients with T2D were selected. A network meta-analysis was conducted to indirectly compare the treatments, focusing on efficacy in reducing glycated haemoglobin (HbA1c) levels and body weight (BW). A total of 18 RCTs were included in this analysis. Tirzepatide 15 mg showed the most significant reduction in HbA1c levels and BW compared with subcutaneous semaglutide 1.0 mg and oral semaglutide 14 mg (HbA1c: mean difference [95% confidence interval] -0.52 [-0.96; -0.08] and - 1.23 [-1.64; -0.81]; BW: -5.07 [-8.28; -1.86] and -6.84 [-8.97; -4.71], respectively). Subcutaneous semaglutide showed a superior reduction in HbA1c compared with oral semaglutide. Both subcutaneous and oral semaglutide were more effective than conventional GLP-1RAs, such as dulaglutide, liraglutide and lixisenatide. Among Japanese patients with T2D, tirzepatide showed the greatest effectiveness in reducing HbA1c levels and inducing weight loss. The study provides evidence to guide GLP-1RA treatment strategies in Japanese patients with T2D.

The Effects of Mindfulness on Glycemic Control in People with Diabetes: An Overview of Systematic Reviews and Meta-Analyses.

Background: Previous research has demonstrated the effectiveness of mindfulness interventions in improving glycemic control. By enhancing attention control, emotion regulation, and self-awareness, mindfulness shows promise in managing the lifestyle factors associated with cardiovascular disease risk. However, the impact of mindfulness on glycemic control in people with diabetes remains unclear. This overview aims to summarize the current evidence of the impact of mindfulness interventions on glycemic control in people with diabetes and propose suggestions for future research. Methods: The author searched electronic databases (PubMed/MEDLINE, Embase, and Cochrane Library) to identify relevant systematic reviews and meta-analyses. The current evidence regarding the effects of mindfulness on glycemic control in people with diabetes was summarized. Results: This review evaluated a total of five systematic reviews and meta-analyses of randomized controlled trials (RCTs). Mindfulness interventions show potential for improving glycemic control as measured by hemoglobin A1c (HbA1c) levels, as well as reducing stress, depression, and anxiety in people with diabetes. Four out of five systematic reviews and meta-analyses reported a significant reduction in HbA1c levels by approximately 0.3%. However, the available studies lacked adequate description of key characteristics of study subjects, such as body mass index, medication, and disease conditions, which are essential for assessing the impact of mindfulness on glycemic control. Moreover, there was significant heterogeneity in the intervention methods employed across the included RCTs. Conclusions: Mindfulness interventions are effective in improving glycemic control in people with type 2 diabetes. However, the overall quality of the reviewed studies raises uncertainty regarding the effectiveness of mindfulness as a treatment for people with diabetes. Further research is necessary to elucidate the biological effects of mindfulness on physiological, neurological, and endocrinological functions in humans.

Digital Interventions in Type 2 Diabetes Mellitus

Introduction: Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease with an increasing mortality rate over the last decade. Diabetes self-management education (DSME) programs have been reported as essential to improve survival; however, patient adherence rates are very low. Therefore, digital devices have been created to deliver DSME at a distance and enhance program attendance. This study aims to assess the effects of digitally delivered DSME programs on the glycosylated hemoglobin (HbA1C) of patients with prediabetes and T2DM. Methods: We researched PUBMED databases for randomized controlled trials (RCT) and observational studies (OS) published between 2012-2022 in English, Portuguese, or Spanish. The selected articles tested digital DSME interventions against treatment as usual (TAU) on adults (&gt;18 years) previously diagnosed with T2DM or prediabetes. The result was measured by determining the HbA1c levels. Results: Out of 261 articles, 14 RCTs were selected based on eligibility criteria. Digital DSME technologies have different objectives, including monitoring glycemic fluctuation, insulin titration, nutritional guidance, sleeping assessment, enhancement of physical activity, control of comorbidities, relevant task notifications, personalized treatment recommendations, educational content, and patient/medical staff remote interaction. Some of the technologies combined machine learning techniques for different functions, including detecting adverse glycemic events, physical activity, and blood pressure, among others. Although the level of adherence varied among the various trials, 4 of the 14 RCTs analyzed reported a significant reduction of HbA1c levels using these digital devices compared to TAU. Discussion: Programs providing digital DSME education is a potentially cost-effective tool to improve diabetes care worldwide by overcoming distance barriers, facilitating physician-patient communication, and reducing HbA1c levels. Future improvements in implementing these technologies could enhance user compliance and contribute effectively to diabetes management.

Assessing the Effectiveness of mHealth Interventions for Diabetes and Hypertension Management in Africa: Systematic Review and Meta-Analysis.

Mobile health (mHealth) interventions are effective in improving chronic disease management, mainly in high-income countries. However, less is known about the efficacy of mHealth interventions for the reduction of cardiovascular risk factors, including for hypertension and diabetes, which are rapidly increasing in low- and middle-income countries. This study aimed to assess the efficacy of mHealth interventions for diabetes and hypertension management in Africa. We searched PubMed, Cochrane Library, Google Scholar, African Journals Online, and Web of Science for relevant studies published from inception to July 2022. The main outcomes of interest were changes in hemoglobin A1c (HbA1c), systolic blood pressure, and diastolic blood pressure. The random or fixed effect model was used for the meta-analysis, and the I2 statistic was used to gauge study heterogeneity. Z tests and P values were used to evaluate the effect of mHealth interventions on HbA1c and blood pressure levels. This review included 7 studies (randomized controlled trials) with a total of 2249 participants. Two studies assessed the effect of mHealth on glycemic control, and 5 studies assessed the effect of mHealth on blood pressure control. The use of mHealth interventions was not associated with significant reductions in HbA1c levels (weighted mean difference [WMD] 0.20, 95% CI -0.40 to 0.80; P=.51) among patients with diabetes and systolic blood pressure (WMD -1.39, 95% CI -4.46 to 1.68; P=.37) and diastolic blood pressure (WMD 0.36, 95% CI -1.37 to 2.05; P=.69) among patients with hypertension. After conducting sensitivity analyses using the leave-one-out method, the Kingue et al study had an impact on the intervention, resulting in a 2 mm Hg reduction in systolic blood pressure (WMD -2.22, 95% CI -3.94 to -0.60; P=.01) but was nonsignificant for diastolic blood pressure and HbA1c levels after omitting the study. Our review provided no conclusive evidence for the effectiveness of mHealth interventions in reducing blood pressure and glycemic control in Africa among persons with diabetes and hypertension. To confirm these findings, larger randomized controlled trials are required.

Glucometabolic control of once-weekly dulaglutide switched from DPP4 inhibitor versus daily empagliflozin add-on in patients with type 2 diabetes inadequately controlled with metformin, sulfonylurea, and DPP4 inhibitor: A randomised trial

AimsTo compare the effectiveness and safety of empagliflozin and dulaglutide in patients with type 2 diabetes (T2D) inadequately controlled by oral triple therapy. MethodsIn this 24-week, multi-center, randomized trial, patients with T2D and HbA1c level ≥7.5% (58 mmol/mol) on metformin, sulfonylurea, and dipeptidyl peptidase 4 inhibitor (DPP4-i) were randomly assigned into two groups: daily empagliflozin add-on or once-weekly dulaglutide switched from DPP4-i. The primary endpoint was changes from baseline HbA1c at 24 weeks. ResultsIn total, 152 patients were recruited to the empagliflozin-added quadruple group (n = 76) or the switched-to-dulaglutide triple group (n = 76). At week 24, both groups showed significant reduction in HbA1c level from baseline with greater reduction with empagliflozin (the mean treatment difference: –0.27% [95% CI –0.50 to –0.04, p = 0.024]) (–2.88 mmol/mol [95% CI –5.37 to –0.39], p = 0.024). Empagliflozin significantly reduced body weight from baseline to week 24 (–1.72 kg [95% CI –1.98 to –0.59, p < 0.001]). No serious adverse events were reported with either empagliflozin or dulaglutide. ConclusionsEmpagliflozin, compared with once-weekly dulaglutide switched from DPP4-i, demonstrated greater HbA1c reduction and weight loss in patients with T2D inadequately controlled with metformin, sulfonylurea, and DPP4-i.Trial registration:cris.nih.go.kr (KCT0006157)

Effect of Lixisenatide (Short-acting Glucagon-Like Peptide 1 Receptor Agonist) as an Add-on to Insulin in Lowering HbA1C among Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis

Objective: This systematic review and meta-analysis aimed to evaluate the effect of Lixisenatide, a short-acting glucagon-like peptide 1 receptor agonist, as an add-on therapy to insulin in patients with type 2 diabetes (T2DM). The primary outcome of interest was the change in HbA1c levels. Methods: A comprehensive literature search was conducted in major databases for relevant studies published up to the present. Seven studies were included in the quantitative data synthesis. The characteristics of the included studies, including intervention, design, duration, sample size, demographics, baseline characteristics, and outcome measures, were summarized in a descriptive manner. A pooled analysis was performed to assess the overall effect of Lixisenatide on HbA1c levels. Heterogeneity among the studies was evaluated, and sensitivity analyses were conducted when necessary. Results: The pooled analysis of the seven included studies demonstrated a significant reduction in HbA1c levels with Lixisenatide as an add-on therapy to insulin. The mean difference (MD) was -0.41% (95% CI: -0.55 to -0.28), indicating a clinically meaningful improvement in glycemic control. Although heterogeneity was observed among the studies (I² = 80%, p &lt; 0.0001), the overall effect estimate remained consistent. Conclusion: Our systematic review and meta-analysis provide robust evidence supporting the efficacy of Lixisenatide as an add-on therapy to insulin in lowering HbA1c levels in patients with T2DM. The significant reduction in HbA1c levels indicates mproved long-term glucose control, which is associated with reduced risks of diabetes-related complications. Clinicians should consider incorporating Lixisenatide into the treatment regimen of patients with T2DM who require additional glycemic control beyond insulin monotherapy. Further research is needed to explore secondary outcomes and safety profiles associated with Lixisenatide in this patient population. Key words: lixisenatide , add on therapy, insulin , glp-1 receptor agonist, Type 2 diabetes

Effectiveness of Short Message Service (SMS) based Glycaemic Control

Objective: To find out the effectiveness of short message service (SMS) on glycaemic control among patients with diabetes at a tertiary care hospital in Rawalpindi.&#x0D; Study Design: Quasi-experimental study.&#x0D; Place and Duration of Study: Department of Endocrinology, Pak Emirates Military Hospital, Rawalpindi Pakistan, from Jan to Jul 2020.&#x0D; Methodology: A total of 218 patients with diabetes were included in the study. Patients were randomized into two groups by lottery method. Group-A received a tailored SMS package daily for six months along with printed dietary instructions, while Group-B was given only printed dietary instructions. After six months, HbA1c levels and other sociodemographic factors were compared among the two Groups A and B.&#x0D; Results: In Group-A (SMS-Group) mean HbA1c levels reduced from 9.3±2.0 to 7.0±0.4 compared to Group-B (non-SMSGroup) with mean HbA1c levels from 9.7±1.8 to 8.8 ±1.4. Before SMS intervention, all variables, including HbA1c levels between the two groups, were insignificant. However, the use of structured SMS-based intervention in Group-A showed a statistically significant reduction in HbA1c levels compared to Group-B (p-value &lt;0.05). The mean difference was 1.77(95% CI:-2.44 to -1.10).&#x0D; Conclusion: This study showed Short Message Service (SMS) effectiveness by significantly reducing glycaemic levels (HbA1c)among people with diabetes compared to conventional methods of diabetic education for glycaemic control.

Glycosylated haemoglobin as an indicator of diabetes control in pregnancy: A 10-year review of the relationship between HbA1c trends and delivery outcome in type I and type II diabetes

BackgroundPregestational diabetes mellitus (PGDM) confers an increased risk of adverse maternal and neonatal outcomes [1,2]. Glycaemic control in the medium and long term is commonly evaluated by examining glycosylated haemoglobin (HbA1c) levels. However, the value of HbA1c in pregnancy may be diminished by increased level of red cell turnover characteristic of pregnancy [3,4]. We sought to examine the impact of HbA1c in the first trimester and pre-delivery, and the within-patient change throughout gestation on mode of delivery and birthweight in pregnancies complicated by a pre-pregnancy diagnosis of type I or type II diabetes. MethodsA 10-year consecutive cohort of pregnancies complicated by PGDM, from Jan 2010 until Dec 2019, was examined for HbA1c data in the first trimester and within 6 weeks of delivery. Perinatal outcome data, including gestational age at delivery, mode of delivery and birthweight centile, were obtained from hospital records. The Spearman Rank correlation was used to correlate HcA1c levels in the first trimester with birthweight centiles. Non-parametric summaries and rank-based tests, Signed-rank test and Kruskal-Wallis test, were used to compare Hba1c levels. ResultsDuring the 10-year study period, a consecutive cohort of 396 pregnancies that attained a viable gestational age (>24 weeks’ gestation) and complicated by pregestational diabetes was identified; representing 81 % of the population of pregestational diabetic pregnancies managed by this service during the study period. The median [IQR] HbA1c levels (mmol/mol) in the first trimester, pre-delivery and the differential across gestation were 51 [19] mmol/mol, 43 [11] mmol/mol and −8 [13] mmol/mol, respectively. A statistically significant reduction in HbA1c levels throughout gestation was observed (p < 0.001). The median [IQR] birthweight centile was 69 [50 – 96]. The distributions in HbA1c levels and birthweight centiles were heavily skewed. No correlation was identified between HbA1c levels and mode of delivery. ConclusionNeither baseline HbA1c levels, pre-delivery values, nor trends across gestation appear to impact birthweight centile or mode of delivery in PGDM. While optimising glycaemic control can affect the long term health of the mother, these indices cannot be relied upon to reflect the impact of glycaemic control on fetal growth aberrations that influence mode of delivery.

PP78 Effectiveness And Safety Of The FreeStyle Libre® Glucose Monitoring System For T1DM In Childhood And Adolescence

IntroductionFreeStyle Libre System (FSL) is a minimally invasive technology, which provides frequent information about interstitial glucose levels, which allows adjustment of insulin dose and a reduction in the number of fingersticks. This study aims to evaluate the effectiveness and safety of FSL in childhood and adolescence.MethodsProspective case series in 27 Spanish hospitals. Patients aged 4-17 years with type 1 diabetes mellitus (T1DM) were included. Follow-up was done at 3, 6 and 12 months after starting to use the FSL. Outcome measures were HbA1c levels, acute complications of DM (severe hypoglycemia, ketoacidosis), DM knowledge, health-related quality of life, satisfaction and adverse effects. Biochemical glycemic outcomes (e.g., glycemic variability, time in therapeutic range) were available from 3 to 12 months. Mixed regression models with repeated time measurements were implemented.ResultsThe mean age of patients was 12.6 years, with 56.4 percent had HbA1c values above 7.5 percent at baseline. This subgroup significantly improved their HbA1c levels at 3, 6 and 12 months (-0.46%, -0.44% and -0.35%, respectively). Patients with controlled HbA1c levels significantly worsened at 12 months (0.29%). There was a significant reduction in severe hypoglycemic episodes, but only in the multiple imputation analysis. In patients controlled at baseline, there were significant reductions between 3 and 12 months in the percentage of time under 55mg/dl (-0.64%), above 250mg/dl (-1.8%) and glycemic variability (-2.6%). In uncontrolled patients, there was a significant reduction in time above 250mg/dl (-5.8%) between 3 and 12 months follow-up. There was no significant improvement in knowledge about disease, although general self-perceived health worsened and general satisfaction improved. Mild adverse events such as skin reactions (14%) and discomfort or pain (11.3%) with no significant reductions in follow-up were recorded.ConclusionsThe use of FSL in childhood and adolescence with T1DM produces a significant reduction in HbA1c levels in patients with uncontrolled HbA1c levels along with a reduction in severe hypoglycemic episodes (in the multiple imputation analysis). FSL-related adverse effects are considered mild.

A personalized multi-interventional approach focusing on customized nutrition, progressive fitness, and lifestyle modification resulted in the reduction of HbA1c, fasting blood sugar and weight in type 2 diabetes: a retrospective study

BackgroundType 2 diabetes (T2D) is a chronic, progressive lifestyle disease and the most rapidly growing health challenge of the twenty-first century. The American Diabetes Association recommends that T2D reversal can be achieved through an organized, and systematic approach focusing on nutrition, fitness, and lifestyle management.AimThis study aimed to evaluate the effectiveness of a comprehensive and multi-interventional diabetes care program called Sugar. Fit Diabetes Reversal Programme (SDRP) on glycosylated haemoglobin (HbA1c), fasting blood sugar (FBS), and body weight for T2D reversal.MethodologySDRP is a personalized intervention study that uses technology-enabled medical management, dedicated coach-led diabetes, and nutrition experts. The study involved 150 patients living with type 2 diabetes in the age group of 20 to 80 years and having HbA1c of > 6.5%. In SDRP, the participants were assigned personal medical doctors specializing in diabetes, along with health coaches for providing customized nutrition, personalized fitness routines, relevant lifestyle modifications to holistically reverse type 2 diabetes. The HbA1c level, fasting blood sugar, and weight of the participants were measured at baseline and the end of the study (90th day). The effectiveness of SDRP was analyzed by comparing it with a control group that involved 110 individuals with type 2 diabetes managed by conventional pharmacotherapy and regular dietary advice but not participating in the SDRP.ResultsAll 150 participants adhered to the program for 90 days. The analysis was performed on participants and represented as mean ± standard deviation (mean ± SD). At the end of SDRP, a significant reduction in HbA1c level, FBS, and weight was observed as compared to the control group. The results showed that Hba1c levels dropped from 9.0 ± 1.5% to 7.1 ± 1.3% with a mean change of 1.9 ± 1.5%; FBS levels decreased from 178.3 ± 57.1 mg/dL to 116.1 ± 24.2 mg/dL with a mean loss of 62.2 ± 51.8 mg/dL, and the weight decreased from 76.7 ± 12.7 kg to 73.8 ± 11.8 kg with a mean weight loss of 2.8 ± 1.6 kg. The results also showed that participants between 20 to 35 years showed the highest drop in HbA1c, FBS, and weight.ConclusionThe findings indicate that a comprehensive and multi-interventional diabetes care program involving personalized nutrition, fitness, and lifestyle modification such as SDRP, help in significant and sustained improvements in HbA1c level, glycaemic control, and weight loss in adults with type 2 diabetes.

Trends in the relation between hyperglycemia correction and active Charcot neuroarthropathy: results from the EPICHAR study

IntroductionThe pathophysiology of Charcot neuroarthropathy (CN) remains unclear. There are a number of hypotheses but these are not exclusive. In its clinical presentation, this complication intersects with the semiology of...

Effect of high-intensity interval training protocols on VO2max and HbA1c level in people with type 2 diabetes: A systematic review and meta-analysis.

The effect of high-intensity interval training (HIIT) protocols according to different work intervals, session volumes and training periods has not been evaluated in patients with type 2 diabetes mellitus (T2DM). This was a systematic review and meta-analysis of the effect of HIIT and its different protocols compared to moderate-intensity continuous training (MICT) and the control group on VO2max and glycated hemoglobin (HbA1c) level in patients with T2DM. The search strategy considered studies published up to September 2020 in the databases MEDLINE (PubMed), EMBASE, Cochrane CENTRAL, Web of Science and SPORTDiscus. Two authors independently searched the selected databases for randomized clinical trials that compared HIIT to MICT or the control in adults with T2DM. A random-effects meta-analysis was performed and the data are presented as the mean difference (95% confidence intervals [95% CIs]) between HIIT, MICT and control groups. A total of 20 studies (738 participants) were included. Overall, HIIT increased VO2max by 5.09mL/kg/min (95% CI 2.99; 7.19, I²=80.89) versus the control and by 1.9mL/kg/min (95% CI 0.81; 2.98, I²=25.62) versus MICT. HIIT promoted a significant reduction in HbA1c level of -0.8% (95% CI -1.06; -0.49, I²=77.31) versus the control but with no difference versus MICT. Moderate-interval, high-volume and long-term training promoted a greater increase in VO2max. A long interval and moderate volume and period conferred a greater increase in VO2max versus MICT. A short interval and moderate volume and period conferred a greater reduction in HbA1c level versus the control. No publication bias was detected, as evaluated by a funnel chart and Egger's test (p>0.05). As compared with MICT, HIIT had better effect on VO2max and a similar effect on HbA1C level. Interval protocols, moderate to long training period and moderate to high volume may maximize the HIIT effect in patients with T2DM.

Effect of Exercise Instructions With Ambulatory Accelerometer in Japanese Patients With Type 2 Diabetes: a Randomized Control Trial.

This study aimed to investigate the effects of physical therapists’ exercise instructions in Japanese patients with type 2 diabetes. Thirty-six participants were recruited from the outpatient clinic at Matsushita Memorial Hospital, Osaka, Japan from June 2020 to September 2020 and were randomly assigned to either the non-intervention or intervention group. The intervention group received exercise instructions from physical therapists for 30 min at baseline (week 0) and at week 4 by referring to ambulatory accelerometer records. Laboratory parameters, physical activity, body composition, motor skill, and transtheoretical model were assessed in both the groups at baseline (week 0) and week 8. In week 8, patients in the intervention group had a statistically significant reduction in HbA1c levels compared with those in the non-intervention group (7.3% [6.8-%–7.9%] vs. 7.4% [7.3%–7.7%], P = 0.04). The number of steps per day (P = 0.001), energy expenditure (P = 0.01), lower extremity muscle strength (P = 0.002), and 6-min walk test results (P = 0.04) were significantly increased in the intervention group compared with those in the non-intervention group in week 8. The transtheoretical model varied between baseline (week 0) and week 8 only in the intervention group (P < 0.001). Thus, outpatient exercise instructions from physical therapists could improve glycemic control owing to physical activity by improving motor skills and changing the transtheoretical model in Japanese patients with type 2 diabetes.

Comparison of Efficacy of Glimepiride, Alogliptin, and Alogliptin-Pioglitazone as the Initial Periods of Therapy in Patients with Poorly Controlled Type 2 Diabetes Mellitus: An Open-Label, Multicenter, Randomized, Controlled Study.

BackgroundThe choice of an optimal oral hypoglycemic agent in the initial treatment periods for type 2 diabetes mellitus (T2DM) patients remains difficult and deliberate. We compared the efficacy and safety of glimepiride (GLIM), alogliptin (ALO), and alogliptin-pioglitazone (ALO-PIO) in poorly controlled T2DM patients with drug-naïve or metformin failure.MethodsIn this three-arm, multicenter, open-label, randomized, controlled trial, poorly controlled T2DM patients were randomized to receive GLIM (n=35), ALO (n=31), or ALO-PIO (n=33) therapy for 24 weeks. The primary endpoint was change in the mean glycosylated hemoglobin (HbA1c) levels at week 24 from baseline. Secondary endpoints were changes in HbA1c level at week 12 from baseline, fasting plasma glucose (FPG) levels, lipid profiles at weeks 12 and 24, and parameters of glycemic variability, assessed by continuous glucose monitoring for 24 weeks.ResultsAt weeks 12 and 24, the ALO-PIO group showed significant reduction in HbA1c levels compared to the ALO group (–0.96%±0.17% vs. –0.37%±0.17% at week 12; –1.13%±0.19% vs. –0.18%±0.2% at week 24). The ALO-PIO therapy caused greater reduction in FPG levels and significant increase in high-density lipoprotein cholesterol levels at weeks 12 and 24 than the ALO therapy. Compared to low-dose GLIM therapy, ALO-PIO therapy showed greater improvement in glycemic variability. The adverse events were similar among the three arms.ConclusionALO-PIO combination therapy during the early period exerts better glycemic control than ALO monotherapy and excellency in glycemic variability than low-dose sulfonylurea therapy in uncontrolled, drug-naïve or metformin failed T2DM patients.