Journal of Drug Delivery and Therapeutics (JDDT)
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Independent Analysis of Clinical Trial Data: GS1 Continuous Glucose Monitoring System (CGMS) in Pediatric Diabetes Management
No full textBackground: Diabetes mellitus poses significant challenges in pediatric populations, necessitating advanced glycemic monitoring technologies. This study presents an independent analysis of the GS1 Continuous Glucose Monitoring System (CGMS), originally developed by Shenzhen SiSensing Co., Ltd., and provided by its Turkish partner, BMED Pharmaceuticals. The analysis evaluates the efficacy, safety, and usability of the GS1 CGMS in pediatric patients aged 3 to under 18 years with diabetes mellitus.
Methods: This multicenter, prospective trial included 81 pediatric participants across three clinical centers in China: Beijing Children’s Hospital, Capital Medical University (Center 01); Shenzhen Children’s Hospital (Center 02); and Fujian Medical University Union Hospital (Center 03). Participants underwent 14 days of CGMS monitoring, with venous blood glucose measurements as reference. Key metrics included concordance rates within the 20/20% error range, Clarke and Consensus Error Grid analyses, and Mean Absolute Relative Difference (MARD%). Safety and usability were assessed through adverse event monitoring and participant feedback.
Results: A total of 79 participants completed the trial, achieving a 97.5% completion rate. Concordance rates were 93.9% across all glycemic ranges, surpassing predefined thresholds. Sensitivity and specificity for hypoglycemia detection were 97.6% and 87.3%, respectively, while hyperglycemia detection achieved 89.8% sensitivity and 97.0% specificity. The MARD% was 8.7%, consistently below the target of 18%. Usability scores averaged 95.3 ± 7.59, reflecting high satisfaction. Device-related adverse events, such as mild skin irritation, were self-limiting, and no serious adverse events were reported.
Conclusion: This independent analysis demonstrated that the GS1 CGMS offers high accuracy, safety, and usability in pediatric glycemic monitoring. These findings support its broader application in routine pediatric diabetes care. Future studies should explore long-term efficacy and comparative evaluations with other CGMS technologies.
Keywords Independent analysis, Continuous Glucose Monitoring (CGM), GS1 CGMS, Pediatric diabetes patient
Experimental animal models for gastric ulcer / peptic ulcer: An overview
Get PDFIn the present study we have discussed around sixteen different animal models used worldwide for the scientific research and new drug discovery. The main aim of the using experimental animal models in drug discovery is to establish and provide evidence for non-clinical \u27proof-of-concept\u27 for the safety, efficacy, and target of interest for specific drug molecules. Experimental preparations developed in one species for the purpose of studying phenomena occurring in another species. The use of experimental animal models serves to better understand the origins, pathology, and the overall nature of comparable diseases of humans being. Similarly, animal models perform duties for in the development of safe and effective treatments and cures of such diseases and/or associated symptoms. Experimental animal models for drug discovery and development have played a major role in the characterization of the pathophysiology of diseases and associated mechanisms of injury, drug target identification, and evaluation of novel therapeutic agents for toxicity, pharmacokinetics and pharmacodynamics activity. Through animal model researchers can perform experiments that would be impractical or ethically prohibited with humans. There are various animal models used for screening of uncountable therapeutic activities, in this review our main focus is animal models used for peptic ulcer. Peptic ulcer is one of the worldwide diseases where 10% of adults are affected by peptic ulcer once in their lifetime. The antiulcer models for drug development against gastric and duodenal ulcer studies are limited in number that has hindered the progress of targeted therapy in this field. Therefore, it is necessary to review the literature on experimental animal models that are used to screen agents with potential anti-gastric ulcer activity and describe their biochemical basis in order to facilitate their use in the development of new preventive and curative antiulcer drugs. There are many models used to induce ulcer such as pylorus ligation or it can be chemically induced by ethanol, NSAIDs (e.g. indomethacin) or many more. In this review paper, current in-vivo animal models of ulcers and the pathophysiological mechanisms underlying their induction, their drawbacks, as well as the challenges associated with their use have been discussed
DNA tetrahedron as nanoparticulated delivery system in combating diseases
Get PDFMany diseases suffer from drug resistance and nucleic acid cargo delivery. To optimize pharmaceutics and to enhance their efficiency of cellular uptake, DNA nanomaterial tetrahedrons, owing to their precise control in size, shape, excellent biocompatibility and cellular permeability, reduced cytotoxicity, good stability, ease synthesis and multiple sites for targeting design, have attracted attention for targeting cargos delivery. Their nanostructural binding efficiency with many cargos depends on their electrostatic attractions among free electrons of phosphate oxygen, sugar and base nitrogen. Self-assembled DNA tetrahedrons (DTs) alone also can regulate cellular processes to some extent, especially, on migration, differentiation, proliferation and autophagy, and their modifications with the attachment of aptamers, peptides, nucleic acids, antibodies, different low-molecular-weight drugs and other components, make them a novel targeted delivery system as effective nanomedicine. This review demonstrates the current progress of DTs towards their synthesis, characterization, biomedical applications, biodistribution, elimination and toxicity as possible nanoparticulated delivery system.
Keywords: Diseases; Drug resistance; DNA tetrahedron; nanoparticulated delivery system; Nanomedicin
Phytochemical investigation and evaluation of antihyperglycemic activity of Praecitrullus fistulosus fruits
Get PDFDiabetes mellitus [antihyperglycemic] is the endocrine metabolic disorder characterized by raised glucose level in the sanguine liquid of body i.e. blood serum due to disturbance of carbohydrate metabolism. In Diabetes mellitus extent of glucose is maintained by well know endocrine pancreatic secreted hormone fuel called insulin which help in metabolizing the glucose level by muscular utilization and other organ pathological activity. When the levels of insulin fall below the body desire it can to hyperglycemic condition. Antihyperglycemic therapeutic plant has an ability to restore abnormal pancreatic condition by increase of insulin, enhancement of body carbohydrate utilization. There are more than 400 reported plant species used an antihyperglycemic and antihyperlipidemic. Praecitrullus fistulosus is reported to contain polyphenols, flavonoids, ascorbic acid, tannin, alkaloid, saponin, phytosterol, diterpines, thiamin, and carotene that possess antidiabetic, antioxidative and anthelmintic activity. On investigation and understanding the cause of diabetes mellitus, had opened the large view for the treatment. Phytomedicine has considerably taken the prominent position for the treatment of many metabolic disorders. Biochemical studies concluded that Praecitrullus fistulosus extract shows alteration in blood glucose level and also Praecitrullus fistulosus improved the lipid profile and showed positive aspect on different parameter in diabetic control rats and it was noted that Praecitrullus fistulosus drug extract was effective and helped in controlling the BG level in Albino Wistar Rat Praecitrullus fistulosus is reported to contain polyphenols, flavonoids, ascorbic acid, tannin, alkaloid, saponin, Phytosterol, diterpines, thiamin, and carotene that possess antidiabetic, antioxidative properties. The aim of research is to evaluate and investigate the anti-hyperglycemic activity of Praecitrullus fistulosus fruit extract on Streptozotocin (STZ)-Nicotinamide induced diabetic rat.
Keywords: Antihyperglycemic, Praecitrullus fistulosus, Phytochemicals, Phytomedicin
Preterm Birth: A Review of Its Early Diagnosis and Prevention
Get PDFPreterm birth, a major global healthcare concern, is characterized by infants being born before completing 37 weeks of gestation. Accurate diagnosis and effective interventions are critical to managing this complex issue. This abstract provides an overview of the diagnosis and prevention of preterm birth, focusing on risk assessment, diagnostic techniques, and various interventions for mothers and newborns. The diagnostic process involves evaluating risk factors, clinical history, and the assessment of potential membrane rupture. Techniques such as speculum examination, the Nitrazine test, the Fern test, ultrasonography, and the Placental Alpha Microglobulin-1 test play vital roles in identifying membrane rupture and infection. Additional diagnostic markers include cervical ultrasonography and fetal fibronectin testing. Prevention strategies include lifestyle changes, maternal therapies, and antenatal interventions. Smoking cessation programs, low-dose aspirin, antenatal corticosteroid therapy, progesterone supplementation, magnesium sulfate, and antibiotic treatment are employed to reduce the risk of preterm birth. Cervical cerclage, another surgical intervention, is recommended in specific cases.
For preterm newborns, immediate and effective care is vital. This includes thermal care, early breastfeeding, infection prevention, and respiratory distress syndrome management. These interventions are crucial in reducing infant mortality and morbidity associated with preterm birth. Efforts to diagnose and prevent preterm birth are essential in improving the well-being of both mothers and their newborns. A comprehensive approach, combining accurate diagnosis and effective interventions, can make a significant impact in reducing the burden of preterm birth on healthcare systems and families.
Keywords: Preterm birth, infants, gestation, potential membrane ruptur
Prevalence of Thyroid Disorders and Reference Range of Thyroid Hormones among Pregnant Women in Bosaso City, Somalia: Cross-sectional Hospital Based Study University of Health Science Hospital (Prof Abdirisak Hospital)
No full textBackground: Thyroid dysfunctions are among the most prevalent of medical conditions, and considered the most prevalent disorders in women during pregnancy, and can adversely affect obstetric outcomes. The aim of this study was to determine the prevalence of thyroid disorders among pregnant women in Bosaso city, Somalia, and to initiate normal levels of thyroid related hormones
Materials and methods: This study was cross-sectional hospital-based study conducted at University of Health Science Hospital (Prof Abdirisak Hospital), Bosaso city, Somalia during the period of August 2023 to December 2023. a total of 250 pregnant women were included in the study. A total of five ml of whole blood was collected from each participant into sterile plain containers for thyroid hormones estimation. Estimation of thyroid hormones was done by using CLIA technique (Maglumi 800). The data was gathered using per-designed structural questionnaire and the SPSS 26.0 statistical software (SPSS Inc., USA) was used for statistical analysis.
Results: The overall prevalence of thyroid disorders were 33 (13.2%), 8% of them were hyperthyroidism and the rest 5.2% were hypothyroidism. The reference range for TSH, T3 and T4 were (0.07 mlU/L–4.14 mlU/L), (0.19 nmol/L–4.98 nmol/L), and (0.21 nmol/L–3.69 nmol/L) respectively.
Conclusion: This study concluded that there is a slightly higher frequency of thyroid dysfunction disorders among pregnant women.
Keywords: Thyroid function test, Thyroid dysfunction, T3, T4, TSH, Pregnant wome
Solid dispersion: application and limitations: Solid dispersion Application and limitations
No full textSolubility and dissolution rate are essential factors in the bioavailability of a drug. The drug must be well-soluble in water to have good bioavailability. Solid dispersion is among the most widely used and effective methods for increasing solubility and releasing inadequately water-soluble medications. Solid dispersion requires the choice of a suitable carrier for the right active pharmaceutical ingredients and the proper techniques for preparing solid dispersions. The reliable dispersion system is designed in various ways to achieve the goal and avoid the accompanying obstacles.
Keywords: solid dispersion, solubility, solvent evaporation, lyophilization, generation, method
Application of Sigma Metrics for Evaluating Analytical Performance of HbA1C Testing on D10- HbA1C Analyzer
Get PDFIn this study, analyzed HbA1C over a period of 6 months. Six Sigma improves the quality of process outputs by analyzing and eliminating the source of defects and reducing variability in manufacturing and business practices. In terms of clinical laboratory, the identification of test with low Sigma values (< 3σ) indicate that actions should be taken to improve analytic quality or the laboratory should use alternate methods and reagents. Our study showed methodologies for HbA1C is of world class performance achieving Sigma value ˃6, to maintain and improve this frequency of QC should be run as rule as per the westguard QC rule. Sigma metrics helps to assess analytical methodologies and augment laboratory performance. It acts as a guide for planning quality control strategy. It can be a self -assessment tool regarding the functioning of clinical laboratory. Using Six Sigma techniques, able to identify problem areas as well as recurring issues that affect the overall quality expectation of laboratory result.
Keywords: HbA1C, Six Sigma, Six Sigma value
Clinical study to Evaluate Safety and Efficacy of Boozidaan (Pyrethrum indicum) in the management of Niqris Muzmin (Chronic Gout)
Get PDFObjectives: The objectives of this study were to observe the Efficacy of unani pharmacopoeial formulation Boozidan (Pyrethrum indicum) for the management of Niqris Muzmin (Chronic gout) and to observe any concomitant and adverse effects of formulation.
Methods: This single blind, randomized and standard control clinical study was conducted between April 2021 to October 2021 for a period of 28 days. 60 patients diagnosed with chronic gout were divided into two groups, 30 Test group and 30 Control group. The test group was administered with 5g boozidaan in powder form once daily with water and the patients of control group were given tablet febuxostat 80mg once daily. Patients were followed up and improvements in subjective parameters were assessed weekly at 7th, 14th, 21st, and 29th day. Objective parameters were assessed at the baseline and at 29th day. The data obtained was subjected to statistical analysis.
Results: Both the test and control drug were effective in reducing Serum uric acid level, ESR and CRP levels. A significant improvement in subjective and objective parameters was observed in both test and control groups and no adverse effects were observed during and after the study.
However, the test drug had superior efficacy in reducing the objective parameters and it was statistically significant (p-value<0.0001).
Conclusion: Both Boozidaan and Febuxostat were safe and significantly effective in resolving the symptoms and signs of gouty arthritis and both have significant effect on reducing serum uric acid level.
Keywords: Boozidaan, Chronic gout, Niqris, Febuxostat, serum uric acid, unani medicin
Nanotechnology at Work: Hydrogel Drug Delivery Architectures
Get PDFHydrogels represent three-dimensional, interconnected networks known to absorb substantial amounts of H2O but at the same time, being insoluble in the aforementioned solvent. Their exceptional hydrophilic nature, biocompatibility and diverse therapeutic potential position them as highly promising biomaterials within biological and biomedical fields. These materials, on account of their innoxious innate characteristics and safe utilization, have garnered widespread acceptance across tremendous and diverse biomedical applications ranging from traditional therapies to state-of-the-art advancements. This extensive review incorporates a spectrum of varied types of hydrogels, elaborating on both their chemical, physical aspects and also throws light on the rheological, analytical and spectroscopic tools employed for their characterization. It also continues to elaborate on the various mechanisms of gelation for facilitating a better understanding of the topic under discussion. The review also discusses the different strategies which are substantiated in recent times to expand the utilisation of hydrogels. The primary intent of this review is to render a comprehensive understanding of hydrogels as an ideal drug delivery system to undergraduates, graduates, biomedical students and researchers across the globe. It also targets to unravel the fundamental, applied and general aspects of hydrogels, offering valuable insights to help individuals associated with multidisciplinary research and application spheres.
Keywords: Gelation, Biocompatibility, Cross-linking, Smart hydrogels, Polymerization, Architecture, Polymer networ