View clinical trials related to Diabete Mellitus.
Filter by:The primary objective of this clinical trial is to assess the clinical efficacy and safety of the Buyuan Zhixiao Formula in treating elderly patients with diabetes and multiple metabolic disorders exhibiting symptoms of renal deficiency and blood stasis. Furthermore, this study aims to intervene in high-risk factors to prevent arteriosclerosis and to investigate the clinical efficacy of the Buyuan Zhixiao Formula in the prevention and treatment of cognitive impairments. The main questions it aims to answer are: 1. What are the clinical effects of Buyuan Zhixiao Formula, including lowering blood sugar, lowering blood pressure, lowering lipids, and treating obesity? 2. Can Buyuan Zhixiao Formula improve cognitive impairment in diabetes? Researchers compared Buyuan Zhixiao Formula with a placebo (a drug that looks similar but contains only 10% of the active ingredients) to see if the drug Buyuan Zhixiao Formula can treat elderly people with diabetes and multiple metabolic disorders. Participants will: 1. Take the drug Bu Yuan Zhi XiaoFormula or placebo every day for 6 months；Follow-up for 6 months； 2. Check fasting blood sugar and 2-hour postprandial blood sugar every month; check HbA1c, blood lipids, vascular function, and cognitive impairment serum markers every 3 months; 3. Conduct scores on TCM symptoms, cognitive ability, nutritional status and other scales and adverse events; 4. Urine and serum samples were collected before and after treatment;
This study is designed as a double-blind, placebo-controlled, parallel series randomized trial aimed at verifying the effiicacy and safety of a local calcium-sulphate bio-absorbable antibiotic delivery (tobramicina+vancomicina) versus placebo (calcium-sulphate matrix without antibiotics) in patients with diabetic foot osteomyelitis treated with surgical procedures.
Objectives The aim of this intervention is to assess how well and how efficiently the O2O Service Model works in delivering primary healthcare and managing chronic diseases for patients living in Pyeongchang-gun at the local government level. Trial design This is a randomized controlled trial with restricted, batch, blocked and individual random assignment. Investigators will allocate 1,000 participants from Pyeongchang-gun into two groups: one with diabetes (and pre-diabetes) and one with hypertension (including borderline cases), focusing on poorly controlled patients. As participants visit local health centers, their data will be sent to the research team for blocked randomization based on disease type, severity, and region. Assignment results will be communicated back to the centers and patients. Study setting The intervention will take place in Pyeongchang-gun, Kangwon-do, South Korea. The Smart Healthcare Center affiliated to Public Medical Center of Pyeongchang will primarily manage the O2O service by providing necessary education and human resources while receiving and monitoring data from each participant and local medical centers. The overall study (including the design of trial) is managed by Seoul National University College of Medicine while the provision of O2O service and data collection are primarily in charge of Smart Healthcare Center of Pyeongchang. Intervention in O2O Service Model: After initial health exams, each patient gets a custom care plan, classifying their disease and care level. The Pyeongchang Smart Healthcare Center, with doctors, tracks patients via an online platform, sending automated health messages. High-risk patients receive a two-week glucose monitor and guidance on lifestyle adjustments. Doctors access patient health records through the participant's personal online datastore (POD), with consent, integrating health and prescription history from national insurance, and can assess heart disease risk. Sample size The trial's sample size is determined using the MDES(Minimum Detectable Effect Size), with 1,000 participants divided equally between diabetes and hypertension groups. Each group is then split into treatment and control subgroups through random allocation. The MDES calculation, accounting for an explained outcome variation of 50% due to blocking and controls, and based on 500 subjects per group with equal allocation, aims for a high-accuracy effect size of 0.216 at a 5% significance level and 80% power. Assignment of interventions: allocation Participants will be randomly placed into groups by a computer program. This study uses a specific randomization method that is restricted and organized by individual characteristics. The research team will tell the centers and patients about their group assignment via phone and email. Neither the healthcare staff nor the participants will know the group allocation beforehand. The research team is in charge of the randomization process and informing everyone involved. The staff at Pyeongchang's Smart Healthcare Center will sign up participants and manage their placement into the assigned intervention groups. There will be no blinding after participants are assigned to their groups. List of Data For the study, the investigators have created questionnaires and interview formats to collect various data types, including random assignment records, baseline information, outcomes, service usage and costs, demographic and health details, physician-collected health records, life-log data from apps or web, clinical exam results, and service effectiveness and efficiency from the perspective of medical staff and administrators. Statistical methods For the analysis of primary and secondary outcomes, the investigators will employ ITT(Intention-to-Treat) and Regression-Adjusted Impact Estimate. When data allows (especially data from control group), the investigators will also conduct timeseries effect analysis. To investigate the time-series changes in program effects across multiple time points, the dependent variable (outcome variable) should be measured at each time point to estimate program effects repeatedly. Data management and monitoring The data management for the study will be conducted using electronic systems for secure and accurate data entry, coding, and storage, with robust checks and backups to ensure data quality, which will be archived for three years in compliance with bioethics standards before disposal according to privacy regulations. Participant confidentiality is prioritized through secure data collection and restricted access, with sharing only to authorized research team members and regulators using password protection or encryption. Additionally, a dedicated Data Monitoring Committee will oversee trial progress and adherence to protocols, while the Smart Healthcare Center collaborates with healthcare workers to manage patient services, with minimal adverse events expected.
The prevalence of Diabetes Mellitus (DM) in the world is currently around 9.3% of adults aged between 20 and 79 years, which corresponds to 463 million people living with DM, and about 80% of these people are found in developing countries. In Brazil, fourth in the number of patients with Type 2 Diabetes Mellitus (DM2) in the world, the prevalence of DM is around 12%, with a significant increase in the last three decades. Non-adherence to DM treatment is known as a problem in the scenario and internationally, as it impairs the physiological response to the disease, increasing the direct and indirect cost of treatment. Pharmaceutical care is a practice model characterized by the provision of pharmaceutical services that optimize treatment, improve the process of medicines used, and aim at their best use. With the calamity situation arising from the COVID-19 pandemic created in the state of Rio Grande do Sul, the Pharmaceutical Telecare service was implemented. Dapagliflozin was recently incorporated into the Brazilian public system for the treatment of type 2 DM. Considering that there are no studies in Brazil to date on the use, treatment adherence, and problems related to pharmacotherapy (PRM) associated with dapagliflozin, and also considering that the guidance and monitoring of patients remotely have become more frequent and necessary, the purpose of this protocol is to describe a clinical trial that will evaluate the impact of a pharmaceutical telecare service in aspects related to treatment adherence, disease control, and costs, offered to people with DM2 using dapagliflozin. The hypothesis that will be tested is that Pharmaceutical Telecare can be as effective as standard care for type 2 diabetes and assess the associated costs related to teleconsultation in public health settings.
incidence of AKI in diabetic patients seems to be influenced by multiple risk Factors like severe infections, elderly, poor diabetic control, previous AKI, chronic kidney disease and drugs like SGLT2-I increase risk of AKI in diabetic patients.
Low mobility is a mediator for poor outcomes of hospital care. Wearable devices will be used and 2-way texting via patient smartphones to monitor patients' physical activity during hospitalization with and without gamification to improve patient adherence to existing guidance on recommended activity. After discharge, investigators will assess patient care utilization (SNF, inpatient vs home rehab, ED visits, readmission) and conduct validated surveys on patient function at 30 days after discharge.
The main objective is to evaluate the effectiveness of a continuing education program on the Knowledge, Attitudes and Practices of primary health care physicians towards a high quality of diabetes care in Aseer region, Saudi Arabia.
The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.