Diabetic Retinopathy

Researchers are evaluating an AI-assisted digital health tool called the "Smart family doctor" to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted "Smart family doctor" app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the intervention's impact over the 6 months.

This research aims to understand how daily movement patterns affect glucose control in adults aged 25 to 50 with type 1 diabetes mellitus (T1DM). Despite the use of continuous glucose monitors, managing blood sugar levels remains challenging, and this study focuses on the combined impact of physical activity, sedentary behavior, and sleep on glucose stability and cardiometabolic health markers. Participants will wear an Actigraph accelerometer for 14 consecutive days to track their 24-hour movement behaviors. Alongside, they will use their own continuous glucose monitor to provide daily glucose data. Additional information will be collected through an online questionnaire, a food diary, and a single visit to a study center for measurements such as blood pressure, weight, and waist and hip circumference. During the study, researchers will evaluate glucose control through measures like time in range and coefficient of variation, as well as cardiometabolic health markers including blood pressure and cholesterol levels. The study is observational and will gather data over approximately one year to inform future interventions that support healthy daily movement behaviors in adults with T1DM.

Researchers are evaluating the first use of a new imaging technology called 4D Microscope Integrated Optical Coherence Tomography (4D MIOCT) combined with a Zeiss Artevo 800 surgical microscope during eye surgeries. This study focuses on adult patients undergoing clinically indicated surgery for various eye diseases, aiming to assess how easy the system is to use, its safety, and how well it visualizes the eye's structures during both front and back segment procedures. The study involves using the investigational 4D MIOCT device integrated into the Zeiss Artevo 800 microscope to capture detailed images of the eye during surgery. This imaging is performed in the operating room as part of the standard surgical care, with no additional treatment or interventions added. Up to eight patients may be enrolled, and images will be taken of one or both eyes during surgery to observe normal and abnormal microanatomy, as well as track any injections under the retina. Participants will have their eye imaged during surgery, and researchers will collect related clinical data and previous eye care records for comparison. The images and data will be analyzed after surgery to explore new details captured by the 4D MIOCT system. Researchers will measure ease of use, surgical workflow impact, and the presence of normal and abnormal microanatomy based on the images. There is no extra risk beyond the usual surgery, and no new medications or procedures will be performed solely for research purposes.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called "diabesity," a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index (BMI) and diabetes or glucose intolerance status. Groups include individuals with BMI ≥ 35 kg/m2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kg/m2 and BMI between 27 and 35 kg/m2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups: one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are conducting a Phase I clinical trial to compare the bioavailability and safety of different forms of SHR-3167 injection in healthy adults between 18 and 55 years old. This study aims to understand how the drug is absorbed and processed in the body, focusing on the maximum plasma concentration and overall exposure to the drug over time. Participants will receive one of three different specifications of SHR-3167 injection in a randomized, parallel, and open-label design. The study will monitor the drug's levels in the blood from Day 1 through Day 71, including measurements such as maximum concentration, area under the curve, time to reach maximum concentration, and half-life. Safety will be assessed by tracking any adverse events and immune responses during this period. During the study, participants will undergo physical exams, vital signs checks, ECGs, chest X-rays, and laboratory tests to ensure health status. Blood samples will be collected multiple times to analyze drug levels and antibodies. The study lasts about 71 days, with continuous monitoring for safety and drug behavior. Participants must comply with study procedures and provide informed consent before joining.

Researchers are evaluating enicepatide, a drug that acts on two receptors related to blood sugar and weight control, for its effects on weight management in people with obesity or overweight who also have Type 2 diabetes mellitus (T2DM). This Phase III study compares multiple doses of enicepatide to a placebo to assess both effectiveness and safety over a long period. Participants will be randomly assigned to one of four groups: three different dosing regimens of enicepatide or a placebo. Both enicepatide and placebo are given once weekly using an integrated drug-device combination product. The study uses a double-blind design, so neither participants nor researchers know who receives the active drug or placebo. Treatment lasts for 72 weeks, allowing detailed assessment of changes over time. Throughout the study, participants will regularly have their body weight measured to track percentage change from baseline, along with many other health indicators including blood sugar levels, cholesterol, blood pressure, and quality of life surveys. Safety will also be closely monitored through assessments of adverse events and specific health questionnaires. The total participation period extends through 72 weeks of treatment and follow-up to observe long-term effects.

Researchers are evaluating if the drugs Empagliflozin and Semaglutide, alone or combined, can improve blood sugar control by increasing time-in-range in adults with Type 1 Diabetes who use Automated Insulin Delivery (AID) systems. This study also monitors the safety of these drugs in this setting. It is a randomized, double-blind, placebo-controlled Phase 3 crossover trial designed to compare the effects of these treatments in the same participants. Participants will receive four different treatment combinations through a crossover design: semaglutide injection plus empagliflozin tablet, semaglutide injection plus placebo tablet, placebo injection plus empagliflozin tablet, and placebo injection plus placebo tablet. Semaglutide is given by weekly subcutaneous injection with a 12-week dose escalation period to reach a stable dose. Empagliflozin or its placebo is taken daily by tablet. Washout periods between treatments help avoid carryover effects. During the study, participants will use their personal AID systems continuously while researchers collect continuous glucose monitoring data to measure time-in-range and other blood sugar outcomes. Questionnaires will assess diabetes distress and treatment satisfaction after each intervention period. Safety is closely monitored throughout, including tracking adverse events and providing rescue medications for low blood sugar. The entire participation involves multiple treatment periods with careful monitoring and data collection.

This research aims to find out if the weekly medication tirzepatide can help adults with type 1 diabetes use their insulin pump more easily by reducing or stopping the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, but counting carbs is challenging and stressful. Tirzepatide, approved for type 2 diabetes and weight management, may lower appetite, slow digestion, reduce insulin needs, and smooth blood sugar rises after meals in type 1 diabetes as well. The study includes 105 adults with type 1 diabetes, all using the Tandem Control-IQ insulin pump paired with the Dexcom G7 continuous glucose monitor. Participants are randomly assigned to two groups: one receives weekly tirzepatide injections with gradually increasing doses for 12 weeks, then stops counting carbs for the last 6 weeks while continuing tirzepatide; the other group continues usual therapy, counting carbs throughout. Both groups use the same insulin delivery system and receive training and monitoring. Participants attend clinic visits, complete remote follow-ups, and undergo lab tests, with some also having heart and body composition assessments. Researchers monitor glucose control, insulin use, weight, metabolic markers, meal patterns, and quality of life. The main outcome is whether glucose control without carb counting is as good as with standard care. Safety is closely watched due to possible side effects like nausea and rare risks such as gallbladder disease. The study lasts 32 weeks and aims to see if tirzepatide can simplify diabetes care safely.

Diabetic Macular Edema (DME) is a complication of diabetes that causes swelling in the central part of the retina, leading to vision loss. This condition results from changes in the small blood vessels of the retina, causing leakage and retinal thickening, often linked to increased levels of vascular endothelial growth factor (VEGF). DME is a common cause of blindness in people with diabetes, and it is especially significant in Bangladesh due to the high number of adults living with diabetes. This study compares the effectiveness and safety of two treatments for DME: a proposed biosimilar of Ranibizumab and Lucentis, both given as 0.5 mg injections into the eye every four weeks. A total of 70 adults with DME will be randomly assigned to receive one of these treatments in three doses over eight weeks. Safety visits will occur 48 hours after each injection, and the study concludes with an evaluation visit at week 12. Participants will undergo vision tests and imaging of the retina at the start and end of the study to measure changes in visual acuity and retinal thickness. Safety will be monitored throughout with follow-up visits shortly after each injection. Researchers will track how many patients maintain or improve their vision and assess any side effects. The total participation time for each patient is approximately 12 weeks.