Diabetes Paid Clinical Trials in New York

This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness. Read Less

To assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment. Read Less

Rationale: The accrual of data from the laboratory and from epidemiologic and prevention trials has improved the understanding of the etiology and pathogenesis of type 1 diabetes mellitus (T1DM). Genetic and immunologic factors play a key role in the development of T1DM, and characterization of the early metabolic abnormalities in T1DM is steadily increasing. However, information regarding the natural history of T1DM remains incomplete. The TrialNet Natural History Study of the Development of T1DM (Pathway to Prevention Study) has been designed to clarify this picture, and in so doing, will contribute to the development and implementation of studies aimed at prevention of and early treatment in T1DM. Purpose: TrialNet is an international network dedicated to the study, prevention, and early treatment of type 1 diabetes. TrialNet sites are located throughout the United States, Canada, Finland, United Kingdom, Italy, Germany, Sweden, Australia, and New Zealand. TrialNet is dedicated to testing new approaches to the prevention of and early intervention for type 1 diabetes. The goal of the TrialNet Natural History Study of the Development of Type 1 Diabetes is to enhance our understanding of the demographic, immunologic, and metabolic characteristics of individuals at risk for developing type 1 diabetes. The Natural History Study will screen relatives of people with type 1 diabetes to identify those at risk for developing the disease. Relatives of people with type 1 diabetes have about a 5% percent chance of being positive for the antibodies associated with diabetes. TrialNet will identify adults and children at risk for developing diabetes by testing for the presence of these antibodies in the blood. A positive antibody test is an early indication that damage to insulin-secreting cells may have begun. If this test is positive, additional testing will be offered to determine the likelihood that a person may develop diabetes. Individuals with antibodies will be offered the opportunity for further testing to determine their risk of developing diabetes over the next 5 years and to receive close monitoring for the development of diabetes. Read Less

The goal of this study is to compare the impact of a SMART ((specific, measurable, attainable, realistic, or timely) Goal setting protocol on body weight, metabolic parameters (Hemoglobin A1c, lipids), diet quality and physical activity frequency in obese children with prediabetes in the outpatient setting. The main question is if participants using the SMART Goal Setting Protocol (SGSP) will have a significant reduction. The participants randomized to the study group will receive the SGSP, consisting of the SMART Goal Selection Guide (SGSG) and Weekly Goal Monitoring Tool (WGMT), in BMI Z-score, A1c, and dyslipidemia in 6 months compared to controls. Read Less

Patient Power is a patient research network and database (registry) to collect prospective information about demographics, self-reported diagnoses and medications, and willingness to participate in research from participants with rheumatoid arthritis (RA), spondyloarthritis (SpA), other musculoskeletal conditions, chronic neurological conditions like migraine, chronic pulmonary conditions like Chronic Obstructive Pulmonary Disease (COPD), asthma, autoimmune dermatological conditions such as psoriasis, and other chronic inflammatory or immune-mediated conditions. In addition, since patients with chronic conditions often have other co-morbidities like cardiovascular health and obesity-related metabolic disorders, these conditions will also be included. Participants will provide information from their smartphones or personal computers. The information will be used by researchers and clinicians to help patients and their providers make better, more informed decisions about treatment of chronic conditions. Read Less

This clinical trial develops and tests a culturally-appropriate educational program (Indigenous SIPin) for reducing sugar-sweetened beverage consumption in men affiliated with Native American athletics communities. Sugary drinks are drinks like pop, soda, and juice. Increased sugar consumption may lead to an increased risk of chronic diseases, including obesity, diabetes, some types of obesity-related cancers, coronary heart disease, hypertension, and dental decay. A culturally sensitive program may help reduce sugar-sweetened beverage consumption in Native American men Read Less

Eligible older adults with Type 2 Diabetes-Mild Cognitive Impairment (T2D-MCI) will be provided a Continuous Glucose Monitoring (CGM) device and asked to share CGM data with their care partners for daily decision-making for diabetes self-management. After 2 weeks, individual interviews will be conducted in 20 participants (10 dyads). Older adults with T2D-MCI (n=10) and their care partners (n=10) will be interviewed separately to identify key features of the Care Partner-Assisted Intervention through linking continuous glucose monitoring and Mobile Health (CP-CGMH) app. Read Less

This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes. Read Less

This research study is called 'PRenatal and Obstetric Maternal Exposures and ISlet Autoantibodies in Early Life: The PROMISE Study'. The purpose of this study is to find out more about how exposures during pregnancy, such as having an infection, diet and growth may impact later risk of type 1 diabetes (TID) and islet autoimmunity in the child. We are also interested in finding out more about why having a father or sibling with T1D increases risk of autoimmunity in the child more than having a mother with T1D. We are enrolling women who are pregnant and either have T1D or another first degree relative (father or full sibling) of the baby has T1D. The biological father is also invited to enroll in study, as it is important to understand how the father's health and genetics may contribute to the child's risk of developing T1D. The study procedures for the mother, father and baby are explained below. Mother: Pregnant women will be asked to complete a visit once per trimester (3 visits) during pregnancy and one visit up to 12 weeks after delivery. At each visit, mothers will consent to a blood draw, collection of biological samples and the completion of questionnaires. . Mothers who have T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data. Father: The (biological) father will be invited to enroll in a single visit. He will consent to a blood draw and completion of questionnaires. Fathers with T1D will also be asked to download any diabetes device data they have, such as continuous glucose monitor or insulin pump data. Baby: The baby will have blood collected at birth to determine the genetic risk for T1D. Families will consent to the completion of questionnaires about growth, health and diet at 6, 12, 18 and 24 months of age and between 5-7 years of age, and to complete blood testing for islet autoantibodies at 24 months and between 5-7 years of age. For those children with a high genetic risk score, we will also collect blood for autoantibody testing at 6, 12, and 18 months of age. Read Less

The purpose of this study is to evaluate whether placing stent(s) for a blockage in a leg vein will help improve the healing of diabetic foot ulcers (DFU). The investigators know from having taken care of many patients with diabetic foot ulcers that it is a major cause of disability and amputation. These diabetic foot ulcers frequently heal slowly or not at all. They sometimes become infected and require antibiotic therapy, debridement and amputation. The investigators normally take care of a diabetic foot ulcer with a combination of local wound care, surgical debridement if necessary, antibiotics if there is an infection, and reduction of pressure on the area of the foot with the ulcer. The investigators observed that some patients with a diabetic foot ulcer also have a blockage in a major leg vein referred to as the iliac vein. This blockage in the iliac vein prevents the proper flow of blood from the leg. This blockage results in pressure within the leg veins leading to swelling in the legs which may also prevent healing of the diabetic foot ulcer. This study will investigate whether placing stent(s) to treat the blockage(s) will improve healing of the diabetic foot ulcer and reduce some of the complications associated with a diabetic foot ulcer. The results of this study could result in a new treatment that will allow future patients with diabetic foot ulcers to heal better. Right now, placing stents for these blockages in the iliac vein is not the standard of care treatment for a diabetic foot ulcer. In order for us to determine whether stent placement is helpful, the researchers will have to randomize each patient. In other words, to reduce bias, patients will be assigned either to a group receiving a stent or to a group not receiving a stent. Every patient in both groups will receive the standard of care for a diabetic foot ulcer and undergo an x-ray with contrast and intravenous ultrasound examination of the legs. The standard of care for a diabetic foot ulcer may include local wound care, antibiotic therapy, debridement and/or amputation, and pressure offloading in the foot. Read Less

In a randomized trial of 255 participants with early-stage T2D, participants will be randomized with equal allocation (n=85 each) to 1 of 3 groups: Standardized, Personalized, or a Usual Care Control (UCC). Read Less

This study will conduct a two-arm randomized controlled trial to test the efficacy of a culturally tailored version of the NYU Caregiver Intervention (NYUCI) plus enhanced support (ES) through online chat groups (the NYUCI plus WeChat/Kakaotalk [population social media app for Chinese/Korean] peer support which we call the NYUCI-ES in reducing health risks for cardiometabolic disease among older Chinese and Korean American adults caring for relatives with ADRD. In collaboration with community organizations across the New York and northern New Jersey metropolitan area, we will enroll 300 caregivers of people with ADRD (150 Chinese and 150 Korean) in this study. Aim 1: Develop culturally adapted informational and educational materials about dementia and caregiving issues for social service providers of the intervention and for family caregivers. Aim 2: Test the hypothesis, H1: A counseling and support intervention (the NYUCI-ES) will significantly improve psychosocial factors such as depression, stress self-rated health and chronic disease management among Chinese and Korean-American ADRD caregivers and these changes will be mediated by improvement in social support. H1a: By the first (6- month) follow-up, the mediators (increases in social support, stress reaction) will improve significantly in the intervention group compared to baseline values and the control group. H1b: These improvements will be maintained, and lead to reduction in depressive symptoms, and improvement in self-reported health and chronic disease self-management by the 12-month follow-up compared to the control group. Aim 3: Test the hypothesis, H2: the NYUCI-ES will reduce biologic risk factors, including metabolic health (glycosylated hemoglobin) and inflammation (Oxidative stress, lipid metabolism, etc.) within 6 months of enrollment compared to baseline and a control group; these changes will be mediated through increases in social support and decreases in depressive symptoms and will be maintained at the 12-month follow-up. The public health significance of these findings will likely have an impact on health care policy for CGs from diverse underserved ethnic and cultural backgrounds, potentially reducing morbidity, and improving their quality of life. Read Less