View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:Study of the response to SGLT2 inhibitors in type 2 diabetic patients with relevance to the erythropoesis and indexes of cardiorenal function. The study enrolls type 2 diabetic patients in whom the introduction of a SGLT2 inhibitor is deemed necessary as part of their routine treatment during their visit to our outpatient diabetes unit. A whole blood, a serum and a urine sample is obtained before and one month after the initiation of treatment with a SGLT2 inhibitor.
The investigators are conducting a pre-randomized controlled trial to assess the effect of a 6 month Produce Prescription intervention for patients enrolled in Medicaid who experience consistently uncontrolled Hemoglobin A1c (HbA1c). The study is conducted at Kaiser Permanente Southern California, a large and diverse integrated health care system that serves 4.7 million members. Eligible participants are members aged 18 or older, currently enrolled in Medicaid who were diagnosed with diabetes for at least 24 months and had at least two Hba1c measurements of 7.5% or higher in the past 12 months. Patients in the intervention arm may enroll in tele nutrition counseling. The study team will recruit a total of 450. Participants, will be pre-randomized into one of three arms, 1) high dose intervention arm, a 2) low dose intervention and 3) a usual care group to achieve 150 participants enrolled in each arm. Produce is delivered weekly for participants of both intervention arms. Participants randomized to the high dose arm will receive a greater amount per month of produce versus the low dose amount (for a family of 3-4, $180 per month versus $135 respectively). Foods are provided along with recipes. The amount of food delivered is adjusted for each additional family member for up to 5 family members. The primary outcome is change in hemoglobin A1c pre-intervention and 6 months after enrollment. Secondary outcomes include, food insecurity status, dietary intake and other patient reported outcomes related to barriers to healthy eating including family conflict and cooking habits.
Cardiovascular disease is a leading cause of death and disease in Chile. It explains 27.6% of the causes of death and 14% of disabled adjusted life years in the Chilean population. Low levels of physical activity and low levels of adherence to pharmacological therapy are major risk factors for cardiovascular disease in at-risk populations. This project will design and test the effectiveness of a mobile application based on gamification theory for improving cardiovascular disease control in a population of 900 primary care patients with moderate or high cardiovascular risk levels. A randomized controlled trial was designed to test the effect of the App in improving 30% of the levels of physical activity and adherence to pharmacological therapy and a significant reduction of 20% in cardiovascular risk levels.
Lipohypertrophy is swelling of the fatty tissue located below the skin ("subcutaneous tissue") where many patients with diabetes inject their insulin. Lipohypertrophy can sometimes be felt as firm swelling, lumps or small bumps near insulin injection sites. Previous studies have shown that injecting insulin into areas of lipohypertrophy can affect how insulin is absorbed, and can increase insulin requirements in patients. New data suggest that lipohypertrophy can be detected using ultrasound technology. The ultrasonographic presence of changes to the subcutaneous tissue without swelling that can be felt ("subclinical lipohypertrophy") and the effect of injecting insulin into these sites is unknown. 100 people will participate in the Phase 1 of this study. In the second phase of the study, 40 patients identified with subclinical lipohypertrophy in Phase 1 will be asked to participate in the randomized study using crossover design by checking your glucose levels.
The goal of this project is to test the feasibility, acceptability, and preliminary efficacy of an adolescent-mediated intervention designed to improve the glycemic control and self-care practices of a parent/grandparent. The preliminary impact of the intervention on adult glycemic control (HbA1c) and self-care behaviors, as well as adolescent risk factors, will be explored with the goal of informing future programs that can be scaled to reduce diabetes burden and eliminate health disparities among at risk, ethnic minority groups.
The overarching aim of this proposal is to test the efficacy of financial incentives in improving HbA1c, blood pressure, and quality of life in food insecure adults with poorly controlled type 2 diabetes. Using a clinical trial design, the investigators will randomize food insecure adults with type 2 diabetes to one of three financial incentive structures in combination with monthly mailings that will include diabetes education, healthy recipes, and meal planning resources.
The transplant of the insulin-producing cell into the liver (Islet transplant) has been proven an effective and valuable treatment for type 1 diabetics patients with poor blood sugar. However, Islet transplant is currently limited by the number of pancreas organ donors and the need for lifelong medication requirements such as antirejection drugs. The investigators have learned that Regulatory T cells (Tregs), a small subset of a cluster of differentiation 4+ (CD4+) T cells, have emerged as the major contributor to self-tolerance by preventing the initiation of unwanted immune activation and by suppressing ongoing immune responses to limit bystander tissue destruction. It has been suggested that infusion of Tregs before extensive graft damage may improve long-term graft outcomes. In this trial, we propose to study Analogous cryopreserved PolyTregs (cePolyTregs). cePolyTregs is a product with the same in vivo functionality to that of the non-cryopreserved PolyTregs.
A two-arm non-blinded randomised feasibility protocol trial designed to assess the feasibility, safety, and acceptability of an intermittent low energy diet (ILED) vs best National Health Service (NHS) care in women with gestational diabetes and obesity in Greater Manchester.
Type 2 Diabetes Mellitus (T2DM) affects over 30 million Americans and requires patients to competently manage their conditions at home. However, the majority of diabetes self-management education (DSME) and aftercare print materials remain overly complicated, with excessively high reading difficulty and fall short in supporting functional readiness for self- management at home, especially for the 18% of U.S. adults unable to read beyond a second-grade level. This project will determine the feasibility of implementing assistive reading technology, designed for patients with limited print or English proficiency, that will immediately expand patient capacity to understand DSME materials, increase T2DM self- management adherence and eventually reduce, at a scale, disparate outcomes in a chronic disease. It will use a small pilot trial design of the GogyUp Reader app to use with print materials versus print materials with no app support and test effects of GogyUp on three-month follow-up measures of health literacy (primary outcome) using the Health Literacy Questionnaire subscales 9 (Understanding health information well enough to know what to do") and 2 ("Having sufficient information to manage my health"); and on three-month follow-up self-reported diabetes management (secondary outcome) using the Perceived Diabetes Self-Management Scale (PDSMS).
The overarching goal of this study is to decrease disparities and increase access to continuous glucose monitoring (CGM) for patients with diabetes, regardless of where people receive their diabetes care. This study aims to evaluate the effectiveness of three implementation strategies for CGM in primary care practices in an efficient, sustainable, and scalable fashion. The investigators will also perform economic analysis of the implementation strategies. This 3-year study will compare practices that implement CGM with (a) an evidence-based educational module only, (b) an educational module plus practice facilitation support, or (c) a virtual CGM initiation clinic for patients. There will be up to 30 practices in each group for a possible total of 90 primary care practices. The investigators expect to enroll up to 500 patient participants across these 90 practices and to compare outcomes among patients from each study arm. This comparison will help investigators to understand the different implementation strategies and their ability to help primary care practice adopt, implement, and maintain CGM for their patients. The information the investigators collect will also help to understand how patients in these primary care practices experience initiation and use of CGM. The results will help to develop strategies and tools to train more primary care practices to offer CGM more widely to patients for whom it is recommended, especially for those where access to specialty care is limited.