View clinical trials related to Diabetes Mellitus, Type 2.
Filter by:Focusing on patients with diabetes complicated with pulmonary infection, the purpose of this study is: 1) to identify the epidemiology, etiologic spectrum and status of diagnosis and treatment; 2) to explore the lower respiratory microenvironment and host immune response and then make an application in clinic.
PRO-MENTAL is a non-interventional, prospective, observational study investigating longitudinal associations between diabetes distress, mental disorders, and glycemic outcomes in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). The study aims to determine mental health subtypes, trajectories, and patterns and to advance a precision medicine approach to improve mental health in people with diabetes through personalized care and interventions. A total of 1500 people with T1D or T2D will participate in the study, running over a 24-month period. Participants will be recruited at different levels of diabetes care including specialized centers and hospitals. The assessment includes a baseline assessment (clinical interview, questionnaire survey, and laboratory assessment) and four subsequent measurement time points - every six months - to a total period of two years. Each measurement time point includes an online questionnaire survey as well as a 14-day ambulatory assessment of daily mental and somatic variables (smartphone-based ecological momentary assessment (EMA) of daily sleep quality, mood, stress, and diabetes-related burdens/distress, as well as continuous glucose measurement (CGM) of daily glucose levels). The study uses precision monitoring to identify evidence-based subgroups of people with diabetes with regard to mental disorders/problems and glycemic outcome. Epidemiological data regarding prevalence and incidence rates of depression, anxiety, and eating disorders will be analyzed, and patient trajectories and patterns will be determined. The study also aims to shed more light on the mediating mechanisms between mental health and glycemic outcomes. The findings of the study will be used as the basis to develop a precision medicine approach with personalized interventions for specific sub-groups of people with type 1 and type 2 diabetes.
RADIANT is a network of 14 clinical sites and several laboratories dedicated to the study of atypical diabetes. The objective of this study is to define new forms of diabetes and the unique mechanisms underlying these forms of atypical diabetes. The specific aims are to: 1. Identify and enroll individuals and families with undiagnosed rare and atypical forms of diabetes. 2. Determine the etiologic basis of the metabolic disorder among individuals and families with novel forms of rare and atypical diabetes. 3. Understand the pathophysiology of individuals and families with novel forms of rare and atypical forms of diabetes.
In Canada, 3 out of 4 Canadians aged 65 and older have at least one chronic condition, while 1 in 4 seniors reported having three or more. Caring for complex patients who usually have multiple chronic conditions (MCC) is one of the biggest challenges facing our healthcare system. For patients, the lack of coordination and continuity of care as they transfer between healthcare settings and healthcare providers (HCPs) often results in a higher risk of readmission, suboptimal and fragmented care plans, delays in required medical intervention, inadequate self-care, and confusion on whom they should contact when they have questions. For the patient's care team, they often have no indication how patients are doing between clinic visits unless the patient can provide a log of their home measurements (e.g., blood pressure). Therefore, they are unable to detect and intervene if their patient's health is worsening between visits. In order to address this increasing need to bridge the current gap in clinical management and self-care of complex patients during their transition from healthcare settings to home care, our team aims to design, implement and evaluate the SMaRT (Safe, Managed, and Responsive Transitions) Clinic, a nurse-led integrated care model facilitated by telemonitoring (TM). Specifically, the SMaRT Clinics aim to meaningfully introduce a nurse (or nurse practitioner) role to improve clinical coordination across patient care teams and reinforce proper self-care education through the use of telemonitoring. This project will be conducted in two phases across four years; Phase I: Design and Development, and Phase II: Implementation and Effectiveness Evaluation. Phase II research activities include enrolling 350 patients with complex chronic conditions in the SMaRT clinics across four study sites. The implementation and effectiveness of the SMaRT clinics will be evaluated through a mix of semi-structured interviews, ethnographic observation, patient questionnaires, and analyses of health utilization outcomes using propensity-matched controls from the ICES provincial database.
This proposed study will test whether measurement of breath acetone (BrAce) can be used for the purpose of identifying ketosis (elevated ketones) in persons with type 1 diabetes (T1D). This is important for the potential use of sodium glucose co-transport inhibitors (SGLT2i) in persons with T1D.
the aim of the study is to obtain CGM data concomitant with OGTT and to determine what CGM metrics obtained in pregnant women with and without a high risk of GDM correlate best with the diagnostic OGTT (obtained via the 2-step and 1-step approaches).
Diabetes self-management support, education, and training are increasingly being delivered through digital technology such as mobile phones. This protocol aims to evaluate the effectiveness of GLOW, a diabetes companion app with a conversational agent.
One of the most common problems in people with diabetes (DM) and chronic kidney disease (CKD) is the high frequency of other coinciding medical conditions such as osteoporosis and frailty. Frailty in particular is very common in adults with DM and CKD and it can result in significant muscle weakness which can result in increasing difficulties with performing activities of daily life (ADL). This can lead to an increase risk for falls, bone fractures and increasing hospitalization. The investigators have showed that adults with DM and CKD who have frailty use hospital services more frequently, have reduced quality of life and difficulties with performing their ADLs1. There is some evidence that early screening for frailty and lifestyle interventions that focus on healthier eating and physical activity can help prevent frailty from getting worse. The study purpose is to develop and test a home-based lifestyle intervention program focused on optimizing diet and the ability to perform your ADLs in adults with DM and CKD. The goal of this program is to ensure that adults with DM can live healthier lives within the community.
Hypertension (HTN) has become the largest driver of morbidity and mortality (M&M) worldwide, affecting nearly 1 billion persons, the vast majority living in low- and middle-income countries (LMICs). While clinical research has identified highly-efficacious and inexpensive options to control HTN, rates of awareness, treatment and control of HTN are abysmally low. Implementation strategies that can effectively reach and engage patient populations while feasible within the constraints of frail health systems are urgently needed. In Peru, less than 10% of those with HTN are optimally controlled and thus avoidable M&M continues to increase at unacceptable levels. In the proposed ANDES strategy, ANDES research team will study a vulnerable, impoverished indigenous Andean population that has a high prevalence of HTN (18.5%) and Type 2 Diabetes (T2D) (7.4%); living at high altitude. The study has two phases: UG3/UH3. During the formative UG3 phase (ended 12/31/22) we completed 3 aims, including: a) adapting community-based service delivery models for detection/control of HTN/T2D using stakeholder-engaged approaches; and b) assessed short-term implementation and service outcomes of pilot Health Fairs to detect HTN/T2D and a CHW-led model for engagement and treatment of HTN/T2D in two communities. A number of stakeholder in-depth interviews revealed significant limitations to HTN control. Discrete Choice Experiments (DCEs) surveys helped understand attributes for a community health worker (CHW)-led HTN care program that patients would value. Human-Centered Design was used to refine CHWs manual prototype, frequency and content of training sessions on patients, training CHW, supervision and integration into the healthcare system; facility-based health worker training content and approaches; identified opportunities for CHWs to improve health care system by helping to promote hypertension diagnosis, treatment and control. All these activities were used to refine the protocol that was tested in the pilot study where 1,079 subjects underwent blood pressure monitoring under a Standard Operating Procedure using electronic tablets to construct a REDCap database. The UH3 phase will test the adapted ANDES strategy. ANDES is a two-arm, individually randomized superiority trial with parallel assignment. The overall objective of ANDES is to evaluate the effectiveness of a home-based Health Agent-led intervention in reducing blood pressure and improving diabetes control in patients from under-resourced communities in Puno, Peru. Potential ANDES study participants will be identified, screened, and recruited via 2 different mechanisms: 1) community health fairs and 2) healthcare facility-based enrollment. Health fair planning, will be conducted in collaboration with DIRESA & EsSalud and local healthcare facility leaders. All health fair attendees will be screened for blood pressure measurements. ANDES research study staff will do screening at tents in the health facilities after doctors refer patients (or for any patients to visit who want) to inquire about their willingness for an in-person screening visit at their home. Recruitment will be rolling over 24 months during which 1068 participants in total (534 participants per arm) will be enrolled. To detect a difference in systolic blood pressure of 2.5 mmHg between intervention and control arms with 95% confidence, 90% power and a standard deviation of 12 mmHg, ANDES research team would need 485 participants per arm. Assuming a conservative lost-to-follow-up of 10% at 12 months, ANDES research team would need to randomize 1068 participants in total (534 participants per arm). The primary outcome is to determine if the ANDES intervention impacts SBP in comparison to the usual care arm 12 months after randomization. ANDES participants will initiate one of two care pathways according to the randomization assignment. Participants in the usual care group will be referred to their local healthcare facility for evaluation and/or to receive medical therapy per typical standard of care and at the discretion of the treating physician for the entirety of the ANDES study. Participants in the ANDES intervention group will receive the ANDES implementation package consisting of health agent home visits for 12 consecutive months. Implementation package delivery will end after month 12, at which time intervention participants will be advised to obtain standard care from their local healthcare facility. Study outcome measures will be obtained in both the usual care and ANDES intervention group at months 12 and 18 post-randomization. All participants will receive visits at baseline, 12 and 18 months for study outcome assessments. Intervention participants will additionally receive a total of 12 visits by health agents as part of the intervention package, for a total of 18 visits for those assigned to the intervention group.
Type 1 diabetes mellitus (DM) is an autoimmune disease characterized by absolute insulin deficiency, defined as insulin-dependent diabetes mellitus and develops due to autoimmune damage of beta cells in the pancreas. Approximately 425 million people worldwide are diabetic patients, 5% to 10% of whom are T1DM. In the majority of type 1 DM prevention studies, the main aim is to stop beta cell destruction. Primary prevention studies aim to prevent or alter exposure to environmental stimuli before autoimmunity is developed. Secondary prevention studies address interventions in the autoimmune processes that cause betacell destruction. Tertiary prevention studies include interventions to stop or reverse beta-cell destruction after clinical diagnosis of type 1 DM. Despite all technological advances, type1DM has not shown a permanent improvement in metabolic control over the last 5 years. Breast milk provides protection against Type 1 DM through the prevention of diabetogenic infections, delaying exposure to diet antigens including cow's milk, and the ability to produce healthy intestinal microbiota. Xiao et al. (2018) published in Nature, investigated the effect of human milk oligosaccharides on non-obese diabetic rats, where it was found that it improved intestinal flora and insulitis scores and brought the blood glucose level closer to the optimum level. This study is expected to fill the gap in the literature about dose-dependent efficacy and placebo of breastmilk oligosaccharides in diabetic humans. This project will investigate 1) the possible contribution of 2-FL oligosaccharides to the disease's metabolic control 2) their effects on beta-cell preservation in the pancreas 3)their effects on intestinal microbiota 4) whether there is a doseresponse relationship as compared to placebo among type 1 diabetic children. This project is designed as a double-blind randomized placebo-controlled experiment lasting for 36 months. The proposed research population consists of 111 children aged 4-16-year-old who were diagnosed with Type 1 DM at the Department of Pediatric Endocrinology of Ege University. The sample size was calculated as 111 with an effect size of 0.33, an error of 0.05 and a power of 80% using the F-test group (for a numerical variable such as blood glucose) for 3 groups. It is planned that the two intervention arms consist of 37 volunteers and the placebo group of 37 volunteers. In the research, 1.5 g/day of human milk oligosaccharides will be supplemented in the first intervention group and 3 g/day for the second intervention group. The placebo group will receive maltodextrin as a placebo at a dose with no effect on metabolic control. Patients included in the study will be provided human milk oligosaccharides for 3 months and will be under follow-up for 12 months. All variables, mainly C-peptide, HbA1c, immunoglobulins, lymphocytes and faecal analysis will be examined. The project aims to ameliorate the microbiota profile, optimize C-peptide levels, reduce exogenous insulin dependence through the provision of 2-FL from human milk oligosaccharides and develop a more applicable, acceptable and an innovative method in the metabolic control of the disease. It is believed that the psychosocial and economic burdens of the disease will be reduced by increasing the metabolic control of the disease.