View clinical trials related to Diabetes Mellitus, Type 2.
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To prospectively determine the burden of hypoglycemia (minutes spent below 70 mg/dl per day, measured by continuous glucose monitor (CGM)) among residents of long term care facilities (LTC) with a diagnosis of type 1 or type 2 diabetes including key clinical subgroups (living in skilled nursing facility (SNF) or nursing home (NH), on different hypoglycemic medications). This aim will be achieved by recruiting 300 residents with diabetes in 4 LTC facilities. All participants will undergo masked CGM for 10 days.
This Study aims to develop machine learning models with the ability to predict patients' BMI and complications after Bariatric Surgery (CABS-Score). This Study also aims to develop machine learning models with the ability to predict diabetic (DM II)patients' remission rate after Bariatric Surgery. The service mentioned above will be publicly available as a web-based application
The aim of this study is to evaluate the effectiveness of an online intervention for people with type 1 diabetes who present not optimal control of the disease.
This is a prospective, multicentre, unblinded, randomised, controlled trial. The primary aim is to assess a targeted screening strategy to detect undiagnosed heart failure in high-risk patients with diabetes.
The increasing prevalence of diabetes mellitus represents a major health problem, especially since around 40% of diabetic patients develop diabetic retinopathy, which severely impairs vision and can lead to blindness. This development could be prevented by annual check-ups and timely referral for treatment. However, there are major differences in the quality of examinations and bottlenecks in examination appointments. A solution to the problem could be the use of artificial intelligence (AI), especially deep learning. Initial studies have shown that deep learning algorithms can be used successfully to detect diabetic retinopathy. However, it remains to be clarified whether the use of AI can achieve a sufficiently high level of accuracy in the detection of retinopathies. Therefore, in the present study, the positive predictive value (PPV), the negative predictive value (NPV), the sensitivity (SEN) and the specificity (SPEZ) of the AI algorithm 'MONA-DR-Model' in the detection of diabetic retinopathy should be measured. In addition, it is to be examined how well the classification into mild and severe retinopathy corresponds and how well this new examination method is accepted by the patients.
Cerebral small vessel disease (CSVD) can lead to vascular cognitive impairment and dementia (VCID). The hallmark of CSVD is the appearance and progression of white matter hyperintensities (WMH) on MRI. The goal of this study it to recruit and follow individuals at risk for WMH progression and use serial MRI scanning to gain insights into the pathogenesis of CSVD.
Background: Post-transplant hyperglycaemia occurs frequently in renal transplant recipients within the first two weeks after transplantation. Standard-of-care is primarily based on insulin treatment with the adherent risk of hypoglycaemia and weight gain. Semaglutide produces an effective lowering of plasma glucose in diabetes patients with chronic kidney disease (CKD) and leads to a reduction in weight and the incidence of hypoglycaemia. The efficacy of semaglutide is untested in renal transplant recipients, and safety concerns remain, primarily on renal graft function. Objectives: The primary objective is to establish whether tablet semaglutide (Rybelsus) compared with placebo, both as add-on to standard-of-care, is non-inferior in regulating plasma glucose in patients with hyperglycaemia after renal transplantation. Secondary objectives aim to evaluate the effect of tablet semaglutide on renal graft function, weight, use of insulin, cardiovascular parameters and safety parameters (plasma semaglutide concentration, gastrointestinal side effects, dose of immunosuppressants). Design: An investigator-initiated, placebo-controlled, double-blinded, parallel-group, randomised trial. Population: Patients (n = 104) with post-transplant hyperglycaemia and an estimated glomerular filtration rate (eGFR) > 15 ml/min/1.73 m2. Methods: Participants diagnosed with post-transplant hyperglycaemia, 10 to 15 days post-transplant, will be randomised 1:1 to either 14 weeks of tablet semaglutide once daily or placebo both as add-on to standard glucose-lowering therapy. Participants will maintain weekly contact with the clinic during the first five weeks and at two to four weeks intervals during the remaining study period. During the trial, each patient will be monitored according to blood laboratory values with safety assessed at every visit by a nephrologist. Pre-prandial plasma glucose will be measured in the morning and evening to adjust glucose-lowering therapy after consultation with an endocrinologist. Double blinded continuous glucose monitoring (CGM) will be performed for 10-14 days from baseline and at weeks 5, 9, and 13. Primary endpoint: - Mean sensor glucose (mmol/L) evaluated by CGM Key secondary endpoints: - Incidence of hypoglycaemia - Body weight (kg) - Creatinine (μmol/L) - Daily insulin dose (IE per day) - Plasma concentration of semaglutide (nmol/L) - Blood concentrations of cyclosporine and tacrolimus (μg/L)
This phase 2 study will include patients suffering from type 2 diabetes mellitus and will first study their response to enteric coated aspirin at a dose of 80 mg per day for a 7-day period. Participants with an incomplete platelet inhibition after exposure to EC aspirin at doses of 80 mg once daily will be randomized to a random order of 3 different ASA regimens: EC ASA 162 mg once daily, EC ASA 81 mg twice daily and chewable ASA 40 mg twice daily. The aims are to determine the feasibility of a larger scale trial, and to determine the regimen associated with the lowest proportion of non-responders after randomization. Platelet function will be assessed at baseline and at day 7 of each arms of the study.
Introduction: Type 2 diabetes represents a growing health risk for the society. An easy-access and low-cost intervention for the whole family will be developed to help families with (at risk of) type 2 diabetes maintain diabetes-frendly everyday life. The intervention will be tested for feasibility. Methods: Following the framework for developing and conduct of complex interventions, the intervention will be developed on the basis of current evidence on family-based diabetes treatment and opinions of families with type 2 diabetes. The feasibility test will have embedded mixed methods one-group study design. Participants: Families will answer a brief screening questionnaire. Families (n=25) that consist of at least one adult with (in risk of) type 2 diabetes living in the same household with at least one 5-18 yeard old child, and at least one family member living sedentary lifestyle, will participate. Intervention: The 3-months long hybrid telehealth/face-to-face intervention with weekly 1-hour contacts with health professionals will deliver diabetes education and tailored support to implement more physical activity and healthy meals in the family everyday life. A 3-months long supervised maintenance phase with monthly professional contacts will be included. Outcomes: Feasibility evaluation will be conducted using quantitative (quantifiable) and qualitative research methods. The feasibility data will be the primary outcomes of the study, collected and evaluated using the predefined research progression criteria applied the green-amber-red method. Sociodemography and secondary outcomes, such as physical activity, dieting habits, daily occupations, occupational balance, health and quality of life will be assessed at baseline and 3 and 6-months follow-ups. The quantitative results will be comprehended through qualitative data from participant interviews which will nuance the feasibility evaluation. Analysis: Relevant statistical methods and qualitative analysis method will be applied. Expected results: The intervention will help families achieve sustainable lifestyle changes, e.g., diabetes stabilized blood glucose in adults with type 2 diabetes, increased physical activity time and improved dieting habits, for better family health and well-being. Ethics and dissemination: The trial does not have any obvious health risks for the participants. All the results - significant, non-significant and/ or inconclusive - will be reported.