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NCT05348733
This is an observational study in people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who will be receiving finerenone. Kidneys filter extra water and waste out of the blood and make urine. CKD is a long-term, progressive, decrease in the kidneys' ability to filter the blood properly. In people with T2D, the body does not make enough of a hormone called insulin, or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. Finerenone works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys and the heart. By lowering their stimulation, finerenone reduces the risk of kidney disease progressively getting worse. Finerenone is available and approved for doctors to prescribe to people with CKD and T2D. Since it has only recently become available for these patients, there is a need for more information about the use of finerenone in the real-world setting. The main purpose of the study is to learn more about treatment patterns in people with CKD and T2D who just started or will start finerenone treatment as decided and prescribed by their doctor as part of their routine medical care. To answer this question, the researchers will collect data on: * Clinical characteristics (e.g., history of CKD and T2D, blood pressure, heart health) of the participants * Reasons for starting finerenone * Reasons for stopping finerenone early * How long participants have been taking finerenone (planned by their doctor compared to actual time it was taken) * Dosing of finerenone * Other medications used while taking finerenone The researchers will also collect data on medical problems (called adverse events) that the participants may have during the study. All adverse events are collected, even if they might not be related to the study treatment. Hyperkalemia, a medical term used to describe a potassium level in the blood that is higher than normal, is of special interest when finerenone is combined with some medications commonly taken to control blood pressure. Researchers want to know how often higher potassium levels occur, and when it leads to: * Stopping finerenone treatment too early * Dialysis (a medical procedure to filter the blood of extra water and waste) * Care in a hospital All data will come from medical records or from interviews study doctors will have with the participants during visits that take place during routine medical care. Participants in the US will be invited to provide voluntary blood and urine samples that could be analyzed later to better understand possible changes in protein or nucleic acid levels over time. Each participant will be in the study for 12 months. This time participating in the study may be shorter if their finerenone treatment is stopped early or the study comes to an end as planned in September 2027.
NCT07669038
Type 2 diabetes requires active self-management from the time of diagnosis, but participation in traditional face-to-face diabetes self-management education is often limited by access-related and personal barriers. Online education may provide a more flexible and accessible way to deliver structured diabetes education, particularly for newly diagnosed adults who need timely support in understanding and managing their condition. This study evaluated the effects of online diabetes self-management education compared with traditional face-to-face education on diabetes knowledge retention, body mass index (BMI), and HbA1c in adults newly diagnosed with type 2 diabetes who were not receiving antidiabetic medication. A total of 123 participants were included: 49 participants received online diabetes self-management education, 52 participants received traditional face-to-face education, and 22 participants who declined education formed a non-randomized control group. Diabetes knowledge was assessed at baseline, immediately after the intervention, and at three-month follow-up, while BMI and HbA1c were measured at baseline and follow-up. At three-month follow-up, both online and traditional education groups showed significantly greater diabetes knowledge compared with the control group. The online education group also showed better immediate post-intervention knowledge than the traditional education group. Both education groups had significant reductions in BMI from baseline to follow-up, while no significant short-term effect on HbA1c was observed.
NCT07590193
The main objective of this trial is to assess the safety and tolerability of AMG 127 as single dose and multiple doses in healthy participants and participants with type 2 diabetes mellitus (T2DM).
NCT06982846
The purpose of this study is to measure the effect of retatrutide versus placebo, administered every week, on time to recovery from hypoglycemia during hypoglycemic clamp in participants with Type 2 Diabetes Mellitus (T2DM) following 16 weeks of treatment.
NCT03837405
The investigators plan an R33 phase trial in which 120 persons with type 2 diabetes (T2DM) will be randomized (using a 1:1 ratio) to education alone (Ed) on following a carbohydrate restricted diet for T2DM, or this same education content with added mindful eating/Mindfulness-Based Intervention components (Ed+MBI).
NCT07647523
The purpose of this study is to evaluate the effectiveness of a web and mobile-based clinical decision support and monitoring system (1B4T mobile application) on blood glucose control, medication adherence, quality of life, and self-management in patients with poorly controlled Type 2 Diabetes Mellitus. This open-label, parallel-group, randomized controlled trial was conducted with 100 type 2 diabetes patients registered at primary care family health centers in Izmir, Turkey. Participants were randomly assigned to either the intervention group (n=50) or the control group (n=50). * Intervention Group: Participants installed the 1B4T mobile application on their smartphones, created personal accounts, and recorded their home blood glucose measurements through the app for 3 months. The app allowed patients to track their previous data and view a 10-day blood glucose prediction without directing any treatment changes. * Control Group: Participants continued with their routine healthcare follow-ups and standard controls. At baseline and at the 3-month follow-up, fasting plasma glucose and HbA1c levels were measured for all participants. Additionally, sociodemographic characteristics, medication adherence (Modified Morisky Medication Adherence Scale), quality of life (WHOQOL-BREF-TR), and diabetes self-management (Diabetes Self-Management Questionnaire - DSMQ) were evaluated to assess the clinical and behavioral outcomes of the mobile health intervention.
NCT04621929
The investigator proposes an 18 month, feasibility pilot study, randomizing obese and diabetic individuals with pure uric acid nephrolithiasis (UAN) or mixed calcium oxalate (CO) UAN to either phentermine/topiramate or a pragmatic control group who will remain on their standard medication regimen (citrate salts, allopurinol, diet, etc.).
NCT01939834
The purpose of this study is to use an Advisory/Automated Adaptive (AAA) or Closed-Loop Control (CLC) system for insulin delivery in adults with Type 1 Diabetes (T1DM) in an outpatient setting to evaluate the system's ability to significantly improve blood glucose levels. A component of this study evaluated AAA or CLC Control overnight only in 5 consecutive overnights in a cross-over trial with sensor-augmented pump therapy occurring prior to or following CLC overnight. Another component of this study planned evaluating if the AAA Control system run on the Diabetes Assistant (DiAs) system can prevent hypoglycemia during and following exercise more efficiently during a 40 hour trial this part of the trial was not conducted due to a preference for overnight only configuration in pilot testing. This protocol represents a culmination of prior clinical trials in development of this AAA system and benefits from the synthesis of those components.
NCT06897202
This study is designed to test how well once-weekly MET097 (an ultra-long-acting GLP-1 receptor agonist) works to treat adults with obesity or overweight and type 2 diabetes mellitus (T2DM) compared to placebo. MET097 or placebo will be administered to individuals via subcutaneous injection once weekly for 28 weeks. If an individual is randomly assigned to MET097 they will receive one of four different dose regimens.
NCT07645313
This post-market clinical follow-up (PMCF) investigation evaluates the accuracy and safety of two CE-marked continuous glucose monitoring (CGM) systems, the Anytime 5Pro and the Anytime 4Pro, in adults with type 1 or type 2 diabetes. Each participant simultaneously wears one Anytime 5Pro sensor and one Anytime 4Pro sensor, one on each upper arm, for the full labelled wear period of each device (up to 16 and 15 days, respectively). CGM readings are compared against venous blood glucose measured by a laboratory reference analyzer (YSI 2500) during four in-clinic sampling sessions that include controlled glucose manipulation. Participants are masked to real-time CGM readings throughout the study. The investigation is conducted to confirm device performance and safety under real-world conditions of use in a European population, in line with the manufacturer's post-market clinical follow-up obligations under the EU Medical Device Regulation.
NCT06574035
The Michigan Men's Diabetes Project III: Mind \& Motion is an 7-month pilot randomized clinical trial. The investigators are looking to recruit 80 Black men with type 2 diabetes (T2D) (need to have diagnosis for at least one year) that are over the age of 18. Participants also must be under the care of a physician for their diabetes, self report an Hemoglobin A1c (A1C) of 7.0% or more in the last year, be willing to participate in study events (weekly physical activity, exercise and Cognitive Behavioral Therapy (CBT) sessions, group discussion sessions, and in-person health assessments), have reliable internet access (steady internet connection or unlimited data) that will allow them to use a tablet/phone/computer to complete study related tasks, live in the Wayne or Washtenaw County, and have reliable transportation to in-person events. All participants will receive 8 hours/sessions of cognitive behavioral therapy. Participants randomized to the intervention arm will also receive 8 sessions of guided exercise at the same time. Following that they will also receive 8 group discussion sessions that will serve as on-going support. All sessions will be help via Zoom. Additionally, all participants will participate in The 4 health assessments will take place at baseline, 10 weeks, 18 weeks, and 30 weeks.
NCT07011147
The goal of this randomized controlled trial is to compare the efficacy and safety of the iLet Bionic Pancreas (BP) System in adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes) compared to standard of care when ordered by primary care providers. The main question it aims to answer is: Can the iLet BP by deployed in primary care settings to adults with insulin-treated diabetes (type 1 diabetes or type 2 diabetes)? Researchers will compare 13-weeks of iLet BP use to routine care to see if iLet BP use has a greater reduction in HbA1c compared to13-weeks of routine care. Participants will: Use the iLet BP for 13-weeks or continue their routine care Be trained to use the study devices or continue their routine care Complete a virtual screening visit, mid-period follow up calls and a final visit Complete baseline CGM collection Complete surveys and fingerstick a1c blood tests Routine care participants will have the option to complete an observational extension phase where they will wear the iLet BP for 13-weeks
NCT07472725
The purpose of this study is to evaluate the safety and glycemic control of SHR-3167 fixed-dose titration and individualized-dose titration in adults with Type 2 Diabetes inadequately controlled with oral antihyperglycemic agents.
NCT07617766
This study aims to evaluate the effects of mindfulness-based self-management education on diabetes-related difficulties and empowerment in individuals with type 2 diabetes. Participants will receive a structured education program designed to improve self-care behaviors, emotional well-being, and confidence in managing their condition. The program includes mindfulness practices, diabetes self-management education, and supportive group sessions. Outcomes such as diabetes distress, self-management behaviors, and patient empowerment will be measured before and after the intervention. The findings of this study are expected to contribute to improving patient-centered care and supporting individuals with type 2 diabetes in managing their health more effectively.
NCT04426474
The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.
NCT06185491
The goal of this clinical trial is to learn about the variability of HGI (Hemoglobin Glycation Index) over time in patients living with diabetes using a continuous glucose monitoring.
NCT06897618
Diabetes mellitus (DM) is a global public health concern. In the United States, adult Hispanic males are particularly vulnerable to type 2 diabetes mellitus and are more likely to develop complications and subsequently die from it, compared to non-Hispanic White males. Evidence suggests good self-management behaviors can potentially prevent disease-related complications and improve clinical outcomes. The American Diabetes Association and Association of Diabetes Care and Education Specialists have endorsed diabetes self-management education as a necessary component of care for all individuals living with the disease. However, adult Hispanic males with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S., especially those who are underserved, typically lack access to formal diabetes self-management education (DSME). Further, the majority have never participated in such educational activities. A large body of evidence suggests DSME can effectively improve self-management behaviors in diverse populations around the globe. The purpose of the proposed study is to examine the effect of culturally tailored diabetes education on self-management behaviors of adult Hispanic males, aged 18-64 years, with type 2 diabetes mellitus living in the Middle Atlantic Region of the U.S. This study can shed more light on the effectiveness of community-based, culturally tailored diabetes educational activities in this vulnerable population and guide future efforts towards enhancing self-management.
NCT04545151
This study has been set up within the framework of the INNODIA network. INNODIA is a global partnership between 31 academic institutions, 6 industrial partners, a small sized enterprise and 2 patient organizations, bringing their knowledge and experience together with one common goal: "To fight type 1 diabetes". (www.innodia.eu) The overall aim of INNODIA is to advance in a decisive way how to predict, stage, evaluate and prevent the onset and progression of type 1 diabetes (T1D). For this, INNODIA has established a comprehensive and interdisciplinary network of clinical and basic scientists, who are leading experts in the field of T1D research in Europe and UK (United Kingdom), with complementary expertise from the areas of immunology, Beta-cell biology, biomarker research and T1D therapy, joining forces in a coordinated fashion with industry partners and two foundations, as well as with all major stakeholders in the process, including regulatory bodies and patients with T1D and their families.
NCT06448182
The goal of this randomized clinical trial is to evaluate the effect of the administration of a postbiotic on glycemic control, insulin resistance and microbiota composition in subjects with type 2 diabetes. The main questions it aims to answer are: * Study the evolution of biochemical variables related to glycemic metabolism: basal glucose, basal insulin, glycemic variability through sensors, glycosylated hemoglobin (HbA1c), HOMA-IR index, C peptide. * Perform a metagenomic analysis of intestinal microbiota in stool samples. * Perform a metabolomics analysis on blood samples. * Analyze the genetic profile in blood. * Evaluate the evolution of biochemical variables related to lipid metabolism: total serum cholesterol, HDL-cholesterol, LDL-cholesterol and triglycerides. * Assess the evolution of variables related to liver function: transaminases (ALT/AST). * Analyze the evolution of the blood count. * Evaluate the evolution of anthropometric variables (weight, height, waist and hip) and body composition. * Analyze the evolution of blood pressure. * Analyze eating and physical activity habits. * Evaluate adherence to treatment and adverse events. * Personalization on the use of postbiotics and other nutritional recommendations based on the genetic profile and the identification of patient clusters. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 158 subjects. Participants will be allocated in two groups for 12 weeks: * Experimental group (n=79): daily consumption of one postbiotic capsule. * Placebo group (n=79): daily consumption of one placebo capsule. Researchers will compare the consumption of a postbiotic supplement to a placebo. Participants will visit nutritional intervention unit at week 0, week 2, week 10 and week 12 of the study.
NCT04469855
The purpose of this study is to assess the safety of long-term treatment with Ozempic® in patients with type 2 diabetes mellitus. People will get Ozempic® as prescribed by their doctor. People will be in this study about 3 years. People above the age of 18 will be asked to fill in the quality of life (QOL) questionnaire (the QOL questionnaire is for the assessment of the influence of diabetes treatment on people's life). There is a possibility that people's blood sample would be provided to Novo Nordisk from their doctors in case of severe allergic reaction that might be caused by Ozempic®.