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Diabetes Mellitus, Type 2 clinical trials

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NCT ID: NCT05039970 Completed - Diabetes Mellitus Clinical Trials

A Real-World Study of a Mobile Device-based Serious Health Game on Session Attendance in the National Diabetes Prevention Program

Start date: September 7, 2021
Phase: N/A
Study type: Interventional

The overall prevalence of type 2 diabetes in the United States (US) is estimated at more than 30 million people, with an estimated 88 million more adults meeting the criteria for having prediabetes and being at risk for progressing to type 2 diabetes. The significant burden of diabetes, as well as the high individual and societal cost it bears, renders this disease among the highest public health priorities for the health authorities and policy makers. In response to the rising diabetes prevalence, the US Centers for Disease Control and Prevention (CDC) established the National Diabetes Prevention Program (National DPP) in 2010 as a framework for diabetes prevention by providing evidence-based, affordable, and high-quality lifestyle change programs (LCPs). The National DPP LCP is a yearlong education-based curriculum focused on achieving modest weight loss (5% to 7%) and increasing participants' physical activity to reduce the risk of progressing to type 2 diabetes. To ensure high-quality programs and meaningful impact on participants, the CDC sets standards for organizations that wish to offer an LCP through the Diabetes Prevention Recognition Program (DPRP). The DPRP plays a critical role in ensuring that organizations can effectively deliver the evidence-based lifestyle change program with quality and fidelity. To achieve recognition status, organizations must periodically provide evidence that they are following a CDC-approved curriculum and achieving meaningful results on session attendance, body weight change, and physical activity minutes. A recent analysis of National DPP data has shown that the attrition rates in this program are substantial and that they differ by age and race. Moreover, the attrition rates were inversely associated with the program success, as reflected by the LCP outcomes, and, specifically, participants' weight and level of physical activity. In view of these findings, the CDC is undertaking an effort to increase participant retention in the National DPP. The proposed study will evaluate the pilot use of a free-of-charge mobile device-based serious health game (WellQuest™) within the frame of the National DPP LCP. WellQuest™ was designed with the goals to improve participant engagement and retention in the LCP, to encourage adoption and maintenance of healthy lifestyle habits among LCP participants, and to reinforce knowledge of the LCP curriculum.

NCT ID: NCT05039034 Completed - Stroke Clinical Trials

Screening and Management of High-risk Populations of Stroke in Dehui City

SAMHPSDC
Start date: January 1, 2016
Phase:
Study type: Observational [Patient Registry]

This epidemiological survey is to analyze the prevalence rate of stroke and exposure rate of risk factors in sampling population aged 40 years and over (born before December 31,1975) in Dehui City, to provide scientific basis for pertinent prevention and control of stroke in Jilin Province, and to provide valuable data for the high-risk groups to carry out regular follow-up and standardized management.

NCT ID: NCT05038761 Completed - Diabetes Mellitus Clinical Trials

A Study to Learn How Well a Monitoring System Called Continuous Glucose Monitoring (CGM) Which Measures Glucose on an Ongoing Basis Works and How Safe it is in Chinese Patients in Usual Practice

CareMins
Start date: October 8, 2021
Phase:
Study type: Observational

Researchers are looking for a better way to help Chinese people who have diabetes to monitor their blood sugar (blood glucose) situation. There are 2 types of diabetes. In people with type 1 diabetes, the body's immune system attacks and destroys cells in the pancreas that produce a hormone called insulin. In people with type 2 diabetes, the body does not make enough insulin or does not use insulin well. This results in high blood glucose levels. Over time, high blood glucose levels can cause damage to certain parts of the body. These include the eyes, the kidneys, the nerves, and the heart. There are tests and devices available for doctors and patients to measure blood glucose levels. Repeated measurements of blood glucose levels are needed to see whether the treatments that prevent blood glucose levels from becoming too high work well and to notice when the blood glucose is decreasing too much. Such tracking of the blood glucose is also called blood glucose monitoring. Blood glucose monitoring tests and devices can however be difficult to use, and one test or device may not work for all patients. Researchers think that better monitoring systems would help patients improve the control of their blood glucose levels. This could help stop their diabetes from getting worse. In this study, the researchers want to learn more about how well a new monitoring system called CGM works in Chinese patients with diabetes. CGM is a continuous glucose monitoring system. It regularly measures the level of glucose in the tissue throughout the day and night. CGM is made up of a small sensor that patients apply in the belly region where it is placed just under the skin, into the so-called subcutaneous tissue. The sensor measures the level of glucose in the fluid that surrounds cells in the subcutaneous tissue. It also has a transmitter which attaches to the sensor and sends via Bluetooth the results to a device, which can instantly display the glucose level. The glucose levels can then be used to adjust the treatment. The main purpose of this study is to learn how well CGM monitors glucose levels in Chinese patients when used in usual practice. To answer this question, the researchers will compare the glucose levels collected with the CGM monitor to the blood glucose levels collected with another type of monitoring called "venous blood glucose testing". This is where a blood sample is taken from the veins, and then the level of glucose in the blood sample is measured. The study will include adult Chinese patients who have type 1 or type 2 diabetes and who the study doctors think need to monitor their diabetes using CGM and venous blood glucose testing. There will be no treatments given as part of this study. The device will be worn up to a maximum of 14 days. The patients will get training on how to use the CGM monitor and will attach it to their belly on Day 1 of the study. The researchers will then collect the information about their glucose levels. The study doctors will also take blood samples and measure blood glucose levels using venous blood glucose testing. They will compare the glucose levels recorded from the blood samples to the glucose levels recorded by CGM at the closest time points. After wearing CGM for 14 days, the study doctors will remove it from the patients' bellies. About 3 days later, the researchers will call the patients to check if they have any swelling or areas of rash where CGM was worn. The patients may also take photos of the area and send these to the study doctors. During the study, the study staff will: - take blood samples as part of the usual care - compare glucose levels recorded by CGM to the levels recorded from the venous blood glucose tests - check the skin for any swelling or areas of rash where CGM was worn - record any instances of CGM errors or alarms for when glucose levels are too high or too low - check the patients' overall health - ask the patients about how they are feeling and what medical problems they are having.

NCT ID: NCT05038176 Completed - Clinical trials for Diabetes Mellitus, Type 2

Improving the Diabetic Health of Black Men: MANUP Feasibility Trial

MANUP-NC
Start date: February 12, 2022
Phase: N/A
Study type: Interventional

Many Black Americans continue to be suffer from diabetes especially Black men. Although previous diabetes efforts have reduced overall disease burden, they have failed to eliminate racial and geographic disparities. The story of John Henry, the "steel-drivin' man" represents strength and self-determination among Black Men. But often these traits lead men to "manup" about their health and prevents them from taking care of their diabetes. This study examines how we can assist Black men in improving their diabetes. Based on the traits of John Henry, we will conduct a culturally-tailored study to 1) determine if our education program including coping strategies and motivation text messages lowers A1c; and, 2) how program operates in a rural setting while learning how we can best improve it for a larger study. We hope to have the information to conduct a larger study with Black men in rural areas to improve their diabetes outcomes.

NCT ID: NCT05037591 Completed - Obesity Clinical Trials

Effect of Sea Grapes-antioxidants Extract in Obese Men : 4 Weeks Randomized-Double Blind Controlled Trial

Start date: August 1, 2021
Phase: Early Phase 1
Study type: Interventional

Doses of 150 mg/kg BW (30 mg/200g BW) sea grape extract in a previous pre-clinical trial, showed that it could improve blood glucose, total cholesterol and serum PGC-1 levels in rats fed a diet high in fat and cholesterol. In addition, you also have hepatoprotective activity (aka non-toxic) in diabetic mice. Previous research, is an in vivo (Pre-clinical) study that has not represented the benefits or efficacy of sea grape extract on variables tested in humans. Therefore, this clinical trial was conducted to support the effect of sea grape extract-antioxidant on blood glucose, total cholesterol, and PGC-1 levels in obese men for 4 weeks using a Randomized-Double Blind Controlled Trial.

NCT ID: NCT05031572 Completed - Obesity Clinical Trials

Energy -Sensing Metabolites in Caloric Restriction

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

General integrated goal of the coordinated project: To elucidate the role of succinate and other metabolites derived from the intestinal microbiota such as Short Chain Fatty Acids (SCFAs), as energy sensing metabolites in the context of obesity and type 2 diabetes (T2D). Specific objectives of Subproject 1 (SP1): 1a. - To investigate whether intermittent fasting (IF) is better than Continued Daily Caloric Restriction (DCR) in terms of metabolic improvement through the study of: 1) the dynamics of gastrointestinal hormones and energy sensing metabolites, 2) the intestinal microbiome, 3) variability on succinate and SCFAs, MCFAs and Biliary Acid after weight loss; Methodology: clinical study: randomized, cross-over design, study participants (n=15) will consume either lifestyle recommendations for a healthy Mediterranean diet under a continued caloric restriction diet (DCR) or will undertake an intermittent (IF) protocol. Clinical, anthropometrical and functional studies. Metabolomics for gut derived metabolites in plasma. Enteroendocrine gastrointestinal dynamics. Metagenomic analysis.

NCT ID: NCT05031000 Completed - Diabetes Mellitus Clinical Trials

Blood Glucose Monitoring Systems: Discounter Versus Brand

Start date: September 3, 2021
Phase: N/A
Study type: Interventional

This study assesses the system accuracy of 5 blood glucose monitoring systems pursuant to ISO 15197 under the aspect of the system's prospected costs for the user.

NCT ID: NCT05029271 Completed - Diabetes Type 1 Clinical Trials

InPen User Experience

Start date: April 17, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the user experience of InPen™ with InPen™ Diabetes Management App and Guardian 4 system in adult patients with type 1 diabetes for the design of a future pivotal study.

NCT ID: NCT05027334 Completed - Diabetes Mellitus Clinical Trials

Self-Management of Type-2 Diabetes Using a Mobile Application

Start date: July 1, 2017
Phase: N/A
Study type: Interventional

Diabetes Mellitus (DM) is a global health emergency, since its prevalence has become alarming in many countries in the previous years. Because of the increasing healthcare requirement, it has also progressively become an economic burden for every country. From the International Diabetes Federation (IDF) Atlas (International Diabetes Federation, 2015), 415 million people worldwide were estimated to have DM in 2015 and this figure is expected to rise to 642 million in 2040. DM contributed to 5 million adult deaths globally in 2015. Mauritius has one of the highest DM prevalence in the world (24.3% prevalence for ages 20 - 79) for 2015 (International Diabetes Federation, 2015). 2,932 adult died due to Diabetes, and the average cost of DM related problems amount to 2 billion rupees per year. The Mauritius Non Communicable Diseases Survey (Ministry of Health and Quality of Life, 2015) reports an estimated 257,442 people between the ages of 25 and 74 with Diabetes in Mauritius. A high prevalence of pre-diabetes is also noted, which may subsequently result in diabetes and heart disease, if not appropriately managed. The DM epidemic has a significant impact locally and globally, calling for urgent remedial strategies to curb the spread. Studies have shown that patient's self-care including monitoring of blood glucose improve glycemic control (Allemann et al, 2009; Skeie et al, 2009; Istepanian et al, 2009). Patients are currently empowered through face to face counselling, websites, social media and other state of the art technologies. The use of smart phones for self-monitoring of blood glucose has shown to have substantial beneficial effects (Liang et al, 2011; Pal et al 2014). This project aims at using mobile technologies to instil behavioural changes in people living with DM and pre-diabetes in an attempt to alleviate the long term problems associated with DM. More precisely, it will constitute the development of an autonomous system for self-management of type 2 diabetes mellitus (T2DM) patients in Mauritius. The prototype will be tested for feasibility among patients with T2DM and pre-diabetes. It is expected that the proposed system will help to reduce the financial burden on the healthcare system in Mauritius through patient empowerment and improved self-care in the long run.

NCT ID: NCT05026424 Completed - Clinical trials for Diabetes Mellitus, Type 2

Glycemic Response in Adults With Diabetes

Start date: August 2, 2021
Phase: N/A
Study type: Interventional

This will be a randomized crossover design with oral nutrition supplement interventions.