Diabetic Gastroparesis

Researchers are evaluating an AI-assisted digital health tool called the Smart family doctor to improve control of hypertension, diabetes, and dyslipidemia in adults who have undergone coronary artery bypass grafting CABG or percutaneous coronary intervention PCI. This study uses a randomized controlled design involving about 536 participants across 5-10 hospitals. Participants must be adults aged 18 or older with a history of CABG or PCI and the specified conditions. Participants in the experimental group will use the AI-assisted Smart family doctor app that provides personalized health education, targeted guidance on managing blood pressure, blood sugar, medication adherence, exercise, and smoking cessation. They will also receive tailored reminders and can report self-measured health data for feedback. Both groups receive weekly 3-hour health management guidance from health managers, and participants will wear a smart band daily for health data collection during the 6-month study period. Throughout the study, participants will be assessed for control rates of hypertension, diabetes, and hyperlipidemia at 6 months. Additional measures include blood pressure, cholesterol levels, blood glucose, physical activity, quality of life, psychological status, and cognitive function. The study monitors health data continuously via smart bands and collects self-reports and clinical assessments to evaluate the interventions impact over the 6 months.

Researchers are investigating the relationship between obesity and type 2 diabetes, conditions influenced by both genetic and environmental factors. This study aims to better understand how different genetic variations affect gene expression in tissues involved in glucose and lipid metabolism, which may contribute to what is called diabesity, a combined condition of diabetes and obesity. The study uses advanced genomic techniques and bioinformatics to analyze these factors in both humans and animal models. Participants in this observational study are grouped based on their body mass index BMI and diabetes or glucose intolerance status. Groups include individuals with BMI 35 kgm2 with diabetes, glucose intolerance, or without diabetes, as well as those with BMI < 27 kgm2 and BMI between 27 and 35 kgm2 without diabetes. Samples are collected during abdominal surgeries such as bariatric surgery or cholecystectomy to study gene expression and metabolic pathways. During the study, researchers collect biological samples at baseline and follow participants over several years to assess changes in gene expression and insulin resistance. They also evaluate clinical and biological features before and after bariatric surgery at 1, 2, and 5 years. The primary measurement focuses on gene expression in tissues related to glucose metabolism. This long-term observation helps to understand the genetic and phenotypic factors influencing obesity and diabetes, with participation lasting up to 5 years.

Researchers are evaluating a program called LINKED-HEARTS aimed at improving health outcomes for adults with uncontrolled high blood pressure who also have type 2 diabetes or chronic kidney disease. This trial involves 600 adults receiving care at community health centers and compares usual care with an enhanced program that includes home blood pressure monitoring linked to telemonitoring technology and team-based support. The goal is to reduce blood pressure, lower blood sugar levels, and improve kidney function through integrated clinical and community support. The study has two groups one receives enhanced usual care with home blood pressure monitors, and the other participates in the LINKED-HEARTS Program. Participants in the LINKED-HEARTS group will use the Omron 10 series blood pressure monitor with the Sphygmo telemonitoring app. They will also receive education and support from community health workers and telehealth visits with pharmacists who collaborate with providers to optimize medication. The enhanced usual care group also uses the blood pressure monitor with training but receives standard care from their primary doctors. Participants will measure and transmit blood pressure data using the telemonitoring app, and their health will be tracked over 12 months. Researchers will assess blood pressure control, changes in blood pressure readings, blood sugar levels, body mass index, kidney function, and quality of life. The study includes regular monitoring and support to help participants manage their chronic conditions. Total participation lasts at least one year, with outcome measurements at baseline, 12 months, and some quality of life assessments continuing to 24 months.

Researchers are conducting a Phase I clinical trial to compare the bioavailability and safety of different forms of SHR-3167 injection in healthy adults between 18 and 55 years old. This study aims to understand how the drug is absorbed and processed in the body, focusing on the maximum plasma concentration and overall exposure to the drug over time. Participants will receive one of three different specifications of SHR-3167 injection in a randomized, parallel, and open-label design. The study will monitor the drugs levels in the blood from Day 1 through Day 71, including measurements such as maximum concentration, area under the curve, time to reach maximum concentration, and half-life. Safety will be assessed by tracking any adverse events and immune responses during this period. During the study, participants will undergo physical exams, vital signs checks, ECGs, chest X-rays, and laboratory tests to ensure health status. Blood samples will be collected multiple times to analyze drug levels and antibodies. The study lasts about 71 days, with continuous monitoring for safety and drug behavior. Participants must comply with study procedures and provide informed consent before joining.

Researchers are evaluating if the drugs Empagliflozin and Semaglutide, alone or combined, can improve blood sugar control by increasing time-in-range in adults with Type 1 Diabetes who use Automated Insulin Delivery AID systems. This study also monitors the safety of these drugs in this setting. It is a randomized, double-blind, placebo-controlled Phase 3 crossover trial designed to compare the effects of these treatments in the same participants. Participants will receive four different treatment combinations through a crossover design semaglutide injection plus empagliflozin tablet, semaglutide injection plus placebo tablet, placebo injection plus empagliflozin tablet, and placebo injection plus placebo tablet. Semaglutide is given by weekly subcutaneous injection with a 12-week dose escalation period to reach a stable dose. Empagliflozin or its placebo is taken daily by tablet. Washout periods between treatments help avoid carryover effects. During the study, participants will use their personal AID systems continuously while researchers collect continuous glucose monitoring data to measure time-in-range and other blood sugar outcomes. Questionnaires will assess diabetes distress and treatment satisfaction after each intervention period. Safety is closely monitored throughout, including tracking adverse events and providing rescue medications for low blood sugar. The entire participation involves multiple treatment periods with careful monitoring and data collection.

This research aims to find out if the weekly medication tirzepatide can help adults with type 1 diabetes use their insulin pump more easily by reducing or stopping the need to count carbohydrates at meals. People with type 1 diabetes must take insulin for life, but counting carbs is challenging and stressful. Tirzepatide, approved for type 2 diabetes and weight management, may lower appetite, slow digestion, reduce insulin needs, and smooth blood sugar rises after meals in type 1 diabetes as well. The study includes 105 adults with type 1 diabetes, all using the Tandem Control-IQ insulin pump paired with the Dexcom G7 continuous glucose monitor. Participants are randomly assigned to two groups one receives weekly tirzepatide injections with gradually increasing doses for 12 weeks, then stops counting carbs for the last 6 weeks while continuing tirzepatide the other group continues usual therapy, counting carbs throughout. Both groups use the same insulin delivery system and receive training and monitoring. Participants attend clinic visits, complete remote follow-ups, and undergo lab tests, with some also having heart and body composition assessments. Researchers monitor glucose control, insulin use, weight, metabolic markers, meal patterns, and quality of life. The main outcome is whether glucose control without carb counting is as good as with standard care. Safety is closely watched due to possible side effects like nausea and rare risks such as gallbladder disease. The study lasts 32 weeks and aims to see if tirzepatide can simplify diabetes care safely.

Researchers are evaluating a fruit and vegetable prescription F&V Rx program designed to improve diabetes management among low-income Hispanic adults with type 2 diabetes. The study aims to test how F&V prescriptions affect participation in diabetes self-management education and support DSMES, fruit and vegetable intake, diet quality, blood sugar control measured by hemoglobin A1c, and the programs acceptability and sustainability. This pilot randomized controlled trial addresses gaps in understanding the role of F&V prescriptions combined with DSMES attendance in diabetes care. The study includes three groups one receiving usual care, one receiving usual care plus four monthly F&V Rx vouchers regardless of DSMES attendance, and one receiving usual care plus F&V Rx vouchers contingent on monthly DSMES group attendance over 16 weeks. Participants in the intervention groups receive vouchers to purchase fruits and vegetables at local stores. The trial tests the impact of these approaches on education uptake and retention as well as health and dietary outcomes. Participants will attend study visits at the beginning and end of the 16-week period for assessments including blood samples for A1c and plasma carotenoids, dietary intake surveys, and diabetes self-management questionnaires. Researchers will monitor voucher use, DSMES attendance, and collect feedback from both participants and care providers to evaluate program implementation. The study is conducted with cultural adaptations and community involvement to support relevance for Hispanic adults with type 2 diabetes.

This research aims to evaluate the effectiveness and implementation of Supporting Teen Problem Solving STePS, an intervention designed to reduce diabetes-specific emotional distress in teenagers with Type 1 Diabetes Mellitus. The study includes 360 teens aged 14 to 18 from diverse backgrounds across six clinical sites. It compares STePS delivered in-person or via telehealth against an educational control group, focusing on improving emotional distress and preventing worsening blood sugar control over time. Participants are randomly assigned to one of three groups STePS in-person, STePS via telehealth, or diabetes education via telehealth. Each group participates in a 4.5-month program consisting of nine sessions held twice monthly. STePS is a group-based behavioral intervention teaching emotion regulation and problem-solving skills to help teens manage diabetes-related distress. The study also examines how these delivery methods affect the uptake and sustainability of the intervention in real-world diabetes clinics. Throughout the study, participants complete surveys at the start, immediately after the intervention, and at 6 and 12 months post-intervention to measure diabetes distress and blood sugar control Time in Range. Qualitative data from focus groups will explore participant and provider experiences. Researchers will assess recruitment, adherence, acceptability, costs, and program fidelity. The total participation spans about 16.5 months, including follow-up assessments to evaluate both clinical and practical outcomes of the intervention.

Researchers are investigating how metabolism, body composition, and body surface area relate in both healthy individuals and those with metabolic conditions such as diabetes, obesity, renal disease, or cancer. The study aims to improve the accuracy of metabolic rate measurements, which have traditionally relied on simple formulas using height and weight, which may not work well for everyone. Participants will spend two days and one night in the hospital during each visit. They will provide medical history, answer questions about their activity, diet, and lifestyle, and consume a special diet. They will undergo various tests including breathing gas measurements while lying under a clear hood, body scanning on a padded table and with a 3D scanner, electrical signal speed testing through the body, hand strength measurement, and collection of blood and urine after drinking salty water. Participants may return up to eight times per year with at least two weeks between visits. During the study, participants will be evaluated through these tests and questionnaires to understand their resting energy expenditure and body measurements. The primary outcomes include comparing measured versus predicted body surface area and determining how measured body surface area relates to energy expenditure independent of body composition. The study will continue until July 2031, and participants health and ability to complete tests will be monitored throughout their involvement.

Researchers are conducting a randomized controlled trial to assess a new digital health tool called Prioritize Personalize Prescribe EXercise P3-EX. This tool is designed to help physicians prescribe personalized exercise programs to adults with cardiovascular disease CVD risk factors such as obesity, hypertension, dyslipidemia, and diabetes. The trial aims to test the usability and satisfaction of P3-EX compared to a generic exercise prescription method called the American College of Sports Medicine Physical Activity Vital Sign ACSM-PAVS. In the study, 24 physicians will each recruit two patients with CVD risk factors, assigning one patient to receive an exercise prescription via P3-EX and the other to receive the ACSM-PAVS prescription in a randomized crossover design. Patients will follow their prescribed exercise programs unsupervised for 12 weeks, with virtual weekly oversight from University of Connecticut Graduate Research Assistants. The P3-EX tool uses cardiovascular health scoring and tailored exercise recommendations based on the patients highest risk factors, while ACSM-PAVS provides a general exercise guideline. Patients will record their exercise using a self-report diary, and receive exercise guidance through virtual visits and weekly emails. Throughout the 12 weeks, patients will attend in-person visits before and after the intervention to assess CVD risk factors, physical activity levels using accelerometers, and satisfaction with the exercise programs. Physicians and patients will complete usability questionnaires shortly after exercise prescription delivery to evaluate feasibility and acceptability. The study will also analyze changes in cardiovascular health markers, exercise adherence, and physical activity to explore preliminary efficacy. The total participation includes initial assessments, 12-week exercise monitoring with virtual support, and follow-up evaluations.