Clinical Research Directory

CGM-Based Glycemic Analysis After ESI

The goal of this clinical study is to learn how blood glucose levels change after an epidural steroid injection (ESI) with dexamethasone in adults. It will specifically compare the glycemic response between patients with type 2 diabetes and those without diabetes. The main questions it aims to answer are: Does the injection cause higher or longer-lasting blood glucose elevation in diabetic patients compared to non-diabetic patients? How do the mean glucose level and Time in Range (TIR) change after the injection in both groups? Researchers will compare a Type 2 Diabetes group to a Non-Diabetes group to see the differences in glycemic fluctuations using a continuous glucose monitoring (CGM) device. Participants will: * Wear a small CGM sensor on their arm for about 15 days to monitor blood glucose levels continuously * Receive an epidural steroid injection containing 5 mg of dexamethasone on Day 3 * Visit the clinic 3 times (Day 1, Day 3, and Day 15) for sensor attachment, the injection procedure, and data collection

Standardized Italian netwoRk Enrolling iNdividuals With Islet-Autoantibodies

This project characterizes the longitudinal progression of children and adults who have tested positive for one or more islet cell autoantibodies across the early stages of type 1 diabetes (T1D). Despite advances in screening, limited evidence exists on how clinical, metabolic, and immunological markers evolve over time and predict progression to symptomatic disease. Using a screened cohort, participants are followed for up to 10 years with repeated standardized assessments. The study evaluates whether population-based screening can reduce diabetic ketoacidosis (DKA) at diagnosis and identify early predictors of progression to clinical T1D. Results are expected to improve risk stratification, inform surveillance strategies, and guide the timing of preventive interventions, with implications for clinical practice and health policy.

CGM in Acute Ischemic Stroke

The goal of this randomized clinical trial is to evaluate whether continuous glucose monitoring (CGM) can be used to guide glucose management in patients with type 2 diabetes who are admitted with an acute ischemic stroke and undergo endovascular therapy. Hyperglycemia frequently occurs during hospitalization in stroke and is associated with worse neurological and clinical outcomes. In current clinical practice, glucose levels are monitored using intermittent point-of-care testing (POCT) with finger-prick measurements, which may miss clinically relevant glucose fluctuations. CGM provides continuous glucose measurements and may allow earlier detection of hyperglycemia and more timely glucose management. This study is designed as a non-inferiority randomized controlled trial comparing CGM-guided glucose management with standard POCT-guided glucose management. The primary objective is to determine whether CGM-guided glucose management is non-inferior to POCT-guided management in terms of percentage time spent in hyperglycemia (glucose \>10 mmol/L) during the first 72 hours of hospitalization. Researchers will compare CGM-guided glucose management to POCT-guided glucose management to evaluate whether CGM can be used as an alternative strategy to guide glucose control in hospitalized stroke patients. Participants will: * Be randomly assigned to either CGM-guided glucose management or standard POCT-guided glucose management * Have their glucose levels continuously monitored (blinded in the POCT-guided group) during hospitalization * Receive glucose management according to the assigned monitoring strategy, based on the hospital insulin protocol

Shunt-dependency After aSAH - Role of Early Hyperglycaemia in CSF and Blood

The goal of this study is to confirm the association of early increased glucose levels in cerebro-spinal fluid (CSF) and ventriculo-peritoneal-shunt (VPS)-dependency also evaluating the influence of blood glucose on VPS dependency in patients suffering from an aneurysmal subarachnoid haemorrhage (aSAH). The main questions we aim to answer are: * Is there an association of glucose levels on VPS dependency in patients requiring extra-ventricular-drain (EVD) placement for aSAH? * In addition, if there is, what is the influence the course of glucose levels has on VPS dependency? Glucose levels in CSF and serum will be measured on admission, or in case of CSF, upon EVD placement. Glucose in CSF will then be measured every day until EVD removal together with serum glucose. Follow-up will be conducted in person after 3 and 6 months.

Early Detection Initiative for Pancreatic Cancer

The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.

Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

This study aims to improve patient awareness of the utility of continuous glucose monitoring systems in blood glucose monitoring and to improve patient satisfaction regarding diabetes care, particularly in the matter of blood glucose monitoring, at the transitions of care from the inpatient setting to the ambulatory setting.

Feasibility of CGM Use in Hospitalized Youth

This study is assessing the feasibility of a continuous glucose monitor during hospital admissions in youth and young adults with hyperglycemia due to diabetes or other underlying conditions that requires frequent glucose monitoring, through patient/family and nursing staff feedback on their perspectives and usability of the system in the hospital will be assessed through surveys. In addition, retrospective glycemic comparisons between CGM data and POC will be conducted.

Pilot-Testing Real-Time Engagement for Learning to Effectively Control Type 2 Diabetes

The goal of this study is to pilot test features of a new smartphone app and to gather feedback related to wearing a continuous glucose monitor (CGM) and a Fitbit device, as well as to obtain input on health behavior-focused messages delivered through the app. The study will enroll English-speaking participants aged 16-24 years who were diagnosed with type 2 diabetes before age 18. Participants will be asked to fill out surveys about diabetes, physical activity, and diet before and after wearing a CGM for 30 days. At the end of wearing the CGM, participants will complete an interview about their experience.

Trans-Auricular Stimulation for Postoperative Inflammation in Spine Surgery

This study is a randomized controlled trial that will evaluate the effect of non-invasive auricular vagal nerve stimulation on inflammatory markers, glycemic control, postoperative pain, and inflammation-related clinical outcomes after long-segment spinal fusion surgeries when compared to current accepted management.

Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support Tools in the Management of Patients With "Four Highs" (Hypertension, Hyperglycemia, Hyperlipidemia, Hyperuricemia)

This study conducted a six-month exploratory clinical trial to evaluate the impact of an exercise prescription mini-program, based on the "Exercise Guidelines for the 'Four Highs'", on the physical activity levels and related health indicators of patients with hypertension, hyperglycemia, hyperlipidemia, and hyperuricemia in primary healthcare settings in China.

Monitoring Exhaled Breath to Noninvasively Detect Glycemic Events

The purpose of this study is to determine whether an array of biosensors can noninvasively identify hyperglycemic or hypoglycemic events in persons diagnosed with diabetes through noninvasive detection of volatile organic compounds in exhaled breath.

Effect of Probiotics Versus Metformin on Glycemic Control, Insulin Sensitivity and Insulin Secretion in Prediabetes.

Pre diabetes (PD) is a term that refers to alterations in blood glucose levels, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, and increase in glycated hemoglobin (HbA1c), all this factors involving a higher risk to develop type 2 diabetes mellitus (T2DM). The efficacy of pharmacotherapy in the prevention of diabetes in adults with pre diabetes has been demonstrated, the first line of pharmacology treatment is metformin, on the other hand, probiotics administration has been reported to be one of the most widely used approaches to modulate the gut microbiota and subsequently prevent or delay the incidence of T2DM. Probiotics are live microorganisms which when administered in adequate amounts confer a health benefit on the host. Has been demonstrated the hypoglycemic effects of the probiotics in different clinical trials in type 2 diabetes mellitus and pre diabetes, but no yet compared with metformin, for this reason comparing it´s activity against metformin in pre diabetes would provide impact information on a new alternative treatment compared with the standard pharmacological treatment. The aim of the study is evaluate the effect of administration of probiotic versus metformin on glycemic control, insulin secretion and insulin sensitivity in patients with pre diabetes.

Early Investigation of Glucose Monitoring After Gestational Diabetes Pilot

One third of women with gestational diabetes (GDM), diabetes diagnosed during pregnancy, have abnormal glucose levels within 3 years after pregnancy, but follow up is low. Continuous glucose monitors (CGM), a small sensor inserted under the skin, may be able to screen women with GDM for diabetes risk. The investigators will ask postpartum women to use CGM at 6-8 weeks postpartum and answer surveys about quality of life after wearing the CGM. The investigators will collect data on blood glucose trends for future studies if participants find CGM use acceptable. The investigators hope to learn if CGM could improve postpartum follow up experiences for people with recent GDM.

A Clinical Trial Evaluating TQF3250 Capsules in Healthy Adult Subjects

TQF3250 capsule is a biased GLP-1 (glucagon-like peptide-1) receptor agonist developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. By binding to the GLP-1 receptor, it can selectively activate certain signaling pathways of the GLP-1 receptor and reduce activation of other pathways, thereby bringing higher efficacy and lower side effects.

Semaglutide Treatment for Hyperglycaemia After Renal Transplantation

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 or type 2 diabetes and an estimated glomerular filtration rate (eGFR) \> 15 ml/min/1.73 m2. Methods: Participants diagnosed with post-transplant hyperglycaemia or type 2 diabetes, 10 to 40 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)

Combined Bitter Melon Extract and Snakehead Fish Powder Supplementation for Glycemic Control in Type 2 Diabetes

Type 2 diabetes mellitus (T2DM) remains a major global health problem due to its high prevalence, long-term complications, and substantial economic burden. Conventional antidiabetic therapies, including insulin and oral hypoglycemic agents, may cause significant side effects during long-term use and are contraindicated in certain clinical conditions. Therefore, safe and effective herbal-based alternatives are needed. Previous preclinical and early clinical studies have shown that bitter melon (Momordica charantia L.) and snakehead fish (Channa striata) possess antidiabetic and anti-inflammatory properties, including improvement in glucose regulation, stimulation of insulin secretion, and regeneration of pancreatic cells. However, clinical evidence on their combined use remains limited. This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effect of daily supplementation with a combination of bitter melon extract and snakehead fish powder on glycemic status in adults with Type 2 diabetes mellitus. Ninety eligible participants will be randomly assigned to a treatment group receiving 500 mg/day of the herbal combination or a placebo for 4 weeks. Glycemic status will be assessed primarily through glycated albumin (GA) levels. The findings of this study are expected to provide scientific evidence regarding the safety and efficacy of this herbal combination as a complementary antidiabetic therapy.

Optimizing Enteral Nutrition Regimen for Critically Ill Patients

Clinical Trial The goal of this clinical trial is to learn whether different enteral feeding cycles (18-hour, 20-hour, or standard 24-hour continuous feeding) improve outcomes for critically ill ICU patients who need tube feeding. It will also look at tolerance, nutrition delivery, and safety. The main questions it aims to answer are: Do shorter feeding cycles (with fasting windows) reduce ICU length of stay? Do they lower the risk of infections like ventilator-associated pneumonia? How do they affect calorie delivery, blood sugar control, and gastrointestinal tolerance? Researchers will compare: Continuous 24-hour feeding (standard care) 20-hour feeding with a 4-hour fasting window 18-hour feeding with a 6-hour fasting window Participants will: Be critically ill adults in the ICU who require at least 7 days of enteral feeding Be randomized to one of the three feeding schedules Receive daily monitoring of calories, protein, blood sugar, and GI tolerance Have outcomes measured, including ICU length of stay, infections, metabolic control, and feeding tolerance

The Effects of Fresh Mango Consumption on Cardiometabolic Outcomes in Free-living Individuals With Prediabetes

The goal of this clinical trial is to test the effect of 12 weeks of 1.5 cups per day of fresh mango on glucose control, insulin resistance, lipids, inflammation, oxidation and body composition in individuals with prediabetes. The main questions it aims to answer are: * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on indicators of glycemic control including fasting glucose and HgbA1c? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on fasting blood insulin and insulin resistance (HOMA-IR)? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on lipids including LDL-cholesterol, total cholesterol, HDL-cholesterol and triglycerides? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on oxidative stress including oxidized LDL-cholesterol and 8-iso-PGF2-alpha? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on markers of inflammation including c-reactive protein, e-selectin, ICAM, VCAM, TNF-alpha and IL-beta? * What is the effect of 1.5 cups per day of fresh mango over 12 weeks on percent body fat, fat mass, and lean mass? Participants will be asked to: * Consume 1.5 cups of mango per day for 12 weeks, take a 4 to 8 week break, and then avoid consuming mangos for 12 weeks * Attend a prerandomization clinic prior to study * Attend three (3) clinics where blood will be drawn during weeks 0, and 12 of the first phase and last week of the second phase of the study * Attend eight (8) clinics where anthropometric measurements (height, weight, body composition) will be conducted and interaction with study clinicians will occur during weeks 0, 4, 8, 12 of each phase of the study * Complete questionnaires and surveys in person and remotely, including six (6) 24-hour dietary recalls. Researchers will compare the 12 weeks participants consume mango to the 12 weeks the participants are not consuming mango to see if there are differences in glycemic indicators, insulin resistance, lipids, inflammation, oxidation and body composition between the two time periods.

Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control

This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.

Real-time Engagement for Learning to Effectively Control Type 2 Diabetes

This is a clinical trial that includes a run-in period, a 90 day micro-randomized trial, and a 90-day observational period. The goal of this study is to evaluate whether providing paired real time glycemic and health behavior data in a smartphone app leads to better glycemic control among adolescents and young adults with T2D. Glycemic control will be monitored using Continuous Glucose Monitors (CGM), and health behavior data will be collected via a Fitbit activity tracker and a research app (Healthmine). Participants will be prompted to view and reflect on glycemic trends and health behavior data (Fitbit data, logging of diet and medication adherence) during the 90-day micro-randomized trial period, then observed for ongoing use of the Healthmine app and engagement with CGM in the following 90-day observation period.

Monitoring and Managing Glucose Levels in People With Pancreatic Cancer

This study will investigate whether or not it is feasible to closely monitor and manage glucose levels in people with pancreatic cancer. It will also investigate what impact glucose management may have on pancreatic cancer. This is a pilot study that will use continuous glucose monitors (CGM) to monitor glucose levels in approximately 50 participants with pancreatic cancer. Participants will receive standard chemotherapy with a combination of up to four drugs to treat their pancreatic cancer: oxaliplatin, irinotecan, 5-fluorouracil, and leucovorin (FOLFIRINOX). To treat high glucose levels, participants will be randomly assigned to one of two groups: Group 1 will receive anti-hyperglycemic treatment as guided by an endocrinologist with the aim of maintaining glucose levels between 4 and 10 mmol/L; Group 2 will receive anti-hyperglycemic treatment if their glucose levels are above 15 mmol/L, which is standard care. Participants in both Groups 1 and 2 will receive standard anti-hyperglycemic treatments: metformin, insulin, glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose co-transporter (SGLT2) inhibitors, and dipeptidyl peptidase 4 (DPP-4) inhibitors. After 4 cycles of FOLFIRINOX, the CGM will be removed but any anti-hyperglycemic treatments will continue as needed. If participants discontinue treatment with FOLFIRINOX, they will continue to be followed for survival and subsequent anti-cancer therapy and will continue follow-up for glucose-related concerns at the discretion of their endocrinologist and/or medical oncologist.

Diabetes Clinical Decision Support

The purpose of this study is to determine the impact of an electronic medical record clinical decision support tool on rates of dysglycemia in the hospital, and its clinical and economical outcomes. The study also evaluates the perspectives of providers regarding the tool's usefulness on disease management support, knowledge, and practice performance.

Targeting Metabolic Syndrome From the Emergency Department Through Mixed-Methods: Pilot Trial

The objective of this study is to pilot a multifaceted, optimized intervention for metabolic syndrome (MetS) in emergency department patients to establish feasibility. Participants (n=20) will be randomized to intervention or control (usual care). The composite intervention will include an educational video outlining the adverse effects of MetS and the benefit of walking, a written exercise prescription with a defined goal of walking 150 minutes per week, a Fitbit accelerometer device, resources for healthy eating practices, periodic text message reminders, and an urgent referral to primary care and our health system's Healthy Me clinic for follow-up visit. Investigators hypothesize that this approach will change patient understanding and motivation to increase physical activity and healthy eating habits.

Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors

This clinical trial investigates the effects of adding different diabetes medications to patients with type 2 diabetes who are currently being treated with DPP4 inhibitors. The study evaluates three treatment strategies: SGLT2 inhibitor monotherapy, TZD monotherapy, and a combination of both SGLT2 inhibitor and TZD. Participants will be randomly assigned to one of four groups, including a control group continuing DPP4 inhibitor alone. The primary objective is to assess changes in blood sugar control, specifically HbA1c levels, after 12 and 24 weeks of treatment. Secondary outcomes include changes in fasting and postprandial glucose, insulin, C-peptide, lipid profiles (total cholesterol, triglycerides, HDL-C, LDL-C), body composition (muscle mass, visceral fat, subcutaneous fat), and insulin resistance indicators such as HOMA-IR, HOMA-beta, and Insulinogenic Index. Eligible participants are adults aged 19 to 75 years with type 2 diabetes who have been on stable doses of DPP4 inhibitors, with or without metformin or sulfonylurea, for at least 8 weeks. Individuals with recent use of SGLT2 inhibitors or TZDs, significant organ dysfunction, or other exclusion criteria will not be enrolled. The study is open-label and multicenter, conducted at four hospitals in Korea. All medications used in the trial are provided by the sponsor. Participants will receive lifestyle counseling throughout the study period, including guidance on diet and exercise. Safety monitoring will be conducted regularly, and adverse events will be documented and managed according to protocol.