Clinical Research Directory

Incretin Hormones in Type 1 Diabetes Mellitus;Effect of Metformin Treatment

Investigators aim is to conduct an RCT to study the effect of adjunct metformin treatment to insulin monotherapy in patients with type 1 diabetes, targeting the intestinal incretin secretion. The patients will be randomly allocated to metformin or placebo treatment for 4 months

Accuracy of Dexcom G6® and FreeStyle Libre® Sensors in Standardized Hypoxemia Conditions

The major aim is to evaluate accuracy of 2 Continuous Glucose Monitoring Systems (CGMS) : Dexcom G6® and FreeStyle Libre® in standardized hypoxemia conditions (artificial normobaric hypoxia). Our purpose is to demonstrate the good performance and calibration of these CGM sensors in hypoxemia conditions.

Frexalimab in Preservation of Endogenous Insulin Secretion Compared to Placebo in Adults and Adolescents on Top of Insulin Therapy (FABULINUS)

This is a randomized, parallel group, double-blind Phase 2 study with a blinded extension evaluating the safety and efficacy of 3 dose levels of frexalimab in comparison with placebo in participants with newly diagnosed T1D on insulin treatment. Study details include: Screening period: at least 3 weeks and up to 5 weeks. Enrollment date of the participant must take into consideration this constraint) Double-blind treatment period 104 weeks: Main treatment period: 52 weeks Blinded extension: 52 weeks Optional OLE period: 104 weeks Safety follow-up: 26 weeks The treatment duration will be up to 104 weeks , the total study duration will be up to 135 weeks for Part A and Part B. If participants enter the OLE period, the treatment duration will be up to approximately 208 weeks , and the total study duration will be 240 weeks approximately .

Probiotics in Newly Diagnosed T1D

The investigators aim to further the understanding of environmental factors that underlie the development of Type 1 diabetes (T1D) and the post-onset disease trajectory. Dysbiosis, defined as alterations in intestinal microbiota composition and function, has been hypothesized to increase the risk of developing T1D in those with genetic susceptibility. Dysbiosis may result from modern dietary habits, such as broad consumption of the highly processed Western Diet, or by widespread use of antibiotics. Here, the investigators propose to examine the impact of dysbiosis on the endogenous innate inflammatory state that potentiates T1D progression. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

A Study of CT-868 in Type 1 Diabetes Mellitus

This study will evaluate the changes in glycemic control in overweight and obese adults with Type 1 Diabetes Mellitus after receiving CT-868 for 16 weeks. The effectiveness and safety of CT-868 will be compared to placebo. All participants will continue with their standard diabetes care using either an insulin pump (CSII) or multiple daily injections (MDI). Alongside their designated treatment, participants will receive guidance on managing their diabetes, including monitoring blood glucose levels and diet and exercise recommendations. Treatment assignments, either CT-868 plus insulin or placebo plus insulin will be randomly determined.

Epidemiology of Diabetes Interventions and Complications (EDIC)

The Diabetes Control and Complications Trial (DCCT,1983-1993) compared intensive therapy aimed at near-normal glycemia versus conventional therapy with no specific glucose targets in 1441 subjects with type 1 diabetes (T1DM) over a mean follow-up of 6.5 years. Intensive therapy reduced the risks of retinopathy, nephropathy, and neuropathy by 35-76%. The level of glycemia was the primary determinant of complications. We also described the adverse effects of intensive therapy; assessed its effects on cardiovascular disease (CVD) risk factors, neurocognition and quality of life; and projected the lifetime health-economic impact. After the primary DCCT results were reported in 1993, intensive therapy aiming for a HbA1c \<7% was adopted world-wide as standard-of-care for T1DM. The Epidemiology of Diabetes Interventions and Complications (EDIC, 1994-present) is the observational follow-up study of the DCCT cohort. Micro- and cardio-vascular complications and a wide range of established and putative risk factors, including genetic and epigenetic factors, have been measured with standardized methods, carefully documented and events adjudicated. EDIC has notably shown that the early beneficial effects of intensive versus conventional therapy on complications persisted for \~15 years despite the convergence of HbA1c levels in the two groups during EDIC, a novel concept termed metabolic memory. Prior intensive therapy was also shown to reduce substantially the risk of CVD events and mortality. The overarching goals for the current cycle (2022-2027) are to study the occurrence and identify potentially modifiable risk factors of the more advanced microvascular and cardiovascular complications and physical and cognitive dysfunction that are occurring with increasing diabetes duration and age. With increasing longevity, the increased adiposity that has affected patients with T1DM, including EDIC participants, has potential adverse consequences. Thus, the impact of diabetes duration, aging and adiposity on morbidities and their underlying risk factors will be studied. The results will guide treatment priorities as T1DM patients age.

A Study to Learn How Well the Study Treatment Finerenone Works and How Safe it is in People With Long-term Decrease in the Kidneys' Ability to Work Properly (Chronic Kidney Disease) Together With Type 1 Diabetes

Researchers are looking for a better way to treat people with chronic kidney disease (CKD), a progressive decrease in the kidneys' ability to work properly, and type 1 diabetes. In people with type 1 diabetes, the body does not make enough of a hormone called insulin, resulting in high blood sugar levels that can cause damage to the kidneys. CKD often occurs together with or as a consequence of type 1 diabetes. The study treatment 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 approved for doctors to prescribe to people with CKD and type 2 diabetes. In this study, researchers want to learn if finerenone works better than placebo in reducing the participants' kidney disease from getting worse when given in addition to standard of care (SOC) treatment. A placebo looks like a treatment but does not have any medicine in it. SOC is a procedure or treatment that medical experts consider most appropriate for a condition or disease. To find out how well finerenone works, the level of a protein (albumin) in the urine will be measured. Researchers also want to know how safe finerenone is. To do this, the researchers will collect the number of participants with: * medical problems (also called treatment-emergent adverse events (TEAEs)) * serious TEAEs. A TEAE is considered 'serious' when it leads to death, puts the participant's life at risk, requires hospitalization, causes disability, causes a baby being born with medical problems, or is medically important * higher than normal blood levels of potassium (hyperkalaemia). Depending on the treatment group, the participants will either take finerenone or placebo, Importantly, the participants will also continue to take their regular SOC medicines. The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, they will visit the study site at least 6 times. The study team will: * collect blood and urine samples * check the participants' vital signs such as blood pressure and heart rate * do a physical examination including height and weight * check the participants' heart health by using an electrocardiogram (ECG) * do pregnancy tests in women of childbearing potential

Islet Cell Transplant for Type 1 Diabetes

City of Hope National Medical Center, located in Duarte, CA, is hosting a clinical study on islet cell transplantation, an experimental procedure being evaluated as a treatment for patients with type 1 diabetes. Islet cell transplantation involves taking insulin-producing cells from organ donors and transplanting them into the liver of a patient with diabetes. Once transplanted, the islets produce insulin, which can improve blood sugar control and eliminate the need to inject insulin or use an insulin pump. Anti-thymocyte globulin (ATG) and alemtuzumab (Campath) are anti-rejection medications that work by decreasing a patient's T-cells. T-cells are special white blood cells that recognize and destroy unwanted things like infections but can also attack transplanted cells and organs. Reducing the number of T-cells at the time of transplant may protect islets and improve long-term transplant success. In previous research studies, islet transplantation has been successful in reducing low blood sugar episodes, improving overall blood sugar control, and in some cases, allowing patients with type 1 diabetes to stop taking insulin. The purpose of this study is to determine if islet cell transplantation using ATG or alemtuzumab, along with additional medications to prevent the body from rejecting the transplanted cells, is a safe and effective treatment for type 1 diabetes. Study participants may receive up to three islet transplants and will be followed for five years to monitor blood sugar control, islet transplant function, and changes in quality of life.

Structured Carbohydrate-Counting Education in Adults With Type 1 Diabetes

This study evaluated changes in glycemic outcomes following a structured carbohydrate-counting education program in adults with type 1 diabetes using continuous glucose monitoring (CGM). Participants received an individualized, three-level carbohydrate-counting education program delivered by a diabetes dietitian over 12 weeks. Glycemic outcomes, including time in range, time above range, time below range, glycemic variability, and HbA1c, were assessed at baseline and after the education program. Changes in insulin requirements, body weight, and dietary intake were also evaluated. In addition, individually determined insulin-to-carbohydrate ratios were compared with estimates calculated using conventional formula-based approaches.

Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus

This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime. The goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg/dl compared with that using self-monitoring of blood glucose (SMBG).

Mitigating DKA in Type 1 Diabetes for Safe Use of SGLT Inhibitors Using Dual Continuous Ketone and Glucose Monitoring.

The goal of this clinical trial is to develop and evaluate a novel diabetes ketoacidosis risk mitigation strategy to support the safe use of sodium-glucose cotransporter-2 inhibitors (SGLT2i) therapy in participants with type 1 diabetes (T1D) and mild to moderate chronic kidney disease (CKD). The main objectives of this study are to: 1. Evaluate how ketone metrics differ between participants no chronic kidney disease (CKD), moderate risk CKD and high or very high-risk CKD in three time periods. 2. Identify potentially modifiable ketosis risk factors. 3. Use continuous dual ketone and glucose monitoring (DGK) data prior to and following treatment to determine ketosis risk factors and gain knowledge to further refine reporting of risk factors and determine which factors in the Ketone Action Plan (KAP) were most valuable. 4. Gather information on how participants and clinicians like and use the DGK reports. Participants will be asked to: * Meet with study investigators to determine if they are eligible * Sign written informed consent * Take a pregnancy test, if applicable * Have blood taken to assess kidney function and hemoglobin A1c * Take the study medication, following the study team instructions * Wear the study provided sensor throughout participation. * Complete 5 in person visits, and 11 phone check ins over a nine-month period * Provide feedback on their experience, usefulness of CGM/CKM reports, and the most valuable factors of the Ketone Action Plan (KAP).

MENA/Levant Epidemiological, Registry of Immunological & Clinical Traits (MERIT)

The primary objective of this multicenter observational registry is to characterize the clinical, epidemiological, and biological profiles of individuals of Middle Eastern, North African, and Levantine ancestry, including individuals with chronic medical conditions and healthy volunteers. The registry will collect standardized clinical and participant-reported data, along with biological samples, to support the investigation of disease patterns, health-related characteristics, and population-specific biological and immunological profiles in populations historically underrepresented in biomedical research. The resulting data and samples may support future research into disease-associated biomarkers and underlying biological mechanisms.

A Phase 2 Two-Part Study of Oral PS1 in Healthy Volunteers and Adults With Newly Diagnosed Type 1 Diabetes

This study consists of 2 sub-studies, including Part A and Part B. Part A is intended to further characterize the pharmacokinetic (PK) profile of PS1 based on existing single ascending dose (SAD) and multiple ascending dose (MAD) data, while Part B is designed as an exploratory study to evaluate the potential clinical effects of PS1 in adults with newly diagnosed type 1 diabetes mellitus (T1DM). PS1 is a potential blood glucose-lowering medication being developed by Pharmasaga Co., Ltd. for the treatment of T1DM.

A Study of GNTI-122 in Adults Recently Diagnosed With T1D

This is a 78-week single arm, multi-center, Phase 1 study to evaluate the safety, tolerability, cellular kinetics, and biomarker changes in C-peptide over time of GNTI-122, an investigational cell therapy manufactured from a participant's own blood cells in adult participants with recently diagnosed T1D. After assessment of eligibility, participants who qualify for the study will be enrolled sequentially in 1 of 3 cohorts. Cohort 1 participants (n=3) receive a low dose of GNTI-122 . Cohort 2 participants (n=3) receive a high dose of GNTI-122. Cohort 3 participants (n=10) receive a high dose of GNTI-122 in combination with rapamycin. Participants are followed for 78 weeks after the administration of GNTI-122 during which safety and efficacy assessments are made, including vital signs, ECG, physical exam, clinical labs, and monitoring of adverse events and concomitant medications. Disease markers (e.g., MMTT-stimulated C-peptide, HbA1c) and pharmacodynamic activity (e.g., lymphocyte subsets and phenotypes, effector T cell responses to islet antigens ex vivo, T1D autoantibodies) will be monitored serially throughout the study. The study will include sentinel dosing and a Safety Review Committee to ensure participant safety. Visit https://www.polarisstudy.com to learn more!

Cardiometabolic Effects of Non-Nutritive Sweeteners (NNS) in Type 1 Diabetes (T1D)

This project will apply a novel non-nutritive sweetener (NNS) dietary assessment tool with measurement of circulating NNS levels in a pediatric population, allowing correlation of NNS exposure to clinically meaningful cardiometabolic health outcomes.

Reducing Innate Inflammation in New Onset Type 1 Diabetes

This study aims to determine whether Lactiplantibacillus plantarum 299v (Lp299v) supplementation will reduce systemic inflammation and prolong residual beta cell function in individuals newly diagnosed with Type 1 diabetes. The investigators hypothesize that probiotic-induced alterations in the intestinal microbiota may favorably alter the post-onset disease state.

Pancreas Transplant Alone in Uremia and Non-uremia Patients

Theoretically, pancreas transplant alone in uremia (PTAu) or pancreas before kidney transplant (PBK) may be considered for patients awaiting both pancreas and kidney grafts, alongside options like simultaneous pancreas-kidney transplant (SPK) and pancreas after kidney transplant (PAK).This study was to assess the justification for PTAu or PBK by comparing the endocrine function, immunological responses, and graft survival outcomes with those of the pancreas transplant alone in non-uremia (PTAn) group. This study also focused on evaluating the feasibility of PTAu or PBK by comparing surgical outcomes and patient survival rates between the PTAu and PTAn groups.

Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes

This is a parallel, Phase 2, two-arm study to assess the efficacy and safety of 14-days intravenous (IV) infusion of teplizumab treatment. Teplizumab has been approved by FDA to delay the onset of Stage 3 Type 1 Diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. The dose regimen of teplizumab in this study is consistent with the regimen approved by US FDA. Given prior clinical studies conducted in Western countries, this design is appropriate to assess the efficacy, safety and tolerability, pharmacokinetic, pharmacodynamic, and immunogenicity of a 14-day IV infusion regimen of teplizumab in Japanese Stage 2 T1D participants aged 1 to 34 years.

Randomized Transition to Gla-300 in Pediatric Type 1 Diabetes: CGM-Derived Outcomes

This study evaluated two different starting dose strategies when switching children and adolescents with type 1 diabetes from insulin glargine U-100 to insulin glargine U-300. Participants were randomly assigned to start insulin glargine U-300 either at the same basal insulin dose they had been using or at a 20% higher dose. Continuous glucose monitoring data were used to compare glucose control and hypoglycemia before and after the switch. Participants were also followed to evaluate longer-term changes in glucose control and insulin requirements

A Study to Investigate Efficacy and Safety of Teplizumab Compared With Placebo in Participants 1 to 25 Years of Age With Stage 3 Type 1 Diabetes

This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase 3, 2-arm study for treatment. The purpose of this study is to measure change in glycemic control and prandial insulin independency over 52 weeks with teplizumab compared with placebo, both administered by intravenous (IV) infusion, in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) aged 1 to 25 years, on standard insulin therapy.

The COCCOS Study: a Transition Program for Young Persons With Chronic Conditions

A study is undertaken to examine the feasibility of the newly developed transition program in adolescents with type 1 diabetes, asthma and obesity in a multicentric setting. Specific objectives for this study are: (1) examining the impact of the program in terms of patient-reported health outcomes, (2) examining patients' and healthcare providers' experiences related to the program implementation process, and (3) examining the impact of the program in terms of cost-effectiveness.

DiaBuddy: AI-Enabled Digital Self-Management for Youth With Type 1 Diabetes

The goal of this clinical trial is to learn whether DiaBuddy, a digital self-management app, can help children and adolescents with Type 1 diabetes better manage their condition and reduce the burden experienced by their caregivers. The study will include children and adolescents aged 6 to 17 years with Type 1 diabetes who live in Pakistan. The main questions it aims to answer are: * Does using DiaBuddy along with usual diabetes care improve diabetes self-management and adherence? * Does using DiaBuddy along with usual diabetes care reduce caregiver burden? * Does using DiaBuddy affect blood sugar control, diabetes-related distress, and other diabetes-related health outcomes? * Is DiaBuddy acceptable and useful for children, adolescents, and their caregivers? Researchers will compare participants who use DiaBuddy along with their usual diabetes care with participants who receive usual diabetes care alone. Participants will: * Use DiaBuddy to record and review information related to their diabetes, including blood glucose and self-management activities. * Receive diabetes education, reminders, and self-management support through the app. * Complete questionnaires about diabetes self-management, diabetes-related experiences, and caregiver burden. * Have blood sugar control assessed through laboratory-verified HbA1c measurements. * Attend scheduled follow-up assessments at approximately 3 and 6 months. * Report relevant diabetes-related health events, such as hypoglycemia, diabetic ketoacidosis, emergency visits, and hospitalization.

A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)

The main purpose of this study is to look at the amount of the study drug LY3938577 that gets into the blood stream and how long it takes the body to get rid of it. At a later stage of this study (part B and C) the blood sugar lowering effect and the duration of action of LY3938577 will be evaluated compared to Insulin Degludec. The study will also evaluate the safety and tolerability of LY3938577 and information about any side effects experienced will be collected. The study will be conducted in four parts (A, B, C, and D). Healthy participants in Part A Period 1 will receive a single dose of LY3938577 or a placebo given via intravenous (IV) infusion. In Part A Period 2, participants will receive a single subcutaneous (SC) dose of either LY3938577 or placebo. Participants in Part B with Type 1 Diabetes Mellitus (T1DM) will receive single doses of either LY3938577 or Insulin Degludec given via IV infusion. Participants in Part C with Type 1 Diabetes Mellitus (T1DM) will receive two doses of either LY3938577 or Insulin Degludec administered SC. Participants in Part D with Type 1 Diabetes Mellitus (T1DM) will be evaluated in 2 periods, with Period 1 administered pre-study basal insulin and lispro mealtime insulin to establish insulin needs, and Period 2 administered lispro mealtime insulin and daily doses of LY3938577. The study will last up to approximately 11 weeks for Part A, 10 weeks for Part B, 13 weeks for Part C, and 10 weeks for Part D , including screening period.

VV-14299 and VV-14300 for the Treatment of Type 1 Diabetes

This study is testing VV-14299 and VV-14300 or VV-14300 alone in adults with long-standing type 1 diabetes (T1D) whose blood sugar is not well controlled despite using an automated insulin delivery (AID) system. VV-14299 and VV-14300 are investigational gene therapies that are injected into muscle and are designed to work together to help remove excess sugar from the blood.