Clinical Research Directory

Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM

This is a prospective, single arm, open-label, interventional, pilot study to evaluate the accuracy and precision of the continuous glucose monitoring (CGM) system of i-SENS, Inc., CareSens Air 3, in adult patients with type 1 diabetes.

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 52-week 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 Double-blind treatment period (104 weeks): * Main treatment period: 52 weeks * Blinded extension: 52 weeks Optional Open Label Extension: 104 weeks Safety follow-up: up to 26 weeks The treatment duration will be up to 104 weeks, the total study duration will be up to 135 weeks.

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).

Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol

In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore, the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol that was developed and proven effective during the Phase 1/2 clinical trial.

HCL in Adults With T1DM, Markedly Elevated HbA1c, and Psychological Vulnerability

The objective of this study is to evaluate whether the mylife CamAPS FX hybrid closed loop (HCL) system improves glycemic control and quality of life in type 1 diabetes (T1DM) patients with a chronic lack of glycemic control and with psychological problems. After screening visit and run-in, patients will be randomized to treatment with mylife CamAPS FX HCL for 12 months (group I) or treatment with their current type of treatment for 3 months and mylife CamAPS FX HCL for next 9 months (group II). The HCL system used in the study will consist of mylife CamAPS FX controller, mylife YpsoPump insulin pump and Dexcom G6 continuous glucose monitoring system (CGM). Main inclusion criteria include: type 1 diabetes for at least 2 years, hemoglobin A1c (HbA1c) ≥ 9.0%, and psychological vulnerability. Primary glycemic outcomes include: differences between study groups in changes in time in range 70-180 mg/dL (TIR) and HbA1c after 3 months. Main secondary outcomes include: differences between groups in CGM-derived data after 3 months and within the entire cohort after 12 months, as well as changes within groups in psychological scores after 3 months and within the entire cohort after 12 months.

Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults

After obtaining informed consent, the investigators will recruit 75 patients with T1DM and 75 with LADA with an age ≥ 18 years and ≤ 75 years, of both sexes. All patients will be selected among outpatients attending the Center of Diabetes and Metabolic Diseases of First Department of Internal Medicine, IRCCS Policlinico San Matteo Foundation. The study design will include one single visit where patients' medical history and blood samples will be collected. For incident cases, a follow-up visit at 3 months from the start of treatment will be scheduled to assess whether a decrease in HbA1c corresponds to a decrease in the biomarkers. For a comprehensive oxidative balance evaluation, the d-ROMs test will be carried out to evaluate the pro-oxidant status linked to one of the parameters related to the antioxidant potential (BAP test, OXY-Adsorbent test, -SHp test and anti-ROMs test). Parameters will be evaluated using Free Radical Elective Evaluator (FREE) Duo by Diacron International s.r.l. (Grosseto, ITALY), an integrated analytical system that permits any type of chemical-clinical analysis based on the principle of photometry. The investigators will also evaluate high sensitivity C-reactive protein (Hs-CRP), superoxide dismutase (SOD), glutathione peroxidase (GSH-Px), malondialdehyde (MDA). To evaluate if there is an association between a worse stage of the diseases and some oxidative stress markers, the investigators will also evaluate glycated hemoglobin (HbA1c) fasting plasma glucose (FPG), post-prandial glucose (PPG). All plasmatic parameters will be determined after a 12-h overnight fast, with the exception of PPG, determined 2 hours after a standardized meal. Venous blood samples will be taken for all patients between 8 A.M. and 9 A.M. The investigators will use plasma obtained by addition of Na2-ethylenediaminetetraacetic acid (EDTA), 1 mg/ml, and centrifuged at 3000 g for 15 minutes at 4°C. Immediately after centrifugation, the plasma samples will be frozen and stored at -80 °C for no more than 3 months. All measurements will be analyzed by the Laboratory of Molecular Medicine, General Medicine 1, IRCCS Policlinico San Matteo Foundation with proven experience in the dosage of these markers.

Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus

This Phase 2 study is a 2-arm, multi-center, double-masked (masking of the participant, care provider and investigator), placebo-controlled, 2:1 randomized trial design in new onset T1D participants (within 100 days of diagnosis). Participants will be administered rezpegaldesleukin/placebo once every 14 days over 26 weeks with an additional 6-month follow-up period.

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!

Polycystic Ovary Syndrome in Type 1 Diabetes

BACKGROUND Functional ovarian hyperandrogenism, including the polycystic ovary syndrome (PCOS), is very prevalent in women with type 1 diabetes (T1D). The pathogenic mechanisms of this association remain unclear. HYPOTHESIS Individual factors expose or protect women with T1D to/from the development of androgen excess and PCOS. Such androgen excess in women with T1D may increase their cardiometabolic risk. MAIN OBJECTIVE Unveiling the pathogenic mechanisms behind functional hyperandrogenism in women with T1D from a sex/gender-medicine and sexual dimorphism perspective. MATERIAL AND METHOS We have designed a cross-sectional comparative clinical study, including 5 groups of study subjects with 12 participans per group: i) Women with T1D \& PCOS. ii) Women with T1D without PCOS. iii) Men with T1D and normal gonadal function. iv) Women with PCOS without diabetes mellitus v) Non-hyperandrogenic control women without T1D. All groups will show similar age and body mass index. T1D groups will be matched for duration of disease. OUTCOMES 1.1 Insulin sensitivity (hyperinsulinaemic euglycaemic clamping). 1.2 Body composition (dual-energy x-ray absorptiometry, bioelectrical impedance analysis \& sonographic studies). 1.3 Ovarian and adrenal steroidogenesis. 2.1 Differential pattern in genetic variants related with insulin signalling and response, inflammation, adiposity, gonadal function, steroidogenesis, and PCOS itself by whole exome sequencing. 2.2 Microbiopsy studies in deep subcutaneous adipose tissue and skeletal muscle tissue: 2.2.1 Differential DNA methylation patterns in genes associated with PCOS. 2.2.2 Differential transcriptomic pattern in genes associated with PCOS. 2.2.3 Differential proteomic patterns in adipose and muscle tissues. 3. Interaction between T1D and PCOS on parameters of metabolic control (intersticial blood glucose monitoring) and morbidities associated with T1D itself.

Effect of Ambient Temperature on Blood Glucose and Insulin Absorption in Adults With Type 1 Diabetes

The goal of this clinical trial is to learn how different temperatures affect blood sugar levels in adults with type 1 diabetes. Climate change is causing more extreme hot and cold weather, and people with type 1 diabetes may be at higher risk during these temperature changes. The main questions it aims to answer are: * Do different temperatures (cold, normal, or hot) change blood sugar levels in people with type 1 diabetes? * How does temperature affect insulin absorption in the body? Researchers will compare three different temperature conditions to see how each affects blood sugar levels and insulin in the body. Participants will: * Complete a screening visit with body measurements and questionnaires * Attend 3 separate study visits, each in a different temperature setting: * Cold room (10°C/50°F) * Normal room temperature (23°C/73°F) * Hot and humid room (36°C/97°F with 65% humidity) * Sit for 2 hours in each temperature condition while researchers monitor their blood sugar, heart rate, and body temperature * Wear a continuous glucose monitor for 48-72 hours before each visit * Keep a diary of food, sleep, and activity for 24 hours before and after each visit Each temperature visit is separated by at least 3 days. The study helps researchers understand if people with type 1 diabetes need special guidance for managing their blood sugar during extreme weather.

Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss

This is a single-center, prospective, open label study in islet transplant recipients after complete islet graft rejection/loss, defined as stimulated c-peptide ≤0.3 ng/mL.

Impact of Dietary Fat and Menstrual Cycle Phases in Type 1 Diabetes

This clinical trial aims to evaluate how variations in dietary fat content and hormonal status influence postprandial glycemic response in individuals with type 1 diabetes (T1D), with a special focus on women. The main objective is to clarify the impact of both factors individually and their interaction, which could inform more personalized strategies for insulin adjustment, optimizing glycemic control, and improving patient outcomes. The main objective is to investigate the effects of low-fat versus high-fat meals, sex, menstrual cycle phases, and their interaction on postprandial glycemic control in adults with T1D treated with advanced hybrid closed-loop (AHCL) insulin delivery systems. Specifically, the study will: * Compare postprandial glycemic responses after standardized low and high-fat meals in men and women with T1D. * Assess the differences in postprandial glycemic responses between early follicular and late luteal phases in women, using standardized meals with low and high fat content. * Identify sex-related differences in glycemic response after equivalent meals. This research addresses the unmet clinical need for precise, tailored postprandial insulin dosing recommendations, especially among women whose insulin sensitivity fluctuates with menstrual phases. The results may contribute to sex-specific predictive models in AHCL systems, reducing acute complications and improving overall quality of life. This is a randomized controlled crossover trial in which each participant serves as her/his own control. Fifty adults will be enrolled: 25 women and 25 men. Women will undergo four mixed-meal tests in random order: * low-fat given during the early follicular phase, * high-fat given during the early follicular phase, * low-fat given during the late luteal phase, * high-fat given during the late luteal phase. The menstrual phase will be confirmed with home-based hormonal monitoring devices that function with urine sample and use a single-use test wand (MIRA system). Men will complete two mixed-meal tests (low-fat and high-fat), in randomized order. All meals will be standardized for carbohydrate content and matched in other macronutrients, except for fat (with a 30-40g difference), administered after an 8-hour fast. The day of the mixed meal test, AHCL systems will be switched from automatic to manual mode just before eating to standardize the prandial insulin dose and to avoid differences in insulin infusion rates in the postprandial state due to algorithm compensations. Continuous glucose monitoring (CGM) and hourly capillary glucose testing will measure the postprandial response. Additional fasting blood samples will assess metabolic, hormonal, and lipid markers. Optional gastric emptying studies may be performed to exclude confounding gastroparesis in selected patients. Participants will be recruited from the endocrinology outpatient unit of La Fe Polytechnic University Hospital . The projected recruitment period is from December 2025 to July 2027, with mixed-meal tests and data collection occurring between January 2026 and December 2027. Women are expected to complete the protocol in 6 weeks (4 tests), while men will require about 2 weeks (2 tests). At baseline, participants will undergo blood tests to rule out endocrine disorders and confirm sex hormone status. Women participating in the study will use the MIRA home device to monitor their hormonal levels, allowing them to accurately determine and record the phases of their menstrual cycle as part of the study protocol. During meal tests, CGM (Freestyle Libre 3) will be used uniformly among subjects. The study dependent variables will be the following: * Postprandial glucose area under the curve - AUC\_PG\_5h * Mean glucose level - MG * Continuous glucose monitoring metrics - TIR, TAR, TBR * Postprandial glucose standard deviation - SD * Postprandial glucose coefficient of variation - CV * Mean amplitude of glycemic excursions - MAGE * Mean of daily differences (MODD) Independent variables are * Type of food: Meals with either low or high fat content. * Sex and Hormonal status: men; women during the early follicular phase; women during the late luteal phase. If successful, this study will inform the development of more sophisticated, individualized insulin dosing algorithms and AHCL system improvements, especially for women with T1D. Results may lead to more effective management strategies, reduced GV, lower incidence of complications, and increased quality of life. Insights may directly support the personalization of diabetes care and improve gender equity in treatment standards.

Long Term Follow up of Recipients of Functional Islet Allografts

Since its inception, the Diabetes Research Institute (DRI) has made significant contributions to the field of diabetes, pioneering many of the techniques used in diabetes centers around the world. Through several clinical trials, DRI has demonstrated that diabetes can be successfully reversed as a result of islet cell transplant. Over the years the following protocols in islet cell transplantation have been initiated: 2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210. All of the studies listed above will be source of study subjects for this study. Approximately 30 subjects are expected to be enrolled and followed in this trial. After islet-cell transplantation in the parent studies, each subject receives maintenance immunosuppressive medications. The purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their parent study.

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.

Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

INHALE-1st: Afrezza® For Youth With Newly-Diagnosed Type 1 Diabetes

INHALE-1st is a Phase 2, single-arm, multi-center, clinical study evaluating the safety and efficacy of Afrezza in combination with subcutaneously-injected basal insulin (BI) for youth 10 to \<18 years old with newly diagnosed stage 3 type 1 diabetes (T1D). The study will also evaluate the effect of an Afrezza plus BI reigmen on participant and parent/legally authorized representative satisfaction. Participants will be followed for 13 weeks during the main phase followed by an optional Extension Phase for participants continuing to use Afrezza in combination with BI for up to 26 weeks.

Feasibility of a Tailored Online Self-compassion Intervention

The goal of this clinical trial is to examine the feasibility and acceptability of an online programme that is based on Compassionate Mind Training (CMT) over four-weeks. The programme intends to share information and strategies to reduce diabetes distress, self-criticism, and shame, and improve physical health in people who have Type 1 and Type 2 Diabetes Mellitus.

Biomarkers of Acute Organ Injury in Pediatric Newly Diagnosed Type 1 Diabetes

Diabetic ketoacidosis (DKA) is a severe metabolic complication in children with newly diagnosed type 1 diabetes mellitus (T1DM) and may be associated with early injury of vital organs such as the kidneys and the heart. Early detection of organ dysfunction is important for identifying children at increased risk for complications. This observational cross-sectional study aims to evaluate biomarkers of acute organ injury and associated clinical and echocardiographic parameters in children with newly diagnosed T1DM presenting with DKA, compared with children with newly diagnosed T1DM without DKA and healthy controls. Biomarkers including KIM-1, NGAL, high-sensitivity troponin, NT-proBNP, interleukin-6, and C-reactive protein will be measured during hospital admission and within the first 24-48 hours of hospitalization.

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.

Treatment of Type 1 Diabetes With Anti-OX40L Bispecific With Anti-TNF Activity In a Single Nanobody® Molecule

This is a randomized, placebo-controlled, parallel group, multicenter, double-blind Phase 2a, 2-arm study. The goal of this Phase 2a study is to assess safety and efficacy of brivekimig in comparison to placebo to preserve β-cell function in participants with recently diagnosed Stage 3 type 1 diabetes (T1D) on insulin therapy. The study design comprises 2 parts: in Part A adult participants (18 to 35 years of age at screening) and in Part B adolescent and young adult participants (age range 12 to 21 years) will be randomized into brivekimig and placebo groups. Approximately 84 participants will be included with randomization ratio 3:1 (active:placebo). The study includes a screening period (3 to 5 weeks), a double-blind treatment period of 52 weeks and a safety follow-up of 26 weeks.

Resistance Training on Depression and Quality of Life in Type 1 Diabetic Women

Find out the effects of resistance training on depression, sleep quality, and quality of life in women with type 1 diabetes mellitus

Physical Activity to Prevent and Treat Hyperglycemia From a Mistimed Bolus Insulin Dose

People living with type 1 diabetes (PwT1D) are recommended to administer insulin 10-15 minutes before meal consumption (pre-bolus), to account for the delay in the glucose lowering action associated with subcutaneously administered insulin. Due to the demands of day-to-day life, pre-bolusing is not always possible or may be forgotten. With continuous glucose monitors (CGMs), PwT1D may be alerted to this missed insulin dose by a CGM alert, including rapidly rising glucose (change \>2.5mmol/L/15min) or hyperglycemia (\>10.0 mmol/L), and deliver a mistimed (post-prandial) dose in response to CGM alert. This study was designed to determine the effect of combining a post-prandial/mistimed insulin dose with 15 minutes of brisk walking. It is expected that walking will help to minimize or prevent hyperglycemia after a mistimed bolus insulin dose, as well as blunt the rise in glucose following a mistimed insulin dose.

Establishment of Screening Pathway for High-Risk Population of Type 1 Diabetes

This study aims to establish a system for identifying and screening high-risk individuals for type 1 diabetes (T1D) and a standardized management pathway for high-risk individuals. It is a prospective cohort study. We plan to enroll 340 eligible subjects, including 40 healthy controls of the same gender and age, 150 T1D patients, and 150 first-degree relatives of T1D patients. The follow-up visit cycle for T1D patients and their first-degree relatives is 4 years. Blood samples will be collected annually for genetic polymorphism testing, pancreatic islet-related autoantibody measurement, blood glucose, hemoglobin A1c, and pancreatic function assessment. Urine samples will be collected for urine proteomics measurement. Fecal samples will be collected for fecal intestinal microbiota measurement. The value of pancreatic islet autoantibody markers in predicting T1D high-risk individuals will be evaluated, and a multi-gene risk score (PRS) prediction model will be established for subtypes of T1D, including acute and chronic T1D. A comprehensive T1D high-risk individual identification and screening system will be established and promoted for application.

Type 1 Diabetes Extension Study

This is a multi-center, prospective, non-interventional study that focuses on the long- term effects following participation in selected ITN new-onset Type1 Diabetes Mellitus studies with immunomodulatory agents (T1DM, T1D). This observational study will: * follow participants to determine how long they continue to produce insulin, and * will also assess how changes in the immune system over time relate to the ability to produce insulin. This information could help design better therapies for type 1 diabetes in the future.