Clinical Research Directory

Immune Function and the Progression to T1D

To elucidate the mechanisms by which type 1 diabetes-associated genes; IFIH1, TYK2, IKZF4, as well as total genetic risk, impart functional immunoregulatory abnormalities that result in expansion of self-reactive adaptive immune cells, defective regulatory/effector mechanisms in T cells, inflammatory antigen presenting cells, and abnormal immune function in T cells and B cells.

French Prospective Multicentric Study in Real World

The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.

Closed-loop Medtronic 780G System in Youth With Type 1 Diabetes

The goal of this observational study is to describe data on Israeli children and youth using the 780G system including data regarding glycemic control parameters, various questionnaires, sleep data, bioimpedance measures, and dietary parameters. The main questions it aims to answer are: • whether the 780G system will improve glycemic control • whether the psychosocial aspects will improve. Participants will be followed once connected to 780G, at baseline, one, three, six months, 1 year, and two years after the connection.

Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes

People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population. In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population. This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.

A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes (AIDANET At Home)

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.

Long-Term Outcomes of Teplizumab in Routine Clinical Care

This is an observational, prospective cohort study designed to evaluate the outcomes after teplizumab treatment in participants with Stage 2 Type 1 Diabetes (T1D) for delaying the onset of Stage 3 T1D. The study will monitor participants receiving teplizumab as part of routine clinical care across multiple sites. Additionally, patient-reported outcomes (PROs) will be evaluated to further assess the treatment's impact on participant's quality of life including emotional and psychosocial aspects associated with T1D. This approach will provide a more comprehensive understanding of how the treatment performs over time and across diverse patient populations, providing valuable insights into the sustained effects of teplizumab and offering a real world picture of its impact on the long-term management of T1D.

Development of Novel Biomarkers for the Early Diagnosis of Type 1 Diabetes

The purpose of this study is to measure the levels of certain substances (biomarkers) in the body that may indicate the triggers of Type 1 Diabetes, to find a better way to diagnose the disease, as well as to follow its progression.

Early Automated Insulin Delivery (AID) Pilot for Newly Diagnosed T1D

Type 1 diabetes is a common chronic medical condition among youth in the US that requires intensive glycemic management to prevent long-term morbidity and mortality. Current pediatric diabetes care in the US underutilizes automated insulin delivery (AID) systems, which are the best available tools for promoting tight glycemic control while reducing user burden. This proposal aims to support early and sustained use of AID systems by examining and optimizing conditions, evaluating glycemic outcomes, and identifying contextual facilitators and barriers of implementation.

ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2

The purpose of this study is to determine if use of a nonmydriatic fundus camera using autonomous artificial intelligence software at the point of care increases the proportion of underserved youth with diabetes screened for diabetic retinopathy, and to determine the diagnostic accuracy of the autonomous AI system in detecting diabetic retinopathy from retinal images of youth with diabetes.

Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)

PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.

Making Diabetes Care Fit for Young Adults Living With Type 1 Diabetes: Observations, Reflections and Expert Opinions

The goal of this clinical study is to assess differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool among young adults with type 1 diabetes and their clinicians. The main question it aims to answer is: What are the differences in collaborative efforts to make care fit between clinical encounters in usual care and those using the Making Care Fit tool? Researchers will compare clinical encounters in usual care with encounters supported by the Making Care Fit tool to examine differences in collaborative efforts to align care and daily life. Participants will: * Take part in an observed clinical encounter with their clinician * Participate in a post-encounter video-stimulated interview reflecting on the consultation * Complete questionnaires about their experiences of the consultation

Sleep Screening and Intervention for Adolescents With Type 1 Diabetes in a Clinical Diabetes Center

This study is evaluating an in-clinic sleep screening and intervention algorithm for youth with type 1 diabetes. This study will assess health care provider feasibility of completion of intervention and long term follow up for adolescents with T1D.

Study of IMC-S118AI in Type 1 Diabetes

This is a first-in-human (FIH) study designed to assess the safety, tolerability, and pharmacokinetic (PK) profile of IMC-S118AI in single-ascending dose (SAD) and multiple-ascending dose (MAD) regimens. This study will potentially also explore the effects of multiple-dosing regimens on preservation of beta-cell function in Stage 3 Type 1 diabetes.

An Efficacy, Safety, and Tolerability Study of VX-880 in Participants With Type 1 Diabetes With a Kidney Transplant

This study will evaluate the efficacy, safety, and tolerability of VX-880 in participants with Type 1 Diabetes (TID) with a kidney transplant.

Prevalence and Risk Factors of Metabolic-Associated Hepatic Steatosis in Individuals Living With Type 1 Diabetes

The goal of this observational cross-sectional study is to assess the prevalence and stage of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), specifically liver steatosis and fibrosis in adults aged 18 and older living with type 1 diabetes or Latent Autoimmune Diabetes in Adults (LADA) in Quebec. The main questions it aims to answer are: 1. What is the prevalence and severity of liver steatosis and fibrosis among people living with type 1 diabetes in Québec? 2. Are there patients with type 1 diabetes who have advanced, undiagnosed stages of liver disease that require management but are missed by current standard care practices? Researchers will compare three participant subgroups based on adiposity (a control group without increased adiposity, an overweight group with increased adiposity, and an obesity group with increased adiposity) to see if the prevalence and severity of hepatic steatosis and fibrosis are highest in the obesity group and lowest in the control group. They will also explore if variables and potential risk factors associated with liver disease differ across these subgroups. Participants will attend a single study visit where they will be asked to: * Provide clinical data through laboratory analyses. * Undergo specific clinical procedures. * Complete validated questionnaires.

Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs)

This study is a multi-country, multi-center retrospective observational cohort study based on secondary data collected via chart review, with the aim of describing patient characteristics (including relevant comorbidities), monitoring and treatment practices related to Type 1 diabetes mellitus (T1D) progression, and time to T1D progression in participants who received teplizumab as part of Managed Access Programs (MAPs). This study design was chosen in order to gain rapid insight into the current use of teplizumab in clinical practice and the characteristics of patients who received the treatment.

Safety, Pharmacokinetics, and Pharmacodynamics of MTX-101 in Healthy Adults and Patients

First in human study to understand the potential side effects of MTX-101, how long MTX-101 lasts in the human body, and how MTX-101 affects specific human immune cells.

Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes

This multicenter observational cohort study aims to evaluate whether estimated first-trimester risk of preeclampsia (PE) is associated with subclinical atherosclerosis, cardiovascular risk profile, and cardiovascular events in women with type 1 diabetes (T1D) at least 3 years after pregnancy. Women with T1D and at least one prior pregnancy with documented first-trimester PE screening will be classified as high or low PE risk according to validated multivariable algorithms. The presence of carotid plaques, cardiometabolic risk factors, and incident cardiovascular events will be assessed during a study visit.

EMPoWER Study - Strengths-based Behavioral Intervention for Youth With Type 1 Diabetes

The EMPoWER Study randomized clinical trial is a strengths-based behavioral intervention delivered to youth with type 1 diabetes (age 10 to 13) and their parents. The purpose of the intervention is to improve glycemic, behavioral, and psychosocial outcomes in youth with diabetes using a multiple systems approach that engages youth, their parents, and diabetes care providers to identify and build youths' diabetes strengths. The primary aim of this study is to assess the intervention impact on glycemic control, adherence, and health-related quality of life (HRQOL). Secondary aims are to evaluate behavioral mediators of intervention impact and to examine intervention dose as a mediator of intervention impact.

Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

The goal of this clinical study is to evaluate the effect of nutritional intervention program based on dietary products in the clinical treatment of newly diagnosed children with type 1 diabetes. The main question aims to answer is: whether high fiber diet can protect beta-cell function in children with newly onset type 1 diabetes. Participants will take 12 weeks of high fiber diet intervention and beta-cell function and gut microbiota structure will be analyzed.

The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment

The purpose of this study is to investigate the effect of early initiated automated insulin de-livery (AID) treatment in type diabetes in children aged 7-16 years to glycemic control, diabe-tes distress of patients and caregivers, long-term micro- and macrovascular complications and cost-effectiveness compared to multiple daily injections (MDI) and continuous glucose monitoring (CGM). The immediate costs of AID therapy are higher than costs of multiple daily injection therapy, and there has been debate whether the more expensive AID therapy is justified. No research on the cost-effectiveness of AID use in children has been conducted so far in Finland, and there is generally very little research data on the long-term treatment of type 1 diabetes with AID systems. AID therapy has been studied from the point of diagno-sis of type 1 diabetes in two centers (USA and the UK) but from the perspective of maintain-ing subject's own insulin secretion. A long-term randomized and controlled study on the out-comes and cost-effectiveness of AID therapy, started from diagnosis of diabetes, is essential to create evidence-based data for optimizing current treatment recommendations. Our hypothesis is that AID treatment keeps the glycemic outcomes in targets in the long term and decreases diabetes distress. During longer time, AID system decreases the amount of micro- and macrovascular complications and is cost-effective treatment for children with type 1 diabetes (CwT1D).

Aerobic vs Resistance Exercise in Post-menopausal Women With Type 1 Diabetes

Participants will be asked to wear a continuous glucose monitor for at least three days on three separate occasions. One testing session will be a no-exercise resting control session (90 minutes). One will be a moderate aerobic exercise session (30 minutes of exercise, 60 minutes of recovery), and the third will be a moderate weight-lifting session (\~30 minutes of exercise, 60 minutes of recovery).The investigators will measure changes in blood glucose during exercise by drawing blood during and after exercise. Post-exercise glucose trends will be examined using continuous glucose monitoring.

Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 Diabetes Using Automated Insulin Delivery

To evaluate the safety and feasibility of a novel self-learning bolus calculator along with simplified meal announcement (AID+InsuLearn-SMA) in adolescents and young adults with T1D using Automated Insulin Delivery.

A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New Onset Type 1 Diabetes

This multi-center randomized controlled trial will assess the safety and efficacy of ATG followed by either adalimumab or verapamil in preserving insulin secretion 2 years from randomization in persons aged 9 to \<21 with recent-onset stage 3 T1D.