Type 1 Diabetes Clinical Trials

237 recruiting

Understanding Type 1 Diabetes Clinical Trials

Teplizumab (Tzield), approved in 2022, became the first drug proven through clinical trials to delay the onset of type 1 diabetes in high-risk individuals — a historic breakthrough that marked the first time any therapy could alter the disease's course before it fully developed. This approval was built on years of trial data showing that a single 14-day course of the drug delayed clinical diagnosis by a median of two years. Clinical trials in type 1 diabetes are now pursuing even more ambitious goals, including preserving insulin-producing beta cells after diagnosis, developing artificial pancreas systems, and working toward biological cures through cell replacement therapies.

Why Consider a Clinical Trial?

Type 1 diabetes management has improved dramatically with modern insulin pumps, continuous glucose monitors (CGMs), and hybrid closed-loop systems, but even the best technology cannot fully replicate a healthy pancreas. People with type 1 diabetes still face the daily burden of blood sugar management, the risk of hypoglycemia and hyperglycemia, and long-term complications affecting the eyes, kidneys, nerves, and heart. Clinical trials offer access to therapies aimed at the root cause of the disease — the autoimmune destruction of insulin-producing beta cells — rather than just managing its symptoms. Trials in type 1 diabetes span an unusually wide range, from prevention studies in people who have autoantibodies but have not yet developed clinical diabetes, to newly diagnosed studies testing drugs that may preserve remaining beta cell function, to advanced technology trials evaluating next-generation closed-loop insulin delivery systems. There are also trials studying islet cell transplantation and stem cell-derived beta cells that could one day eliminate the need for insulin injections entirely. Regardless of how long you have had type 1 diabetes, there are likely trials relevant to your situation.

Frequently Asked Questions

Common questions about Type 1 Diabetes clinical trials

Yes. While some trials focus on newly diagnosed individuals, many are open to adults who have had type 1 diabetes for years. Technology trials for closed-loop systems and adjunctive therapy trials for drugs used alongside insulin are often open regardless of disease duration. Cell replacement trials are also studying long-term patients.

Many type 1 diabetes trials include pediatric participants, and these trials undergo additional ethical review specifically focused on child safety. Trials in children use age-appropriate dosing and monitoring protocols. Parental consent and, depending on age, the child's assent are both required before enrollment.

This depends entirely on the trial. Technology trials may require you to switch to the study device. Drug trials generally allow you to continue using your current insulin delivery system and CGM, though they may ask you to use a specific CGM for standardized data collection. Ask the study team about device requirements before enrolling.

Cure-oriented trials aim to restore the body's ability to produce insulin, through approaches like beta cell replacement or immune reprogramming. Management trials aim to improve blood sugar control, reduce complications, or decrease the burden of daily disease management. Both types are valuable and serve different goals.

TrialNet offers free autoantibody screening to relatives (ages 2.5 to 45) of people with type 1 diabetes. You can visit the TrialNet website to find a screening location or request an at-home test kit. If autoantibodies are detected, TrialNet provides monitoring and may offer enrollment in prevention trials.

Showing 120 of 237 trials

Recruiting

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

Type 1 Diabetes MellitusDiabetic Ketoacidosis
Aristotle University Of Thessaloniki45 enrolled1 locationNCT07483879
Recruiting
Phase 1

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

Healthy VolunteersType 1 Diabetes
Mozart Therapeutics Australia Pty Ltd96 enrolled4 locationsNCT06324604
Recruiting
Not Applicable

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

Type 1 Diabetes
Baylor College of Medicine250 enrolled1 locationNCT06014879
Recruiting
Not Applicable

Intervention for Children With Type 1 Diabetes Targeting Gut Microbes

Type 1 Diabetes
Children's Hospital of Fudan University110 enrolled1 locationNCT06198725
Recruiting

Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.

Type 1 Diabetes (T1D)
University Hospital, Strasbourg, France36 enrolled1 locationNCT07470593
Recruiting
Not Applicable

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

Type 1 Diabetes
Anas El Fathi6 enrolled1 locationNCT07212179
Recruiting
Phase 1Phase 2

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

Type 1 DiabetesNew Onset
City of Hope Medical Center120 enrolled11 locationsNCT07061574
Recruiting
Not Applicable

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

Type 1 DiabetesPost-menopause
University of Alberta20 enrolled2 locationsNCT05188027
Recruiting
Not Applicable

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

Type 1 Diabetes Mellitus
Jane Yardley30 enrolled1 locationNCT06686329
Recruiting
Not Applicable

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

Type 1 Diabetes MellitusType 2 Diabetes Mellitus
Hoffmann-La Roche270 enrolled14 locationsNCT06704672
Recruiting

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

Type 1 Diabetes Mellitus
Peking University First Hospital340 enrolled1 locationNCT07468474
Recruiting

Characterization of Type 1 Diabetes Subgroup: An Artificial Intelligence Analysis of Clinical and Glucometric Features

Type 1 Diabetes Mellitus
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau800 enrolled1 locationNCT07461805
Recruiting
Phase 1Phase 2

CNP-103 in Adolescent and Adult Subjects Ages 12-35 With Recently Diagnosed (Within 6 Months) Stage 3 Type 1 Diabetes (T1D)

Type 1 DiabetesType 1 Diabetes MellitusType 1 Diabetes Mellitis+7 more
COUR Pharmaceutical Development Company, Inc.72 enrolled31 locationsNCT06783309
Recruiting

Type 1 Diabetes Extension Study

Type 1 Diabetes MellitusT1DT1DM
National Institute of Allergy and Infectious Diseases (NIAID)111 enrolled12 locationsNCT02734277
Recruiting
Phase 3

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

Type 1 Diabetes Mellitus
Sanofi723 enrolled107 locationsNCT07088068
Recruiting

Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening

Type 1 Diabetes
Yale University60 enrolled1 locationNCT07155252
Recruiting
Phase 1Phase 2

Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D)

Type 1 Diabetes Mellitus
University of Chicago70 enrolled1 locationNCT06305286
Recruiting
Not Applicable

Dysautonomia in Children With Type 1 Diabetes

Healthy VolunteerDysautonomia in Children With Type 1 Diabetes
Centre Hospitalier Universitaire de Saint Etienne100 enrolled1 locationNCT07455994
Recruiting
Phase 3

Clinical Study for Dimethyl Fumarate in Preserving Islet β-Cell Function in Type 1 Diabetes Mellitus

Type 1 Diabetes
Nanjing Medical University90 enrolled1 locationNCT07258394
Recruiting
Not Applicable

Continuous Glucose Monitoring for Outpatient Diabetes Management After Hospital Discharge

Type 1 Diabetes Mellitus (T1DM)Type 2 Diabetes Mellitus (T2DM)Hyperglycemia
Vanderbilt University Medical Center60 enrolled1 locationNCT06852950