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ClinicalTrials.gov 23 recruiting now official registry

Type 1 Diabetes Mellitus clinical trials

23 of 106 indexed Type 1 Diabetes Mellitus trials are currently recruiting.

106 US clinical trials · 23 currently recruiting

Type 1 Diabetes Mellitus is the subject of 106 registered US clinical trials on ClinicalTrials.gov, 23 of them currently open to new participants. 19 are in Phase 3-4 (later-stage) and 35 in Phase 1-2 (earlier-stage). The most active sponsor is University of Virginia, running 8 of these trials.

The research picture

Type 1 Diabetes Mellitus has 106 registered US clinical trials, 23 of them open to new participants right now, about 22% of the total.

23
recruiting participants now
22%
of trials open to enrollment
19
in Phase 3–4 (later-stage)
8
top sponsor: University of Virginia
Phase 119Phase 216Phase 314Phase 45

Active & Recent Trials

106 total, page 1 of 3

RECRUITING 1,875 participants

Twiist Postmarket Surveillance Study for Type 1 Diabetes

Deka Research and Development

NCT07356089

RECRUITING Phase 3 723 participants

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

Sanofi

NCT07088068

RECRUITING NA 400 participants

GATEWAY: Safety Evaluation of the MiniMed™ NMX8-AID System in Children and Adults Living With Diabetes

Medtronic Diabetes

NCT07228117

RECRUITING NA 360 participants

A Hybrid Effectiveness-implementation Trial to Reduce Diabetes Distress in Teenagers

Ann & Robert H Lurie Children's Hospital of Chicago

NCT06709755

RECRUITING Phase 2 192 participants

FrexalimAB in Preservation of Endogenous insULIN Secretion Compared to Placebo in adUlts and Adolescents on Top of inSulin Therapy (FABULINUS)

Sanofi

NCT06111586

RECRUITING Phase 4 120 participants

Dapagliflozin Plus Pioglitazone in T1DM

The University of Texas Health Science Center at San Antonio

NCT03878459

RECRUITING 111 participants

Type 1 Diabetes Extension Study

National Institute of Allergy and Infectious Diseases (NIAID)

NCT02734277

RECRUITING Phase 2 100 participants

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

Mannkind Corporation

NCT07224321

RECRUITING Phase 1 72 participants

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

COUR Pharmaceutical Development Company

NCT06783309

RECRUITING Phase 1 70 participants

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)

University of Chicago

NCT06305286

RECRUITING 60 participants

The PRECISION II Study: Evaluating the Accuracy of the LabPatch Glucose Sensing System

Joslin Diabetes Center

NCT05754281

RECRUITING Early Phase 1 60 participants

The Effects of Fluoxetine and/or DHEA

University of Maryland, Baltimore

NCT03228732

RECRUITING NA 60 participants

Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

Children's Mercy Hospital Kansas City

NCT06390371

RECRUITING 60 participants

Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Rodolfo Alejandro

NCT02000687

RECRUITING NA 32 participants

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

i-SENS

NCT07296276

RECRUITING Phase 2 30 participants

Evaluate Use of Tropocells(R) Autologous Platelet-rich Fibrin (PRF) for Wagner Grade 1 and Grade 2, Mild to Mod Neuroischemic Plantar Diabetic Foot Ulcer Wound Care.

Estar Medical dba Medical Technologies

NCT06810726

RECRUITING 30 participants

Long Term Follow up of Recipients of Functional Islet Allografts

Rodolfo Alejandro

NCT01999374

RECRUITING Early Phase 1 27 participants

Cardiometabolic Benefit of Reducing Iatrogenic Hyperinsulinemia Using Insulin Adjunctive Therapy in Type 1 Diabetes

Vanderbilt University Medical Center

NCT06609356

RECRUITING Phase 1 20 participants

Subcutaneous Pharmacokinetic Evaluation of Monomeric Insulin and Lyumjev in Adults With Type 1 Diabetes

Stanford University

NCT07090824

RECRUITING NA 20 participants

PACTAID App in Adults With Type 1 Diabetes to Help Manage Exercise

Mayo Clinic

NCT06730906

RECRUITING NA 18 participants

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

Rodolfo Alejandro

NCT01999361

RECRUITING Phase 1 16 participants

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

GentiBio

NCT06919354

RECRUITING Phase 1 13 participants

A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus

Otsuka Pharmaceutical Factory

NCT06575426

ACTIVE NOT RECRUITING NA 396 participants

Home Video-based Telemedicine to Reduce Hypoglycemia Fear in Parents of Young Children

Nemours Children's Clinic

NCT03914547

ACTIVE NOT RECRUITING Phase 3 330 participants

A Phase III Study to Investigate if the Study Drug Diamyd Can Preserve Insulin Production and Improve Glycemic Control in Patients Newly Diagnosed With Type 1 Diabetes

Diamyd Medical AB

NCT05018585

ACTIVE NOT RECRUITING NA 120 participants

Safety and Effectiveness of the Luna System in People With Type 1 Diabetes Mellitus

Luna Diabetes

NCT06627517

ACTIVE NOT RECRUITING Phase 2 84 participants

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

Sanofi

NCT06812988

ACTIVE NOT RECRUITING Phase 2 78 participants

Triple Therapy in T1DM

State University of New York at Buffalo

NCT03899402

ACTIVE NOT RECRUITING Phase 2 74 participants

Rituximab-pvvr and Abatacept vs Rituximab-pvvr Alone in New Onset Type 1 Diabetes

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NCT03929601

ACTIVE NOT RECRUITING Phase 2 60 participants

Reducing Innate Inflammation in New Onset Type 1 Diabetes

Medical College of Wisconsin

NCT04335656

ACTIVE NOT RECRUITING Phase 2 43 participants

Probiotics in Newly Diagnosed T1D

Medical College of Wisconsin

NCT04141761

ACTIVE NOT RECRUITING NA 40 participants

Impact of Metabolic Health on Sperm Epigenetic Marks in Humans

Joslin Diabetes Center

NCT03860558

ACTIVE NOT RECRUITING Phase 3 21 participants

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

CellTrans

NCT00679042

ACTIVE NOT RECRUITING Phase 1 17 participants

A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation

Sernova Biotherapeutics

NCT03513939

ACTIVE NOT RECRUITING Phase 2 10 participants

Islet Cell Transplant for Type 1 Diabetes

City of Hope Medical Center

NCT01909245

ACTIVE NOT RECRUITING Phase 1 6 participants

An Immunotherapy Vaccine (PIpepTolDC) for the Treatment of Patients With Type 1 Diabetes

City of Hope Medical Center

NCT04590872

COMPLETED Phase 3 1,392 participants

A Study of LY900014 in Participants With Type 1 Diabetes

Eli Lilly and Company

NCT03214367

COMPLETED 1,297 participants

An Observational Study Evaluating SYMLIN® (Pramlintide Acetate) Injection Use in Insulin Using Patients With Type 2 and Type 1 Diabetes

AstraZeneca

NCT00229658

COMPLETED Phase 2 554 participants

The Protégé Study - Clinical Trial of MGA031 in Children and Adults With Recent-Onset Type 1 Diabetes Mellitus

MacroGenics

NCT00385697

COMPLETED Phase 3 549 participants

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Sanofi

NCT01683266

COMPLETED Phase 3 518 participants

Clinical Trial Evaluating Technosphere® Insulin Versus Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Over a 24-week Treatment Period

Mannkind Corporation

NCT01445951

COMPLETED Phase 4 456 participants

CONSISTENT 1: Metabolic and Safety Outcomes of Hylenex Recombinant (Hyaluronidase Human Injection) Preadministered at CSII Infusion Site in Participants With Type 1 Diabetes Mellitus (T1DM)

Halozyme Therapeutics

NCT01848990

COMPLETED NA 400 participants

Positive Psychology Intervention to Treat Diabetes Distress in Teens With Type 1 Diabetes

Vanderbilt University Medical Center

NCT03845465

COMPLETED Phase 3 328 participants

Recent-Onset Type 1 Diabetes Trial Evaluating Efficacy and Safety of Teplizumab

Provention Bio

NCT03875729

COMPLETED NA 317 participants

Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics

Medtronic Diabetes

NCT04436822

COMPLETED Phase 3 241 participants

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

Bayer

NCT05901831

COMPLETED NA 168 participants

Technological Advances in Glucose Management in Older Adults

Joslin Diabetes Center

NCT03078491

COMPLETED NA 153 participants

Shared Medical Decision Making in Pediatric Diabetes

Nemours Children's Clinic

NCT02496156

COMPLETED NA 149 participants

Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)

Wayne State University

NCT03168867

COMPLETED Phase 2 136 participants

Tocilizumab (TCZ) in New-onset Type 1 Diabetes

National Institute of Allergy and Infectious Diseases (NIAID)

NCT02293837

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Phase Distribution

PhaseTrial count
Phase 1 19
Phase 2 16
Phase 3 14
Phase 4 5

Source: ClinicalTrials.gov, National Library of Medicine. Data is informational only.

Reading the Type 1 Diabetes Mellitus Trial Landscape

106 indexed Type 1 Diabetes Mellitus studies · 23 recruiting (22%).

Phase mix: 19 late (III/IV) vs 35 early (I/II).

Top sponsor: University of Virginia (8 trials), 9 others listed. 50 shown below, recruiting first.

How to read this condition's trial landscape

That ratio is a useful proxy for activity level: a high share of recruiting studies often signals that research interest is current and that new enrollment opportunities are appearing, while a low share typically means the field is dominated by completed or follow-up work where most participant spots have already been filled. These counts reflect the public registry only and include studies at every stage of design, so they should be read as an index of research attention rather than as a measure of treatment availability.

Phase 1 and Phase 2 studies focus on early safety signals, dosing, and preliminary effect, while Phase 3 studies are typically the larger efficacy and safety trials submitted toward regulatory review, and Phase 4 studies follow approved interventions in real-world use. A condition weighted toward later phases often reflects a mature research pipeline with several interventions already close to or past approval, whereas a heavier early-phase tilt suggests the field is still exploring new mechanisms and candidate approaches.

All figures are derived from the public ClinicalTrials.gov dataset maintained by the National Library of Medicine and are reproduced here for reference. Inclusion of a trial, sponsor, or intervention on this page is neither an endorsement nor a recommendation, eligibility, protocol changes, and site-level status can shift frequently, so always verify current details on ClinicalTrials.gov and consult a qualified healthcare provider before acting on anything you see here.

Frequently Asked Questions

How many clinical trials are there for Type 1 Diabetes Mellitus?

PlainTrial tracks 106 US clinical trials for Type 1 Diabetes Mellitus, of which 23 are currently recruiting participants. Data sourced from ClinicalTrials.gov.

How do I find a recruiting trial for Type 1 Diabetes Mellitus?

Use the trial list above filtered by "Recruiting" status, or visit our trial finder at /recruiting to search by condition and state. Always discuss trial participation with your healthcare provider before enrolling.

Is this data current?

Data is sourced from ClinicalTrials.gov and reflects our most recent data pull. Trial status may have changed since then. Always verify current information at ClinicalTrials.gov before making decisions about participation.

Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Data is sourced from ClinicalTrials.gov (National Library of Medicine). Consult a qualified professional before making decisions based on this data.

Source: ClinicalTrials.gov (NIH/NLM) ClinicalTrials.gov AACT registry · 2026 Trial counts and statuses sourced from ClinicalTrials.gov. Sponsor counts include both industry and federal/academic sponsors.

Verify with NIH →

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page aggregates every registered trial for this condition, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.