Evidence map›Paper›PMID 41535597›Full record

Observational studyDiabetologia2026

Teplizumab treatment for stage 2 type 1 diabetes: a real-world evaluation of metabolic and immunological outcomes.

Kagan E Karakus, Lexie Chesshir, Sonya Walker, Erin E Baschal, Kristen A McDaniel, Taylor M Triolo, Andrea K Steck, Brigitte I Frohnert, Peter A Gottlieb, Aaron W Michels and 1 more

Abstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Diabetologia, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Kagan E KarakusBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.ORCID http://orcid.org/0000-0002-8552-5206
Lexie ChesshirBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Sonya WalkerBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Erin E BaschalBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Kristen A McDanielBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Taylor M TrioloBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Andrea K SteckBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Brigitte I FrohnertBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Peter A GottliebBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.
Aaron W MichelsBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA.ORCID http://orcid.org/0000-0003-3766-5244
Kimber M SimmonsBarbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO, USA. Kimber.simmons@cuanschutz.edu.ORCID http://orcid.org/0000-0003-0560-5773

Funding

Division of Diabetes, Endocrinology, and Metabolic Diseases DK032083Division of Diabetes, Endocrinology, and Metabolic Diseases DK099317Division of Diabetes, Endocrinology, and Metabolic Diseases DK108868Division of Diabetes, Endocrinology, and Metabolic Diseases DK116073Leona M. and Harry B. Helmsley Charitable Trust 2101-04969
6 · The paper itself

Abstract

aims/hypothesisThis is the first real-world prospective observational study of teplizumab use following approval by the United States Food and Drug Administration in individuals with stage 2 type 1 diabetes. We examined whether glycaemic responses observed in controlled trials were reproduced in real-world practice and explored immunological biomarkers associated with treatment.

methodsChildren and adults with stage 2 type 1 diabetes were prospectively followed in the Early Type 1 Diabetes Clinic at the Barbara Davis Center. Individuals who received teplizumab between April 2023 and February 2025 (n=30) were compared with an untreated group (n=10). Key assessments included OGTTs, HbA

resultsAmong treated individuals followed up between 2 and 6 months after treatment, OGTT 2 h glucose improved (10.7 ± 2.1 to 8.8 ± 2.8 mmol/l, p=0.007), as did HbA CONCLUSIONS/

interpretationTeplizumab can be safely and effectively administered in clinical practice. Early glycaemic improvements and reductions in CD4 preproinsulin-specific TCRs suggest that post-treatment immunological changes may serve as biomarkers to guide early-stage intervention.

Indexed as

Antibodies, Monoclonal, HumanizedDiabetes Mellitus, Type 1Hypoglycemic AgentsAdolescentAdultBlood GlucoseChildContinuous Glucose MonitoringC-PeptideFemaleGlucose Tolerance TestGlycated HemoglobinHerpesvirus 4, HumanHumansMaleProspective StudiesAntibodies, Monoclonal, HumanizedBlood GlucoseC-PeptideGlycated HemoglobinHypoglycemic AgentsteplizumabCGMC-peptideOGTTReal-worldT cell receptorTeplizumabType 1 diabetes

Identifiers

PMID41535597
PMCPMC13005873

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.